{ "article": { "LEGIARTI000025378819": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5161-1", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2012-02-20" } }, "META_COMMUN": { "ID": "LEGIARTI000025378819", "URL": "article/LEGI/ARTI/00/00/25/37/88/LEGIARTI000025378819.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000025378223", "@num": "4", "#text": "Décret n°2012-232\n du 17 février 2012 - art. 4", "@sens": "cible", "@cidtexte": "JORFTEXT000025377246", "@nortexte": "DEVP1123456D", "@numtexte": "2012-232", "@typelien": "CREE", "@naturetexte": "DECRET", "@datesignatexte": "2012-02-17" }, { "@id": "LEGIARTI000006690187", "@num": "L5141-1", "#text": "Code de la santé publique - art. L5141-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690188", "@num": "L5141-2", "#text": "Code de la santé publique - art. L5141-2", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690344", "@num": "L5311-1", "#text": "Code de la santé publique - art. L5311-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025378597", "@num": "R523-12", "#text": "Code de l'environnement - art. R523-12", "@sens": "source", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000025378805", "@fin": "2999-01-01", "#text": "Titre VI : Produits de santé concernant des substances à l'état nanoparticulaire", "@debut": "2012-02-20" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000025378819", "@fin": "2999-01-01", "@num": "R5161-1", "@etat": "VIGUEUR", "@debut": "2012-02-20", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Les articles R. 523-12 à R. 523-21 du code de l'environnement s'appliquent aux substances à l'état nanoparticulaire entrant dans la composition des produits à finalité sanitaire destinés à l'homme, des produits à finalité cosmétique mentionnés à l'article L. 5311-1 ainsi qu'aux médicaments vétérinaires mentionnés aux articles L. 5141-1 et L. 5141-2.

" } }, "LEGIARTI000006690187": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5141-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2022-03-25", "DATE_DEBUT": "2000-06-22" } }, "META_COMMUN": { "ID": "LEGIARTI000006690187", "URL": "article/LEGI/ARTI/00/00/06/69/01/LEGIARTI000006690187.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5141L01XXAA" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006630983", "@num": "1", "#text": "Décret n°81-278 du 25 mars 1981 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000503017", "@numtexte": "81-278", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1981-03-25" }, { "@id": "LEGIARTI000006631025", "@num": "Annexe I", "#text": "Décret n°81-278 du 25 mars 1981 - art. Annexe I (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000503017", "@numtexte": "81-278", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1981-03-25" }, { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000006228008", "@num": "1", "#text": "Arrêté du 15 janvier 2004 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000415652", "@nortexte": "SANP0420224A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2004-01-15" }, { "@id": "LEGIARTI000025860019", "@num": "1", "#text": "Arrêté du 30 juillet 2004 - art. 1 (VT)", "@sens": "cible", "@cidtexte": "JORFTEXT000000806957", "@nortexte": "SANP0422322A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2004-07-30" }, { "@id": "LEGIARTI000006734074", "@num": "ANNEXE", "#text": "Arrêté du 21 avril 2005 - art. ANNEXE (VT)", "@sens": "cible", "@cidtexte": "JORFTEXT000000627974", "@nortexte": "SANP0521551A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2005-04-21" }, { "@id": "LEGIARTI000006697048", "@num": "39", "#text": "Loi n°2007-248 du 26 février 2007 - art. 39 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000613381", "@nortexte": "SANX0600004L", "@numtexte": "2007-248", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2007-02-26" }, { "@id": "LEGIARTI000018650932", "@num": "2", "#text": "LOI n°2008-337\n du 15 avril 2008 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000018649718", "@nortexte": "SJSX0755912L", "@numtexte": "2008-337", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2008-04-15" }, { "@id": "LEGIARTI000025882873", "@num": "1", "#text": "Arrêté du 24 avril 2012 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025837104", "@nortexte": "ETSP1221693A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-04-24" }, { "@id": "LEGIARTI000033202304", "#text": "Arrêté du 29 août 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027910341", "@nortexte": "PROI1311061A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-08-29" }, { "@id": "LEGITEXT000043543262", "#text": "Décret n°2021-662 du 26 mai 2021 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043541690", "@nortexte": "ECOI2106880D", "@numtexte": "2021-662", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-05-26" }, { "@id": "LEGIARTI000043543283", "#text": "Décret n°2021-662 du 26 mai 2021 - art.", "@sens": "cible", "@cidtexte": "JORFTEXT000043541690", "@nortexte": "ECOI2106880D", "@numtexte": "2021-662", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-05-26" }, { "@id": "LEGIARTI000043545974", "@num": "Annexe I à l'article D523-8", "#text": "Code de l'environnement - art. Annexe I à l'article D523-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000027912149", "@num": "D523-8", "#text": "Code de l'environnement - art. D523-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000046871815", "@num": "L521-2", "#text": "Code de l'environnement - art. L521-2 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033642702", "@num": "D6141-42", "#text": "Code de la santé publique - art. D6141-42 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689866", "@num": "L5111-1", "#text": "Code de la santé publique - art. L5111-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689868", "@num": "L5111-2", "#text": "Code de la santé publique - art. L5111-2 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000047291490", "@num": "L5141-16", "#text": "Code de la santé publique - art. L5141-16 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045405162", "@num": "L5142-4", "#text": "Code de la santé publique - art. L5142-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045405779", "@num": "L5150-1", "#text": "Code de la santé publique - art. L5150-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045405438", "@num": "L5441-6", "#text": "Code de la santé publique - art. L5441-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000047293552", "@num": "L5521-7", "#text": "Code de la santé publique - art. L5521-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693773", "@num": "L606", "#text": "Code de la santé publique - art. L606 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693773", "@num": "L606", "#text": "Code de la santé publique - art. L606 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033627212", "@num": "R1340-10", "#text": "Code de la santé publique - art. R1340-10 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033627238", "@num": "R1340-11", "#text": "Code de la santé publique - art. R1340-11 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033627266", "@num": "R1340-12", "#text": "Code de la santé publique - art. R1340-12 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033627093", "@num": "R1340-8", "#text": "Code de la santé publique - art. R1340-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028617383", "@num": "R1341-12", "#text": "Code de la santé publique - art. R1341-12 (T)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028617377", "@num": "R1341-13", "#text": "Code de la santé publique - art. R1341-13 (T)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028617371", "@num": "R1341-14", "#text": "Code de la santé publique - art. R1341-14 (T)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028603774", "@num": "R1341-30", "#text": "Code de la santé publique - art. R1341-30 (T)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000031443661", "@num": "R1342-19", "#text": "Code de la santé publique - art. R1342-19 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025378819", "@num": "R5161-1", "#text": "Code de la santé publique - art. R5161-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006582512", "@num": "L227-2", "#text": "Code rural - art. L227-2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006071367", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006586350", "@num": "L927-1", "#text": "Code rural - art. L927-1 (T)", "@sens": "cible", "@cidtexte": "LEGITEXT000006071367", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006586351", "@num": "L927-2", "#text": "Code rural - art. L927-2 (T)", "@sens": "cible", "@cidtexte": "LEGITEXT000006071367", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006587786", "@num": "R203-1", "#text": "Code rural - art. R203-1 (T)", "@sens": "cible", "@cidtexte": "LEGITEXT000006071367", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045405665", "@num": "L227-1", "#text": "Code rural et de la pêche maritime - art. L227-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006071367", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000035415194", "@num": "R202-35", "#text": "Code rural et de la pêche maritime - art. R202-35 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006071367", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171385", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155087", "@fin": "2999-01-01", "#text": "Titre IV : Médicaments vétérinaires", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140630", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690187", "@fin": "2022-03-25", "@num": "L5141-1", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000045405083", "@fin": "2999-01-01", "@num": "L5141-1", "@etat": "VIGUEUR", "@debut": "2022-03-25", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
On entend par médicament vétérinaire, tout médicament destiné à l'animal tel que défini à l'article L. 5111-1.
\n
On entend par spécialité pharmaceutique vétérinaire, toute spécialité pharmaceutique telle que définie à l'article L. 5111-2 et destinée à l'animal.
" } }, "LEGIARTI000006690188": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5141-2", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2007-04-27", "DATE_DEBUT": "2000-06-22" } }, "META_COMMUN": { "ID": "LEGIARTI000006690188", "URL": "article/LEGI/ARTI/00/00/06/69/01/LEGIARTI000006690188.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5141L02XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006207056", "@num": "1", "#text": "Arrêté du 18 décembre 2001 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000215293", "@nortexte": "AGRG0102675A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2001-12-18" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000006209506", "@num": "1", "#text": "Arrêté du 7 mars 2002 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000217836", "@nortexte": "AGRG0200239A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2002-03-07" }, { "@id": "LEGITEXT000005764961", "#text": "Arrêté du 2 décembre 2003", "@sens": "cible", "@cidtexte": "JORFTEXT000000798573", "@nortexte": "AGRG0302575A", "@typelien": "TXT_SOURCE", "@naturetexte": "ARRETE", "@datesignatexte": "2003-12-02" }, { "@id": "LEGIARTI000006227830", "@num": "1", "#text": "Arrêté du 2 décembre 2003 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000798573", "@nortexte": "AGRG0302575A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2003-12-02" }, { "@id": "LEGIARTI000006227830", "@num": "1", "#text": "Arrêté du 2 décembre 2003 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000798573", "@nortexte": "AGRG0302575A", "@typelien": "TXT_SOURCE", "@naturetexte": "ARRETE", "@datesignatexte": "2003-12-02" }, { "@id": "LEGIARTI000006227831", "@num": "2", "#text": "Arrêté du 2 décembre 2003 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000798573", "@nortexte": "AGRG0302575A", "@typelien": "TXT_SOURCE", "@naturetexte": "ARRETE", "@datesignatexte": "2003-12-02" }, { "@id": "LEGIARTI000006733878", "@num": "ANNEXE", "#text": "Arrêté du 9 juin 2004 - art. ANNEXE (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000255672", "@nortexte": "SANP0422019A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2004-06-09" }, { "@id": "LEGIARTI000006734074", "@num": "ANNEXE", "#text": "Arrêté du 21 avril 2005 - art. ANNEXE (VT)", "@sens": "cible", "@cidtexte": "JORFTEXT000000627974", "@nortexte": "SANP0521551A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2005-04-21" }, { "@id": "LEGIARTI000019279088", "@num": "12", "#text": "LOI n°2008-757\n du 1er août 2008 - art. 12 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019277729", "@nortexte": "DEVX0700028L", "@numtexte": "2008-757", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2008-08-01" }, { "@id": "LEGIARTI000025882819", "#text": "Arrêté du 1er septembre 2009 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000021021310", "@nortexte": "SASP0920309A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-09-01" }, { "@id": "LEGIARTI000033960696", "@num": "1", "#text": "Arrêté du 14 novembre 2016 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033956149", "@nortexte": "AGRG1634102A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-11-14" }, { "@id": "LEGIARTI000006689866", "@num": "L5111-1", "#text": "Code de la santé publique - art. L5111-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690218", "@num": "L5141-11", "#text": "Code de la santé publique - art. L5141-11 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690225", "@num": "L5141-15", "#text": "Code de la santé publique - art. L5141-15 (T)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000047291490", "@num": "L5141-16", "#text": "Code de la santé publique - art. L5141-16 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021666229", "@num": "L5141-5-3", "#text": "Code de la santé publique - art. L5141-5-3 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021941917", "@num": "L5141-5-4", "#text": "Code de la santé publique - art. L5141-5-4 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045405162", "@num": "L5142-4", "#text": "Code de la santé publique - art. L5142-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045405438", "@num": "L5441-6", "#text": "Code de la santé publique - art. L5441-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693777", "@num": "L607", "#text": "Code de la santé publique - art. L607 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693774", "@num": "L607", "#text": "Code de la santé publique - art. L607 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033642625", "@num": "R1341-10", "#text": "Code de la santé publique - art. R1341-10 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043335118", "@num": "R1342-20", "#text": "Code de la santé publique - art. R1342-20 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915228", "@num": "R5125-46", "#text": "Code de la santé publique - art. R5125-46 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000022292440", "@num": "R5141-141", "#text": "Code de la santé publique - art. R5141-141 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018776012", "@num": "R5141-19", "#text": "Code de la santé publique - art. R5141-19 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916131", "@num": "R5142-45", "#text": "Code de la santé publique - art. R5142-45 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800687", "@num": "R5145-37", "#text": "Code de la santé publique - art. R5145-37 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025378819", "@num": "R5161-1", "#text": "Code de la santé publique - art. R5161-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171385", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155087", "@fin": "2999-01-01", "#text": "Titre IV : Médicaments vétérinaires", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140630", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690188", "@fin": "2007-04-27", "@num": "L5141-2", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690189", "@fin": "2009-02-28", "@num": "L5141-2", "@etat": "MODIFIE", "@debut": "2007-04-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000020317411", "@fin": "2010-02-26", "@num": "L5141-2", "@etat": "MODIFIE", "@debut": "2009-02-28", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000021941924", "@fin": "2011-06-18", "@num": "L5141-2", "@etat": "MODIFIE", "@debut": "2010-02-26", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000024198071", "@fin": "2022-03-25", "@num": "L5141-2", "@etat": "MODIFIE", "@debut": "2011-06-18", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000045405073", "@fin": "2999-01-01", "@num": "L5141-2", "@etat": "VIGUEUR", "@debut": "2022-03-25", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
On entend par :
\n
1° Médicament vétérinaire préfabriqué, tout médicament vétérinaire préparé à l'avance, présenté sous une forme pharmaceutique utilisable sans transformation ;
\n
2° Médicament vétérinaire immunologique, tout médicament vétérinaire administré en vue de provoquer une immunité active ou passive ou de diagnostiquer l'état d'immunité ;
\n
3° Autovaccin à usage vétérinaire, tout médicament vétérinaire immunologique fabriqué en vue de provoquer une immunité active à partir d'organismes pathogènes provenant d'un animal ou d'animaux d'un même élevage, inactivés et utilisés pour le traitement de cet animal ou des animaux de cet élevage ;
\n
4° Prémélange médicamenteux, tout médicament vétérinaire préparé à l'avance et exclusivement destiné à la fabrication ultérieure d'aliments médicamenteux ;
\n
5° Aliment médicamenteux, tout médicament vétérinaire constitué à partir d'un mélange d'aliment et de prémélange médicamenteux, présenté pour être administré aux animaux sans transformation dans un but thérapeutique, préventif ou curatif, au sens de l'alinéa premier de l'article L. 5111-1 ;
\n
6° Médicament vétérinaire antiparasitaire, tout produit antiparasitaire à usage vétérinaire ;
\n
7° Médicament homéopathique vétérinaire, tout médicament vétérinaire obtenu à partir de produits, substances ou compositions appelés souches homéopathiques, selon un procédé de fabrication homéopathique décrit par la pharmacopée européenne, la pharmacopée française ou, à défaut, par les pharmacopées utilisées de façon officielle dans un autre Etat membre de la Communauté européenne ; un médicament homéopathique vétérinaire peut aussi contenir plusieurs principes.
" } }, "LEGIARTI000006690189": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5141-2", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2009-02-28", "DATE_DEBUT": "2007-04-27" } }, "META_COMMUN": { "ID": "LEGIARTI000006690189", "URL": "article/LEGI/ARTI/00/00/06/69/01/LEGIARTI000006690189.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5141L02XXAB" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006207056", "@num": "1", "#text": "Arrêté du 18 décembre 2001 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000215293", "@nortexte": "AGRG0102675A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2001-12-18" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000006209506", "@num": "1", "#text": "Arrêté du 7 mars 2002 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000217836", "@nortexte": "AGRG0200239A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2002-03-07" }, { "@id": "LEGITEXT000005764961", "#text": "Arrêté du 2 décembre 2003", "@sens": "cible", "@cidtexte": "JORFTEXT000000798573", "@nortexte": "AGRG0302575A", "@typelien": "TXT_SOURCE", "@naturetexte": "ARRETE", "@datesignatexte": "2003-12-02" }, { "@id": "LEGIARTI000006227830", "@num": "1", "#text": "Arrêté du 2 décembre 2003 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000798573", "@nortexte": "AGRG0302575A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2003-12-02" }, { "@id": "LEGIARTI000006227830", "@num": "1", "#text": "Arrêté du 2 décembre 2003 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000798573", "@nortexte": "AGRG0302575A", "@typelien": "TXT_SOURCE", "@naturetexte": "ARRETE", "@datesignatexte": "2003-12-02" }, { "@id": "LEGIARTI000006227831", "@num": "2", "#text": "Arrêté du 2 décembre 2003 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000798573", "@nortexte": "AGRG0302575A", "@typelien": "TXT_SOURCE", "@naturetexte": "ARRETE", "@datesignatexte": "2003-12-02" }, { "@id": "LEGIARTI000006733878", "@num": "ANNEXE", "#text": "Arrêté du 9 juin 2004 - art. ANNEXE (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000255672", "@nortexte": "SANP0422019A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2004-06-09" }, { "@id": "LEGIARTI000006734074", "@num": "ANNEXE", "#text": "Arrêté du 21 avril 2005 - art. ANNEXE (VT)", "@sens": "cible", "@cidtexte": "JORFTEXT000000627974", "@nortexte": "SANP0521551A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2005-04-21" }, { "@id": "LEGIARTI000006698447", "@num": "29", "#text": "Ordonnance n°2007-613 du 26 avril 2007 - art. 29 () JORF 27 avril 2007", "@sens": "source", "@cidtexte": "JORFTEXT000000646989", "@nortexte": "SANX0700046R", "@numtexte": "2007-613", "@typelien": "MODIFICATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2007-04-26" }, { "@id": "LEGIARTI000019279088", "@num": "12", "#text": "LOI n°2008-757\n du 1er août 2008 - art. 12 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019277729", "@nortexte": "DEVX0700028L", "@numtexte": "2008-757", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2008-08-01" }, { "@id": "LEGIARTI000025882819", "#text": "Arrêté du 1er septembre 2009 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000021021310", "@nortexte": "SASP0920309A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-09-01" }, { "@id": "LEGIARTI000033960696", "@num": "1", "#text": "Arrêté du 14 novembre 2016 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033956149", "@nortexte": "AGRG1634102A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-11-14" }, { "@id": "LEGIARTI000006279394", "@num": "L611-2", "#text": "Code de la propriété intellectuelle - art. L611-2 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006069414", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689866", "@num": "L5111-1", "#text": "Code de la santé publique - art. L5111-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690218", "@num": "L5141-11", "#text": "Code de la santé publique - art. L5141-11 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690225", "@num": "L5141-15", "#text": "Code de la santé publique - art. L5141-15 (T)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000047291490", "@num": "L5141-16", "#text": "Code de la santé publique - art. L5141-16 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021666229", "@num": "L5141-5-3", "#text": "Code de la santé publique - art. L5141-5-3 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021941917", "@num": "L5141-5-4", "#text": "Code de la santé publique - art. L5141-5-4 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045405162", "@num": "L5142-4", "#text": "Code de la santé publique - art. L5142-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045405438", "@num": "L5441-6", "#text": "Code de la santé publique - art. L5441-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693777", "@num": "L607", "#text": "Code de la santé publique - art. L607 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693774", "@num": "L607", "#text": "Code de la santé publique - art. L607 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033642625", "@num": "R1341-10", "#text": "Code de la santé publique - art. 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On entend par :

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1° (Abrogé) ;

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2° Médicament vétérinaire immunologique, tout médicament vétérinaire administré en vue de provoquer une immunité active ou passive ou de diagnostiquer l'état d'immunité, ou tout allergène, défini comme tout produit destiné à identifier ou à provoquer une modification spécifique et acquise de la réponse immunologique à un agent allergisant ;

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3° Autovaccin à usage vétérinaire, tout médicament vétérinaire immunologique fabriqué en vue de provoquer une immunité active à partir d'organismes pathogènes provenant d'un animal ou d'animaux d'un même élevage, inactivés et utilisés pour le traitement de cet animal ou des animaux de cet élevage ;

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4° Prémélange médicamenteux, tout médicament vétérinaire préparé à l'avance et exclusivement destiné à la fabrication ultérieure d'aliments médicamenteux ;

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5° Aliment médicamenteux, tout médicament vétérinaire constitué à partir d'un mélange d'aliment et de prémélange médicamenteux, présenté pour être administré aux animaux sans transformation dans un but thérapeutique, préventif ou curatif, au sens de l'alinéa premier de l'article L. 5111-1 ;

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6° Médicament vétérinaire antiparasitaire, tout produit antiparasitaire à usage vétérinaire ;

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7° Médicament homéopathique vétérinaire, tout médicament vétérinaire obtenu à partir de substances appelées, souches homéopathiques, selon un procédé de fabrication homéopathique décrit par la pharmacopée européenne, la pharmacopée française ou, à défaut, par les pharmacopées utilisées de façon officielle dans un autre Etat membre de la Communauté européenne ; un médicament homéopathique vétérinaire peut aussi contenir plusieurs principes ;

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8° Médicament générique vétérinaire, tout médicament vétérinaire qui, sans préjudice des dispositions des articles L. 611-2 et suivants du code de la propriété intellectuelle, a la même composition qualitative et quantitative en principes actifs et la même forme pharmaceutique qu'un médicament vétérinaire dit de référence et dont la bioéquivalence avec le médicament de référence est démontrée par des études de biodisponibilité appropriées. Un médicament vétérinaire ne peut être qualifié de médicament de référence que si son autorisation de mise sur le marché a été délivrée au vu d'un dossier comportant, dans des conditions fixées par voie réglementaire, l'ensemble des données nécessaires et suffisantes à elles seules pour son évaluation. Pour l'application du présent alinéa, les différentes formes pharmaceutiques orales à libération immédiate sont considérées comme une même forme pharmaceutique. De même, les différents sels, esters, éthers, isomères, mélanges d'isomères, complexes ou dérivés d'un principe actif sont regardés comme ayant la même composition qualitative en principe actif, sauf s'ils présentent des propriétés sensiblement différentes au regard de la sécurité ou de l'efficacité. Dans ce cas, des informations supplémentaires fournissant la preuve de la sécurité et de l'efficacité des différents sels, esters ou dérivés d'une substance active autorisée doivent être données par le demandeur de l'autorisation de mise sur le marché ;

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9° Médicament biologique vétérinaire, tout médicament vétérinaire dont la substance active est produite à partir d'une source biologique ou en est extraite et dont la caractérisation et la détermination de la qualité nécessitent une combinaison d'essais physiques, chimiques et biologiques ainsi que la connaissance de son procédé de fabrication et de contrôle ;

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10° Médicament biologique vétérinaire similaire, tout médicament biologique vétérinaire qui, sans préjudice des dispositions des articles L. 611-2 et suivants du code de la propriété intellectuelle, a la même composition qualitative et quantitative en substance active et la même forme pharmaceutique qu'un médicament vétérinaire biologique de référence mais qui ne remplit pas les conditions prévues au 8° du présent article pour être regardé comme un médicament générique vétérinaire en raison de différences liées notamment à la variabilité de la matière première ou aux procédés de fabrication et nécessitant que soient produites des données précliniques et cliniques supplémentaires dans des conditions déterminées par voie réglementaire ;

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11° Préparation extemporanée vétérinaire, tout médicament vétérinaire qui est préparé au moment de son utilisation ;

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12° Préparation magistrale vétérinaire, toute préparation extemporanée vétérinaire réalisée selon une prescription destinée à un animal ou à des animaux d'une même exploitation ;

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13° Préparation officinale vétérinaire, tout médicament vétérinaire préparé en pharmacie inscrit à la pharmacopée ou au formulaire national et destiné à être délivré directement à l'utilisateur final ;

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14° Temps d'attente, la période nécessaire entre la dernière administration du médicament vétérinaire à l'animal dans les conditions normales d'emploi et l'obtention des denrées alimentaires provenant de cet animal, afin de protéger la santé publique, en garantissant que de telles denrées alimentaires ne contiennent pas de résidus en quantités supérieures aux limites maximales de résidus des substances pharmacologiquement actives, telles que fixées en vertu du règlement du Conseil (CEE) n° 2377/90 du 26 juin 1990 modifié établissant une procédure communautaire pour la fixation des limites maximales de résidus de médicaments vétérinaires dans les aliments d'origine animale.

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" } }, "LEGIARTI000006690344": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5311-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2001-03-03", "DATE_DEBUT": "2000-06-22" } }, "META_COMMUN": { "ID": "LEGIARTI000006690344", "URL": "article/LEGI/ARTI/00/00/06/69/03/LEGIARTI000006690344.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5311L01XXAA" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006630983", "@num": "1", "#text": "Décret n°81-278 du 25 mars 1981 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000503017", "@numtexte": "81-278", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1981-03-25" }, { "@id": "LEGIARTI000006631025", "@num": "Annexe I", "#text": "Décret n°81-278 du 25 mars 1981 - art. Annexe I (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000503017", "@numtexte": "81-278", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1981-03-25" }, { "@id": "LEGIARTI000035606736", "@num": "2-1", "#text": "Décret n°90-975 du 30 octobre 1990 - art. 2-1 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000000160314", "@nortexte": "SPSG9001546D", "@numtexte": "90-975", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1990-10-30" }, { "@id": "LEGIARTI000006712582", "@num": "2", "#text": "Décret n°92-1432 du 30 décembre 1992 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000726011", "@nortexte": "SPSG9202710D", "@numtexte": "92-1432", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1992-12-30" }, { "@id": "LEGIARTI000006355280", "@num": "87", "#text": "Loi n°93-122 du 29 janvier 1993 - art. 87 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000711604", "@nortexte": "PRMX9200148L", "@numtexte": "93-122", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "1993-01-29" }, { "@id": "LEGIARTI000006865783", "@num": "Annexe", "#text": "Décret n°96-850 du 20 septembre 1996 - art. Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000195660", "@nortexte": "ENVP9640024D", "@numtexte": "96-850", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1996-09-20" }, { "@id": "LEGIARTI000006506987", "@num": "3", "#text": "Décret n°98-385 du 18 mai 1998 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000571865", "@nortexte": "MESG9820693D", "@numtexte": "98-385", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1998-05-18" }, { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006724441", "@num": "5", "#text": "Décret n°2001-35 du 11 janvier 2001 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000388987", "@nortexte": "MJSK0070147D", "@numtexte": "2001-35", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2001-01-11" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000006254318", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254325", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639980", "@nortexte": "SANP0623382A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254307", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254319", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326653", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020320295", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326611", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254321", "@num": "4", "#text": "Arrêté du 16 août 2006 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254313", "@num": "7", "#text": "Arrêté du 16 août 2006 - art. 7 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006734099", "@num": "ANNEXE", "#text": "Arrêté du 16 août 2006 - art. ANNEXE (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639975", "@nortexte": "SANP0623370A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006255223", "@num": "1", "#text": "Arrêté du 11 septembre 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000271992", "@nortexte": "SANP0623792A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-09-11" }, { "@id": "LEGIARTI000020322856", "@num": "3", "#text": "Arrêté du 11 septembre 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000271992", "@nortexte": "SANP0623792A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-09-11" }, { "@id": "LEGIARTI000006697048", "@num": "39", "#text": "Loi n°2007-248 du 26 février 2007 - art. 39 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000613381", "@nortexte": "SANX0600004L", "@numtexte": "2007-248", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2007-02-26" }, { "@id": "LEGIARTI000006868630", "@num": "29", "#text": "Décret n° 2007-358 du 19 mars 2007 - art. 29 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000821090", "@nortexte": "AGRG0700644D", "@numtexte": "2007-358", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-19" }, { "@id": "LEGIARTI000006726837", "@num": "5", "#text": "Décret n°2007-462 du 25 mars 2007 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000466314", "@nortexte": "MJSK0770075D", "@numtexte": "2007-462", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-25" }, { "@id": "LEGIARTI000018361459", "@num": "Annexe", "#text": "Arrêté du 5 mars 2008 - art. Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000018360158", "@nortexte": "SJSP0805973A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-03-05" }, { "@id": "LEGIARTI000019382668", "@num": "2", "#text": "Arrêté du 11 août 2008 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019381783", "@nortexte": "SJSP0820319A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-08-11" }, { "@id": "LEGIARTI000034448482", "@num": "7", "#text": "Arrêté du 6 février 2009 - art. 7 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000020234297", "@nortexte": "SJSG0824493A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-06" }, { "@id": "LEGITEXT000020319418", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318429", "@nortexte": "SASP0904387A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319427", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318439", "@nortexte": "SASP0904427A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319436", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318449", "@nortexte": "SASP0904394A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGIARTI000021782780", "@num": "Annexe au règlement intérieur", "#text": "Arrêté du 13 janvier 2010 - art. Annexe au règlement intérieur (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000021782073", "@nortexte": "SASP1001133A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-01-13" }, { "@id": "LEGITEXT000022416787", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415149", "@nortexte": "SASP1017123A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416463", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415125", "@nortexte": "SASP1017105A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416472", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415141", "@nortexte": "SASP1017114A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGIARTI000023430029", "@num": "6", "#text": "Décret n°2011-57\n du 13 janvier 2011 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000023428330", "@nortexte": "SPOV1017553D", "@numtexte": "2011-57", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-01-13" }, { "@id": "LEGITEXT000023778069", "#text": "Arrêté du 17 mars 2011 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000023776935", "@nortexte": "ETSP1108041A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-03-17" }, { "@id": "LEGIARTI000025071143", "@num": "38", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 38 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000025071141", "@num": "39", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 39 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000026480621", "@num": "4", "#text": "Arrêté du 10 octobre 2012 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000026479723", "@nortexte": "AFSP1221372A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-10-10" }, { "@id": "LEGIARTI000027648252", "#text": "Arrêté du 23 janvier 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027047902", "@nortexte": "AFSP1228322A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-01-23" }, { "@id": "LEGITEXT000027434552", "#text": "Décret n°2013-414\n du 21 mai 2013 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027434029", "@nortexte": "AFSP1304115D", "@numtexte": "2013-414", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2013-05-21" }, { "@id": "LEGIARTI000027594512", "#text": "Arrêté du 20 juin 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027592947", "@nortexte": "AFSP1313848A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-20" }, { "@id": "LEGIARTI000027699119", "@num": "1", "#text": "Arrêté du 17 juin 2013 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027697076", "@nortexte": "AFSP1301854A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-17" }, { "@id": "LEGIARTI000033202304", "#text": "Arrêté du 29 août 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027910341", "@nortexte": "PROI1311061A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-08-29" }, { "@id": "LEGIARTI000035971526", "#text": "DÉCRET n°2014-1286 du 23 octobre 2014 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029675991", "@nortexte": "AFSX1419046D", "@numtexte": "2014-1286", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000036393921", "@num": "166", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 166 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000031916570", "@num": "169", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 169 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000043508038", "#text": "Arrêté du 28 novembre 2016 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033507693", "@nortexte": "AFSP1633477A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-11-28" }, { "@id": "LEGIARTI000033554483", "@num": "3", "#text": "Arrêté du 2 décembre 2016 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033553349", "@nortexte": "AFSP1635656A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000038887172", "@num": "2", "#text": "LOI n°2017-220 du 23 février 2017 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034078423", "@nortexte": "AFSP1622342L", "@numtexte": "2017-220", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2017-02-23" }, { "@id": "LEGIARTI000034152829", "@num": "1", "#text": "Arrêté du 27 février 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150863", "@nortexte": "AFSP1706243A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000035988048", "@num": "3", "#text": "Arrêté du 27 février 2017 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150842", "@nortexte": "AFSP1706241A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000035269375", "@num": "1", "#text": "Arrêté du 17 juillet 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000035268202", "@nortexte": "SSAE1720859A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-07-17" }, { "@id": "LEGITEXT000036406189", "#text": "Décret n°2017-1781 du 27 décembre 2017 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036299141", "@nortexte": "SSAP1728401D", "@numtexte": "2017-1781", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-12-27" }, { "@id": "LEGIARTI000038432466", "@num": "1", "#text": "Décret n°2019-389 du 30 avril 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000038431240", "@nortexte": "SSAS1906324D", "@numtexte": "2019-389", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-04-30" }, { "@id": "LEGITEXT000039664011", "#text": "Arrêté du 20 décembre 2019 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000039663324", "@nortexte": "SSAP1936730A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-12-20" }, { "@id": "LEGIARTI000041898595", "@num": "10-3-1", "#text": "Arrêté du 23 mars 2020 - art. 10-3-1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000042645749", "@num": "17", "#text": "Ordonnance n°2020-460 du 22 avril 2020 - art. 17 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041814597", "@nortexte": "ECOX2009794R", "@numtexte": "2020-460", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2020-04-22" }, { "@id": "LEGIARTI000041890409", "@num": "1", "#text": "Arrêté du 18 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041889362", "@nortexte": "SSAZ2011564A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-18" }, { "@id": "LEGIARTI000041898504", "@num": "1", "#text": "Arrêté du 20 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041897919", "@nortexte": "SSAZ2012596A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-20" }, { "@id": "LEGIARTI000043298218", "@num": "25", "#text": "Arrêté du 10 juillet 2020 - art. 25 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042609739", "@num": "26", "#text": "Arrêté du 10 juillet 2020 - art. 26 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000043103458", "#text": "Arrêté du 5 février 2021 - art. (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000043100729", "@nortexte": "SSAP2104251A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-02-05" }, { "@id": "LEGIARTI000043298491", "@num": "3", "#text": "Décret n°2021-331 du 26 mars 2021 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000043297285", "@nortexte": "SSAS2034156D", "@numtexte": "2021-331", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-03-26" }, { "@id": "LEGITEXT000043543262", "#text": "Décret n°2021-662 du 26 mai 2021 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043541690", "@nortexte": "ECOI2106880D", "@numtexte": "2021-662", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-05-26" }, { "@id": "LEGIARTI000043543283", "#text": "Décret n°2021-662 du 26 mai 2021 - art.", "@sens": "cible", "@cidtexte": "JORFTEXT000043541690", "@nortexte": "ECOI2106880D", "@numtexte": "2021-662", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-05-26" }, { "@id": "LEGIARTI000047779186", "@num": "25", "#text": "Arrêté du 1 juin 2021 - art. 25 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000043770220", "@num": "27", "#text": "Arrêté du 1er juin 2021 - art. 27 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000046567251", "@num": "Annexe 2", "#text": "Arrêté du 14 novembre 2022 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000046566303", "@nortexte": "SPRP2231874A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-11-14" }, { "@id": "LEGIARTI000049976728", "@num": "Annexe 1", "#text": "Arrêté du 14 novembre 2022 - art. Annexe 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000046566303", "@nortexte": "SPRP2231874A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-11-14" }, { "@id": "LEGIARTI000050409030", "#text": "Arrêté du 24 octobre 2024 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000050407232", "@nortexte": "MSAP2428789A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-10-24" }, { "@id": "LEGIARTI000050409032", "#text": "Arrêté du 24 octobre 2024 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000050407232", "@nortexte": "MSAP2428789A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-10-24" }, { "@id": "LEGIARTI000043545974", "@num": "Annexe I à l'article D523-8", "#text": "Code de l'environnement - art. Annexe I à l'article D523-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000027912149", "@num": "D523-8", "#text": "Code de l'environnement - art. D523-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000042654871", "@num": "L521-2", "#text": "Code de l'environnement - art. L521-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021666283", "@num": "L531-3", "#text": "Code de l'environnement - art. L531-3 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028749087", "@num": "L221-10", "#text": "Code de la consommation - art. L221-10 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069565", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000041985451", "@num": "L511-22", "#text": "Code de la consommation - art. L511-22 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069565", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000046012786", "@num": "R422-1", "#text": "Code de la consommation - art. R422-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069565", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006574178", "@num": "R*1142-25", "#text": "Code de la défense. - art. R*1142-25 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006071307", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006574182", "@num": "R*1142-29", "#text": "Code de la défense. - art. R*1142-29 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006071307", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049599041", "@num": "D1413-58", "#text": "Code de la santé publique - art. D1413-58 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033642702", "@num": "D6141-42", "#text": "Code de la santé publique - art. 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L'Agence française de sécurité sanitaire des produits de santé est un établissement public de l'Etat, placé sous la tutelle du ministre chargé de la santé.
\n
L'agence participe à l'application des lois et règlements relatifs à l'évaluation, aux essais, à la fabrication, à la préparation, à l'importation, à l'exportation, à la distribution en gros, au conditionnement, à la conservation, à l'exploitation, à la mise sur le marché, à la publicité, à la mise en service ou à l'utilisation des produits à finalité sanitaire destinés à l'homme et des produits à finalité cosmétique, et notamment :
\n
l° Les médicaments, y compris les préparations magistrales, hospitalières et officinales, les substances stupéfiantes, psychotropes ou autres substances vénéneuses utilisées en médecine, les huiles essentielles et plantes médicinales, les matières premières à usage pharmaceutique ;
\n
2° Les produits contraceptifs et contragestifs ;
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3° Les biomatériaux et les dispositifs médicaux ;
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4° Les dispositifs médicaux de diagnostic in vitro ;
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5° Les produits sanguins labiles ;
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6° Les organes, tissus, cellules et produits d'origine humaine ou animale, y compris lorsqu'ils sont prélevés à l'occasion d'une intervention chirurgicale ;
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7° Les produits de thérapie génique et cellulaire ;
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8° Les réactifs de laboratoire ainsi que les réactifs conditionnés en vue de la vente au public et destinés au diagnostic médical ou à celui de la grossesse et les réactifs utilisés pour les examens d'anatomie et de cytologie pathologiques ;
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9° Les produits destinés à l'entretien ou à l'application des lentilles de contact ;
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10° Les produits insecticides, acaricides et antiparasitaires à usage humain ;
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11° Les procédés, produits et appareils destinés à la désinfection des locaux dans les cas prévus à l'article L. 3114-1 ;
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12° Les produits thérapeutiques annexes ;
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13° Les aliments diététiques destinés à des fins médicales spéciales qui, du fait de leur composition, sont susceptibles de présenter un risque pour les personnes auxquelles ils ne sont pas destinés ;
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14° Les lentilles oculaires non correctrices ;
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15° Les produits cosmétiques.
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L'agence procède à l'évaluation des bénéfices et des risques liés à l'utilisation de ces produits et objets à tout moment opportun et notamment lorsqu'un élément nouveau est susceptible de remettre en cause l'évaluation initiale. Elle assure la mise en oeuvre des systèmes de vigilance et prépare la pharmacopée.
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Elle rend publique une synthèse des dossiers d'autorisation de tout nouveau médicament. Elle organise des réunions régulières d'information avec les associations de patients et d'usagers de la médecine sur les problèmes de sécurité sanitaire des produits de santé.
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Elle contrôle la publicité en faveur de tous les produits, objets, appareils et méthodes revendiquant une finalité sanitaire.
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Elle prend ou demande aux autorités compétentes de prendre les mesures de police sanitaire nécessaires lorsque la santé de la population est menacée, dans les conditions prévues au présent code ou par toute autre disposition législative ou réglementaire visant à préserver la santé humaine.
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Elle peut être saisie par les associations agréées de consommateurs ou d'usagers, dans des conditions fixées par décret.
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Elle établit un rapport annuel d'activité adressé au Gouvernement et au Parlement. Ce rapport est rendu public.
" } }, "LEGIARTI000006690345": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5311-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2002-03-05", "DATE_DEBUT": "2001-03-03" } }, "META_COMMUN": { "ID": "LEGIARTI000006690345", "URL": "article/LEGI/ARTI/00/00/06/69/03/LEGIARTI000006690345.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5311L01XXAB" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006630983", "@num": "1", "#text": "Décret n°81-278 du 25 mars 1981 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000503017", "@numtexte": "81-278", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1981-03-25" }, { "@id": "LEGIARTI000006631025", "@num": "Annexe I", "#text": "Décret n°81-278 du 25 mars 1981 - art. Annexe I (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000503017", "@numtexte": "81-278", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1981-03-25" }, { "@id": "LEGIARTI000035606736", "@num": "2-1", "#text": "Décret n°90-975 du 30 octobre 1990 - art. 2-1 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000000160314", "@nortexte": "SPSG9001546D", "@numtexte": "90-975", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1990-10-30" }, { "@id": "LEGIARTI000006712582", "@num": "2", "#text": "Décret n°92-1432 du 30 décembre 1992 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000726011", "@nortexte": "SPSG9202710D", "@numtexte": "92-1432", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1992-12-30" }, { "@id": "LEGIARTI000006355280", "@num": "87", "#text": "Loi n°93-122 du 29 janvier 1993 - art. 87 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000711604", "@nortexte": "PRMX9200148L", "@numtexte": "93-122", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "1993-01-29" }, { "@id": "LEGIARTI000006865783", "@num": "Annexe", "#text": "Décret n°96-850 du 20 septembre 1996 - art. Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000195660", "@nortexte": "ENVP9640024D", "@numtexte": "96-850", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1996-09-20" }, { "@id": "LEGIARTI000006506987", "@num": "3", "#text": "Décret n°98-385 du 18 mai 1998 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000571865", "@nortexte": "MESG9820693D", "@numtexte": "98-385", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1998-05-18" }, { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006724441", "@num": "5", "#text": "Décret n°2001-35 du 11 janvier 2001 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000388987", "@nortexte": "MJSK0070147D", "@numtexte": "2001-35", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2001-01-11" }, { "@id": "LEGIARTI000006698254", "@num": "14", "#text": "n°2001-198 du 1 mars 2001 - art. 14 () JORF 3 mars 2001", "@sens": "source", "@cidtexte": "JORFTEXT000000588097", "@nortexte": "MESX0100017R", "@numtexte": "2001-198", "@typelien": "MODIFICATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2001-03-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000006254318", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254325", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639980", "@nortexte": "SANP0623382A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254307", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254319", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326653", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020320295", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326611", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254321", "@num": "4", "#text": "Arrêté du 16 août 2006 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254313", "@num": "7", "#text": "Arrêté du 16 août 2006 - art. 7 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006734099", "@num": "ANNEXE", "#text": "Arrêté du 16 août 2006 - art. 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Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000018360158", "@nortexte": "SJSP0805973A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-03-05" }, { "@id": "LEGIARTI000019382668", "@num": "2", "#text": "Arrêté du 11 août 2008 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019381783", "@nortexte": "SJSP0820319A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-08-11" }, { "@id": "LEGIARTI000034448482", "@num": "7", "#text": "Arrêté du 6 février 2009 - art. 7 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000020234297", "@nortexte": "SJSG0824493A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-06" }, { "@id": "LEGITEXT000020319418", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318429", "@nortexte": "SASP0904387A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319427", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318439", "@nortexte": "SASP0904427A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319436", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318449", "@nortexte": "SASP0904394A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGIARTI000021782780", "@num": "Annexe au règlement intérieur", "#text": "Arrêté du 13 janvier 2010 - art. Annexe au règlement intérieur (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000021782073", "@nortexte": "SASP1001133A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-01-13" }, { "@id": "LEGITEXT000022416787", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415149", "@nortexte": "SASP1017123A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416463", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415125", "@nortexte": "SASP1017105A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416472", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415141", "@nortexte": "SASP1017114A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGIARTI000023430029", "@num": "6", "#text": "Décret n°2011-57\n du 13 janvier 2011 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000023428330", "@nortexte": "SPOV1017553D", "@numtexte": "2011-57", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-01-13" }, { "@id": "LEGITEXT000023778069", "#text": "Arrêté du 17 mars 2011 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000023776935", "@nortexte": "ETSP1108041A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-03-17" }, { "@id": "LEGIARTI000025071143", "@num": "38", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 38 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000025071141", "@num": "39", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 39 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000026480621", "@num": "4", "#text": "Arrêté du 10 octobre 2012 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000026479723", "@nortexte": "AFSP1221372A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-10-10" }, { "@id": "LEGIARTI000027648252", "#text": "Arrêté du 23 janvier 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027047902", "@nortexte": "AFSP1228322A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-01-23" }, { "@id": "LEGITEXT000027434552", "#text": "Décret n°2013-414\n du 21 mai 2013 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027434029", "@nortexte": "AFSP1304115D", "@numtexte": "2013-414", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2013-05-21" }, { "@id": "LEGIARTI000027594512", "#text": "Arrêté du 20 juin 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027592947", "@nortexte": "AFSP1313848A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-20" }, { "@id": "LEGIARTI000027699119", "@num": "1", "#text": "Arrêté du 17 juin 2013 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027697076", "@nortexte": "AFSP1301854A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-17" }, { "@id": "LEGIARTI000033202304", "#text": "Arrêté du 29 août 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027910341", "@nortexte": "PROI1311061A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-08-29" }, { "@id": "LEGIARTI000035971526", "#text": "DÉCRET n°2014-1286 du 23 octobre 2014 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029675991", "@nortexte": "AFSX1419046D", "@numtexte": "2014-1286", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000036393921", "@num": "166", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 166 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000031916570", "@num": "169", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 169 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000043508038", "#text": "Arrêté du 28 novembre 2016 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033507693", "@nortexte": "AFSP1633477A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-11-28" }, { "@id": "LEGIARTI000033554483", "@num": "3", "#text": "Arrêté du 2 décembre 2016 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033553349", "@nortexte": "AFSP1635656A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000038887172", "@num": "2", "#text": "LOI n°2017-220 du 23 février 2017 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034078423", "@nortexte": "AFSP1622342L", "@numtexte": "2017-220", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2017-02-23" }, { "@id": "LEGIARTI000034152829", "@num": "1", "#text": "Arrêté du 27 février 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150863", "@nortexte": "AFSP1706243A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000035988048", "@num": "3", "#text": "Arrêté du 27 février 2017 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150842", "@nortexte": "AFSP1706241A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000035269375", "@num": "1", "#text": "Arrêté du 17 juillet 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000035268202", "@nortexte": "SSAE1720859A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-07-17" }, { "@id": "LEGITEXT000036406189", "#text": "Décret n°2017-1781 du 27 décembre 2017 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036299141", "@nortexte": "SSAP1728401D", "@numtexte": "2017-1781", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-12-27" }, { "@id": "LEGIARTI000038432466", "@num": "1", "#text": "Décret n°2019-389 du 30 avril 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000038431240", "@nortexte": "SSAS1906324D", "@numtexte": "2019-389", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-04-30" }, { "@id": "LEGITEXT000039664011", "#text": "Arrêté du 20 décembre 2019 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000039663324", "@nortexte": "SSAP1936730A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-12-20" }, { "@id": "LEGIARTI000041898595", "@num": "10-3-1", "#text": "Arrêté du 23 mars 2020 - art. 10-3-1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000042645749", "@num": "17", "#text": "Ordonnance n°2020-460 du 22 avril 2020 - art. 17 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041814597", "@nortexte": "ECOX2009794R", "@numtexte": "2020-460", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2020-04-22" }, { "@id": "LEGIARTI000041890409", "@num": "1", "#text": "Arrêté du 18 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041889362", "@nortexte": "SSAZ2011564A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-18" }, { "@id": "LEGIARTI000041898504", "@num": "1", "#text": "Arrêté du 20 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041897919", "@nortexte": "SSAZ2012596A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-20" }, { "@id": "LEGIARTI000043298218", "@num": "25", "#text": "Arrêté du 10 juillet 2020 - art. 25 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042609739", "@num": "26", "#text": "Arrêté du 10 juillet 2020 - art. 26 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000043103458", "#text": "Arrêté du 5 février 2021 - art. (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000043100729", "@nortexte": "SSAP2104251A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-02-05" }, { "@id": "LEGIARTI000043298491", "@num": "3", "#text": "Décret n°2021-331 du 26 mars 2021 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000043297285", "@nortexte": "SSAS2034156D", "@numtexte": "2021-331", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-03-26" }, { "@id": "LEGITEXT000043543262", "#text": "Décret n°2021-662 du 26 mai 2021 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043541690", "@nortexte": "ECOI2106880D", "@numtexte": "2021-662", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-05-26" }, { "@id": "LEGIARTI000043543283", "#text": "Décret n°2021-662 du 26 mai 2021 - art.", "@sens": "cible", "@cidtexte": "JORFTEXT000043541690", "@nortexte": "ECOI2106880D", "@numtexte": "2021-662", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-05-26" }, { "@id": "LEGIARTI000047779186", "@num": "25", "#text": "Arrêté du 1 juin 2021 - art. 25 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000043770220", "@num": "27", "#text": "Arrêté du 1er juin 2021 - art. 27 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000046567251", "@num": "Annexe 2", "#text": "Arrêté du 14 novembre 2022 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000046566303", "@nortexte": "SPRP2231874A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-11-14" }, { "@id": "LEGIARTI000049976728", "@num": "Annexe 1", "#text": "Arrêté du 14 novembre 2022 - art. Annexe 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000046566303", "@nortexte": "SPRP2231874A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-11-14" }, { "@id": "LEGIARTI000050409030", "#text": "Arrêté du 24 octobre 2024 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000050407232", "@nortexte": "MSAP2428789A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-10-24" }, { "@id": "LEGIARTI000050409032", "#text": "Arrêté du 24 octobre 2024 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000050407232", "@nortexte": "MSAP2428789A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-10-24" }, { "@id": "LEGIARTI000043545974", "@num": "Annexe I à l'article D523-8", "#text": "Code de l'environnement - art. Annexe I à l'article D523-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000027912149", "@num": "D523-8", "#text": "Code de l'environnement - art. D523-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000042654871", "@num": "L521-2", "#text": "Code de l'environnement - art. L521-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021666283", "@num": "L531-3", "#text": "Code de l'environnement - art. L531-3 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028749087", "@num": "L221-10", "#text": "Code de la consommation - art. L221-10 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069565", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000041985451", "@num": "L511-22", "#text": "Code de la consommation - art. L511-22 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069565", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000046012786", "@num": "R422-1", "#text": "Code de la consommation - art. R422-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069565", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006574178", "@num": "R*1142-25", "#text": "Code de la défense. - art. R*1142-25 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006071307", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006574182", "@num": "R*1142-29", "#text": "Code de la défense. - art. R*1142-29 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006071307", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049599041", "@num": "D1413-58", "#text": "Code de la santé publique - art. D1413-58 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033642702", "@num": "D6141-42", "#text": "Code de la santé publique - art. D6141-42 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025104470", "@num": "L1121-1", "#text": "Code de la santé publique - art. L1121-1 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000024325597", "@num": "L1121-11", "#text": "Code de la santé publique - art. L1121-11 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025457563", "@num": "L1121-16", "#text": "Code de la santé publique - art. L1121-16 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025104351", "@num": "L1121-3", "#text": "Code de la santé publique - art. L1121-3 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000032722946", "@num": "L1123-12", "#text": "Code de la santé publique - art. L1123-12 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685881", "@num": "L1123-7", "#text": "Code de la santé publique - art. L1123-7 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685885", "@num": "L1123-8", "#text": "Code de la santé publique - art. L1123-8 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685887", "@num": "L1123-9", "#text": "Code de la santé publique - art. 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L'Agence française de sécurité sanitaire des produits de santé est un établissement public de l'Etat, placé sous la tutelle du ministre chargé de la santé.
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L'agence participe à l'application des lois et règlements relatifs à l'évaluation, aux essais, à la fabrication, à la préparation, à l'importation, à l'exportation, à la distribution en gros, au conditionnement, à la conservation, à l'exploitation, à la mise sur le marché, à la publicité, à la mise en service ou à l'utilisation des produits à finalité sanitaire destinés à l'homme et des produits à finalité cosmétique, et notamment :
\n
l° Les médicaments, y compris les préparations magistrales, hospitalières et officinales, les substances stupéfiantes, psychotropes ou autres substances vénéneuses utilisées en médecine, les huiles essentielles et plantes médicinales, les matières premières à usage pharmaceutique ;
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2° Les produits contraceptifs et contragestifs ;
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3° Les biomatériaux et les dispositifs médicaux ;
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4° Les dispositifs médicaux de diagnostic in vitro ;
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5° Les produits sanguins labiles ;
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6° Les organes, tissus, cellules et produits d'origine humaine ou animale, y compris lorsqu'ils sont prélevés à l'occasion d'une intervention chirurgicale ;
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7° Les produits de thérapie génique et cellulaire ;
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8°
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9° Les produits destinés à l'entretien ou à l'application des lentilles de contact ;
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10° Les produits insecticides, acaricides et antiparasitaires à usage humain ;
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11° Les procédés, produits et appareils destinés à la désinfection des locaux dans les cas prévus à l'article L. 3114-1 ;
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12° Les produits thérapeutiques annexes ;
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13° Les aliments diététiques destinés à des fins médicales spéciales qui, du fait de leur composition, sont susceptibles de présenter un risque pour les personnes auxquelles ils ne sont pas destinés ;
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14° Les lentilles oculaires non correctrices ;
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15° Les produits cosmétiques.
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L'agence procède à l'évaluation des bénéfices et des risques liés à l'utilisation de ces produits et objets à tout moment opportun et notamment lorsqu'un élément nouveau est susceptible de remettre en cause l'évaluation initiale. Elle assure la mise en oeuvre des systèmes de vigilance et prépare la pharmacopée.
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Elle rend publique une synthèse des dossiers d'autorisation de tout nouveau médicament. Elle organise des réunions régulières d'information avec les associations de patients et d'usagers de la médecine sur les problèmes de sécurité sanitaire des produits de santé.
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Elle contrôle la publicité en faveur de tous les produits, objets, appareils et méthodes revendiquant une finalité sanitaire.
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Elle prend ou demande aux autorités compétentes de prendre les mesures de police sanitaire nécessaires lorsque la santé de la population est menacée, dans les conditions prévues au présent code ou par toute autre disposition législative ou réglementaire visant à préserver la santé humaine.
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Elle peut être saisie par les associations agréées de consommateurs ou d'usagers, dans des conditions fixées par décret.
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Elle établit un rapport annuel d'activité adressé au Gouvernement et au Parlement. Ce rapport est rendu public.
" } }, "LEGIARTI000006690346": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5311-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-07", "DATE_DEBUT": "2002-03-05" } }, "META_COMMUN": { "ID": "LEGIARTI000006690346", "URL": "article/LEGI/ARTI/00/00/06/69/03/LEGIARTI000006690346.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5311L01XXAC" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006630983", "@num": "1", "#text": "Décret n°81-278 du 25 mars 1981 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000503017", "@numtexte": "81-278", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1981-03-25" }, { "@id": "LEGIARTI000006631025", "@num": "Annexe I", "#text": "Décret n°81-278 du 25 mars 1981 - art. Annexe I (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000503017", "@numtexte": "81-278", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1981-03-25" }, { "@id": "LEGIARTI000035606736", "@num": "2-1", "#text": "Décret n°90-975 du 30 octobre 1990 - art. 2-1 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000000160314", "@nortexte": "SPSG9001546D", "@numtexte": "90-975", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1990-10-30" }, { "@id": "LEGIARTI000006712582", "@num": "2", "#text": "Décret n°92-1432 du 30 décembre 1992 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000726011", "@nortexte": "SPSG9202710D", "@numtexte": "92-1432", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1992-12-30" }, { "@id": "LEGIARTI000006355280", "@num": "87", "#text": "Loi n°93-122 du 29 janvier 1993 - art. 87 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000711604", "@nortexte": "PRMX9200148L", "@numtexte": "93-122", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "1993-01-29" }, { "@id": "LEGIARTI000006865783", "@num": "Annexe", "#text": "Décret n°96-850 du 20 septembre 1996 - art. Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000195660", "@nortexte": "ENVP9640024D", "@numtexte": "96-850", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1996-09-20" }, { "@id": "LEGIARTI000006506987", "@num": "3", "#text": "Décret n°98-385 du 18 mai 1998 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000571865", "@nortexte": "MESG9820693D", "@numtexte": "98-385", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1998-05-18" }, { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006724441", "@num": "5", "#text": "Décret n°2001-35 du 11 janvier 2001 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000388987", "@nortexte": "MJSK0070147D", "@numtexte": "2001-35", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2001-01-11" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000006697405", "@num": "20", "#text": "Loi n°2002-303 du 4 mars 2002 - art. 20 () JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000006697418", "@num": "32", "#text": "Loi n°2002-303 du 4 mars 2002 - art. 32 () JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000006254318", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254325", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639980", "@nortexte": "SANP0623382A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254307", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254319", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326653", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020320295", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326611", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254321", "@num": "4", "#text": "Arrêté du 16 août 2006 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254313", "@num": "7", "#text": "Arrêté du 16 août 2006 - art. 7 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006734099", "@num": "ANNEXE", "#text": "Arrêté du 16 août 2006 - art. 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Annexe au règlement intérieur (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000021782073", "@nortexte": "SASP1001133A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-01-13" }, { "@id": "LEGITEXT000022416787", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415149", "@nortexte": "SASP1017123A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416463", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415125", "@nortexte": "SASP1017105A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416472", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415141", "@nortexte": "SASP1017114A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGIARTI000023430029", "@num": "6", "#text": "Décret n°2011-57\n du 13 janvier 2011 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000023428330", "@nortexte": "SPOV1017553D", "@numtexte": "2011-57", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-01-13" }, { "@id": "LEGITEXT000023778069", "#text": "Arrêté du 17 mars 2011 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000023776935", "@nortexte": "ETSP1108041A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-03-17" }, { "@id": "LEGIARTI000025071143", "@num": "38", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 38 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000025071141", "@num": "39", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 39 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000026480621", "@num": "4", "#text": "Arrêté du 10 octobre 2012 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000026479723", "@nortexte": "AFSP1221372A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-10-10" }, { "@id": "LEGIARTI000027648252", "#text": "Arrêté du 23 janvier 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027047902", "@nortexte": "AFSP1228322A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-01-23" }, { "@id": "LEGITEXT000027434552", "#text": "Décret n°2013-414\n du 21 mai 2013 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027434029", "@nortexte": "AFSP1304115D", "@numtexte": "2013-414", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2013-05-21" }, { "@id": "LEGIARTI000027594512", "#text": "Arrêté du 20 juin 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027592947", "@nortexte": "AFSP1313848A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-20" }, { "@id": "LEGIARTI000027699119", "@num": "1", "#text": "Arrêté du 17 juin 2013 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027697076", "@nortexte": "AFSP1301854A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-17" }, { "@id": "LEGIARTI000033202304", "#text": "Arrêté du 29 août 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027910341", "@nortexte": "PROI1311061A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-08-29" }, { "@id": "LEGIARTI000035971526", "#text": "DÉCRET n°2014-1286 du 23 octobre 2014 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029675991", "@nortexte": "AFSX1419046D", "@numtexte": "2014-1286", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000036393921", "@num": "166", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 166 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000031916570", "@num": "169", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 169 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000043508038", "#text": "Arrêté du 28 novembre 2016 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033507693", "@nortexte": "AFSP1633477A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-11-28" }, { "@id": "LEGIARTI000033554483", "@num": "3", "#text": "Arrêté du 2 décembre 2016 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033553349", "@nortexte": "AFSP1635656A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000038887172", "@num": "2", "#text": "LOI n°2017-220 du 23 février 2017 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034078423", "@nortexte": "AFSP1622342L", "@numtexte": "2017-220", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2017-02-23" }, { "@id": "LEGIARTI000034152829", "@num": "1", "#text": "Arrêté du 27 février 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150863", "@nortexte": "AFSP1706243A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000035988048", "@num": "3", "#text": "Arrêté du 27 février 2017 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150842", "@nortexte": "AFSP1706241A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000035269375", "@num": "1", "#text": "Arrêté du 17 juillet 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000035268202", "@nortexte": "SSAE1720859A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-07-17" }, { "@id": "LEGITEXT000036406189", "#text": "Décret n°2017-1781 du 27 décembre 2017 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036299141", "@nortexte": "SSAP1728401D", "@numtexte": "2017-1781", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-12-27" }, { "@id": "LEGIARTI000038432466", "@num": "1", "#text": "Décret n°2019-389 du 30 avril 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000038431240", "@nortexte": "SSAS1906324D", "@numtexte": "2019-389", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-04-30" }, { "@id": "LEGITEXT000039664011", "#text": "Arrêté du 20 décembre 2019 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000039663324", "@nortexte": "SSAP1936730A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-12-20" }, { "@id": "LEGIARTI000041898595", "@num": "10-3-1", "#text": "Arrêté du 23 mars 2020 - art. 10-3-1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000042645749", "@num": "17", "#text": "Ordonnance n°2020-460 du 22 avril 2020 - art. 17 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041814597", "@nortexte": "ECOX2009794R", "@numtexte": "2020-460", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2020-04-22" }, { "@id": "LEGIARTI000041890409", "@num": "1", "#text": "Arrêté du 18 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041889362", "@nortexte": "SSAZ2011564A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-18" }, { "@id": "LEGIARTI000041898504", "@num": "1", "#text": "Arrêté du 20 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041897919", "@nortexte": "SSAZ2012596A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-20" }, { "@id": "LEGIARTI000043298218", "@num": "25", "#text": "Arrêté du 10 juillet 2020 - art. 25 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042609739", "@num": "26", "#text": "Arrêté du 10 juillet 2020 - art. 26 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000043103458", "#text": "Arrêté du 5 février 2021 - art. (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000043100729", "@nortexte": "SSAP2104251A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-02-05" }, { "@id": "LEGIARTI000043298491", "@num": "3", "#text": "Décret n°2021-331 du 26 mars 2021 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000043297285", "@nortexte": "SSAS2034156D", "@numtexte": "2021-331", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-03-26" }, { "@id": "LEGITEXT000043543262", "#text": "Décret n°2021-662 du 26 mai 2021 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043541690", "@nortexte": "ECOI2106880D", "@numtexte": "2021-662", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-05-26" }, { "@id": "LEGIARTI000043543283", "#text": "Décret n°2021-662 du 26 mai 2021 - art.", "@sens": "cible", "@cidtexte": "JORFTEXT000043541690", "@nortexte": "ECOI2106880D", "@numtexte": "2021-662", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-05-26" }, { "@id": "LEGIARTI000047779186", "@num": "25", "#text": "Arrêté du 1 juin 2021 - art. 25 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000043770220", "@num": "27", "#text": "Arrêté du 1er juin 2021 - art. 27 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000046567251", "@num": "Annexe 2", "#text": "Arrêté du 14 novembre 2022 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000046566303", "@nortexte": "SPRP2231874A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-11-14" }, { "@id": "LEGIARTI000049976728", "@num": "Annexe 1", "#text": "Arrêté du 14 novembre 2022 - art. Annexe 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000046566303", "@nortexte": "SPRP2231874A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-11-14" }, { "@id": "LEGIARTI000050409030", "#text": "Arrêté du 24 octobre 2024 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000050407232", "@nortexte": "MSAP2428789A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-10-24" }, { "@id": "LEGIARTI000050409032", "#text": "Arrêté du 24 octobre 2024 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000050407232", "@nortexte": "MSAP2428789A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-10-24" }, { "@id": "LEGIARTI000043545974", "@num": "Annexe I à l'article D523-8", "#text": "Code de l'environnement - art. Annexe I à l'article D523-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000027912149", "@num": "D523-8", "#text": "Code de l'environnement - art. D523-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000042654871", "@num": "L521-2", "#text": "Code de l'environnement - art. 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L'Agence française de sécurité sanitaire des produits de santé est un établissement public de l'Etat, placé sous la tutelle du ministre chargé de la santé.
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L'agence participe à l'application des lois et règlements relatifs à l'évaluation, aux essais, à la fabrication, à la préparation, à l'importation, à l'exportation, à la distribution en gros, au conditionnement, à la conservation, à l'exploitation, à la mise sur le marché, à la publicité, à la mise en service ou à l'utilisation des produits à finalité sanitaire destinés à l'homme et des produits à finalité cosmétique, et notamment :
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1° Les médicaments, y compris les préparations magistrales, hospitalières et officinales, les substances stupéfiantes, psychotropes ou autres substances vénéneuses utilisées en médecine, les huiles essentielles et plantes médicinales, les matières premières à usage pharmaceutique ;
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2° Les produits contraceptifs et contragestifs ;
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3° Les biomatériaux et les dispositifs médicaux ;
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4° Les dispositifs médicaux de diagnostic in vitro ;
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5° Les produits sanguins labiles ;
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6° Les organes, tissus, cellules et produits d'origine humaine ou animale, y compris lorsqu'ils sont prélevés à l'occasion d'une intervention chirurgicale ;
\n
7° Les produits de thérapie génique et cellulaire ;
\n
8°
\n
9° Les produits destinés à l'entretien ou à l'application des lentilles de contact ;
\n
10° Les produits insecticides, acaricides et antiparasitaires à usage humain ;
\n
11° Les procédés, produits et appareils destinés à la désinfection des locaux dans les cas prévus à l'article L. 3114-1 ;
\n
12° Les produits thérapeutiques annexes ;
\n
13° Les aliments diététiques destinés à des fins médicales spéciales qui, du fait de leur composition, sont susceptibles de présenter un risque pour les personnes auxquelles ils ne sont pas destinés ;
\n
14° Les lentilles oculaires non correctrices ;
\n
15° Les produits cosmétiques.
\n
L'agence procède à l'évaluation des bénéfices et des risques liés à l'utilisation de ces produits et objets à tout moment opportun et notamment lorsqu'un élément nouveau est susceptible de remettre en cause l'évaluation initiale. Elle assure la mise en oeuvre des systèmes de vigilance et prépare la pharmacopée.
\n
Elle rend publique une synthèse des dossiers d'autorisation de tout nouveau médicament. Elle organise des réunions régulières d'information avec des associations agréées de personnes malades et d'usagers du système de santé mentionnées à l'article L. 1114-1 sur les problèmes de sécurité sanitaire des produits de santé.
\n
Elle contrôle la publicité en faveur de tous les produits, objets, appareils et méthodes revendiquant une finalité sanitaire.
\n
Elle prend ou demande aux autorités compétentes de prendre les mesures de police sanitaire nécessaires lorsque la santé de la population est menacée, dans les conditions prévues au présent code ou par toute autre disposition législative ou réglementaire visant à préserver la santé humaine.
\n
Elle établit un rapport annuel d'activité adressé au Gouvernement et au Parlement. Ce rapport est rendu public.
\n
Elle organise des auditions publiques sur des thèmes de santé publique.
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Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000195660", "@nortexte": "ENVP9640024D", "@numtexte": "96-850", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1996-09-20" }, { "@id": "LEGIARTI000006506987", "@num": "3", "#text": "Décret n°98-385 du 18 mai 1998 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000571865", "@nortexte": "MESG9820693D", "@numtexte": "98-385", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1998-05-18" }, { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006724441", "@num": "5", "#text": "Décret n°2001-35 du 11 janvier 2001 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000388987", "@nortexte": "MJSK0070147D", "@numtexte": "2001-35", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2001-01-11" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000006697589", "@num": "20", "#text": "Loi n°2004-800 du 6 août 2004 - art. 20 () JORF 7 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000441469", "@nortexte": "SANX0100053L", "@numtexte": "2004-800", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-06" }, { "@id": "LEGIARTI000006254318", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254325", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639980", "@nortexte": "SANP0623382A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254307", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254319", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326653", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020320295", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326611", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254321", "@num": "4", "#text": "Arrêté du 16 août 2006 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254313", "@num": "7", "#text": "Arrêté du 16 août 2006 - art. 7 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006734099", "@num": "ANNEXE", "#text": "Arrêté du 16 août 2006 - art. ANNEXE (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639975", "@nortexte": "SANP0623370A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006255223", "@num": "1", "#text": "Arrêté du 11 septembre 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000271992", "@nortexte": "SANP0623792A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-09-11" }, { "@id": "LEGIARTI000020322856", "@num": "3", "#text": "Arrêté du 11 septembre 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000271992", "@nortexte": "SANP0623792A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-09-11" }, { "@id": "LEGIARTI000006697048", "@num": "39", "#text": "Loi n°2007-248 du 26 février 2007 - art. 39 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000613381", "@nortexte": "SANX0600004L", "@numtexte": "2007-248", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2007-02-26" }, { "@id": "LEGIARTI000006868630", "@num": "29", "#text": "Décret n° 2007-358 du 19 mars 2007 - art. 29 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000821090", "@nortexte": "AGRG0700644D", "@numtexte": "2007-358", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-19" }, { "@id": "LEGIARTI000006726837", "@num": "5", "#text": "Décret n°2007-462 du 25 mars 2007 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000466314", "@nortexte": "MJSK0770075D", "@numtexte": "2007-462", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-25" }, { "@id": "LEGIARTI000018361459", "@num": "Annexe", "#text": "Arrêté du 5 mars 2008 - art. Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000018360158", "@nortexte": "SJSP0805973A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-03-05" }, { "@id": "LEGIARTI000019382668", "@num": "2", "#text": "Arrêté du 11 août 2008 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019381783", "@nortexte": "SJSP0820319A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-08-11" }, { "@id": "LEGIARTI000034448482", "@num": "7", "#text": "Arrêté du 6 février 2009 - art. 7 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000020234297", "@nortexte": "SJSG0824493A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-06" }, { "@id": "LEGITEXT000020319418", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318429", "@nortexte": "SASP0904387A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319427", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318439", "@nortexte": "SASP0904427A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319436", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318449", "@nortexte": "SASP0904394A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGIARTI000021782780", "@num": "Annexe au règlement intérieur", "#text": "Arrêté du 13 janvier 2010 - art. Annexe au règlement intérieur (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000021782073", "@nortexte": "SASP1001133A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-01-13" }, { "@id": "LEGITEXT000022416787", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415149", "@nortexte": "SASP1017123A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416463", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415125", "@nortexte": "SASP1017105A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416472", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415141", "@nortexte": "SASP1017114A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGIARTI000023430029", "@num": "6", "#text": "Décret n°2011-57\n du 13 janvier 2011 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000023428330", "@nortexte": "SPOV1017553D", "@numtexte": "2011-57", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-01-13" }, { "@id": "LEGITEXT000023778069", "#text": "Arrêté du 17 mars 2011 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000023776935", "@nortexte": "ETSP1108041A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-03-17" }, { "@id": "LEGIARTI000025071143", "@num": "38", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 38 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000025071141", "@num": "39", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 39 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000026480621", "@num": "4", "#text": "Arrêté du 10 octobre 2012 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000026479723", "@nortexte": "AFSP1221372A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-10-10" }, { "@id": "LEGIARTI000027648252", "#text": "Arrêté du 23 janvier 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027047902", "@nortexte": "AFSP1228322A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-01-23" }, { "@id": "LEGITEXT000027434552", "#text": "Décret n°2013-414\n du 21 mai 2013 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027434029", "@nortexte": "AFSP1304115D", "@numtexte": "2013-414", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2013-05-21" }, { "@id": "LEGIARTI000027594512", "#text": "Arrêté du 20 juin 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027592947", "@nortexte": "AFSP1313848A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-20" }, { "@id": "LEGIARTI000027699119", "@num": "1", "#text": "Arrêté du 17 juin 2013 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027697076", "@nortexte": "AFSP1301854A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-17" }, { "@id": "LEGIARTI000033202304", "#text": "Arrêté du 29 août 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027910341", "@nortexte": "PROI1311061A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-08-29" }, { "@id": "LEGIARTI000035971526", "#text": "DÉCRET n°2014-1286 du 23 octobre 2014 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029675991", "@nortexte": "AFSX1419046D", "@numtexte": "2014-1286", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000036393921", "@num": "166", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 166 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000031916570", "@num": "169", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 169 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000043508038", "#text": "Arrêté du 28 novembre 2016 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033507693", "@nortexte": "AFSP1633477A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-11-28" }, { "@id": "LEGIARTI000033554483", "@num": "3", "#text": "Arrêté du 2 décembre 2016 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033553349", "@nortexte": "AFSP1635656A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000038887172", "@num": "2", "#text": "LOI n°2017-220 du 23 février 2017 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034078423", "@nortexte": "AFSP1622342L", "@numtexte": "2017-220", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2017-02-23" }, { "@id": "LEGIARTI000034152829", "@num": "1", "#text": "Arrêté du 27 février 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150863", "@nortexte": "AFSP1706243A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000035988048", "@num": "3", "#text": "Arrêté du 27 février 2017 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150842", "@nortexte": "AFSP1706241A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000035269375", "@num": "1", "#text": "Arrêté du 17 juillet 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000035268202", "@nortexte": "SSAE1720859A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-07-17" }, { "@id": "LEGITEXT000036406189", "#text": "Décret n°2017-1781 du 27 décembre 2017 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036299141", "@nortexte": "SSAP1728401D", "@numtexte": "2017-1781", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-12-27" }, { "@id": "LEGIARTI000038432466", "@num": "1", "#text": "Décret n°2019-389 du 30 avril 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000038431240", "@nortexte": "SSAS1906324D", "@numtexte": "2019-389", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-04-30" }, { "@id": "LEGITEXT000039664011", "#text": "Arrêté du 20 décembre 2019 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000039663324", "@nortexte": "SSAP1936730A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-12-20" }, { "@id": "LEGIARTI000041898595", "@num": "10-3-1", "#text": "Arrêté du 23 mars 2020 - art. 10-3-1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000042645749", "@num": "17", "#text": "Ordonnance n°2020-460 du 22 avril 2020 - art. 17 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041814597", "@nortexte": "ECOX2009794R", "@numtexte": "2020-460", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2020-04-22" }, { "@id": "LEGIARTI000041890409", "@num": "1", "#text": "Arrêté du 18 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041889362", "@nortexte": "SSAZ2011564A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-18" }, { "@id": "LEGIARTI000041898504", "@num": "1", "#text": "Arrêté du 20 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041897919", "@nortexte": "SSAZ2012596A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-20" }, { "@id": "LEGIARTI000043298218", "@num": "25", "#text": "Arrêté du 10 juillet 2020 - art. 25 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042609739", "@num": "26", "#text": "Arrêté du 10 juillet 2020 - art. 26 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000043103458", "#text": "Arrêté du 5 février 2021 - art. 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L'Agence française de sécurité sanitaire des produits de santé est un établissement public de l'Etat, placé sous la tutelle du ministre chargé de la santé.
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L'agence participe à l'application des lois et règlements relatifs à l'évaluation, aux essais, à la fabrication, à la préparation, à l'importation, à l'exportation, à la distribution en gros, au conditionnement, à la conservation, à l'exploitation, à la mise sur le marché, à la publicité, à la mise en service ou à l'utilisation des produits à finalité sanitaire destinés à l'homme et des produits à finalité cosmétique, et notamment :
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1° Les médicaments, y compris les préparations magistrales, hospitalières et officinales, les substances stupéfiantes, psychotropes ou autres substances vénéneuses utilisées en médecine, les huiles essentielles et plantes médicinales, les matières premières à usage pharmaceutique ;
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2° Les produits contraceptifs et contragestifs ;
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3° Les biomatériaux et les dispositifs médicaux ;
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4° Les dispositifs médicaux de diagnostic in vitro ;
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5° Les produits sanguins labiles ;
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6° Les organes, tissus, cellules et produits d'origine humaine ou animale, y compris lorsqu'ils sont prélevés à l'occasion d'une intervention chirurgicale ;
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7° Les produits cellulaires à finalité thérapeutique ;
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8°
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9° Les produits destinés à l'entretien ou à l'application des lentilles de contact ;
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10° Les produits insecticides, acaricides et antiparasitaires à usage humain ;
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11° Les procédés, produits et appareils destinés à la désinfection des locaux dans les cas prévus à l'article L. 3114-1 ;
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12° Les produits thérapeutiques annexes ;
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13° Les aliments diététiques destinés à des fins médicales spéciales qui, du fait de leur composition, sont susceptibles de présenter un risque pour les personnes auxquelles ils ne sont pas destinés ;
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14° Les lentilles oculaires non correctrices ;
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15° Les produits cosmétiques.
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L'agence procède à l'évaluation des bénéfices et des risques liés à l'utilisation de ces produits et objets à tout moment opportun et notamment lorsqu'un élément nouveau est susceptible de remettre en cause l'évaluation initiale. Elle assure la mise en oeuvre des systèmes de vigilance et prépare la pharmacopée.
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Elle rend publique une synthèse des dossiers d'autorisation de tout nouveau médicament. Elle organise des réunions régulières d'information avec des associations agréées de personnes malades et d'usagers du système de santé mentionnées à l'article L. 1114-1 sur les problèmes de sécurité sanitaire des produits de santé.
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Elle contrôle la publicité en faveur de tous les produits, objets, appareils et méthodes revendiquant une finalité sanitaire.
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Elle prend ou demande aux autorités compétentes de prendre les mesures de police sanitaire nécessaires lorsque la santé de la population est menacée, dans les conditions prévues au présent code ou par toute autre disposition législative ou réglementaire visant à préserver la santé humaine.
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Elle établit un rapport annuel d'activité adressé au Gouvernement et au Parlement. Ce rapport est rendu public.
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Elle organise des auditions publiques sur des thèmes de santé publique.
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Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000195660", "@nortexte": "ENVP9640024D", "@numtexte": "96-850", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1996-09-20" }, { "@id": "LEGIARTI000006506987", "@num": "3", "#text": "Décret n°98-385 du 18 mai 1998 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000571865", "@nortexte": "MESG9820693D", "@numtexte": "98-385", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1998-05-18" }, { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006724441", "@num": "5", "#text": "Décret n°2001-35 du 11 janvier 2001 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000388987", "@nortexte": "MJSK0070147D", "@numtexte": "2001-35", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2001-01-11" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000006697775", "@num": "149", "#text": "Loi n°2004-806 du 9 août 2004 - art. 149 () JORF 11 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787078", "@nortexte": "SANX0300055L", "@numtexte": "2004-806", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-09" }, { "@id": "LEGIARTI000006697638", "@num": "22", "#text": "Loi n°2004-806 du 9 août 2004 - art. 22 () JORF 11 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787078", "@nortexte": "SANX0300055L", "@numtexte": "2004-806", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-09" }, { "@id": "LEGIARTI000006254318", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254325", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639980", "@nortexte": "SANP0623382A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254307", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254319", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326653", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020320295", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326611", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254321", "@num": "4", "#text": "Arrêté du 16 août 2006 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254313", "@num": "7", "#text": "Arrêté du 16 août 2006 - art. 7 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006734099", "@num": "ANNEXE", "#text": "Arrêté du 16 août 2006 - art. 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Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000018360158", "@nortexte": "SJSP0805973A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-03-05" }, { "@id": "LEGIARTI000019382668", "@num": "2", "#text": "Arrêté du 11 août 2008 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019381783", "@nortexte": "SJSP0820319A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-08-11" }, { "@id": "LEGIARTI000034448482", "@num": "7", "#text": "Arrêté du 6 février 2009 - art. 7 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000020234297", "@nortexte": "SJSG0824493A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-06" }, { "@id": "LEGITEXT000020319418", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318429", "@nortexte": "SASP0904387A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319427", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318439", "@nortexte": "SASP0904427A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319436", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318449", "@nortexte": "SASP0904394A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGIARTI000021782780", "@num": "Annexe au règlement intérieur", "#text": "Arrêté du 13 janvier 2010 - art. Annexe au règlement intérieur (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000021782073", "@nortexte": "SASP1001133A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-01-13" }, { "@id": "LEGITEXT000022416787", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415149", "@nortexte": "SASP1017123A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416463", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415125", "@nortexte": "SASP1017105A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416472", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415141", "@nortexte": "SASP1017114A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGIARTI000023430029", "@num": "6", "#text": "Décret n°2011-57\n du 13 janvier 2011 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000023428330", "@nortexte": "SPOV1017553D", "@numtexte": "2011-57", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-01-13" }, { "@id": "LEGITEXT000023778069", "#text": "Arrêté du 17 mars 2011 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000023776935", "@nortexte": "ETSP1108041A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-03-17" }, { "@id": "LEGIARTI000025071143", "@num": "38", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 38 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000025071141", "@num": "39", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 39 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000026480621", "@num": "4", "#text": "Arrêté du 10 octobre 2012 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000026479723", "@nortexte": "AFSP1221372A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-10-10" }, { "@id": "LEGIARTI000027648252", "#text": "Arrêté du 23 janvier 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027047902", "@nortexte": "AFSP1228322A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-01-23" }, { "@id": "LEGITEXT000027434552", "#text": "Décret n°2013-414\n du 21 mai 2013 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027434029", "@nortexte": "AFSP1304115D", "@numtexte": "2013-414", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2013-05-21" }, { "@id": "LEGIARTI000027594512", "#text": "Arrêté du 20 juin 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027592947", "@nortexte": "AFSP1313848A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-20" }, { "@id": "LEGIARTI000027699119", "@num": "1", "#text": "Arrêté du 17 juin 2013 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027697076", "@nortexte": "AFSP1301854A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-17" }, { "@id": "LEGIARTI000033202304", "#text": "Arrêté du 29 août 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027910341", "@nortexte": "PROI1311061A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-08-29" }, { "@id": "LEGIARTI000035971526", "#text": "DÉCRET n°2014-1286 du 23 octobre 2014 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029675991", "@nortexte": "AFSX1419046D", "@numtexte": "2014-1286", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000036393921", "@num": "166", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 166 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000031916570", "@num": "169", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 169 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000043508038", "#text": "Arrêté du 28 novembre 2016 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033507693", "@nortexte": "AFSP1633477A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-11-28" }, { "@id": "LEGIARTI000033554483", "@num": "3", "#text": "Arrêté du 2 décembre 2016 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033553349", "@nortexte": "AFSP1635656A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000038887172", "@num": "2", "#text": "LOI n°2017-220 du 23 février 2017 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034078423", "@nortexte": "AFSP1622342L", "@numtexte": "2017-220", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2017-02-23" }, { "@id": "LEGIARTI000034152829", "@num": "1", "#text": "Arrêté du 27 février 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150863", "@nortexte": "AFSP1706243A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000035988048", "@num": "3", "#text": "Arrêté du 27 février 2017 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150842", "@nortexte": "AFSP1706241A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000035269375", "@num": "1", "#text": "Arrêté du 17 juillet 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000035268202", "@nortexte": "SSAE1720859A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-07-17" }, { "@id": "LEGITEXT000036406189", "#text": "Décret n°2017-1781 du 27 décembre 2017 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036299141", "@nortexte": "SSAP1728401D", "@numtexte": "2017-1781", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-12-27" }, { "@id": "LEGIARTI000038432466", "@num": "1", "#text": "Décret n°2019-389 du 30 avril 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000038431240", "@nortexte": "SSAS1906324D", "@numtexte": "2019-389", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-04-30" }, { "@id": "LEGITEXT000039664011", "#text": "Arrêté du 20 décembre 2019 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000039663324", "@nortexte": "SSAP1936730A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-12-20" }, { "@id": "LEGIARTI000041898595", "@num": "10-3-1", "#text": "Arrêté du 23 mars 2020 - art. 10-3-1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000042645749", "@num": "17", "#text": "Ordonnance n°2020-460 du 22 avril 2020 - art. 17 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041814597", "@nortexte": "ECOX2009794R", "@numtexte": "2020-460", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2020-04-22" }, { "@id": "LEGIARTI000041890409", "@num": "1", "#text": "Arrêté du 18 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041889362", "@nortexte": "SSAZ2011564A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-18" }, { "@id": "LEGIARTI000041898504", "@num": "1", "#text": "Arrêté du 20 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041897919", "@nortexte": "SSAZ2012596A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-20" }, { "@id": "LEGIARTI000043298218", "@num": "25", "#text": "Arrêté du 10 juillet 2020 - art. 25 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042609739", "@num": "26", "#text": "Arrêté du 10 juillet 2020 - art. 26 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000043103458", "#text": "Arrêté du 5 février 2021 - art. 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L'Agence française de sécurité sanitaire des produits de santé est un établissement public de l'Etat, placé sous la tutelle du ministre chargé de la santé.
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L'agence participe à l'application des lois et règlements relatifs à l'évaluation, aux essais, à la fabrication, à la préparation, à l'importation, à l'exportation, à la distribution en gros, au conditionnement, à la conservation, à l'exploitation, à la mise sur le marché, à la publicité, à la mise en service ou à l'utilisation des produits à finalité sanitaire destinés à l'homme et des produits à finalité cosmétique, et notamment :
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1° Les médicaments, y compris les préparations magistrales, hospitalières et officinales, les substances stupéfiantes, psychotropes ou autres substances vénéneuses utilisées en médecine, les huiles essentielles et plantes médicinales, les matières premières à usage pharmaceutique ;
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2° Les produits contraceptifs et contragestifs ;
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3° Les biomatériaux et les dispositifs médicaux ;
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4° Les dispositifs médicaux de diagnostic in vitro ;
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5° Les produits sanguins labiles ;
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6° Les organes, tissus, cellules et produits d'origine humaine ou animale, y compris lorsqu'ils sont prélevés à l'occasion d'une intervention chirurgicale ;
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7° Les produits cellulaires à finalité thérapeutique ;
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8° (Abrogé)
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9° Les produits destinés à l'entretien ou à l'application des lentilles de contact ;
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10° Les produits insecticides, acaricides et antiparasitaires à usage humain ;
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11° Les procédés et appareils destinés à la désinfection des locaux et des véhicules dans les cas prévus à l'article L. 3114-1 ;
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12° Les produits thérapeutiques annexes ;
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13° Les aliments diététiques destinés à des fins médicales spéciales qui, du fait de leur composition, sont susceptibles de présenter un risque pour les personnes auxquelles ils ne sont pas destinés ;
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14° Les lentilles oculaires non correctrices ;
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15° Les produits cosmétiques ;
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16° Les micro-organismes et toxines mentionnés à l'article L. 5139-1 ;
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17° Les produits de tatouage.
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L'agence procède à l'évaluation des bénéfices et des risques liés à l'utilisation de ces produits et objets à tout moment opportun et notamment lorsqu'un élément nouveau est susceptible de remettre en cause l'évaluation initiale. Elle assure la mise en oeuvre des systèmes de vigilance et prépare la pharmacopée.
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Elle rend publique une synthèse des dossiers d'autorisation de tout nouveau médicament. Elle organise des réunions régulières d'information avec des associations agréées de personnes malades et d'usagers du système de santé mentionnées à l'article L. 1114-1 sur les problèmes de sécurité sanitaire des produits de santé.
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Elle contrôle la publicité en faveur de tous les produits, objets, appareils et méthodes revendiquant une finalité sanitaire.
\n
Elle prend ou demande aux autorités compétentes de prendre les mesures de police sanitaire nécessaires lorsque la santé de la population est menacée, dans les conditions prévues au présent code ou par toute autre disposition législative ou réglementaire visant à préserver la santé humaine.
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Elle établit un rapport annuel d'activité adressé au Gouvernement et au Parlement. Ce rapport est rendu public.
\n
Elle organise des auditions publiques sur des thèmes de santé publique.
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Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000195660", "@nortexte": "ENVP9640024D", "@numtexte": "96-850", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1996-09-20" }, { "@id": "LEGIARTI000006506987", "@num": "3", "#text": "Décret n°98-385 du 18 mai 1998 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000571865", "@nortexte": "MESG9820693D", "@numtexte": "98-385", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1998-05-18" }, { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006724441", "@num": "5", "#text": "Décret n°2001-35 du 11 janvier 2001 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000388987", "@nortexte": "MJSK0070147D", "@numtexte": "2001-35", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2001-01-11" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000006698387", "@num": "4", "#text": "Ordonnance n°2005-1087 du 1 septembre 2005 - art. 4 () JORF 2 septembre 2005", "@sens": "source", "@cidtexte": "JORFTEXT000000261711", "@nortexte": "SANX0500159R", "@numtexte": "2005-1087", "@typelien": "MODIFICATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2005-09-01" }, { "@id": "LEGIARTI000006698388", "@num": "5", "#text": "Ordonnance n°2005-1087 du 1 septembre 2005 - art. 5 () JORF 2 septembre 2005", "@sens": "source", "@cidtexte": "JORFTEXT000000261711", "@nortexte": "SANX0500159R", "@numtexte": "2005-1087", "@typelien": "MODIFICATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2005-09-01" }, { "@id": "LEGIARTI000006254318", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254325", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639980", "@nortexte": "SANP0623382A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254307", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254319", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326653", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020320295", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326611", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254321", "@num": "4", "#text": "Arrêté du 16 août 2006 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254313", "@num": "7", "#text": "Arrêté du 16 août 2006 - art. 7 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006734099", "@num": "ANNEXE", "#text": "Arrêté du 16 août 2006 - art. 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Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000018360158", "@nortexte": "SJSP0805973A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-03-05" }, { "@id": "LEGIARTI000019382668", "@num": "2", "#text": "Arrêté du 11 août 2008 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019381783", "@nortexte": "SJSP0820319A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-08-11" }, { "@id": "LEGIARTI000034448482", "@num": "7", "#text": "Arrêté du 6 février 2009 - art. 7 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000020234297", "@nortexte": "SJSG0824493A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-06" }, { "@id": "LEGITEXT000020319418", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318429", "@nortexte": "SASP0904387A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319427", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318439", "@nortexte": "SASP0904427A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319436", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318449", "@nortexte": "SASP0904394A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGIARTI000021782780", "@num": "Annexe au règlement intérieur", "#text": "Arrêté du 13 janvier 2010 - art. Annexe au règlement intérieur (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000021782073", "@nortexte": "SASP1001133A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-01-13" }, { "@id": "LEGITEXT000022416787", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415149", "@nortexte": "SASP1017123A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416463", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415125", "@nortexte": "SASP1017105A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416472", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415141", "@nortexte": "SASP1017114A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGIARTI000023430029", "@num": "6", "#text": "Décret n°2011-57\n du 13 janvier 2011 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000023428330", "@nortexte": "SPOV1017553D", "@numtexte": "2011-57", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-01-13" }, { "@id": "LEGITEXT000023778069", "#text": "Arrêté du 17 mars 2011 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000023776935", "@nortexte": "ETSP1108041A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-03-17" }, { "@id": "LEGIARTI000025071143", "@num": "38", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 38 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000025071141", "@num": "39", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 39 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000026480621", "@num": "4", "#text": "Arrêté du 10 octobre 2012 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000026479723", "@nortexte": "AFSP1221372A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-10-10" }, { "@id": "LEGIARTI000027648252", "#text": "Arrêté du 23 janvier 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027047902", "@nortexte": "AFSP1228322A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-01-23" }, { "@id": "LEGITEXT000027434552", "#text": "Décret n°2013-414\n du 21 mai 2013 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027434029", "@nortexte": "AFSP1304115D", "@numtexte": "2013-414", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2013-05-21" }, { "@id": "LEGIARTI000027594512", "#text": "Arrêté du 20 juin 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027592947", "@nortexte": "AFSP1313848A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-20" }, { "@id": "LEGIARTI000027699119", "@num": "1", "#text": "Arrêté du 17 juin 2013 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027697076", "@nortexte": "AFSP1301854A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-17" }, { "@id": "LEGIARTI000033202304", "#text": "Arrêté du 29 août 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027910341", "@nortexte": "PROI1311061A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-08-29" }, { "@id": "LEGIARTI000035971526", "#text": "DÉCRET n°2014-1286 du 23 octobre 2014 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029675991", "@nortexte": "AFSX1419046D", "@numtexte": "2014-1286", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000036393921", "@num": "166", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 166 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000031916570", "@num": "169", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 169 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000043508038", "#text": "Arrêté du 28 novembre 2016 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033507693", "@nortexte": "AFSP1633477A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-11-28" }, { "@id": "LEGIARTI000033554483", "@num": "3", "#text": "Arrêté du 2 décembre 2016 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033553349", "@nortexte": "AFSP1635656A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000038887172", "@num": "2", "#text": "LOI n°2017-220 du 23 février 2017 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034078423", "@nortexte": "AFSP1622342L", "@numtexte": "2017-220", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2017-02-23" }, { "@id": "LEGIARTI000034152829", "@num": "1", "#text": "Arrêté du 27 février 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150863", "@nortexte": "AFSP1706243A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000035988048", "@num": "3", "#text": "Arrêté du 27 février 2017 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150842", "@nortexte": "AFSP1706241A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000035269375", "@num": "1", "#text": "Arrêté du 17 juillet 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000035268202", "@nortexte": "SSAE1720859A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-07-17" }, { "@id": "LEGITEXT000036406189", "#text": "Décret n°2017-1781 du 27 décembre 2017 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036299141", "@nortexte": "SSAP1728401D", "@numtexte": "2017-1781", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-12-27" }, { "@id": "LEGIARTI000038432466", "@num": "1", "#text": "Décret n°2019-389 du 30 avril 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000038431240", "@nortexte": "SSAS1906324D", "@numtexte": "2019-389", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-04-30" }, { "@id": "LEGITEXT000039664011", "#text": "Arrêté du 20 décembre 2019 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000039663324", "@nortexte": "SSAP1936730A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-12-20" }, { "@id": "LEGIARTI000041898595", "@num": "10-3-1", "#text": "Arrêté du 23 mars 2020 - art. 10-3-1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000042645749", "@num": "17", "#text": "Ordonnance n°2020-460 du 22 avril 2020 - art. 17 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041814597", "@nortexte": "ECOX2009794R", "@numtexte": "2020-460", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2020-04-22" }, { "@id": "LEGIARTI000041890409", "@num": "1", "#text": "Arrêté du 18 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041889362", "@nortexte": "SSAZ2011564A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-18" }, { "@id": "LEGIARTI000041898504", "@num": "1", "#text": "Arrêté du 20 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041897919", "@nortexte": "SSAZ2012596A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-20" }, { "@id": "LEGIARTI000043298218", "@num": "25", "#text": "Arrêté du 10 juillet 2020 - art. 25 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042609739", "@num": "26", "#text": "Arrêté du 10 juillet 2020 - art. 26 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000043103458", "#text": "Arrêté du 5 février 2021 - art. 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L'Agence française de sécurité sanitaire des produits de santé est un établissement public de l'Etat, placé sous la tutelle du ministre chargé de la santé.
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L'agence participe à l'application des lois et règlements et prend, dans les cas prévus par des dispositions particulières, des décisions relatives à l'évaluation, aux essais, à la fabrication, à la préparation, à l'importation, à l'exportation, à la distribution en gros, au conditionnement, à la conservation, à l'exploitation, à la mise sur le marché, à la publicité, à la mise en service ou à l'utilisation des produits à finalité sanitaire destinés à l'homme et des produits à finalité cosmétique, et notamment :
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1° Les médicaments, y compris les préparations magistrales, hospitalières et officinales, les substances stupéfiantes, psychotropes ou autres substances vénéneuses utilisées en médecine, les huiles essentielles et plantes médicinales, les matières premières à usage pharmaceutique ;
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2° Les produits contraceptifs et contragestifs ;
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3° Les biomatériaux et les dispositifs médicaux ;
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4° Les dispositifs médicaux de diagnostic in vitro ;
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5° Les produits sanguins labiles ;
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6° Les organes, tissus, cellules et produits d'origine humaine ou animale, y compris lorsqu'ils sont prélevés à l'occasion d'une intervention chirurgicale ;
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7° Les produits cellulaires à finalité thérapeutique ;
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8° Le lait maternel collecté, qualifié, préparé et conservé par les lactariums ;
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9° Les produits destinés à l'entretien ou à l'application des lentilles de contact ;
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10° Les produits insecticides, acaricides et antiparasitaires à usage humain ;
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11° Les procédés et appareils destinés à la désinfection des locaux et des véhicules dans les cas prévus à l'article L. 3114-1 ;
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12° Les produits thérapeutiques annexes ;
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13° (Abrogé)
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14° Les lentilles oculaires non correctrices ;
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15° Les produits cosmétiques ;
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16° Les micro-organismes et toxines mentionnés à l'article L. 5139-1 ;
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17° Les produits de tatouage.
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L'agence procède à l'évaluation des bénéfices et des risques liés à l'utilisation de ces produits et objets à tout moment opportun et notamment lorsqu'un élément nouveau est susceptible de remettre en cause l'évaluation initiale. Elle assure la mise en oeuvre des systèmes de vigilance et prépare la pharmacopée.
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Elle rend publique une synthèse des dossiers d'autorisation de tout nouveau médicament. Elle organise des réunions régulières d'information avec des associations agréées de personnes malades et d'usagers du système de santé mentionnées à l'article L. 1114-1 sur les problèmes de sécurité sanitaire des produits de santé.
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Elle contrôle la publicité en faveur de tous les produits, objets, appareils et méthodes revendiquant une finalité sanitaire.
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Elle prend ou demande aux autorités compétentes de prendre les mesures de police sanitaire nécessaires lorsque la santé de la population est menacée, dans les conditions prévues au présent code ou par toute autre disposition législative ou réglementaire visant à préserver la santé humaine.
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Elle établit un rapport annuel d'activité adressé au Gouvernement et au Parlement. Ce rapport est rendu public.
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Elle organise des auditions publiques sur des thèmes de santé publique.
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Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000195660", "@nortexte": "ENVP9640024D", "@numtexte": "96-850", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1996-09-20" }, { "@id": "LEGIARTI000006506987", "@num": "3", "#text": "Décret n°98-385 du 18 mai 1998 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000571865", "@nortexte": "MESG9820693D", "@numtexte": "98-385", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1998-05-18" }, { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006724441", "@num": "5", "#text": "Décret n°2001-35 du 11 janvier 2001 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000388987", "@nortexte": "MJSK0070147D", "@numtexte": "2001-35", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2001-01-11" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000006254318", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254325", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639980", "@nortexte": "SANP0623382A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254307", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254319", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326653", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020320295", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326611", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254321", "@num": "4", "#text": "Arrêté du 16 août 2006 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254313", "@num": "7", "#text": "Arrêté du 16 août 2006 - art. 7 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006734099", "@num": "ANNEXE", "#text": "Arrêté du 16 août 2006 - art. ANNEXE (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639975", "@nortexte": "SANP0623370A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006255223", "@num": "1", "#text": "Arrêté du 11 septembre 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000271992", "@nortexte": "SANP0623792A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-09-11" }, { "@id": "LEGIARTI000020322856", "@num": "3", "#text": "Arrêté du 11 septembre 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000271992", "@nortexte": "SANP0623792A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-09-11" }, { "@id": "LEGIARTI000006697034", "@num": "27", "#text": "Loi n°2007-248 du 26 février 2007 - art. 27 () JORF 27 février 2007", "@sens": "source", "@cidtexte": "JORFTEXT000000613381", "@nortexte": "SANX0600004L", "@numtexte": "2007-248", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2007-02-26" }, { "@id": "LEGIARTI000006697048", "@num": "39", "#text": "Loi n°2007-248 du 26 février 2007 - art. 39 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000613381", "@nortexte": "SANX0600004L", "@numtexte": "2007-248", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2007-02-26" }, { "@id": "LEGIARTI000006868630", "@num": "29", "#text": "Décret n° 2007-358 du 19 mars 2007 - art. 29 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000821090", "@nortexte": "AGRG0700644D", "@numtexte": "2007-358", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-19" }, { "@id": "LEGIARTI000006726837", "@num": "5", "#text": "Décret n°2007-462 du 25 mars 2007 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000466314", "@nortexte": "MJSK0770075D", "@numtexte": "2007-462", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-25" }, { "@id": "LEGIARTI000018361459", "@num": "Annexe", "#text": "Arrêté du 5 mars 2008 - art. Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000018360158", "@nortexte": "SJSP0805973A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-03-05" }, { "@id": "LEGIARTI000019382668", "@num": "2", "#text": "Arrêté du 11 août 2008 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019381783", "@nortexte": "SJSP0820319A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-08-11" }, { "@id": "LEGIARTI000034448482", "@num": "7", "#text": "Arrêté du 6 février 2009 - art. 7 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000020234297", "@nortexte": "SJSG0824493A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-06" }, { "@id": "LEGITEXT000020319418", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318429", "@nortexte": "SASP0904387A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319427", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318439", "@nortexte": "SASP0904427A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319436", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318449", "@nortexte": "SASP0904394A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGIARTI000021782780", "@num": "Annexe au règlement intérieur", "#text": "Arrêté du 13 janvier 2010 - art. Annexe au règlement intérieur (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000021782073", "@nortexte": "SASP1001133A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-01-13" }, { "@id": "LEGITEXT000022416787", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415149", "@nortexte": "SASP1017123A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416463", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415125", "@nortexte": "SASP1017105A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416472", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415141", "@nortexte": "SASP1017114A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGIARTI000023430029", "@num": "6", "#text": "Décret n°2011-57\n du 13 janvier 2011 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000023428330", "@nortexte": "SPOV1017553D", "@numtexte": "2011-57", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-01-13" }, { "@id": "LEGITEXT000023778069", "#text": "Arrêté du 17 mars 2011 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000023776935", "@nortexte": "ETSP1108041A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-03-17" }, { "@id": "LEGIARTI000025071143", "@num": "38", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 38 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000025071141", "@num": "39", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 39 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000026480621", "@num": "4", "#text": "Arrêté du 10 octobre 2012 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000026479723", "@nortexte": "AFSP1221372A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-10-10" }, { "@id": "LEGIARTI000027648252", "#text": "Arrêté du 23 janvier 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027047902", "@nortexte": "AFSP1228322A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-01-23" }, { "@id": "LEGITEXT000027434552", "#text": "Décret n°2013-414\n du 21 mai 2013 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027434029", "@nortexte": "AFSP1304115D", "@numtexte": "2013-414", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2013-05-21" }, { "@id": "LEGIARTI000027594512", "#text": "Arrêté du 20 juin 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027592947", "@nortexte": "AFSP1313848A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-20" }, { "@id": "LEGIARTI000027699119", "@num": "1", "#text": "Arrêté du 17 juin 2013 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027697076", "@nortexte": "AFSP1301854A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-17" }, { "@id": "LEGIARTI000033202304", "#text": "Arrêté du 29 août 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027910341", "@nortexte": "PROI1311061A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-08-29" }, { "@id": "LEGIARTI000035971526", "#text": "DÉCRET n°2014-1286 du 23 octobre 2014 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029675991", "@nortexte": "AFSX1419046D", "@numtexte": "2014-1286", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000036393921", "@num": "166", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 166 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000031916570", "@num": "169", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 169 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000043508038", "#text": "Arrêté du 28 novembre 2016 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033507693", "@nortexte": "AFSP1633477A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-11-28" }, { "@id": "LEGIARTI000033554483", "@num": "3", "#text": "Arrêté du 2 décembre 2016 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033553349", "@nortexte": "AFSP1635656A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000038887172", "@num": "2", "#text": "LOI n°2017-220 du 23 février 2017 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034078423", "@nortexte": "AFSP1622342L", "@numtexte": "2017-220", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2017-02-23" }, { "@id": "LEGIARTI000034152829", "@num": "1", "#text": "Arrêté du 27 février 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150863", "@nortexte": "AFSP1706243A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000035988048", "@num": "3", "#text": "Arrêté du 27 février 2017 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150842", "@nortexte": "AFSP1706241A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000035269375", "@num": "1", "#text": "Arrêté du 17 juillet 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000035268202", "@nortexte": "SSAE1720859A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-07-17" }, { "@id": "LEGITEXT000036406189", "#text": "Décret n°2017-1781 du 27 décembre 2017 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036299141", "@nortexte": "SSAP1728401D", "@numtexte": "2017-1781", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-12-27" }, { "@id": "LEGIARTI000038432466", "@num": "1", "#text": "Décret n°2019-389 du 30 avril 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000038431240", "@nortexte": "SSAS1906324D", "@numtexte": "2019-389", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-04-30" }, { "@id": "LEGITEXT000039664011", "#text": "Arrêté du 20 décembre 2019 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000039663324", "@nortexte": "SSAP1936730A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-12-20" }, { "@id": "LEGIARTI000041898595", "@num": "10-3-1", "#text": "Arrêté du 23 mars 2020 - art. 10-3-1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000042645749", "@num": "17", "#text": "Ordonnance n°2020-460 du 22 avril 2020 - art. 17 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041814597", "@nortexte": "ECOX2009794R", "@numtexte": "2020-460", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2020-04-22" }, { "@id": "LEGIARTI000041890409", "@num": "1", "#text": "Arrêté du 18 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041889362", "@nortexte": "SSAZ2011564A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-18" }, { "@id": "LEGIARTI000041898504", "@num": "1", "#text": "Arrêté du 20 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041897919", "@nortexte": "SSAZ2012596A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-20" }, { "@id": "LEGIARTI000043298218", "@num": "25", "#text": "Arrêté du 10 juillet 2020 - art. 25 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042609739", "@num": "26", "#text": "Arrêté du 10 juillet 2020 - art. 26 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000043103458", "#text": "Arrêté du 5 février 2021 - art. (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000043100729", "@nortexte": "SSAP2104251A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-02-05" }, { "@id": "LEGIARTI000043298491", "@num": "3", "#text": "Décret n°2021-331 du 26 mars 2021 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000043297285", "@nortexte": "SSAS2034156D", "@numtexte": "2021-331", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-03-26" }, { "@id": "LEGITEXT000043543262", "#text": "Décret n°2021-662 du 26 mai 2021 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043541690", "@nortexte": "ECOI2106880D", "@numtexte": "2021-662", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-05-26" }, { "@id": "LEGIARTI000043543283", "#text": "Décret n°2021-662 du 26 mai 2021 - art.", "@sens": "cible", "@cidtexte": "JORFTEXT000043541690", "@nortexte": "ECOI2106880D", "@numtexte": "2021-662", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-05-26" }, { "@id": "LEGIARTI000047779186", "@num": "25", "#text": "Arrêté du 1 juin 2021 - art. 25 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000043770220", "@num": "27", "#text": "Arrêté du 1er juin 2021 - art. 27 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000046567251", "@num": "Annexe 2", "#text": "Arrêté du 14 novembre 2022 - art. 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L'Agence française de sécurité sanitaire des produits de santé est un établissement public de l'Etat, placé sous la tutelle du ministre chargé de la santé.
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L'agence participe à l'application des lois et règlements et prend, dans les cas prévus par des dispositions particulières, des décisions relatives à l'évaluation, aux essais, à la fabrication, à la préparation, à l'importation, à l'exportation, à la distribution en gros, au conditionnement, à la conservation, à l'exploitation, à la mise sur le marché, à la publicité, à la mise en service ou à l'utilisation des produits à finalité sanitaire destinés à l'homme et des produits à finalité cosmétique, et notamment :
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1° Les médicaments, y compris les préparations magistrales, hospitalières et officinales, les substances stupéfiantes, psychotropes ou autres substances vénéneuses utilisées en médecine, les huiles essentielles et plantes médicinales, les matières premières à usage pharmaceutique ;
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2° Les produits contraceptifs et contragestifs ;
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3° Les biomatériaux et les dispositifs médicaux ;
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4° Les dispositifs médicaux de diagnostic in vitro ;
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5° Les produits sanguins labiles ;
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6° Les organes, tissus, cellules et produits d'origine humaine ou animale, y compris lorsqu'ils sont prélevés à l'occasion d'une intervention chirurgicale ;
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7° Les produits cellulaires à finalité thérapeutique ;
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8° Le lait maternel collecté, qualifié, préparé et conservé par les lactariums ;
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9° Les produits destinés à l'entretien ou à l'application des lentilles de contact ;
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10° Les produits insecticides, acaricides et antiparasitaires à usage humain ;
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11° Les procédés et appareils destinés à la désinfection des locaux et des véhicules dans les cas prévus à l'article L. 3114-1 ;
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12° Les produits thérapeutiques annexes ;
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13° (Abrogé)
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14° Les lentilles oculaires non correctrices ;
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15° Les produits cosmétiques ;
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16° Les micro-organismes et toxines mentionnés à l'article L. 5139-1 ;
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17° Les produits de tatouage.
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L'agence procède à l'évaluation des bénéfices et des risques liés à l'utilisation de ces produits et objets à tout moment opportun et notamment lorsqu'un élément nouveau est susceptible de remettre en cause l'évaluation initiale. Elle assure la mise en oeuvre des systèmes de vigilance et prépare la pharmacopée.
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Elle rend publics un rapport de synthèse de l'évaluation effectuée pour tout nouveau médicament dans des conditions déterminées par voie réglementaire, ainsi que les décisions d'octroi, de suspension et de retrait de l'autorisation de mise sur le marché mentionnées aux articles L. 5121-8 et L. 5121-9. Elle organise des réunions régulières d'information avec des associations agréées de personnes malades et d'usagers du système de santé mentionnées à l'article L. 1114-1 sur les problèmes de sécurité sanitaire des produits de santé.
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Elle contrôle la publicité en faveur de tous les produits, objets, appareils et méthodes revendiquant une finalité sanitaire.
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Elle prend ou demande aux autorités compétentes de prendre les mesures de police sanitaire nécessaires lorsque la santé de la population est menacée, dans les conditions prévues au présent code ou par toute autre disposition législative ou réglementaire visant à préserver la santé humaine.
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Elle établit un rapport annuel d'activité adressé au Gouvernement et au Parlement. Ce rapport est rendu public.
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Elle organise des auditions publiques sur des thèmes de santé publique.
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Elle rend également publics l'ordre du jour et les comptes rendus, assortis des détails et explications des votes, y compris les opinions minoritaires, à l'exclusion de toute information présentant un caractère de confidentialité commerciale, des réunions des commissions siégeant auprès d'elle et consultées en matière de mise sur le marché, de pharmacovigilance et de publicité des spécialités pharmaceutiques, son règlement intérieur et celui des commissions précitées.
" } }, "LEGIARTI000006690351": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5311-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2008-06-01", "DATE_DEBUT": "2007-04-27" } }, "META_COMMUN": { "ID": "LEGIARTI000006690351", "URL": "article/LEGI/ARTI/00/00/06/69/03/LEGIARTI000006690351.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5311L01XXAH" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006630983", "@num": "1", "#text": "Décret n°81-278 du 25 mars 1981 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000503017", "@numtexte": "81-278", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1981-03-25" }, { "@id": "LEGIARTI000006631025", "@num": "Annexe I", "#text": "Décret n°81-278 du 25 mars 1981 - art. Annexe I (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000503017", "@numtexte": "81-278", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1981-03-25" }, { "@id": "LEGIARTI000035606736", "@num": "2-1", "#text": "Décret n°90-975 du 30 octobre 1990 - art. 2-1 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000000160314", "@nortexte": "SPSG9001546D", "@numtexte": "90-975", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1990-10-30" }, { "@id": "LEGIARTI000006712582", "@num": "2", "#text": "Décret n°92-1432 du 30 décembre 1992 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000726011", "@nortexte": "SPSG9202710D", "@numtexte": "92-1432", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1992-12-30" }, { "@id": "LEGIARTI000006355280", "@num": "87", "#text": "Loi n°93-122 du 29 janvier 1993 - art. 87 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000711604", "@nortexte": "PRMX9200148L", "@numtexte": "93-122", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "1993-01-29" }, { "@id": "LEGIARTI000006865783", "@num": "Annexe", "#text": "Décret n°96-850 du 20 septembre 1996 - art. Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000195660", "@nortexte": "ENVP9640024D", "@numtexte": "96-850", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1996-09-20" }, { "@id": "LEGIARTI000006506987", "@num": "3", "#text": "Décret n°98-385 du 18 mai 1998 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000571865", "@nortexte": "MESG9820693D", "@numtexte": "98-385", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1998-05-18" }, { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006724441", "@num": "5", "#text": "Décret n°2001-35 du 11 janvier 2001 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000388987", "@nortexte": "MJSK0070147D", "@numtexte": "2001-35", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2001-01-11" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000006254318", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254325", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639980", "@nortexte": "SANP0623382A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254307", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254319", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326653", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020320295", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326611", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254321", "@num": "4", "#text": "Arrêté du 16 août 2006 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254313", "@num": "7", "#text": "Arrêté du 16 août 2006 - art. 7 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006734099", "@num": "ANNEXE", "#text": "Arrêté du 16 août 2006 - art. ANNEXE (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639975", "@nortexte": "SANP0623370A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006255223", "@num": "1", "#text": "Arrêté du 11 septembre 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000271992", "@nortexte": "SANP0623792A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-09-11" }, { "@id": "LEGIARTI000020322856", "@num": "3", "#text": "Arrêté du 11 septembre 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000271992", "@nortexte": "SANP0623792A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-09-11" }, { "@id": "LEGIARTI000006697048", "@num": "39", "#text": "Loi n°2007-248 du 26 février 2007 - art. 39 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000613381", "@nortexte": "SANX0600004L", "@numtexte": "2007-248", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2007-02-26" }, { "@id": "LEGIARTI000006868630", "@num": "29", "#text": "Décret n° 2007-358 du 19 mars 2007 - art. 29 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000821090", "@nortexte": "AGRG0700644D", "@numtexte": "2007-358", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-19" }, { "@id": "LEGIARTI000006726837", "@num": "5", "#text": "Décret n°2007-462 du 25 mars 2007 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000466314", "@nortexte": "MJSK0770075D", "@numtexte": "2007-462", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-25" }, { "@id": "LEGIARTI000006698445", "@num": "27", "#text": "Ordonnance n°2007-613 du 26 avril 2007 - art. 27 () JORF 27 avril 2007", "@sens": "source", "@cidtexte": "JORFTEXT000000646989", "@nortexte": "SANX0700046R", "@numtexte": "2007-613", "@typelien": "MODIFICATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2007-04-26" }, { "@id": "LEGIARTI000018361459", "@num": "Annexe", "#text": "Arrêté du 5 mars 2008 - art. Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000018360158", "@nortexte": "SJSP0805973A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-03-05" }, { "@id": "LEGIARTI000019382668", "@num": "2", "#text": "Arrêté du 11 août 2008 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019381783", "@nortexte": "SJSP0820319A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-08-11" }, { "@id": "LEGIARTI000034448482", "@num": "7", "#text": "Arrêté du 6 février 2009 - art. 7 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000020234297", "@nortexte": "SJSG0824493A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-06" }, { "@id": "LEGITEXT000020319418", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318429", "@nortexte": "SASP0904387A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319427", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318439", "@nortexte": "SASP0904427A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319436", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318449", "@nortexte": "SASP0904394A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGIARTI000021782780", "@num": "Annexe au règlement intérieur", "#text": "Arrêté du 13 janvier 2010 - art. Annexe au règlement intérieur (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000021782073", "@nortexte": "SASP1001133A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-01-13" }, { "@id": "LEGITEXT000022416787", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415149", "@nortexte": "SASP1017123A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416463", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415125", "@nortexte": "SASP1017105A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416472", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415141", "@nortexte": "SASP1017114A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGIARTI000023430029", "@num": "6", "#text": "Décret n°2011-57\n du 13 janvier 2011 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000023428330", "@nortexte": "SPOV1017553D", "@numtexte": "2011-57", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-01-13" }, { "@id": "LEGITEXT000023778069", "#text": "Arrêté du 17 mars 2011 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000023776935", "@nortexte": "ETSP1108041A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-03-17" }, { "@id": "LEGIARTI000025071143", "@num": "38", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 38 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000025071141", "@num": "39", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 39 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000026480621", "@num": "4", "#text": "Arrêté du 10 octobre 2012 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000026479723", "@nortexte": "AFSP1221372A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-10-10" }, { "@id": "LEGIARTI000027648252", "#text": "Arrêté du 23 janvier 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027047902", "@nortexte": "AFSP1228322A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-01-23" }, { "@id": "LEGITEXT000027434552", "#text": "Décret n°2013-414\n du 21 mai 2013 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027434029", "@nortexte": "AFSP1304115D", "@numtexte": "2013-414", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2013-05-21" }, { "@id": "LEGIARTI000027594512", "#text": "Arrêté du 20 juin 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027592947", "@nortexte": "AFSP1313848A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-20" }, { "@id": "LEGIARTI000027699119", "@num": "1", "#text": "Arrêté du 17 juin 2013 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027697076", "@nortexte": "AFSP1301854A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-17" }, { "@id": "LEGIARTI000033202304", "#text": "Arrêté du 29 août 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027910341", "@nortexte": "PROI1311061A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-08-29" }, { "@id": "LEGIARTI000035971526", "#text": "DÉCRET n°2014-1286 du 23 octobre 2014 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029675991", "@nortexte": "AFSX1419046D", "@numtexte": "2014-1286", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000036393921", "@num": "166", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 166 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000031916570", "@num": "169", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 169 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000043508038", "#text": "Arrêté du 28 novembre 2016 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033507693", "@nortexte": "AFSP1633477A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-11-28" }, { "@id": "LEGIARTI000033554483", "@num": "3", "#text": "Arrêté du 2 décembre 2016 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033553349", "@nortexte": "AFSP1635656A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000038887172", "@num": "2", "#text": "LOI n°2017-220 du 23 février 2017 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034078423", "@nortexte": "AFSP1622342L", "@numtexte": "2017-220", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2017-02-23" }, { "@id": "LEGIARTI000034152829", "@num": "1", "#text": "Arrêté du 27 février 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150863", "@nortexte": "AFSP1706243A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000035988048", "@num": "3", "#text": "Arrêté du 27 février 2017 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150842", "@nortexte": "AFSP1706241A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000035269375", "@num": "1", "#text": "Arrêté du 17 juillet 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000035268202", "@nortexte": "SSAE1720859A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-07-17" }, { "@id": "LEGITEXT000036406189", "#text": "Décret n°2017-1781 du 27 décembre 2017 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036299141", "@nortexte": "SSAP1728401D", "@numtexte": "2017-1781", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-12-27" }, { "@id": "LEGIARTI000038432466", "@num": "1", "#text": "Décret n°2019-389 du 30 avril 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000038431240", "@nortexte": "SSAS1906324D", "@numtexte": "2019-389", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-04-30" }, { "@id": "LEGITEXT000039664011", "#text": "Arrêté du 20 décembre 2019 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000039663324", "@nortexte": "SSAP1936730A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-12-20" }, { "@id": "LEGIARTI000041898595", "@num": "10-3-1", "#text": "Arrêté du 23 mars 2020 - art. 10-3-1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000042645749", "@num": "17", "#text": "Ordonnance n°2020-460 du 22 avril 2020 - art. 17 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041814597", "@nortexte": "ECOX2009794R", "@numtexte": "2020-460", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2020-04-22" }, { "@id": "LEGIARTI000041890409", "@num": "1", "#text": "Arrêté du 18 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041889362", "@nortexte": "SSAZ2011564A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-18" }, { "@id": "LEGIARTI000041898504", "@num": "1", "#text": "Arrêté du 20 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041897919", "@nortexte": "SSAZ2012596A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-20" }, { "@id": "LEGIARTI000043298218", "@num": "25", "#text": "Arrêté du 10 juillet 2020 - art. 25 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042609739", "@num": "26", "#text": "Arrêté du 10 juillet 2020 - art. 26 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000043103458", "#text": "Arrêté du 5 février 2021 - art. 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L'Agence française de sécurité sanitaire des produits de santé est un établissement public de l'Etat, placé sous la tutelle du ministre chargé de la santé.
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L'agence participe à l'application des lois et règlements et prend, dans les cas prévus par des dispositions particulières, des décisions relatives à l'évaluation, aux essais, à la fabrication, à la préparation, à l'importation, à l'exportation, à la distribution en gros, au conditionnement, à la conservation, à l'exploitation, à la mise sur le marché, à la publicité, à la mise en service ou à l'utilisation des produits à finalité sanitaire destinés à l'homme et des produits à finalité cosmétique, et notamment :
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1° Les médicaments, y compris les préparations magistrales, hospitalières et officinales, les substances stupéfiantes, psychotropes ou autres substances vénéneuses utilisées en médecine, les insecticides, acaricides et antiparasitaires à usage humain, les huiles essentielles et plantes médicinales, les matières premières à usage pharmaceutique ;
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2° Les produits contraceptifs et contragestifs ;
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3° Les biomatériaux et les dispositifs médicaux ;
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4° Les dispositifs médicaux de diagnostic in vitro ;
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5° Les produits sanguins labiles ;
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6° Les organes, tissus, cellules et produits d'origine humaine ou animale, y compris lorsqu'ils sont prélevés à l'occasion d'une intervention chirurgicale ;
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7° Les produits cellulaires à finalité thérapeutique ;
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8° Le lait maternel collecté, qualifié, préparé et conservé par les lactariums ;
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9° Les produits destinés à l'entretien ou à l'application des lentilles de contact ;
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10° (Abrogé)
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11° Les procédés et appareils destinés à la désinfection des locaux et des véhicules dans les cas prévus à l'article L. 3114-1 ;
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12° Les produits thérapeutiques annexes ;
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13° (Abrogé)
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14° Les lentilles oculaires non correctrices ;
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15° Les produits cosmétiques ;
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16° Les micro-organismes et toxines mentionnés à l'article L. 5139-1 ;
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17° Les produits de tatouage.
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L'agence procède à l'évaluation des bénéfices et des risques liés à l'utilisation de ces produits et objets à tout moment opportun et notamment lorsqu'un élément nouveau est susceptible de remettre en cause l'évaluation initiale. Elle assure la mise en oeuvre des systèmes de vigilance et prépare la pharmacopée.
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Elle rend publics un rapport de synthèse de l'évaluation effectuée pour tout nouveau médicament dans des conditions déterminées par voie réglementaire, ainsi que les décisions d'octroi, de suspension et de retrait de l'autorisation de mise sur le marché mentionnées aux articles L. 5121-8 et L. 5121-9. Elle organise des réunions régulières d'information avec des associations agréées de personnes malades et d'usagers du système de santé mentionnées à l'article L. 1114-1 sur les problèmes de sécurité sanitaire des produits de santé.
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Elle contrôle la publicité en faveur de tous les produits, objets, appareils et méthodes revendiquant une finalité sanitaire.
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Elle prend ou demande aux autorités compétentes de prendre les mesures de police sanitaire nécessaires lorsque la santé de la population est menacée, dans les conditions prévues au présent code ou par toute autre disposition législative ou réglementaire visant à préserver la santé humaine.
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Elle établit un rapport annuel d'activité adressé au Gouvernement et au Parlement. Ce rapport est rendu public.
\n
Elle organise des auditions publiques sur des thèmes de santé publique.
\n
Elle rend également publics l'ordre du jour et les comptes rendus, assortis des détails et explications des votes, y compris les opinions minoritaires, à l'exclusion de toute information présentant un caractère de confidentialité commerciale, des réunions des commissions siégeant auprès d'elle et consultées en matière de mise sur le marché, de pharmacovigilance et de publicité des spécialités pharmaceutiques, son règlement intérieur et celui des commissions précitées.
" } }, "LEGIARTI000018652199": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5311-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2009-07-23", "DATE_DEBUT": "2008-06-01" } }, "META_COMMUN": { "ID": "LEGIARTI000018652199", "URL": "article/LEGI/ARTI/00/00/18/65/21/LEGIARTI000018652199.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Loi n° 2008-337 du 15 avril 2008 article 7 II : Le I entre en vigueur au 1er juin 2008. A cet effet, le ministre chargé de la santé se prononce au titre des articles L. 1123-8 et L. 1123-9 du code de la santé publique sur les demandes d'autorisation déposées jusqu'au 31 mai 2008 inclus concernant les recherches biomédicales autres que celles portant sur des produits mentionnés à l'article L. 5311-1 du même code.

" }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006630983", "@num": "1", "#text": "Décret n°81-278 du 25 mars 1981 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000503017", "@numtexte": "81-278", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1981-03-25" }, { "@id": "LEGIARTI000006631025", "@num": "Annexe I", "#text": "Décret n°81-278 du 25 mars 1981 - art. Annexe I (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000503017", "@numtexte": "81-278", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1981-03-25" }, { "@id": "LEGIARTI000035606736", "@num": "2-1", "#text": "Décret n°90-975 du 30 octobre 1990 - art. 2-1 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000000160314", "@nortexte": "SPSG9001546D", "@numtexte": "90-975", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1990-10-30" }, { "@id": "LEGIARTI000006712582", "@num": "2", "#text": "Décret n°92-1432 du 30 décembre 1992 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000726011", "@nortexte": "SPSG9202710D", "@numtexte": "92-1432", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1992-12-30" }, { "@id": "LEGIARTI000006355280", "@num": "87", "#text": "Loi n°93-122 du 29 janvier 1993 - art. 87 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000711604", "@nortexte": "PRMX9200148L", "@numtexte": "93-122", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "1993-01-29" }, { "@id": "LEGIARTI000006865783", "@num": "Annexe", "#text": "Décret n°96-850 du 20 septembre 1996 - art. Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000195660", "@nortexte": "ENVP9640024D", "@numtexte": "96-850", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1996-09-20" }, { "@id": "LEGIARTI000006506987", "@num": "3", "#text": "Décret n°98-385 du 18 mai 1998 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000571865", "@nortexte": "MESG9820693D", "@numtexte": "98-385", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1998-05-18" }, { "@id": "LEGIARTI000006724441", "@num": "5", "#text": "Décret n°2001-35 du 11 janvier 2001 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000388987", "@nortexte": "MJSK0070147D", "@numtexte": "2001-35", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2001-01-11" }, { "@id": "LEGIARTI000006254318", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254325", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639980", "@nortexte": "SANP0623382A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254307", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254319", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326653", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020320295", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326611", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254321", "@num": "4", "#text": "Arrêté du 16 août 2006 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254313", "@num": "7", "#text": "Arrêté du 16 août 2006 - art. 7 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006734099", "@num": "ANNEXE", "#text": "Arrêté du 16 août 2006 - art. ANNEXE (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639975", "@nortexte": "SANP0623370A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006255223", "@num": "1", "#text": "Arrêté du 11 septembre 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000271992", "@nortexte": "SANP0623792A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-09-11" }, { "@id": "LEGIARTI000020322856", "@num": "3", "#text": "Arrêté du 11 septembre 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000271992", "@nortexte": "SANP0623792A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-09-11" }, { "@id": "LEGIARTI000006697048", "@num": "39", "#text": "Loi n°2007-248 du 26 février 2007 - art. 39 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000613381", "@nortexte": "SANX0600004L", "@numtexte": "2007-248", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2007-02-26" }, { "@id": "LEGIARTI000006868630", "@num": "29", "#text": "Décret n° 2007-358 du 19 mars 2007 - art. 29 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000821090", "@nortexte": "AGRG0700644D", "@numtexte": "2007-358", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-19" }, { "@id": "LEGIARTI000006726837", "@num": "5", "#text": "Décret n°2007-462 du 25 mars 2007 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000466314", "@nortexte": "MJSK0770075D", "@numtexte": "2007-462", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-25" }, { "@id": "LEGIARTI000018361459", "@num": "Annexe", "#text": "Arrêté du 5 mars 2008 - art. Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000018360158", "@nortexte": "SJSP0805973A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-03-05" }, { "@id": "LEGIARTI000018650946", "@num": "6", "#text": "LOI n°2008-337\n du 15 avril 2008 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000018649718", "@nortexte": "SJSX0755912L", "@numtexte": "2008-337", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2008-04-15" }, { "@id": "LEGIARTI000018650936", "@num": "7", "#text": "LOI n°2008-337\n du 15 avril 2008 - art. 7 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000018649718", "@nortexte": "SJSX0755912L", "@numtexte": "2008-337", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2008-04-15" }, { "@id": "LEGIARTI000019382668", "@num": "2", "#text": "Arrêté du 11 août 2008 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019381783", "@nortexte": "SJSP0820319A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-08-11" }, { "@id": "LEGIARTI000034448482", "@num": "7", "#text": "Arrêté du 6 février 2009 - art. 7 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000020234297", "@nortexte": "SJSG0824493A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-06" }, { "@id": "LEGITEXT000020319418", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318429", "@nortexte": "SASP0904387A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319427", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318439", "@nortexte": "SASP0904427A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319436", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318449", "@nortexte": "SASP0904394A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGIARTI000021782780", "@num": "Annexe au règlement intérieur", "#text": "Arrêté du 13 janvier 2010 - art. Annexe au règlement intérieur (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000021782073", "@nortexte": "SASP1001133A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-01-13" }, { "@id": "LEGITEXT000022416787", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415149", "@nortexte": "SASP1017123A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416463", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415125", "@nortexte": "SASP1017105A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416472", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415141", "@nortexte": "SASP1017114A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGIARTI000023430029", "@num": "6", "#text": "Décret n°2011-57\n du 13 janvier 2011 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000023428330", "@nortexte": "SPOV1017553D", "@numtexte": "2011-57", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-01-13" }, { "@id": "LEGITEXT000023778069", "#text": "Arrêté du 17 mars 2011 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000023776935", "@nortexte": "ETSP1108041A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-03-17" }, { "@id": "LEGIARTI000025071143", "@num": "38", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 38 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000025071141", "@num": "39", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 39 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000026480621", "@num": "4", "#text": "Arrêté du 10 octobre 2012 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000026479723", "@nortexte": "AFSP1221372A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-10-10" }, { "@id": "LEGIARTI000027648252", "#text": "Arrêté du 23 janvier 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027047902", "@nortexte": "AFSP1228322A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-01-23" }, { "@id": "LEGITEXT000027434552", "#text": "Décret n°2013-414\n du 21 mai 2013 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027434029", "@nortexte": "AFSP1304115D", "@numtexte": "2013-414", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2013-05-21" }, { "@id": "LEGIARTI000027594512", "#text": "Arrêté du 20 juin 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027592947", "@nortexte": "AFSP1313848A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-20" }, { "@id": "LEGIARTI000027699119", "@num": "1", "#text": "Arrêté du 17 juin 2013 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027697076", "@nortexte": "AFSP1301854A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-17" }, { "@id": "LEGIARTI000033202304", "#text": "Arrêté du 29 août 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027910341", "@nortexte": "PROI1311061A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-08-29" }, { "@id": "LEGIARTI000035971526", "#text": "DÉCRET n°2014-1286 du 23 octobre 2014 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029675991", "@nortexte": "AFSX1419046D", "@numtexte": "2014-1286", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000036393921", "@num": "166", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 166 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000031916570", "@num": "169", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 169 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000043508038", "#text": "Arrêté du 28 novembre 2016 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033507693", "@nortexte": "AFSP1633477A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-11-28" }, { "@id": "LEGIARTI000033554483", "@num": "3", "#text": "Arrêté du 2 décembre 2016 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033553349", "@nortexte": "AFSP1635656A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000038887172", "@num": "2", "#text": "LOI n°2017-220 du 23 février 2017 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034078423", "@nortexte": "AFSP1622342L", "@numtexte": "2017-220", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2017-02-23" }, { "@id": "LEGIARTI000034152829", "@num": "1", "#text": "Arrêté du 27 février 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150863", "@nortexte": "AFSP1706243A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000035988048", "@num": "3", "#text": "Arrêté du 27 février 2017 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150842", "@nortexte": "AFSP1706241A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000035269375", "@num": "1", "#text": "Arrêté du 17 juillet 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000035268202", "@nortexte": "SSAE1720859A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-07-17" }, { "@id": "LEGITEXT000036406189", "#text": "Décret n°2017-1781 du 27 décembre 2017 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036299141", "@nortexte": "SSAP1728401D", "@numtexte": "2017-1781", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-12-27" }, { "@id": "LEGIARTI000038432466", "@num": "1", "#text": "Décret n°2019-389 du 30 avril 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000038431240", "@nortexte": "SSAS1906324D", "@numtexte": "2019-389", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-04-30" }, { "@id": "LEGITEXT000039664011", "#text": "Arrêté du 20 décembre 2019 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000039663324", "@nortexte": "SSAP1936730A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-12-20" }, { "@id": "LEGIARTI000041898595", "@num": "10-3-1", "#text": "Arrêté du 23 mars 2020 - art. 10-3-1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000042645749", "@num": "17", "#text": "Ordonnance n°2020-460 du 22 avril 2020 - art. 17 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041814597", "@nortexte": "ECOX2009794R", "@numtexte": "2020-460", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2020-04-22" }, { "@id": "LEGIARTI000041890409", "@num": "1", "#text": "Arrêté du 18 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041889362", "@nortexte": "SSAZ2011564A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-18" }, { "@id": "LEGIARTI000041898504", "@num": "1", "#text": "Arrêté du 20 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041897919", "@nortexte": "SSAZ2012596A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-20" }, { "@id": "LEGIARTI000043298218", "@num": "25", "#text": "Arrêté du 10 juillet 2020 - art. 25 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042609739", "@num": "26", "#text": "Arrêté du 10 juillet 2020 - art. 26 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000043103458", "#text": "Arrêté du 5 février 2021 - art. (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000043100729", "@nortexte": "SSAP2104251A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-02-05" }, { "@id": "LEGIARTI000043298491", "@num": "3", "#text": "Décret n°2021-331 du 26 mars 2021 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000043297285", "@nortexte": "SSAS2034156D", "@numtexte": "2021-331", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-03-26" }, { "@id": "LEGITEXT000043543262", "#text": "Décret n°2021-662 du 26 mai 2021 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043541690", "@nortexte": "ECOI2106880D", "@numtexte": "2021-662", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-05-26" }, { "@id": "LEGIARTI000043543283", "#text": "Décret n°2021-662 du 26 mai 2021 - art.", "@sens": "cible", "@cidtexte": "JORFTEXT000043541690", "@nortexte": "ECOI2106880D", "@numtexte": "2021-662", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-05-26" }, { "@id": "LEGIARTI000047779186", "@num": "25", "#text": "Arrêté du 1 juin 2021 - art. 25 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000043770220", "@num": "27", "#text": "Arrêté du 1er juin 2021 - art. 27 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000046567251", "@num": "Annexe 2", "#text": "Arrêté du 14 novembre 2022 - art. 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L'Agence française de sécurité sanitaire des produits de santé est un établissement public de l'Etat, placé sous la tutelle du ministre chargé de la santé.

L'agence participe à l'application des lois et règlements et prend, dans les cas prévus par des dispositions particulières, des décisions relatives à l'évaluation, aux essais, à la fabrication, à la préparation, à l'importation, à l'exportation, à la distribution en gros, au conditionnement, à la conservation, à l'exploitation, à la mise sur le marché, à la publicité, à la mise en service ou à l'utilisation des produits à finalité sanitaire destinés à l'homme et des produits à finalité cosmétique, et notamment :

1° Les médicaments, y compris les insecticides, acaricides et antiparasitaires à usage humain, les préparations magistrales, hospitalières et officinales, les substances stupéfiantes, psychotropes ou autres substances vénéneuses utilisées en médecine, les huiles essentielles et plantes médicinales, les matières premières à usage pharmaceutique ;

2° Les produits contraceptifs et contragestifs ;

3° Les biomatériaux et les dispositifs médicaux ;

4° Les dispositifs médicaux de diagnostic in vitro ;

5° Les produits sanguins labiles ;

6° Les organes, tissus, cellules et produits d'origine humaine ou animale, y compris lorsqu'ils sont prélevés à l'occasion d'une intervention chirurgicale ;

7° Les produits cellulaires à finalité thérapeutique ;

8° Le lait maternel collecté, qualifié, préparé et conservé par les lactariums ;

9° Les produits destinés à l'entretien ou à l'application des lentilles de contact ;

10° (Abrogé)

11° Les procédés et appareils destinés à la désinfection des locaux et des véhicules dans les cas prévus à l'article L. 3114-1 ;

12° Les produits thérapeutiques annexes ;

13° (Abrogé)

14° Les lentilles oculaires non correctrices ;

15° Les produits cosmétiques ;

16° Les micro-organismes et toxines mentionnés à l'article L. 5139-1 ;

17° Les produits de tatouage.

L'agence participe à l'application des lois et règlements relatifs aux recherches biomédicales et prend, dans les cas prévus par des dispositions particulières, des décisions relatives aux recherches biomédicales.

L'agence procède à l'évaluation des bénéfices et des risques liés à l'utilisation de ces produits et objets à tout moment opportun et notamment lorsqu'un élément nouveau est susceptible de remettre en cause l'évaluation initiale. Elle assure la mise en oeuvre des systèmes de vigilance et prépare la pharmacopée.

Elle rend publics un rapport de synthèse de l'évaluation effectuée pour tout nouveau médicament dans des conditions déterminées par voie réglementaire, ainsi que les décisions d'octroi, de suspension et de retrait de l'autorisation de mise sur le marché mentionnées aux articles L. 5121-8 et L. 5121-9. Elle organise des réunions régulières d'information avec des associations agréées de personnes malades et d'usagers du système de santé mentionnées à l'article L. 1114-1 sur les problèmes de sécurité sanitaire des produits de santé.

Elle contrôle la publicité en faveur de tous les produits, objets, appareils et méthodes revendiquant une finalité sanitaire.

Elle prend ou demande aux autorités compétentes de prendre les mesures de police sanitaire nécessaires lorsque la santé de la population est menacée, dans les conditions prévues au présent code ou par toute autre disposition législative ou réglementaire visant à préserver la santé humaine.

Elle établit un rapport annuel d'activité adressé au Gouvernement et au Parlement. Ce rapport est rendu public.

Elle organise des auditions publiques sur des thèmes de santé publique.

Elle rend également publics l'ordre du jour et les comptes rendus, assortis des détails et explications des votes, y compris les opinions minoritaires, à l'exclusion de toute information présentant un caractère de confidentialité commerciale, des réunions des commissions siégeant auprès d'elle et consultées en matière de mise sur le marché, de pharmacovigilance et de publicité des spécialités pharmaceutiques, son règlement intérieur et celui des commissions précitées.

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On entend par :

1° (Abrogé) ;

4° Prémélange médicamenteux, tout médicament vétérinaire préparé à l'avance et exclusivement destiné à la fabrication ultérieure d'aliments médicamenteux ;

6° Médicaments vétérinaires antiparasitaires, tout produit antiparasitaire à usage vétérinaire, ainsi que les produits qui revendiquent une action antiparasitaire externe avec une action létale sur le parasite ;

11° Préparation extemporanée vétérinaire, tout médicament vétérinaire qui est préparé au moment de son utilisation ;

12° Préparation magistrale vétérinaire, toute préparation extemporanée vétérinaire réalisée selon une prescription destinée à un animal ou à des animaux d'une même exploitation ;

14° Temps d'attente, la période nécessaire entre la dernière administration du médicament vétérinaire à l'animal dans les conditions normales d'emploi et l'obtention des denrées alimentaires provenant de cet animal, afin de protéger la santé publique, en garantissant que de telles denrées alimentaires ne contiennent pas de résidus en quantités supérieures aux limites maximales de résidus des substances pharmacologiquement actives, telles que fixées en vertu du règlement du Conseil (CEE) n° 2377 / 90 du 26 juin 1990 modifié établissant une procédure communautaire pour la fixation des limites maximales de résidus de médicaments vétérinaires dans les aliments d'origine animale.

" } }, "LEGIARTI000020892075": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5311-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2010-01-16", "DATE_DEBUT": "2009-07-23" } }, "META_COMMUN": { "ID": "LEGIARTI000020892075", "URL": "article/LEGI/ARTI/00/00/20/89/20/LEGIARTI000020892075.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006630983", "@num": "1", "#text": "Décret n°81-278 du 25 mars 1981 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000503017", "@numtexte": "81-278", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1981-03-25" }, { "@id": "LEGIARTI000006631025", "@num": "Annexe I", "#text": "Décret n°81-278 du 25 mars 1981 - art. 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Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000195660", "@nortexte": "ENVP9640024D", "@numtexte": "96-850", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1996-09-20" }, { "@id": "LEGIARTI000006506987", "@num": "3", "#text": "Décret n°98-385 du 18 mai 1998 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000571865", "@nortexte": "MESG9820693D", "@numtexte": "98-385", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1998-05-18" }, { "@id": "LEGIARTI000006724441", "@num": "5", "#text": "Décret n°2001-35 du 11 janvier 2001 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000388987", "@nortexte": "MJSK0070147D", "@numtexte": "2001-35", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2001-01-11" }, { "@id": "LEGIARTI000006254318", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254325", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639980", "@nortexte": "SANP0623382A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254307", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254319", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326653", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020320295", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326611", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254321", "@num": "4", "#text": "Arrêté du 16 août 2006 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254313", "@num": "7", "#text": "Arrêté du 16 août 2006 - art. 7 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006734099", "@num": "ANNEXE", "#text": "Arrêté du 16 août 2006 - art. ANNEXE (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639975", "@nortexte": "SANP0623370A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006255223", "@num": "1", "#text": "Arrêté du 11 septembre 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000271992", "@nortexte": "SANP0623792A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-09-11" }, { "@id": "LEGIARTI000020322856", "@num": "3", "#text": "Arrêté du 11 septembre 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000271992", "@nortexte": "SANP0623792A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-09-11" }, { "@id": "LEGIARTI000006697048", "@num": "39", "#text": "Loi n°2007-248 du 26 février 2007 - art. 39 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000613381", "@nortexte": "SANX0600004L", "@numtexte": "2007-248", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2007-02-26" }, { "@id": "LEGIARTI000006868630", "@num": "29", "#text": "Décret n° 2007-358 du 19 mars 2007 - art. 29 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000821090", "@nortexte": "AGRG0700644D", "@numtexte": "2007-358", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-19" }, { "@id": "LEGIARTI000006726837", "@num": "5", "#text": "Décret n°2007-462 du 25 mars 2007 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000466314", "@nortexte": "MJSK0770075D", "@numtexte": "2007-462", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-25" }, { "@id": "LEGIARTI000018361459", "@num": "Annexe", "#text": "Arrêté du 5 mars 2008 - art. Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000018360158", "@nortexte": "SJSP0805973A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-03-05" }, { "@id": "LEGIARTI000019382668", "@num": "2", "#text": "Arrêté du 11 août 2008 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019381783", "@nortexte": "SJSP0820319A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-08-11" }, { "@id": "LEGIARTI000034448482", "@num": "7", "#text": "Arrêté du 6 février 2009 - art. 7 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000020234297", "@nortexte": "SJSG0824493A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-06" }, { "@id": "LEGITEXT000020319418", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318429", "@nortexte": "SASP0904387A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319427", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318439", "@nortexte": "SASP0904427A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319436", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318449", "@nortexte": "SASP0904394A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGIARTI000020881158", "@num": "84", "#text": "LOI n°2009-879\n du 21 juillet 2009 - art. 84", "@sens": "cible", "@cidtexte": "JORFTEXT000020879475", "@nortexte": "SASX0822640L", "@numtexte": "2009-879", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2009-07-21" }, { "@id": "LEGIARTI000021782780", "@num": "Annexe au règlement intérieur", "#text": "Arrêté du 13 janvier 2010 - art. Annexe au règlement intérieur (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000021782073", "@nortexte": "SASP1001133A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-01-13" }, { "@id": "LEGITEXT000022416787", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415149", "@nortexte": "SASP1017123A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416463", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415125", "@nortexte": "SASP1017105A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416472", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415141", "@nortexte": "SASP1017114A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGIARTI000023430029", "@num": "6", "#text": "Décret n°2011-57\n du 13 janvier 2011 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000023428330", "@nortexte": "SPOV1017553D", "@numtexte": "2011-57", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-01-13" }, { "@id": "LEGITEXT000023778069", "#text": "Arrêté du 17 mars 2011 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000023776935", "@nortexte": "ETSP1108041A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-03-17" }, { "@id": "LEGIARTI000025071143", "@num": "38", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 38 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000025071141", "@num": "39", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 39 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000026480621", "@num": "4", "#text": "Arrêté du 10 octobre 2012 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000026479723", "@nortexte": "AFSP1221372A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-10-10" }, { "@id": "LEGIARTI000027648252", "#text": "Arrêté du 23 janvier 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027047902", "@nortexte": "AFSP1228322A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-01-23" }, { "@id": "LEGITEXT000027434552", "#text": "Décret n°2013-414\n du 21 mai 2013 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027434029", "@nortexte": "AFSP1304115D", "@numtexte": "2013-414", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2013-05-21" }, { "@id": "LEGIARTI000027594512", "#text": "Arrêté du 20 juin 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027592947", "@nortexte": "AFSP1313848A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-20" }, { "@id": "LEGIARTI000027699119", "@num": "1", "#text": "Arrêté du 17 juin 2013 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027697076", "@nortexte": "AFSP1301854A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-17" }, { "@id": "LEGIARTI000033202304", "#text": "Arrêté du 29 août 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027910341", "@nortexte": "PROI1311061A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-08-29" }, { "@id": "LEGIARTI000035971526", "#text": "DÉCRET n°2014-1286 du 23 octobre 2014 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029675991", "@nortexte": "AFSX1419046D", "@numtexte": "2014-1286", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000036393921", "@num": "166", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 166 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000031916570", "@num": "169", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 169 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000043508038", "#text": "Arrêté du 28 novembre 2016 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033507693", "@nortexte": "AFSP1633477A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-11-28" }, { "@id": "LEGIARTI000033554483", "@num": "3", "#text": "Arrêté du 2 décembre 2016 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033553349", "@nortexte": "AFSP1635656A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000038887172", "@num": "2", "#text": "LOI n°2017-220 du 23 février 2017 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034078423", "@nortexte": "AFSP1622342L", "@numtexte": "2017-220", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2017-02-23" }, { "@id": "LEGIARTI000034152829", "@num": "1", "#text": "Arrêté du 27 février 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150863", "@nortexte": "AFSP1706243A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000035988048", "@num": "3", "#text": "Arrêté du 27 février 2017 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150842", "@nortexte": "AFSP1706241A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000035269375", "@num": "1", "#text": "Arrêté du 17 juillet 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000035268202", "@nortexte": "SSAE1720859A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-07-17" }, { "@id": "LEGITEXT000036406189", "#text": "Décret n°2017-1781 du 27 décembre 2017 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036299141", "@nortexte": "SSAP1728401D", "@numtexte": "2017-1781", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-12-27" }, { "@id": "LEGIARTI000038432466", "@num": "1", "#text": "Décret n°2019-389 du 30 avril 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000038431240", "@nortexte": "SSAS1906324D", "@numtexte": "2019-389", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-04-30" }, { "@id": "LEGITEXT000039664011", "#text": "Arrêté du 20 décembre 2019 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000039663324", "@nortexte": "SSAP1936730A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-12-20" }, { "@id": "LEGIARTI000041898595", "@num": "10-3-1", "#text": "Arrêté du 23 mars 2020 - art. 10-3-1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000042645749", "@num": "17", "#text": "Ordonnance n°2020-460 du 22 avril 2020 - art. 17 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041814597", "@nortexte": "ECOX2009794R", "@numtexte": "2020-460", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2020-04-22" }, { "@id": "LEGIARTI000041890409", "@num": "1", "#text": "Arrêté du 18 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041889362", "@nortexte": "SSAZ2011564A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-18" }, { "@id": "LEGIARTI000041898504", "@num": "1", "#text": "Arrêté du 20 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041897919", "@nortexte": "SSAZ2012596A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-20" }, { "@id": "LEGIARTI000043298218", "@num": "25", "#text": "Arrêté du 10 juillet 2020 - art. 25 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042609739", "@num": "26", "#text": "Arrêté du 10 juillet 2020 - art. 26 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000043103458", "#text": "Arrêté du 5 février 2021 - art. (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000043100729", "@nortexte": "SSAP2104251A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-02-05" }, { "@id": "LEGIARTI000043298491", "@num": "3", "#text": "Décret n°2021-331 du 26 mars 2021 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000043297285", "@nortexte": "SSAS2034156D", "@numtexte": "2021-331", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-03-26" }, { "@id": "LEGITEXT000043543262", "#text": "Décret n°2021-662 du 26 mai 2021 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043541690", "@nortexte": "ECOI2106880D", "@numtexte": "2021-662", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-05-26" }, { "@id": "LEGIARTI000043543283", "#text": "Décret n°2021-662 du 26 mai 2021 - art.", "@sens": "cible", "@cidtexte": "JORFTEXT000043541690", "@nortexte": "ECOI2106880D", "@numtexte": "2021-662", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-05-26" }, { "@id": "LEGIARTI000047779186", "@num": "25", "#text": "Arrêté du 1 juin 2021 - art. 25 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000043770220", "@num": "27", "#text": "Arrêté du 1er juin 2021 - art. 27 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000046567251", "@num": "Annexe 2", "#text": "Arrêté du 14 novembre 2022 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000046566303", "@nortexte": "SPRP2231874A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-11-14" }, { "@id": "LEGIARTI000049976728", "@num": "Annexe 1", "#text": "Arrêté du 14 novembre 2022 - art. Annexe 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000046566303", "@nortexte": "SPRP2231874A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-11-14" }, { "@id": "LEGIARTI000050409030", "#text": "Arrêté du 24 octobre 2024 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000050407232", "@nortexte": "MSAP2428789A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-10-24" }, { "@id": "LEGIARTI000050409032", "#text": "Arrêté du 24 octobre 2024 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000050407232", "@nortexte": "MSAP2428789A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-10-24" }, { "@id": "LEGIARTI000043545974", "@num": "Annexe I à l'article D523-8", "#text": "Code de l'environnement - art. Annexe I à l'article D523-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000027912149", "@num": "D523-8", "#text": "Code de l'environnement - art. D523-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000042654871", "@num": "L521-2", "#text": "Code de l'environnement - art. 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L'Agence française de sécurité sanitaire des produits de santé est un établissement public de l'Etat, placé sous la tutelle du ministre chargé de la santé.

2° Les produits contraceptifs et contragestifs ;

3° Les biomatériaux et les dispositifs médicaux ;

4° Les dispositifs médicaux de diagnostic in vitro ;

5° Les produits sanguins labiles ;

6° Les organes, tissus, cellules et produits d'origine humaine ou animale, y compris lorsqu'ils sont prélevés à l'occasion d'une intervention chirurgicale ;

7° Les produits cellulaires à finalité thérapeutique ;

8° Le lait maternel collecté, qualifié, préparé et conservé par les lactariums ;

9° Les produits destinés à l'entretien ou à l'application des lentilles de contact ;

10° (Abrogé)

11° Les procédés et appareils destinés à la désinfection des locaux et des véhicules dans les cas prévus à l'article L. 3114-1 ;

12° Les produits thérapeutiques annexes ;

13° (Abrogé)

14° Les lentilles oculaires non correctrices ;

15° Les produits cosmétiques ;

16° Les micro-organismes et toxines mentionnés à l'article L. 5139-1 ;

17° Les produits de tatouage.

Elle contrôle la publicité en faveur de tous les produits, objets, appareils et méthodes revendiquant une finalité sanitaire.

Elle établit un rapport annuel d'activité adressé au Gouvernement et au Parlement. Ce rapport est rendu public.

Elle organise des auditions publiques sur des thèmes de santé publique.

L'agence est également chargée du contrôle du respect des dispositions des autorisations délivrées en application de l'article L. 1161-5.

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Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000018360158", "@nortexte": "SJSP0805973A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-03-05" }, { "@id": "LEGIARTI000019382668", "@num": "2", "#text": "Arrêté du 11 août 2008 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019381783", "@nortexte": "SJSP0820319A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-08-11" }, { "@id": "LEGIARTI000034448482", "@num": "7", "#text": "Arrêté du 6 février 2009 - art. 7 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000020234297", "@nortexte": "SJSG0824493A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-06" }, { "@id": "LEGITEXT000020319418", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318429", "@nortexte": "SASP0904387A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319427", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318439", "@nortexte": "SASP0904427A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319436", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318449", "@nortexte": "SASP0904394A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGIARTI000021684176", "@num": "3", "#text": "Ordonnance n°2010-49\n du 13 janvier 2010 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000021683301", "@nortexte": "SASX0927179R", "@numtexte": "2010-49", "@typelien": "MODIFIE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2010-01-13" }, { "@id": "LEGIARTI000021782780", "@num": "Annexe au règlement intérieur", "#text": "Arrêté du 13 janvier 2010 - art. Annexe au règlement intérieur (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000021782073", "@nortexte": "SASP1001133A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-01-13" }, { "@id": "LEGITEXT000022416787", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415149", "@nortexte": "SASP1017123A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416463", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415125", "@nortexte": "SASP1017105A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416472", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415141", "@nortexte": "SASP1017114A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGIARTI000023430029", "@num": "6", "#text": "Décret n°2011-57\n du 13 janvier 2011 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000023428330", "@nortexte": "SPOV1017553D", "@numtexte": "2011-57", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-01-13" }, { "@id": "LEGITEXT000023778069", "#text": "Arrêté du 17 mars 2011 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000023776935", "@nortexte": "ETSP1108041A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-03-17" }, { "@id": "LEGIARTI000025071143", "@num": "38", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 38 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000025071141", "@num": "39", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 39 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000026480621", "@num": "4", "#text": "Arrêté du 10 octobre 2012 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000026479723", "@nortexte": "AFSP1221372A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-10-10" }, { "@id": "LEGIARTI000027648252", "#text": "Arrêté du 23 janvier 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027047902", "@nortexte": "AFSP1228322A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-01-23" }, { "@id": "LEGITEXT000027434552", "#text": "Décret n°2013-414\n du 21 mai 2013 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027434029", "@nortexte": "AFSP1304115D", "@numtexte": "2013-414", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2013-05-21" }, { "@id": "LEGIARTI000027594512", "#text": "Arrêté du 20 juin 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027592947", "@nortexte": "AFSP1313848A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-20" }, { "@id": "LEGIARTI000027699119", "@num": "1", "#text": "Arrêté du 17 juin 2013 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027697076", "@nortexte": "AFSP1301854A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-17" }, { "@id": "LEGIARTI000033202304", "#text": "Arrêté du 29 août 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027910341", "@nortexte": "PROI1311061A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-08-29" }, { "@id": "LEGIARTI000035971526", "#text": "DÉCRET n°2014-1286 du 23 octobre 2014 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029675991", "@nortexte": "AFSX1419046D", "@numtexte": "2014-1286", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000036393921", "@num": "166", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 166 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000031916570", "@num": "169", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 169 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000043508038", "#text": "Arrêté du 28 novembre 2016 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033507693", "@nortexte": "AFSP1633477A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-11-28" }, { "@id": "LEGIARTI000033554483", "@num": "3", "#text": "Arrêté du 2 décembre 2016 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033553349", "@nortexte": "AFSP1635656A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000038887172", "@num": "2", "#text": "LOI n°2017-220 du 23 février 2017 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034078423", "@nortexte": "AFSP1622342L", "@numtexte": "2017-220", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2017-02-23" }, { "@id": "LEGIARTI000034152829", "@num": "1", "#text": "Arrêté du 27 février 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150863", "@nortexte": "AFSP1706243A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000035988048", "@num": "3", "#text": "Arrêté du 27 février 2017 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150842", "@nortexte": "AFSP1706241A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000035269375", "@num": "1", "#text": "Arrêté du 17 juillet 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000035268202", "@nortexte": "SSAE1720859A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-07-17" }, { "@id": "LEGITEXT000036406189", "#text": "Décret n°2017-1781 du 27 décembre 2017 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036299141", "@nortexte": "SSAP1728401D", "@numtexte": "2017-1781", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-12-27" }, { "@id": "LEGIARTI000038432466", "@num": "1", "#text": "Décret n°2019-389 du 30 avril 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000038431240", "@nortexte": "SSAS1906324D", "@numtexte": "2019-389", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-04-30" }, { "@id": "LEGITEXT000039664011", "#text": "Arrêté du 20 décembre 2019 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000039663324", "@nortexte": "SSAP1936730A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-12-20" }, { "@id": "LEGIARTI000041898595", "@num": "10-3-1", "#text": "Arrêté du 23 mars 2020 - art. 10-3-1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000042645749", "@num": "17", "#text": "Ordonnance n°2020-460 du 22 avril 2020 - art. 17 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041814597", "@nortexte": "ECOX2009794R", "@numtexte": "2020-460", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2020-04-22" }, { "@id": "LEGIARTI000041890409", "@num": "1", "#text": "Arrêté du 18 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041889362", "@nortexte": "SSAZ2011564A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-18" }, { "@id": "LEGIARTI000041898504", "@num": "1", "#text": "Arrêté du 20 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041897919", "@nortexte": "SSAZ2012596A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-20" }, { "@id": "LEGIARTI000043298218", "@num": "25", "#text": "Arrêté du 10 juillet 2020 - art. 25 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042609739", "@num": "26", "#text": "Arrêté du 10 juillet 2020 - art. 26 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000043103458", "#text": "Arrêté du 5 février 2021 - art. (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000043100729", "@nortexte": "SSAP2104251A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-02-05" }, { "@id": "LEGIARTI000043298491", "@num": "3", "#text": "Décret n°2021-331 du 26 mars 2021 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000043297285", "@nortexte": "SSAS2034156D", "@numtexte": "2021-331", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-03-26" }, { "@id": "LEGITEXT000043543262", "#text": "Décret n°2021-662 du 26 mai 2021 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043541690", "@nortexte": "ECOI2106880D", "@numtexte": "2021-662", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-05-26" }, { "@id": "LEGIARTI000043543283", "#text": "Décret n°2021-662 du 26 mai 2021 - art.", "@sens": "cible", "@cidtexte": "JORFTEXT000043541690", "@nortexte": "ECOI2106880D", "@numtexte": "2021-662", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-05-26" }, { "@id": "LEGIARTI000047779186", "@num": "25", "#text": "Arrêté du 1 juin 2021 - art. 25 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000043770220", "@num": "27", "#text": "Arrêté du 1er juin 2021 - art. 27 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000046567251", "@num": "Annexe 2", "#text": "Arrêté du 14 novembre 2022 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000046566303", "@nortexte": "SPRP2231874A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-11-14" }, { "@id": "LEGIARTI000049976728", "@num": "Annexe 1", "#text": "Arrêté du 14 novembre 2022 - art. Annexe 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000046566303", "@nortexte": "SPRP2231874A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-11-14" }, { "@id": "LEGIARTI000050409030", "#text": "Arrêté du 24 octobre 2024 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000050407232", "@nortexte": "MSAP2428789A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-10-24" }, { "@id": "LEGIARTI000050409032", "#text": "Arrêté du 24 octobre 2024 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000050407232", "@nortexte": "MSAP2428789A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-10-24" }, { "@id": "LEGIARTI000043545974", "@num": "Annexe I à l'article D523-8", "#text": "Code de l'environnement - art. Annexe I à l'article D523-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000027912149", "@num": "D523-8", "#text": "Code de l'environnement - art. D523-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000042654871", "@num": "L521-2", "#text": "Code de l'environnement - art. L521-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021666283", "@num": "L531-3", "#text": "Code de l'environnement - art. L531-3 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028749087", "@num": "L221-10", "#text": "Code de la consommation - art. L221-10 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069565", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000041985451", "@num": "L511-22", "#text": "Code de la consommation - art. L511-22 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069565", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000046012786", "@num": "R422-1", "#text": "Code de la consommation - art. R422-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069565", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006574178", "@num": "R*1142-25", "#text": "Code de la défense. - art. R*1142-25 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006071307", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006574182", "@num": "R*1142-29", "#text": "Code de la défense. - art. R*1142-29 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006071307", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049599041", "@num": "D1413-58", "#text": "Code de la santé publique - art. D1413-58 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033642702", "@num": "D6141-42", "#text": "Code de la santé publique - art. 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L'Agence française de sécurité sanitaire des produits de santé est un établissement public de l'Etat, placé sous la tutelle du ministre chargé de la santé.

2° Les produits contraceptifs et contragestifs ;

3° Les biomatériaux et les dispositifs médicaux ;

4° Les dispositifs médicaux de diagnostic in vitro ;

5° Les produits sanguins labiles ;

6° Les organes, tissus, cellules et produits d'origine humaine ou animale, y compris lorsqu'ils sont prélevés à l'occasion d'une intervention chirurgicale ;

7° Les produits cellulaires à finalité thérapeutique ;

8° Le lait maternel collecté, qualifié, préparé et conservé par les lactariums ;

9° Les produits destinés à l'entretien ou à l'application des lentilles de contact ;

10° (Abrogé)

11° Les procédés et appareils destinés à la désinfection des locaux et des véhicules dans les cas prévus à l'article L. 3114-1 ;

12° Les produits thérapeutiques annexes ;

13° (Abrogé)

14° Les lentilles oculaires non correctrices ;

15° Les produits cosmétiques ;

16° Les micro-organismes et toxines mentionnés à l'article L. 5139-1 ;

17° Les produits de tatouage ;

18° Les logiciels qui ne sont pas des dispositifs médicaux et qui sont utilisés par les laboratoires de biologie médicale, pour la gestion des examens de biologie médicale et lors de la validation, de l'interprétation, de la communication appropriée et de l'archivage des résultats ;

19° Les dispositifs à finalité non strictement médicale utilisés dans les laboratoires de biologie médicale pour la réalisation des examens de biologie médicale.

\n
\n

Elle contrôle la publicité en faveur de tous les produits, objets, appareils et méthodes revendiquant une finalité sanitaire.

Elle établit un rapport annuel d'activité adressé au Gouvernement et au Parlement. Ce rapport est rendu public.

Elle organise des auditions publiques sur des thèmes de santé publique.

L'agence est également chargée du contrôle du respect des dispositions des autorisations délivrées en application de l'article L. 1161-5.\n

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On entend par :

1° (Abrogé) ;

4° Prémélange médicamenteux, tout médicament vétérinaire préparé à l'avance et exclusivement destiné à la fabrication ultérieure d'aliments médicamenteux ;

7° Médicament homéopathique vétérinaire, tout médicament vétérinaire obtenu à partir de substances appelées, souches homéopathiques, selon un procédé de fabrication homéopathique décrit par la pharmacopée européenne, la pharmacopée française ou, à défaut, par les pharmacopées utilisées de façon officielle dans un autre Etat membre de l'Union européenne ; un médicament homéopathique vétérinaire peut aussi contenir plusieurs principes ;

11° Préparation extemporanée vétérinaire, tout médicament vétérinaire qui est préparé au moment de son utilisation ;

12° Préparation magistrale vétérinaire, toute préparation extemporanée vétérinaire réalisée selon une prescription destinée à un animal ou à des animaux d'une même exploitation ;

14° Temps d'attente, la période nécessaire entre la dernière administration du médicament vétérinaire à l'animal dans les conditions normales d'emploi et l'obtention des denrées alimentaires provenant de cet animal, afin de protéger la santé publique, en garantissant que de telles denrées alimentaires ne contiennent pas de résidus en quantités supérieures aux limites maximales de résidus des substances pharmacologiquement actives, telles que fixées en vertu du règlement du Conseil (CEE) n° 2377 / 90 du 26 juin 1990 modifié établissant une procédure communautaire pour la fixation des limites maximales de résidus de médicaments vétérinaires dans les aliments d'origine animale.

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On entend par :

1° (Abrogé) ;

4° Prémélange médicamenteux, tout médicament vétérinaire préparé à l'avance et exclusivement destiné à la fabrication ultérieure d'aliments médicamenteux ;

7° Médicament homéopathique vétérinaire, tout médicament vétérinaire obtenu à partir de substances appelées, souches homéopathiques, selon un procédé de fabrication homéopathique décrit par la pharmacopée européenne, la pharmacopée française ou, à défaut, par les pharmacopées utilisées de façon officielle dans un autre Etat membre de l'Union européenne ; un médicament homéopathique vétérinaire peut aussi contenir plusieurs principes ;

11° Préparation extemporanée vétérinaire, tout médicament vétérinaire qui est préparé au moment de son utilisation ;

12° Préparation magistrale vétérinaire, toute préparation extemporanée vétérinaire réalisée selon une prescription destinée à un animal ou à des animaux d'une même exploitation ;

14° Temps d'attente, la période nécessaire entre la dernière administration du médicament vétérinaire à l'animal dans les conditions normales d'emploi et l'obtention des denrées alimentaires provenant de cet animal, afin de protéger la santé publique, en garantissant que de telles denrées alimentaires ne contiennent pas de résidus en quantités supérieures aux limites maximales de résidus des substances pharmacologiquement actives, telles que fixées en vertu du règlement (CE) n° 470/2009 du Parlement européen et du Conseil du 6 mai 2009 établissant des procédures communautaires pour la fixation des limites de résidus des substances pharmacologiquement actives dans les aliments d'origine animale.

" } }, "LEGIARTI000025104251": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5311-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-12-22", "DATE_DEBUT": "2012-05-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025104251", "URL": "article/LEGI/ARTI/00/00/25/10/42/LEGIARTI000025104251.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Loi n° 2011-2012 du 29 décembre 2011 article 41 III : Les présentes dispositions entrent en vigueur à une date prévue par le décret pris pour leur application et au plus tard le 1er août 2012. Dès cette entrée en vigueur, l'Agence nationale de sécurité du médicament et des produits de santé exerce l'ensemble des droits et supporte l'ensemble des obligations de l'Agence française de sécurité sanitaire des produits de santé. Jusqu'à l'entrée en vigueur de ces dispositions, les compétences et pouvoirs que la présente loi attribue à l'Agence nationale de sécurité du médicament et des produits de santé sont exercés par l'Agence française de sécurité sanitaire des produits de santé.

Le décret n° 2012-597 du 27 avril 2012 est entré en vigueur le 1er mai 2012.

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Annexe I (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000503017", "@numtexte": "81-278", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1981-03-25" }, { "@id": "LEGIARTI000035606736", "@num": "2-1", "#text": "Décret n°90-975 du 30 octobre 1990 - art. 2-1 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000000160314", "@nortexte": "SPSG9001546D", "@numtexte": "90-975", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1990-10-30" }, { "@id": "LEGIARTI000006712582", "@num": "2", "#text": "Décret n°92-1432 du 30 décembre 1992 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000726011", "@nortexte": "SPSG9202710D", "@numtexte": "92-1432", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1992-12-30" }, { "@id": "LEGIARTI000006355280", "@num": "87", "#text": "Loi n°93-122 du 29 janvier 1993 - art. 87 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000711604", "@nortexte": "PRMX9200148L", "@numtexte": "93-122", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "1993-01-29" }, { "@id": "LEGIARTI000006865783", "@num": "Annexe", "#text": "Décret n°96-850 du 20 septembre 1996 - art. Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000195660", "@nortexte": "ENVP9640024D", "@numtexte": "96-850", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1996-09-20" }, { "@id": "LEGIARTI000006506987", "@num": "3", "#text": "Décret n°98-385 du 18 mai 1998 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000571865", "@nortexte": "MESG9820693D", "@numtexte": "98-385", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1998-05-18" }, { "@id": "LEGIARTI000006724441", "@num": "5", "#text": "Décret n°2001-35 du 11 janvier 2001 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000388987", "@nortexte": "MJSK0070147D", "@numtexte": "2001-35", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2001-01-11" }, { "@id": "LEGIARTI000006254318", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254325", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639980", "@nortexte": "SANP0623382A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254307", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254319", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326653", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020320295", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326611", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254321", "@num": "4", "#text": "Arrêté du 16 août 2006 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254313", "@num": "7", "#text": "Arrêté du 16 août 2006 - art. 7 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006734099", "@num": "ANNEXE", "#text": "Arrêté du 16 août 2006 - art. ANNEXE (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639975", "@nortexte": "SANP0623370A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006255223", "@num": "1", "#text": "Arrêté du 11 septembre 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000271992", "@nortexte": "SANP0623792A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-09-11" }, { "@id": "LEGIARTI000020322856", "@num": "3", "#text": "Arrêté du 11 septembre 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000271992", "@nortexte": "SANP0623792A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-09-11" }, { "@id": "LEGIARTI000006697048", "@num": "39", "#text": "Loi n°2007-248 du 26 février 2007 - art. 39 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000613381", "@nortexte": "SANX0600004L", "@numtexte": "2007-248", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2007-02-26" }, { "@id": "LEGIARTI000006868630", "@num": "29", "#text": "Décret n° 2007-358 du 19 mars 2007 - art. 29 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000821090", "@nortexte": "AGRG0700644D", "@numtexte": "2007-358", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-19" }, { "@id": "LEGIARTI000006726837", "@num": "5", "#text": "Décret n°2007-462 du 25 mars 2007 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000466314", "@nortexte": "MJSK0770075D", "@numtexte": "2007-462", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-25" }, { "@id": "LEGIARTI000018361459", "@num": "Annexe", "#text": "Arrêté du 5 mars 2008 - art. Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000018360158", "@nortexte": "SJSP0805973A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-03-05" }, { "@id": "LEGIARTI000019382668", "@num": "2", "#text": "Arrêté du 11 août 2008 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019381783", "@nortexte": "SJSP0820319A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-08-11" }, { "@id": "LEGIARTI000034448482", "@num": "7", "#text": "Arrêté du 6 février 2009 - art. 7 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000020234297", "@nortexte": "SJSG0824493A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-06" }, { "@id": "LEGITEXT000020319418", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318429", "@nortexte": "SASP0904387A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319427", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318439", "@nortexte": "SASP0904427A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319436", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318449", "@nortexte": "SASP0904394A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGIARTI000021782780", "@num": "Annexe au règlement intérieur", "#text": "Arrêté du 13 janvier 2010 - art. Annexe au règlement intérieur (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000021782073", "@nortexte": "SASP1001133A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-01-13" }, { "@id": "LEGITEXT000022416787", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415149", "@nortexte": "SASP1017123A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416463", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415125", "@nortexte": "SASP1017105A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416472", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415141", "@nortexte": "SASP1017114A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGIARTI000023430029", "@num": "6", "#text": "Décret n°2011-57\n du 13 janvier 2011 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000023428330", "@nortexte": "SPOV1017553D", "@numtexte": "2011-57", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-01-13" }, { "@id": "LEGITEXT000023778069", "#text": "Arrêté du 17 mars 2011 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000023776935", "@nortexte": "ETSP1108041A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-03-17" }, { "@id": "LEGIARTI000025071143", "@num": "38", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 38 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000025071141", "@num": "39", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 39 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000025071134", "@num": "5", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 5", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000026480621", "@num": "4", "#text": "Arrêté du 10 octobre 2012 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000026479723", "@nortexte": "AFSP1221372A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-10-10" }, { "@id": "LEGIARTI000027648252", "#text": "Arrêté du 23 janvier 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027047902", "@nortexte": "AFSP1228322A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-01-23" }, { "@id": "LEGITEXT000027434552", "#text": "Décret n°2013-414\n du 21 mai 2013 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027434029", "@nortexte": "AFSP1304115D", "@numtexte": "2013-414", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2013-05-21" }, { "@id": "LEGIARTI000027594512", "#text": "Arrêté du 20 juin 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027592947", "@nortexte": "AFSP1313848A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-20" }, { "@id": "LEGIARTI000027699119", "@num": "1", "#text": "Arrêté du 17 juin 2013 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027697076", "@nortexte": "AFSP1301854A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-17" }, { "@id": "LEGIARTI000033202304", "#text": "Arrêté du 29 août 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027910341", "@nortexte": "PROI1311061A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-08-29" }, { "@id": "LEGIARTI000035971526", "#text": "DÉCRET n°2014-1286 du 23 octobre 2014 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029675991", "@nortexte": "AFSX1419046D", "@numtexte": "2014-1286", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000036393921", "@num": "166", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 166 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000031916570", "@num": "169", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 169 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000043508038", "#text": "Arrêté du 28 novembre 2016 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033507693", "@nortexte": "AFSP1633477A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-11-28" }, { "@id": "LEGIARTI000033554483", "@num": "3", "#text": "Arrêté du 2 décembre 2016 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033553349", "@nortexte": "AFSP1635656A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000038887172", "@num": "2", "#text": "LOI n°2017-220 du 23 février 2017 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034078423", "@nortexte": "AFSP1622342L", "@numtexte": "2017-220", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2017-02-23" }, { "@id": "LEGIARTI000034152829", "@num": "1", "#text": "Arrêté du 27 février 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150863", "@nortexte": "AFSP1706243A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000035988048", "@num": "3", "#text": "Arrêté du 27 février 2017 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150842", "@nortexte": "AFSP1706241A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000035269375", "@num": "1", "#text": "Arrêté du 17 juillet 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000035268202", "@nortexte": "SSAE1720859A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-07-17" }, { "@id": "LEGITEXT000036406189", "#text": "Décret n°2017-1781 du 27 décembre 2017 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036299141", "@nortexte": "SSAP1728401D", "@numtexte": "2017-1781", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-12-27" }, { "@id": "LEGIARTI000038432466", "@num": "1", "#text": "Décret n°2019-389 du 30 avril 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000038431240", "@nortexte": "SSAS1906324D", "@numtexte": "2019-389", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-04-30" }, { "@id": "LEGITEXT000039664011", "#text": "Arrêté du 20 décembre 2019 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000039663324", "@nortexte": "SSAP1936730A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-12-20" }, { "@id": "LEGIARTI000041898595", "@num": "10-3-1", "#text": "Arrêté du 23 mars 2020 - art. 10-3-1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000042645749", "@num": "17", "#text": "Ordonnance n°2020-460 du 22 avril 2020 - art. 17 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041814597", "@nortexte": "ECOX2009794R", "@numtexte": "2020-460", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2020-04-22" }, { "@id": "LEGIARTI000041890409", "@num": "1", "#text": "Arrêté du 18 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041889362", "@nortexte": "SSAZ2011564A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-18" }, { "@id": "LEGIARTI000041898504", "@num": "1", "#text": "Arrêté du 20 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041897919", "@nortexte": "SSAZ2012596A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-20" }, { "@id": "LEGIARTI000043298218", "@num": "25", "#text": "Arrêté du 10 juillet 2020 - art. 25 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042609739", "@num": "26", "#text": "Arrêté du 10 juillet 2020 - art. 26 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000043103458", "#text": "Arrêté du 5 février 2021 - art. (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000043100729", "@nortexte": "SSAP2104251A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-02-05" }, { "@id": "LEGIARTI000043298491", "@num": "3", "#text": "Décret n°2021-331 du 26 mars 2021 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000043297285", "@nortexte": "SSAS2034156D", "@numtexte": "2021-331", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-03-26" }, { "@id": "LEGITEXT000043543262", "#text": "Décret n°2021-662 du 26 mai 2021 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043541690", "@nortexte": "ECOI2106880D", "@numtexte": "2021-662", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-05-26" }, { "@id": "LEGIARTI000043543283", "#text": "Décret n°2021-662 du 26 mai 2021 - art.", "@sens": "cible", "@cidtexte": "JORFTEXT000043541690", "@nortexte": "ECOI2106880D", "@numtexte": "2021-662", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-05-26" }, { "@id": "LEGIARTI000047779186", "@num": "25", "#text": "Arrêté du 1 juin 2021 - art. 25 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000043770220", "@num": "27", "#text": "Arrêté du 1er juin 2021 - art. 27 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000046567251", "@num": "Annexe 2", "#text": "Arrêté du 14 novembre 2022 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000046566303", "@nortexte": "SPRP2231874A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-11-14" }, { "@id": "LEGIARTI000049976728", "@num": "Annexe 1", "#text": "Arrêté du 14 novembre 2022 - art. Annexe 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000046566303", "@nortexte": "SPRP2231874A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-11-14" }, { "@id": "LEGIARTI000050409030", "#text": "Arrêté du 24 octobre 2024 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000050407232", "@nortexte": "MSAP2428789A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-10-24" }, { "@id": "LEGIARTI000050409032", "#text": "Arrêté du 24 octobre 2024 - art. 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L161-39 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000042685822", "@num": "L162-17-2-1", "#text": "Code de la sécurité sociale. - art. L162-17-2-1 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000037064523", "@num": "L245-5-5-1", "#text": "Code de la sécurité sociale. - art. L245-5-5-1 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048701735", "@num": "L245-6", "#text": "Code de la sécurité sociale. - art. L245-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000031093005", "@num": "R245-16-3", "#text": "Code de la sécurité sociale. - art. R245-16-3 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000042779560", "@num": "706-2", "#text": "Code de procédure pénale - art. 706-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006071154", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025859349", "@num": "L251-1", "#text": "Code des assurances - art. L251-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073984", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000038086667", "@num": "R250-1", "#text": "Code des assurances - art. R250-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073984", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043907211", "@num": "R232-49", "#text": "Code du sport. - art. R232-49 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006071318", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000037947963", "@num": "1635 bis AE", "#text": "Code général des impôts, CGI. - art. 1635 bis AE (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069577", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000042160762", "@num": "344 undecies A", "#text": "Code général des impôts, annexe 3, CGIAN3. - art. 344 undecies A (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069574", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000030752201", "@num": "L166 D", "#text": "Livre des procédures fiscales - art. L166 D (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069583", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000029012373", "@num": "R166 D-1", "#text": "Livre des procédures fiscales - art. R166 D-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069583", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171401", "@fin": "2999-01-01", "#text": "Chapitre Ier : Missions.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155093", "@fin": "2999-01-01", "#text": "Titre Ier : Missions et prérogatives", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140633", "@fin": "2012-05-01", "#text": "Livre III : Agence française de sécurité sanitaire des produits de santé", "@debut": "2000-06-22" }, { "@id": "LEGISCTA000025104258", "@fin": "2999-01-01", "#text": "Livre III : Agence nationale de sécurité du médicament et des produits de santé", "@debut": "2012-05-01" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690344", "@fin": "2001-03-03", "@num": "L5311-1", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690345", "@fin": "2002-03-05", "@num": "L5311-1", "@etat": "MODIFIE", "@debut": "2001-03-03", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690346", "@fin": "2004-08-07", "@num": "L5311-1", "@etat": "MODIFIE", "@debut": "2002-03-05", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690347", "@fin": "2004-08-11", "@num": "L5311-1", "@etat": "MODIFIE", "@debut": "2004-08-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690348", "@fin": "2005-09-02", "@num": "L5311-1", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690349", "@fin": "2007-02-27", "@num": "L5311-1", "@etat": "MODIFIE", "@debut": "2005-09-02", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690350", "@fin": "2007-04-27", "@num": "L5311-1", "@etat": "MODIFIE", "@debut": "2007-02-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690351", "@fin": "2008-06-01", "@num": "L5311-1", "@etat": "MODIFIE", "@debut": "2007-04-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000018652199", "@fin": "2009-07-23", "@num": "L5311-1", "@etat": "MODIFIE", "@debut": "2008-06-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000020892075", "@fin": "2010-01-16", "@num": "L5311-1", "@etat": "MODIFIE", "@debut": "2009-07-23", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000021709037", "@fin": "2012-05-01", "@num": "L5311-1", "@etat": "MODIFIE", "@debut": "2010-01-16", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025104251", "@fin": "2012-12-22", "@num": "L5311-1", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026809110", "@fin": "2013-06-01", "@num": "L5311-1", "@etat": "MODIFIE", "@debut": "2012-12-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000027480562", "@fin": "2016-01-28", "@num": "L5311-1", "@etat": "MODIFIE", "@debut": "2013-06-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000031930410", "@fin": "2016-07-17", "@num": "L5311-1", "@etat": "MODIFIE", "@debut": "2016-01-28", "@origine": "LEGI" } }, { "@etat": "MODIFIE_MORT_NE", "LIEN_ART": { "@id": "LEGIARTI000025453562", "@fin": "2016-07-17", "@num": "L5311-1", "@etat": "MODIFIE_MORT_NE", "@debut": "2222-02-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000032908924", "@fin": "2017-07-01", "@num": "L5311-1", "@etat": "MODIFIE", "@debut": "2016-07-17", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000033897163", "@fin": "2021-06-01", "@num": "L5311-1", "@etat": "MODIFIE", "@debut": "2017-07-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000042654751", "@fin": "2021-08-04", "@num": "L5311-1", "@etat": "MODIFIE", "@debut": "2021-06-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000043896283", "@fin": "2022-04-22", "@num": "L5311-1", "@etat": "MODIFIE", "@debut": "2021-08-04", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000045630379", "@fin": "2022-07-31", "@num": "L5311-1", "@etat": "MODIFIE", "@debut": "2022-04-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000046126182", "@fin": "2024-01-01", "@num": "L5311-1", "@etat": "MODIFIE", "@debut": "2022-07-31", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000046871876", "@fin": "2999-01-01", "@num": "L5311-1", "@etat": "VIGUEUR", "@debut": "2024-01-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

I. - L'Agence nationale de sécurité du médicament et des produits de santé est un établissement public de l'Etat, placé sous la tutelle du ministre chargé de la santé.

II. - L'agence procède à l'évaluation des bénéfices et des risques liés à l'utilisation des produits à finalité sanitaire destinés à l'homme et des produits à finalité cosmétique. Elle surveille le risque lié à ces produits et effectue des réévaluations des bénéfices et des risques.

L'agence peut demander que les essais cliniques portant sur des médicaments soient effectués sous forme d'essais contre comparateurs actifs et contre placebo. Si la personne produisant ou exploitant un médicament s'oppose aux essais contre comparateurs actifs, elle doit le justifier.

2° Les produits contraceptifs et contragestifs ;

3° Les biomatériaux et les dispositifs médicaux ;

4° Les dispositifs médicaux de diagnostic in vitro ;

5° Les produits sanguins labiles ;

6° Les organes, tissus, cellules et produits d'origine humaine ou animale, y compris lorsqu'ils sont prélevés à l'occasion d'une intervention chirurgicale ;

7° Les produits cellulaires à finalité thérapeutique ;

8° Le lait maternel collecté, qualifié, préparé et conservé par les lactariums ;

9° Les produits destinés à l'entretien ou à l'application des lentilles de contact ;

10° (Abrogé) ;

11° Les procédés et appareils destinés à la désinfection des locaux et des véhicules dans les cas prévus à l'article L. 3114-1 ;

12° Les produits thérapeutiques annexes ;

13° (Abrogé) ;

14° Les lentilles oculaires non correctrices ;

15° Les produits cosmétiques ;

16° Les micro-organismes et toxines mentionnés à l'article L. 5139-1 ;

17° Les produits de tatouage ;

19° Les dispositifs à finalité non strictement médicale utilisés dans les laboratoires de biologie médicale pour la réalisation des examens de biologie médicale.

III. - L'agence participe à l'application des lois et règlements relatifs aux recherches biomédicales et prend, dans les cas prévus par des dispositions particulières, des décisions relatives aux recherches biomédicales.

Elle assure la mise en oeuvre des systèmes de vigilance et prépare la pharmacopée.

Elle contrôle la publicité en faveur de tous les produits, objets, appareils et méthodes revendiquant une finalité sanitaire.

Elle établit un rapport annuel d'activité adressé au Gouvernement et au Parlement. Ce rapport est rendu public. Le rapport comporte le bilan annuel de la réévaluation du rapport entre les bénéfices et les risques des médicaments à usage humain mentionnés à l'article L. 5121-8.

Elle organise des auditions publiques sur des thèmes de santé publique.

L'agence est également chargée du contrôle du respect des dispositions des autorisations délivrées en application de l'article L. 1161-5.\n

" } }, "LEGIARTI000025378223": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "4", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025378223", "URL": "article/LEGI/ARTI/00/00/25/37/82/LEGIARTI000025378223.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGISCTA000025378755", "#text": "Code de la santé publique - Titre V : Produits de santé composés en tout ou... (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000025378805", "#text": "Code de la santé publique - Titre VI : Produits de santé concernant des sub... (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025378819", "@num": "R5161-1", "#text": "Code de la santé publique - art. R5161-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000025377246", "@nor": "DEVP1123456D", "@num": "2012-232", "@nature": "DECRET", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Décret n° 2012-232 du 17 février 2012 relatif à la déclaration annuelle des substances à l'état nanoparticulaire pris en application de l'article L. 523-4 du code de l'environnement", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000025377246", "@c_titre_court": "Décret n°2012-232 du 17 février 2012" }, { "@fin": "2999-01-01", "#text": "Décret n° 2012-232 du 17 février 2012 relatif à la déclaration annuelle des substances à l'état nanoparticulaire pris en application de l'article L. 523-4 du code de l'environnement", "@debut": "2012-02-20", "@id_txt": "LEGITEXT000025378213", "@c_titre_court": "Décret n°2012-232 du 17 février 2012" } ], "@ministere": "Ministère de l'écologie, du développement durable, des transports et du logement", "@date_publi": "2012-02-19", "@date_signature": "2012-02-17" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000025378223", "@fin": "2999-01-01", "@num": "4", "@debut": "2999-01-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000025377267", "@fin": "2999-01-01", "@num": "4", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
A modifié les dispositions suivantes :

- Code de la santé publique
Sct. Titre V : Produits de santé composés en tout ou partie d'organismes génétiquement modifiés, Sct. Titre VI : Produits de santé concernant des substances à l'état nanoparticulaire, Art. R5161-1\n
\n

\n
" } }, "LEGIARTI000025378597": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R523-12", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2013-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025378597", "URL": "article/LEGI/ARTI/00/00/25/37/85/LEGIARTI000025378597.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000025378221", "@num": "2", "#text": "Décret n°2012-232\n du 17 février 2012 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000025377246", "@nortexte": "DEVP1123456D", "@numtexte": "2012-232", "@typelien": "CREE", "@naturetexte": "DECRET", "@datesignatexte": "2012-02-17" }, { "@id": "LEGIARTI000026279398", "@num": "1", "#text": "Arrêté du 6 août 2012 - art. 1 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000026278450", "@nortexte": "DEVP1227946A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-08-06" }, { "@id": "LEGIARTI000025378819", "@num": "R5161-1", "#text": "Code de la santé publique - art. R5161-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025378873", "@num": "R253-13-1", "#text": "Code rural et de la pêche maritime - art. R253-13-1 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006071367", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000035416767", "@num": "R253-37", "#text": "Code rural et de la pêche maritime - art. R253-37 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006071367", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000025387882", "@fin": "2999-01-01", "#text": "Chapitre IV : Prévention des risques pour la santé et l'environnement résultant de l'exposition aux substances à l'état nanoparticulaire", "@debut": "2013-01-01" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006143785", "@fin": "2012-02-20", "#text": "Titre II : Produits chimiques et biocides", "@debut": "2007-10-16" }, { "@id": "LEGISCTA000025387858", "@fin": "2999-01-01", "#text": "Titre II : Produits chimiques, biocides et substances à l'état nanoparticulaire", "@debut": "2012-02-20" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006129034", "@fin": "2999-01-01", "#text": "Livre V : Prévention des pollutions, des risques et des nuisances", "@debut": "2007-10-16" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006108631", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2003-08-07" } ] }, "@cid": "LEGITEXT000006074220", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de l'environnement", "@debut": "2000-09-21", "@id_txt": "LEGITEXT000006074220", "@c_titre_court": "Code de l'environnement" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000025378597", "@fin": "2999-01-01", "@num": "R523-12", "@etat": "VIGUEUR", "@debut": "2013-01-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "Pour l'application du présent chapitre, on entend par :
\n
\" Substance à l'état nanoparticulaire ” : substance telle que définie à l'article 3 du règlement (CE) n° 1907/2006, fabriquée intentionnellement à l'échelle nanométrique, contenant des particules, non liées ou sous forme d'agrégat ou sous forme d'agglomérat, dont une proportion minimale des particules, dans la distribution des tailles en nombre, présentent une ou plusieurs dimensions externes se situant entre 1 nm et 100 nm.
\n
Cette proportion minimale peut être réduite dans des cas spécifiques lorsque cela se justifie pour des raisons tenant à la protection de l'environnement, à la santé publique, à la sécurité ou à la compétitivité. Elle est précisée par un arrêté conjoint des ministres chargés de l'environnement, de l'agriculture, de la santé, du travail et de l'industrie.
\n
Par dérogation à cette définition, les fullerènes, les flocons de graphène et les nanotubes de carbone à paroi simple présentant une ou plusieurs dimensions externes inférieures à 1 nm sont à considérer comme des substances à l'état nanoparticulaire.
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Aux fins de cette définition, les termes \" particule ”, \" agglomérat ” et \" agrégat ” sont définis comme suit :
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a) On entend par \" particule ” un fragment de matière possédant des contours physiques bien définis ;
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b) On entend par \" agrégat ” une particule constituée de particules fortement liées ou fusionnées ;
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c) On entend par \" agglomérat ” un amas de particules ou d'agrégats faiblement liés dont la surface externe globale correspond à la somme des surfaces de ses constituants individuels.
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\" Substance à l'état nanoparticulaire contenue dans un mélange sans y être liée ” : substance à l'état nanoparticulaire incorporée intentionnellement dans un mélange dont elle est susceptible d'être extraite ou libérée dans des conditions normales ou raisonnablement prévisibles d'utilisation ;
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” Territoire ” : le territoire national, à l'exclusion de la Nouvelle-Calédonie, de la Polynésie française, de Wallis-et-Futuna et des Terres australes et antarctiques françaises ;
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\" Fabricant ” : toute personne fabriquant dans l'exercice de ses activités professionnelles sur le territoire, pour son propre usage ou en vue de leur cession à titre onéreux ou gratuit, une substance à l'état nanoparticulaire, en l'état ou contenue dans un mélange sans y être liée, ou un matériau destiné à rejeter une telle substance dans des conditions normales ou raisonnablement prévisibles d'utilisation ;
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\" Importateur ” : toute personne qui introduit dans l'exercice de ses activités professionnelles sur le territoire une substance à l'état nanoparticulaire, en l'état ou contenue dans un mélange sans y être liée, ou un matériau destiné à rejeter une telle substance dans des conditions normales ou raisonnablement prévisibles d'utilisation, en provenance d'un autre Etat membre de l'Union européenne ou d'un Etat tiers ;
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\" Distributeur ” : toute personne établie sur le territoire, y compris un détaillant, qui exécute des opérations de stockage et de cession à titre onéreux ou gratuit à des utilisateurs professionnels d'une substance à l'état nanoparticulaire, en l'état ou contenue dans un mélange sans y être liée, ou d'un matériau destiné à rejeter une telle substance dans des conditions normales ou raisonnablement prévisibles d'utilisation ;
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\" Utilisateur professionnel ” : toute personne établie sur le territoire, autre que le fabricant ou l'importateur, qui utilise, dans l'exercice de ses activités professionnelles une substance à l'état nanoparticulaire, en l'état ou contenue dans un mélange sans y être liée, ou un matériau destiné à rejeter une telle substance dans des conditions normales ou raisonnablement prévisibles d'utilisation ;
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\" Recherche et développement scientifiques ” : toute activité d'expérimentation scientifique, d'analyse ou de recherche, telle que définie à l'article 3 du règlement (CE) n° 1907/2006 ;
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\" Activités de recherche et de développement axées sur les produits et les processus ” : tout développement scientifique lié à l'élaboration de produits ou à la diversification des utilisations d'une substance, tel que défini à l'article 3 du règlement (CE) n° 1907/2006." } }, "LEGIARTI000025453562": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5311-1", "ETAT": "MODIFIE_MORT_NE", "TYPE": "AUTONOME", "DATE_FIN": "2016-07-17", "DATE_DEBUT": "2222-02-22" } }, "META_COMMUN": { "ID": "LEGIARTI000025453562", "URL": "article/LEGI/ARTI/00/00/25/45/35/LEGIARTI000025453562.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006630983", "@num": "1", "#text": "Décret n°81-278 du 25 mars 1981 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000503017", "@numtexte": "81-278", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1981-03-25" }, { "@id": "LEGIARTI000006631025", "@num": "Annexe I", "#text": "Décret n°81-278 du 25 mars 1981 - art. Annexe I (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000503017", "@numtexte": "81-278", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1981-03-25" }, { "@id": "LEGIARTI000035606736", "@num": "2-1", "#text": "Décret n°90-975 du 30 octobre 1990 - art. 2-1 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000000160314", "@nortexte": "SPSG9001546D", "@numtexte": "90-975", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1990-10-30" }, { "@id": "LEGIARTI000006712582", "@num": "2", "#text": "Décret n°92-1432 du 30 décembre 1992 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000726011", "@nortexte": "SPSG9202710D", "@numtexte": "92-1432", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1992-12-30" }, { "@id": "LEGIARTI000006355280", "@num": "87", "#text": "Loi n°93-122 du 29 janvier 1993 - art. 87 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000711604", "@nortexte": "PRMX9200148L", "@numtexte": "93-122", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "1993-01-29" }, { "@id": "LEGIARTI000006865783", "@num": "Annexe", "#text": "Décret n°96-850 du 20 septembre 1996 - art. Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000195660", "@nortexte": "ENVP9640024D", "@numtexte": "96-850", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1996-09-20" }, { "@id": "LEGIARTI000006506987", "@num": "3", "#text": "Décret n°98-385 du 18 mai 1998 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000571865", "@nortexte": "MESG9820693D", "@numtexte": "98-385", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1998-05-18" }, { "@id": "LEGIARTI000006724441", "@num": "5", "#text": "Décret n°2001-35 du 11 janvier 2001 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000388987", "@nortexte": "MJSK0070147D", "@numtexte": "2001-35", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2001-01-11" }, { "@id": "LEGIARTI000006254318", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254325", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639980", "@nortexte": "SANP0623382A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254307", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254319", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326653", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020320295", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326611", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254321", "@num": "4", "#text": "Arrêté du 16 août 2006 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254313", "@num": "7", "#text": "Arrêté du 16 août 2006 - art. 7 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006734099", "@num": "ANNEXE", "#text": "Arrêté du 16 août 2006 - art. 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Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000018360158", "@nortexte": "SJSP0805973A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-03-05" }, { "@id": "LEGIARTI000019382668", "@num": "2", "#text": "Arrêté du 11 août 2008 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019381783", "@nortexte": "SJSP0820319A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-08-11" }, { "@id": "LEGIARTI000034448482", "@num": "7", "#text": "Arrêté du 6 février 2009 - art. 7 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000020234297", "@nortexte": "SJSG0824493A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-06" }, { "@id": "LEGITEXT000020319418", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318429", "@nortexte": "SASP0904387A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319427", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318439", "@nortexte": "SASP0904427A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319436", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318449", "@nortexte": "SASP0904394A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGIARTI000021782780", "@num": "Annexe au règlement intérieur", "#text": "Arrêté du 13 janvier 2010 - art. Annexe au règlement intérieur (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000021782073", "@nortexte": "SASP1001133A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-01-13" }, { "@id": "LEGITEXT000022416787", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415149", "@nortexte": "SASP1017123A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416463", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415125", "@nortexte": "SASP1017105A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416472", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415141", "@nortexte": "SASP1017114A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGIARTI000023430029", "@num": "6", "#text": "Décret n°2011-57\n du 13 janvier 2011 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000023428330", "@nortexte": "SPOV1017553D", "@numtexte": "2011-57", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-01-13" }, { "@id": "LEGITEXT000023778069", "#text": "Arrêté du 17 mars 2011 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000023776935", "@nortexte": "ETSP1108041A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-03-17" }, { "@id": "LEGIARTI000025071143", "@num": "38", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 38 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000025071141", "@num": "39", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 39 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000025442828", "@num": "1", "#text": "LOI n°2012-300\r\n du 5 mars 2012 - art. 1 (V)", "@sens": "source", "@cidtexte": "JORFTEXT000025441587", "@nortexte": "SASX0901817L", "@numtexte": "2012-300", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2012-03-05" }, { "@id": "LEGIARTI000026480621", "@num": "4", "#text": "Arrêté du 10 octobre 2012 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000026479723", "@nortexte": "AFSP1221372A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-10-10" }, { "@id": "LEGIARTI000026806482", "@num": "14", "#text": "Ordonnance n°2012-1427\r\n du 19 décembre 2012 - art. 14", "@sens": "source", "@cidtexte": "JORFTEXT000026805101", "@nortexte": "AFSX1240311R", "@numtexte": "2012-1427", "@typelien": "MODIFICATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2012-12-19" }, { "@id": "LEGIARTI000027648252", "#text": "Arrêté du 23 janvier 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027047902", "@nortexte": "AFSP1228322A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-01-23" }, { "@id": "LEGITEXT000027434552", "#text": "Décret n°2013-414\n du 21 mai 2013 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027434029", "@nortexte": "AFSP1304115D", "@numtexte": "2013-414", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2013-05-21" }, { "@id": "LEGIARTI000027479341", "@num": "8", "#text": "LOI n°2013-442\r\n du 30 mai 2013 - art. 8", "@sens": "source", "@cidtexte": "JORFTEXT000027478077", "@nortexte": "AFSX1242935L", "@numtexte": "2013-442", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2013-05-30" }, { "@id": "LEGIARTI000027594512", "#text": "Arrêté du 20 juin 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027592947", "@nortexte": "AFSP1313848A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-20" }, { "@id": "LEGIARTI000027699119", "@num": "1", "#text": "Arrêté du 17 juin 2013 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027697076", "@nortexte": "AFSP1301854A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-17" }, { "@id": "LEGIARTI000033202304", "#text": "Arrêté du 29 août 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027910341", "@nortexte": "PROI1311061A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-08-29" }, { "@id": "LEGIARTI000035971526", "#text": "DÉCRET n°2014-1286 du 23 octobre 2014 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029675991", "@nortexte": "AFSX1419046D", "@numtexte": "2014-1286", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000036393921", "@num": "166", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 166 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000031916570", "@num": "169", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 169 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000043508038", "#text": "Arrêté du 28 novembre 2016 - art. 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I. - L'Agence nationale de sécurité du médicament et des produits de santé est un établissement public de l'Etat, placé sous la tutelle du ministre chargé de la santé.

L'agence participe à l'application des lois et règlements et prend, dans les cas prévus par des dispositions particulières, des décisions relatives à l'évaluation, aux essais, à la fabrication, à la préparation, à l'importation, à l'exportation, à la distribution en gros, au courtage, au conditionnement, à la conservation, à l'exploitation, à la mise sur le marché, à la publicité, à la mise en service ou à l'utilisation des produits à finalité sanitaire destinés à l'homme et des produits à finalité cosmétique, et notamment :

2° Les produits contraceptifs et contragestifs ;

3° Les biomatériaux et les dispositifs médicaux ;

4° Les dispositifs médicaux de diagnostic in vitro ;

5° Les produits sanguins labiles ;

6° Les organes, tissus, cellules et produits d'origine humaine ou animale, y compris lorsqu'ils sont prélevés à l'occasion d'une intervention chirurgicale ;

7° Les produits cellulaires à finalité thérapeutique ;

8° Le lait maternel collecté, qualifié, préparé et conservé par les lactariums ;

9° Les produits destinés à l'entretien ou à l'application des lentilles de contact ;

10° (Abrogé) ;

11° Les procédés et appareils destinés à la désinfection des locaux et des véhicules dans les cas prévus à l'article L. 3114-1 ;

12° (Abrogé) ;

13° (Abrogé) ;

14° Les lentilles oculaires non correctrices ;

15° Les produits cosmétiques ;

16° Les micro-organismes et toxines mentionnés à l'article L. 5139-1 ;

17° Les produits de tatouage ;

19° Les dispositifs à finalité non strictement médicale utilisés dans les laboratoires de biologie médicale pour la réalisation des examens de biologie médicale ;

20° Les logiciels d'aide à la prescription et les logiciels d'aide à la dispensation.

III. - L'agence participe à l'application des lois et règlements relatifs aux recherches impliquant la personne humaine et prend, dans les cas prévus par des dispositions particulières, des décisions relatives aux recherches impliquant la personne humaine.

Elle assure la mise en œuvre des systèmes de vigilance, à l'exception de ceux portant sur le lait maternel, les organes, les tissus, les cellules et les préparations de thérapie cellulaire, et prépare la pharmacopée.

Elle contrôle la publicité en faveur de tous les produits, objets, appareils et méthodes revendiquant une finalité sanitaire.

Elle organise des auditions publiques sur des thèmes de santé publique.

L'agence est également chargée du contrôle du respect des dispositions des autorisations délivrées en application de l'article L. 1161-5.\n

" } }, "LEGIARTI000026809110": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5311-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2013-06-01", "DATE_DEBUT": "2012-12-22" } }, "META_COMMUN": { "ID": "LEGIARTI000026809110", "URL": "article/LEGI/ARTI/00/00/26/80/91/LEGIARTI000026809110.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Le décret n° 2012-597 du 27 avril 2012 est entré en vigueur le 1er mai 2012.

" }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006630983", "@num": "1", "#text": "Décret n°81-278 du 25 mars 1981 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000503017", "@numtexte": "81-278", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1981-03-25" }, { "@id": "LEGIARTI000006631025", "@num": "Annexe I", "#text": "Décret n°81-278 du 25 mars 1981 - art. Annexe I (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000503017", "@numtexte": "81-278", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1981-03-25" }, { "@id": "LEGIARTI000035606736", "@num": "2-1", "#text": "Décret n°90-975 du 30 octobre 1990 - art. 2-1 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000000160314", "@nortexte": "SPSG9001546D", "@numtexte": "90-975", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1990-10-30" }, { "@id": "LEGIARTI000006712582", "@num": "2", "#text": "Décret n°92-1432 du 30 décembre 1992 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000726011", "@nortexte": "SPSG9202710D", "@numtexte": "92-1432", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1992-12-30" }, { "@id": "LEGIARTI000006355280", "@num": "87", "#text": "Loi n°93-122 du 29 janvier 1993 - art. 87 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000711604", "@nortexte": "PRMX9200148L", "@numtexte": "93-122", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "1993-01-29" }, { "@id": "LEGIARTI000006865783", "@num": "Annexe", "#text": "Décret n°96-850 du 20 septembre 1996 - art. Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000195660", "@nortexte": "ENVP9640024D", "@numtexte": "96-850", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1996-09-20" }, { "@id": "LEGIARTI000006506987", "@num": "3", "#text": "Décret n°98-385 du 18 mai 1998 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000571865", "@nortexte": "MESG9820693D", "@numtexte": "98-385", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1998-05-18" }, { "@id": "LEGIARTI000006724441", "@num": "5", "#text": "Décret n°2001-35 du 11 janvier 2001 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000388987", "@nortexte": "MJSK0070147D", "@numtexte": "2001-35", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2001-01-11" }, { "@id": "LEGIARTI000006254318", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254325", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639980", "@nortexte": "SANP0623382A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254307", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254319", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326653", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020320295", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326611", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254321", "@num": "4", "#text": "Arrêté du 16 août 2006 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254313", "@num": "7", "#text": "Arrêté du 16 août 2006 - art. 7 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006734099", "@num": "ANNEXE", "#text": "Arrêté du 16 août 2006 - art. ANNEXE (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639975", "@nortexte": "SANP0623370A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006255223", "@num": "1", "#text": "Arrêté du 11 septembre 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000271992", "@nortexte": "SANP0623792A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-09-11" }, { "@id": "LEGIARTI000020322856", "@num": "3", "#text": "Arrêté du 11 septembre 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000271992", "@nortexte": "SANP0623792A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-09-11" }, { "@id": "LEGIARTI000006697048", "@num": "39", "#text": "Loi n°2007-248 du 26 février 2007 - art. 39 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000613381", "@nortexte": "SANX0600004L", "@numtexte": "2007-248", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2007-02-26" }, { "@id": "LEGIARTI000006868630", "@num": "29", "#text": "Décret n° 2007-358 du 19 mars 2007 - art. 29 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000821090", "@nortexte": "AGRG0700644D", "@numtexte": "2007-358", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-19" }, { "@id": "LEGIARTI000006726837", "@num": "5", "#text": "Décret n°2007-462 du 25 mars 2007 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000466314", "@nortexte": "MJSK0770075D", "@numtexte": "2007-462", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-25" }, { "@id": "LEGIARTI000018361459", "@num": "Annexe", "#text": "Arrêté du 5 mars 2008 - art. Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000018360158", "@nortexte": "SJSP0805973A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-03-05" }, { "@id": "LEGIARTI000019382668", "@num": "2", "#text": "Arrêté du 11 août 2008 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019381783", "@nortexte": "SJSP0820319A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-08-11" }, { "@id": "LEGIARTI000034448482", "@num": "7", "#text": "Arrêté du 6 février 2009 - art. 7 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000020234297", "@nortexte": "SJSG0824493A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-06" }, { "@id": "LEGITEXT000020319418", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318429", "@nortexte": "SASP0904387A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319427", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318439", "@nortexte": "SASP0904427A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319436", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318449", "@nortexte": "SASP0904394A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGIARTI000021782780", "@num": "Annexe au règlement intérieur", "#text": "Arrêté du 13 janvier 2010 - art. Annexe au règlement intérieur (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000021782073", "@nortexte": "SASP1001133A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-01-13" }, { "@id": "LEGITEXT000022416787", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415149", "@nortexte": "SASP1017123A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416463", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415125", "@nortexte": "SASP1017105A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416472", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415141", "@nortexte": "SASP1017114A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGIARTI000023430029", "@num": "6", "#text": "Décret n°2011-57\n du 13 janvier 2011 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000023428330", "@nortexte": "SPOV1017553D", "@numtexte": "2011-57", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-01-13" }, { "@id": "LEGITEXT000023778069", "#text": "Arrêté du 17 mars 2011 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000023776935", "@nortexte": "ETSP1108041A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-03-17" }, { "@id": "LEGIARTI000025071143", "@num": "38", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 38 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000025071141", "@num": "39", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 39 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000026480621", "@num": "4", "#text": "Arrêté du 10 octobre 2012 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000026479723", "@nortexte": "AFSP1221372A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-10-10" }, { "@id": "LEGIARTI000026806482", "@num": "14", "#text": "Ordonnance n°2012-1427\n du 19 décembre 2012 - art. 14", "@sens": "cible", "@cidtexte": "JORFTEXT000026805101", "@nortexte": "AFSX1240311R", "@numtexte": "2012-1427", "@typelien": "MODIFIE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2012-12-19" }, { "@id": "LEGIARTI000027648252", "#text": "Arrêté du 23 janvier 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027047902", "@nortexte": "AFSP1228322A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-01-23" }, { "@id": "LEGITEXT000027434552", "#text": "Décret n°2013-414\n du 21 mai 2013 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027434029", "@nortexte": "AFSP1304115D", "@numtexte": "2013-414", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2013-05-21" }, { "@id": "LEGIARTI000027594512", "#text": "Arrêté du 20 juin 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027592947", "@nortexte": "AFSP1313848A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-20" }, { "@id": "LEGIARTI000027699119", "@num": "1", "#text": "Arrêté du 17 juin 2013 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027697076", "@nortexte": "AFSP1301854A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-17" }, { "@id": "LEGIARTI000033202304", "#text": "Arrêté du 29 août 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027910341", "@nortexte": "PROI1311061A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-08-29" }, { "@id": "LEGIARTI000035971526", "#text": "DÉCRET n°2014-1286 du 23 octobre 2014 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029675991", "@nortexte": "AFSX1419046D", "@numtexte": "2014-1286", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000036393921", "@num": "166", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 166 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000031916570", "@num": "169", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 169 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000043508038", "#text": "Arrêté du 28 novembre 2016 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033507693", "@nortexte": "AFSP1633477A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-11-28" }, { "@id": "LEGIARTI000033554483", "@num": "3", "#text": "Arrêté du 2 décembre 2016 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033553349", "@nortexte": "AFSP1635656A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000038887172", "@num": "2", "#text": "LOI n°2017-220 du 23 février 2017 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034078423", "@nortexte": "AFSP1622342L", "@numtexte": "2017-220", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2017-02-23" }, { "@id": "LEGIARTI000034152829", "@num": "1", "#text": "Arrêté du 27 février 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150863", "@nortexte": "AFSP1706243A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000035988048", "@num": "3", "#text": "Arrêté du 27 février 2017 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150842", "@nortexte": "AFSP1706241A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000035269375", "@num": "1", "#text": "Arrêté du 17 juillet 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000035268202", "@nortexte": "SSAE1720859A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-07-17" }, { "@id": "LEGITEXT000036406189", "#text": "Décret n°2017-1781 du 27 décembre 2017 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036299141", "@nortexte": "SSAP1728401D", "@numtexte": "2017-1781", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-12-27" }, { "@id": "LEGIARTI000038432466", "@num": "1", "#text": "Décret n°2019-389 du 30 avril 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000038431240", "@nortexte": "SSAS1906324D", "@numtexte": "2019-389", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-04-30" }, { "@id": "LEGITEXT000039664011", "#text": "Arrêté du 20 décembre 2019 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000039663324", "@nortexte": "SSAP1936730A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-12-20" }, { "@id": "LEGIARTI000041898595", "@num": "10-3-1", "#text": "Arrêté du 23 mars 2020 - art. 10-3-1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000042645749", "@num": "17", "#text": "Ordonnance n°2020-460 du 22 avril 2020 - art. 17 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041814597", "@nortexte": "ECOX2009794R", "@numtexte": "2020-460", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2020-04-22" }, { "@id": "LEGIARTI000041890409", "@num": "1", "#text": "Arrêté du 18 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041889362", "@nortexte": "SSAZ2011564A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-18" }, { "@id": "LEGIARTI000041898504", "@num": "1", "#text": "Arrêté du 20 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041897919", "@nortexte": "SSAZ2012596A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-20" }, { "@id": "LEGIARTI000043298218", "@num": "25", "#text": "Arrêté du 10 juillet 2020 - art. 25 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042609739", "@num": "26", "#text": "Arrêté du 10 juillet 2020 - art. 26 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000043103458", "#text": "Arrêté du 5 février 2021 - art. (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000043100729", "@nortexte": "SSAP2104251A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-02-05" }, { "@id": "LEGIARTI000043298491", "@num": "3", "#text": "Décret n°2021-331 du 26 mars 2021 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000043297285", "@nortexte": "SSAS2034156D", "@numtexte": "2021-331", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-03-26" }, { "@id": "LEGITEXT000043543262", "#text": "Décret n°2021-662 du 26 mai 2021 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043541690", "@nortexte": "ECOI2106880D", "@numtexte": "2021-662", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-05-26" }, { "@id": "LEGIARTI000043543283", "#text": "Décret n°2021-662 du 26 mai 2021 - art.", "@sens": "cible", "@cidtexte": "JORFTEXT000043541690", "@nortexte": "ECOI2106880D", "@numtexte": "2021-662", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-05-26" }, { "@id": "LEGIARTI000047779186", "@num": "25", "#text": "Arrêté du 1 juin 2021 - art. 25 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000043770220", "@num": "27", "#text": "Arrêté du 1er juin 2021 - art. 27 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000046567251", "@num": "Annexe 2", "#text": "Arrêté du 14 novembre 2022 - art. 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R5313-6-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028542287", "@num": "R5313-7", "#text": "Code de la santé publique - art. R5313-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033857104", "@num": "R5322-14", "#text": "Code de la santé publique - art. R5322-14 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025786265", "@num": "R5322-8", "#text": "Code de la santé publique - art. R5322-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025104309", "@num": "L161-39", "#text": "Code de la sécurité sociale. - art. 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I. - L'Agence nationale de sécurité du médicament et des produits de santé est un établissement public de l'Etat, placé sous la tutelle du ministre chargé de la santé.

L'agence participe à l'application des lois et règlements et prend, dans les cas prévus par des dispositions particulières, des décisions relatives à l'évaluation, aux essais, à la fabrication, à la préparation, à l'importation, à l'exportation, à la distribution en gros, au courtage, au conditionnement, à la conservation, à l'exploitation, à la mise sur le marché, à la publicité, à la mise en service ou à l'utilisation des produits à finalité sanitaire destinés à l'homme et des produits à finalité cosmétique, et notamment :

2° Les produits contraceptifs et contragestifs ;

3° Les biomatériaux et les dispositifs médicaux ;

4° Les dispositifs médicaux de diagnostic in vitro ;

5° Les produits sanguins labiles ;

6° Les organes, tissus, cellules et produits d'origine humaine ou animale, y compris lorsqu'ils sont prélevés à l'occasion d'une intervention chirurgicale ;

7° Les produits cellulaires à finalité thérapeutique ;

8° Le lait maternel collecté, qualifié, préparé et conservé par les lactariums ;

9° Les produits destinés à l'entretien ou à l'application des lentilles de contact ;

10° (Abrogé) ;

11° Les procédés et appareils destinés à la désinfection des locaux et des véhicules dans les cas prévus à l'article L. 3114-1 ;

12° Les produits thérapeutiques annexes ;

13° (Abrogé) ;

14° Les lentilles oculaires non correctrices ;

15° Les produits cosmétiques ;

16° Les micro-organismes et toxines mentionnés à l'article L. 5139-1 ;

17° Les produits de tatouage ;

19° Les dispositifs à finalité non strictement médicale utilisés dans les laboratoires de biologie médicale pour la réalisation des examens de biologie médicale.

Elle assure la mise en oeuvre des systèmes de vigilance et prépare la pharmacopée.

Elle contrôle la publicité en faveur de tous les produits, objets, appareils et méthodes revendiquant une finalité sanitaire.

Elle organise des auditions publiques sur des thèmes de santé publique.

L'agence est également chargée du contrôle du respect des dispositions des autorisations délivrées en application de l'article L. 1161-5.\n

" } }, "LEGIARTI000027480562": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5311-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2016-01-28", "DATE_DEBUT": "2013-06-01" } }, "META_COMMUN": { "ID": "LEGIARTI000027480562", "URL": "article/LEGI/ARTI/00/00/27/48/05/LEGIARTI000027480562.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Le décret n° 2012-597 du 27 avril 2012 est entré en vigueur le 1er mai 2012.

" }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006630983", "@num": "1", "#text": "Décret n°81-278 du 25 mars 1981 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000503017", "@numtexte": "81-278", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1981-03-25" }, { "@id": "LEGIARTI000006631025", "@num": "Annexe I", "#text": "Décret n°81-278 du 25 mars 1981 - art. Annexe I (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000503017", "@numtexte": "81-278", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1981-03-25" }, { "@id": "LEGIARTI000035606736", "@num": "2-1", "#text": "Décret n°90-975 du 30 octobre 1990 - art. 2-1 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000000160314", "@nortexte": "SPSG9001546D", "@numtexte": "90-975", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1990-10-30" }, { "@id": "LEGIARTI000006712582", "@num": "2", "#text": "Décret n°92-1432 du 30 décembre 1992 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000726011", "@nortexte": "SPSG9202710D", "@numtexte": "92-1432", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1992-12-30" }, { "@id": "LEGIARTI000006355280", "@num": "87", "#text": "Loi n°93-122 du 29 janvier 1993 - art. 87 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000711604", "@nortexte": "PRMX9200148L", "@numtexte": "93-122", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "1993-01-29" }, { "@id": "LEGIARTI000006865783", "@num": "Annexe", "#text": "Décret n°96-850 du 20 septembre 1996 - art. Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000195660", "@nortexte": "ENVP9640024D", "@numtexte": "96-850", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1996-09-20" }, { "@id": "LEGIARTI000006506987", "@num": "3", "#text": "Décret n°98-385 du 18 mai 1998 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000571865", "@nortexte": "MESG9820693D", "@numtexte": "98-385", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1998-05-18" }, { "@id": "LEGIARTI000006724441", "@num": "5", "#text": "Décret n°2001-35 du 11 janvier 2001 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000388987", "@nortexte": "MJSK0070147D", "@numtexte": "2001-35", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2001-01-11" }, { "@id": "LEGIARTI000006254318", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254325", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639980", "@nortexte": "SANP0623382A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254307", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254319", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326653", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020320295", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326611", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254321", "@num": "4", "#text": "Arrêté du 16 août 2006 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254313", "@num": "7", "#text": "Arrêté du 16 août 2006 - art. 7 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006734099", "@num": "ANNEXE", "#text": "Arrêté du 16 août 2006 - art. ANNEXE (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639975", "@nortexte": "SANP0623370A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006255223", "@num": "1", "#text": "Arrêté du 11 septembre 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000271992", "@nortexte": "SANP0623792A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-09-11" }, { "@id": "LEGIARTI000020322856", "@num": "3", "#text": "Arrêté du 11 septembre 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000271992", "@nortexte": "SANP0623792A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-09-11" }, { "@id": "LEGIARTI000006697048", "@num": "39", "#text": "Loi n°2007-248 du 26 février 2007 - art. 39 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000613381", "@nortexte": "SANX0600004L", "@numtexte": "2007-248", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2007-02-26" }, { "@id": "LEGIARTI000006868630", "@num": "29", "#text": "Décret n° 2007-358 du 19 mars 2007 - art. 29 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000821090", "@nortexte": "AGRG0700644D", "@numtexte": "2007-358", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-19" }, { "@id": "LEGIARTI000006726837", "@num": "5", "#text": "Décret n°2007-462 du 25 mars 2007 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000466314", "@nortexte": "MJSK0770075D", "@numtexte": "2007-462", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-25" }, { "@id": "LEGIARTI000018361459", "@num": "Annexe", "#text": "Arrêté du 5 mars 2008 - art. Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000018360158", "@nortexte": "SJSP0805973A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-03-05" }, { "@id": "LEGIARTI000019382668", "@num": "2", "#text": "Arrêté du 11 août 2008 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019381783", "@nortexte": "SJSP0820319A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-08-11" }, { "@id": "LEGIARTI000034448482", "@num": "7", "#text": "Arrêté du 6 février 2009 - art. 7 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000020234297", "@nortexte": "SJSG0824493A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-06" }, { "@id": "LEGITEXT000020319418", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318429", "@nortexte": "SASP0904387A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319427", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318439", "@nortexte": "SASP0904427A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319436", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318449", "@nortexte": "SASP0904394A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGIARTI000021782780", "@num": "Annexe au règlement intérieur", "#text": "Arrêté du 13 janvier 2010 - art. Annexe au règlement intérieur (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000021782073", "@nortexte": "SASP1001133A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-01-13" }, { "@id": "LEGITEXT000022416787", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415149", "@nortexte": "SASP1017123A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416463", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415125", "@nortexte": "SASP1017105A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416472", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415141", "@nortexte": "SASP1017114A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGIARTI000023430029", "@num": "6", "#text": "Décret n°2011-57\n du 13 janvier 2011 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000023428330", "@nortexte": "SPOV1017553D", "@numtexte": "2011-57", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-01-13" }, { "@id": "LEGITEXT000023778069", "#text": "Arrêté du 17 mars 2011 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000023776935", "@nortexte": "ETSP1108041A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-03-17" }, { "@id": "LEGIARTI000025071143", "@num": "38", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 38 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000025071141", "@num": "39", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 39 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000026480621", "@num": "4", "#text": "Arrêté du 10 octobre 2012 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000026479723", "@nortexte": "AFSP1221372A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-10-10" }, { "@id": "LEGIARTI000027648252", "#text": "Arrêté du 23 janvier 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027047902", "@nortexte": "AFSP1228322A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-01-23" }, { "@id": "LEGITEXT000027434552", "#text": "Décret n°2013-414\n du 21 mai 2013 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027434029", "@nortexte": "AFSP1304115D", "@numtexte": "2013-414", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2013-05-21" }, { "@id": "LEGIARTI000027479341", "@num": "8", "#text": "LOI n°2013-442\n du 30 mai 2013 - art. 8", "@sens": "cible", "@cidtexte": "JORFTEXT000027478077", "@nortexte": "AFSX1242935L", "@numtexte": "2013-442", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2013-05-30" }, { "@id": "LEGIARTI000027594512", "#text": "Arrêté du 20 juin 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027592947", "@nortexte": "AFSP1313848A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-20" }, { "@id": "LEGIARTI000027699119", "@num": "1", "#text": "Arrêté du 17 juin 2013 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027697076", "@nortexte": "AFSP1301854A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-17" }, { "@id": "LEGIARTI000033202304", "#text": "Arrêté du 29 août 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027910341", "@nortexte": "PROI1311061A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-08-29" }, { "@id": "LEGIARTI000035971526", "#text": "DÉCRET n°2014-1286 du 23 octobre 2014 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029675991", "@nortexte": "AFSX1419046D", "@numtexte": "2014-1286", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000036393921", "@num": "166", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 166 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000031916570", "@num": "169", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 169 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000043508038", "#text": "Arrêté du 28 novembre 2016 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033507693", "@nortexte": "AFSP1633477A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-11-28" }, { "@id": "LEGIARTI000033554483", "@num": "3", "#text": "Arrêté du 2 décembre 2016 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033553349", "@nortexte": "AFSP1635656A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000038887172", "@num": "2", "#text": "LOI n°2017-220 du 23 février 2017 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034078423", "@nortexte": "AFSP1622342L", "@numtexte": "2017-220", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2017-02-23" }, { "@id": "LEGIARTI000034152829", "@num": "1", "#text": "Arrêté du 27 février 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150863", "@nortexte": "AFSP1706243A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000035988048", "@num": "3", "#text": "Arrêté du 27 février 2017 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150842", "@nortexte": "AFSP1706241A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000035269375", "@num": "1", "#text": "Arrêté du 17 juillet 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000035268202", "@nortexte": "SSAE1720859A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-07-17" }, { "@id": "LEGITEXT000036406189", "#text": "Décret n°2017-1781 du 27 décembre 2017 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036299141", "@nortexte": "SSAP1728401D", "@numtexte": "2017-1781", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-12-27" }, { "@id": "LEGIARTI000038432466", "@num": "1", "#text": "Décret n°2019-389 du 30 avril 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000038431240", "@nortexte": "SSAS1906324D", "@numtexte": "2019-389", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-04-30" }, { "@id": "LEGITEXT000039664011", "#text": "Arrêté du 20 décembre 2019 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000039663324", "@nortexte": "SSAP1936730A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-12-20" }, { "@id": "LEGIARTI000041898595", "@num": "10-3-1", "#text": "Arrêté du 23 mars 2020 - art. 10-3-1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000042645749", "@num": "17", "#text": "Ordonnance n°2020-460 du 22 avril 2020 - art. 17 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041814597", "@nortexte": "ECOX2009794R", "@numtexte": "2020-460", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2020-04-22" }, { "@id": "LEGIARTI000041890409", "@num": "1", "#text": "Arrêté du 18 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041889362", "@nortexte": "SSAZ2011564A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-18" }, { "@id": "LEGIARTI000041898504", "@num": "1", "#text": "Arrêté du 20 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041897919", "@nortexte": "SSAZ2012596A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-20" }, { "@id": "LEGIARTI000043298218", "@num": "25", "#text": "Arrêté du 10 juillet 2020 - art. 25 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042609739", "@num": "26", "#text": "Arrêté du 10 juillet 2020 - art. 26 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000043103458", "#text": "Arrêté du 5 février 2021 - art. (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000043100729", "@nortexte": "SSAP2104251A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-02-05" }, { "@id": "LEGIARTI000043298491", "@num": "3", "#text": "Décret n°2021-331 du 26 mars 2021 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000043297285", "@nortexte": "SSAS2034156D", "@numtexte": "2021-331", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-03-26" }, { "@id": "LEGITEXT000043543262", "#text": "Décret n°2021-662 du 26 mai 2021 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043541690", "@nortexte": "ECOI2106880D", "@numtexte": "2021-662", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-05-26" }, { "@id": "LEGIARTI000043543283", "#text": "Décret n°2021-662 du 26 mai 2021 - art.", "@sens": "cible", "@cidtexte": "JORFTEXT000043541690", "@nortexte": "ECOI2106880D", "@numtexte": "2021-662", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-05-26" }, { "@id": "LEGIARTI000047779186", "@num": "25", "#text": "Arrêté du 1 juin 2021 - art. 25 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000043770220", "@num": "27", "#text": "Arrêté du 1er juin 2021 - art. 27 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000046567251", "@num": "Annexe 2", "#text": "Arrêté du 14 novembre 2022 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000046566303", "@nortexte": "SPRP2231874A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-11-14" }, { "@id": "LEGIARTI000049976728", "@num": "Annexe 1", "#text": "Arrêté du 14 novembre 2022 - art. Annexe 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000046566303", "@nortexte": "SPRP2231874A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-11-14" }, { "@id": "LEGIARTI000050409030", "#text": "Arrêté du 24 octobre 2024 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000050407232", "@nortexte": "MSAP2428789A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-10-24" }, { "@id": "LEGIARTI000050409032", "#text": "Arrêté du 24 octobre 2024 - art. 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L161-39 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000042685822", "@num": "L162-17-2-1", "#text": "Code de la sécurité sociale. - art. L162-17-2-1 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000037064523", "@num": "L245-5-5-1", "#text": "Code de la sécurité sociale. - art. L245-5-5-1 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048701735", "@num": "L245-6", "#text": "Code de la sécurité sociale. - art. L245-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000031093005", "@num": "R245-16-3", "#text": "Code de la sécurité sociale. - art. R245-16-3 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000042779560", "@num": "706-2", "#text": "Code de procédure pénale - art. 706-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006071154", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025859349", "@num": "L251-1", "#text": "Code des assurances - art. L251-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073984", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000038086667", "@num": "R250-1", "#text": "Code des assurances - art. R250-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073984", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043907211", "@num": "R232-49", "#text": "Code du sport. - art. R232-49 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006071318", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000037947963", "@num": "1635 bis AE", "#text": "Code général des impôts, CGI. - art. 1635 bis AE (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069577", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000042160762", "@num": "344 undecies A", "#text": "Code général des impôts, annexe 3, CGIAN3. - art. 344 undecies A (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069574", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000030752201", "@num": "L166 D", "#text": "Livre des procédures fiscales - art. L166 D (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069583", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000029012373", "@num": "R166 D-1", "#text": "Livre des procédures fiscales - art. R166 D-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069583", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171401", "@fin": "2999-01-01", "#text": "Chapitre Ier : Missions.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155093", "@fin": "2999-01-01", "#text": "Titre Ier : Missions et prérogatives", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140633", "@fin": "2012-05-01", "#text": "Livre III : Agence française de sécurité sanitaire des produits de santé", "@debut": "2000-06-22" }, { "@id": "LEGISCTA000025104258", "@fin": "2999-01-01", "#text": "Livre III : Agence nationale de sécurité du médicament et des produits de santé", "@debut": "2012-05-01" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": 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I. - L'Agence nationale de sécurité du médicament et des produits de santé est un établissement public de l'Etat, placé sous la tutelle du ministre chargé de la santé.

L'agence participe à l'application des lois et règlements et prend, dans les cas prévus par des dispositions particulières, des décisions relatives à l'évaluation, aux essais, à la fabrication, à la préparation, à l'importation, à l'exportation, à la distribution en gros, au courtage, au conditionnement, à la conservation, à l'exploitation, à la mise sur le marché, à la publicité, à la mise en service ou à l'utilisation des produits à finalité sanitaire destinés à l'homme et des produits à finalité cosmétique, et notamment :

2° Les produits contraceptifs et contragestifs ;

3° Les biomatériaux et les dispositifs médicaux ;

4° Les dispositifs médicaux de diagnostic in vitro ;

5° Les produits sanguins labiles ;

6° Les organes, tissus, cellules et produits d'origine humaine ou animale, y compris lorsqu'ils sont prélevés à l'occasion d'une intervention chirurgicale ;

7° Les produits cellulaires à finalité thérapeutique ;

8° Le lait maternel collecté, qualifié, préparé et conservé par les lactariums ;

9° Les produits destinés à l'entretien ou à l'application des lentilles de contact ;

10° (Abrogé) ;

11° Les procédés et appareils destinés à la désinfection des locaux et des véhicules dans les cas prévus à l'article L. 3114-1 ;

12° Les produits thérapeutiques annexes ;

13° (Abrogé) ;

14° Les lentilles oculaires non correctrices ;

15° Les produits cosmétiques ;

16° Les micro-organismes et toxines mentionnés à l'article L. 5139-1 ;

17° Les produits de tatouage ;

19° Les dispositifs à finalité non strictement médicale utilisés dans les laboratoires de biologie médicale pour la réalisation des examens de biologie médicale.

Elle assure la mise en oeuvre des systèmes de vigilance et prépare la pharmacopée.

Elle contrôle la publicité en faveur de tous les produits, objets, appareils et méthodes revendiquant une finalité sanitaire.

Elle organise des auditions publiques sur des thèmes de santé publique.

L'agence est également chargée du contrôle du respect des dispositions des autorisations délivrées en application de l'article L. 1161-5.\n

" } }, "LEGIARTI000031930410": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5311-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2016-07-17", "DATE_DEBUT": "2016-01-28" } }, "META_COMMUN": { "ID": "LEGIARTI000031930410", "URL": "article/LEGI/ARTI/00/00/31/93/04/LEGIARTI000031930410.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Le décret n° 2012-597 du 27 avril 2012 est entré en vigueur le 1er mai 2012.

" }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006630983", "@num": "1", "#text": "Décret n°81-278 du 25 mars 1981 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000503017", "@numtexte": "81-278", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1981-03-25" }, { "@id": "LEGIARTI000006631025", "@num": "Annexe I", "#text": "Décret n°81-278 du 25 mars 1981 - art. Annexe I (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000503017", "@numtexte": "81-278", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1981-03-25" }, { "@id": "LEGIARTI000035606736", "@num": "2-1", "#text": "Décret n°90-975 du 30 octobre 1990 - art. 2-1 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000000160314", "@nortexte": "SPSG9001546D", "@numtexte": "90-975", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1990-10-30" }, { "@id": "LEGIARTI000006712582", "@num": "2", "#text": "Décret n°92-1432 du 30 décembre 1992 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000726011", "@nortexte": "SPSG9202710D", "@numtexte": "92-1432", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1992-12-30" }, { "@id": "LEGIARTI000006355280", "@num": "87", "#text": "Loi n°93-122 du 29 janvier 1993 - art. 87 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000711604", "@nortexte": "PRMX9200148L", "@numtexte": "93-122", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "1993-01-29" }, { "@id": "LEGIARTI000006865783", "@num": "Annexe", "#text": "Décret n°96-850 du 20 septembre 1996 - art. Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000195660", "@nortexte": "ENVP9640024D", "@numtexte": "96-850", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1996-09-20" }, { "@id": "LEGIARTI000006506987", "@num": "3", "#text": "Décret n°98-385 du 18 mai 1998 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000571865", "@nortexte": "MESG9820693D", "@numtexte": "98-385", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1998-05-18" }, { "@id": "LEGIARTI000006724441", "@num": "5", "#text": "Décret n°2001-35 du 11 janvier 2001 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000388987", "@nortexte": "MJSK0070147D", "@numtexte": "2001-35", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2001-01-11" }, { "@id": "LEGIARTI000006254318", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254325", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639980", "@nortexte": "SANP0623382A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254307", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254319", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326653", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020320295", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326611", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254321", "@num": "4", "#text": "Arrêté du 16 août 2006 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254313", "@num": "7", "#text": "Arrêté du 16 août 2006 - art. 7 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006734099", "@num": "ANNEXE", "#text": "Arrêté du 16 août 2006 - art. ANNEXE (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639975", "@nortexte": "SANP0623370A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006255223", "@num": "1", "#text": "Arrêté du 11 septembre 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000271992", "@nortexte": "SANP0623792A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-09-11" }, { "@id": "LEGIARTI000020322856", "@num": "3", "#text": "Arrêté du 11 septembre 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000271992", "@nortexte": "SANP0623792A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-09-11" }, { "@id": "LEGIARTI000006697048", "@num": "39", "#text": "Loi n°2007-248 du 26 février 2007 - art. 39 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000613381", "@nortexte": "SANX0600004L", "@numtexte": "2007-248", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2007-02-26" }, { "@id": "LEGIARTI000006868630", "@num": "29", "#text": "Décret n° 2007-358 du 19 mars 2007 - art. 29 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000821090", "@nortexte": "AGRG0700644D", "@numtexte": "2007-358", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-19" }, { "@id": "LEGIARTI000006726837", "@num": "5", "#text": "Décret n°2007-462 du 25 mars 2007 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000466314", "@nortexte": "MJSK0770075D", "@numtexte": "2007-462", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-25" }, { "@id": "LEGIARTI000018361459", "@num": "Annexe", "#text": "Arrêté du 5 mars 2008 - art. Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000018360158", "@nortexte": "SJSP0805973A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-03-05" }, { "@id": "LEGIARTI000019382668", "@num": "2", "#text": "Arrêté du 11 août 2008 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019381783", "@nortexte": "SJSP0820319A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-08-11" }, { "@id": "LEGIARTI000034448482", "@num": "7", "#text": "Arrêté du 6 février 2009 - art. 7 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000020234297", "@nortexte": "SJSG0824493A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-06" }, { "@id": "LEGITEXT000020319418", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318429", "@nortexte": "SASP0904387A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319427", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318439", "@nortexte": "SASP0904427A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319436", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318449", "@nortexte": "SASP0904394A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGIARTI000021782780", "@num": "Annexe au règlement intérieur", "#text": "Arrêté du 13 janvier 2010 - art. Annexe au règlement intérieur (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000021782073", "@nortexte": "SASP1001133A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-01-13" }, { "@id": "LEGITEXT000022416787", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415149", "@nortexte": "SASP1017123A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416463", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415125", "@nortexte": "SASP1017105A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416472", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415141", "@nortexte": "SASP1017114A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGIARTI000023430029", "@num": "6", "#text": "Décret n°2011-57\n du 13 janvier 2011 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000023428330", "@nortexte": "SPOV1017553D", "@numtexte": "2011-57", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-01-13" }, { "@id": "LEGITEXT000023778069", "#text": "Arrêté du 17 mars 2011 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000023776935", "@nortexte": "ETSP1108041A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-03-17" }, { "@id": "LEGIARTI000025071143", "@num": "38", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 38 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000025071141", "@num": "39", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 39 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000026480621", "@num": "4", "#text": "Arrêté du 10 octobre 2012 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000026479723", "@nortexte": "AFSP1221372A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-10-10" }, { "@id": "LEGIARTI000027648252", "#text": "Arrêté du 23 janvier 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027047902", "@nortexte": "AFSP1228322A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-01-23" }, { "@id": "LEGITEXT000027434552", "#text": "Décret n°2013-414\n du 21 mai 2013 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027434029", "@nortexte": "AFSP1304115D", "@numtexte": "2013-414", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2013-05-21" }, { "@id": "LEGIARTI000027594512", "#text": "Arrêté du 20 juin 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027592947", "@nortexte": "AFSP1313848A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-20" }, { "@id": "LEGIARTI000027699119", "@num": "1", "#text": "Arrêté du 17 juin 2013 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027697076", "@nortexte": "AFSP1301854A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-17" }, { "@id": "LEGIARTI000033202304", "#text": "Arrêté du 29 août 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027910341", "@nortexte": "PROI1311061A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-08-29" }, { "@id": "LEGIARTI000035971526", "#text": "DÉCRET n°2014-1286 du 23 octobre 2014 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029675991", "@nortexte": "AFSX1419046D", "@numtexte": "2014-1286", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000031916470", "@num": "148", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 148", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000031916562", "@num": "165", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 165", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000036393921", "@num": "166", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 166 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000031916570", "@num": "169", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 169 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000031916578", "@num": "173", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 173", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000043508038", "#text": "Arrêté du 28 novembre 2016 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033507693", "@nortexte": "AFSP1633477A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-11-28" }, { "@id": "LEGIARTI000033554483", "@num": "3", "#text": "Arrêté du 2 décembre 2016 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033553349", "@nortexte": "AFSP1635656A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000038887172", "@num": "2", "#text": "LOI n°2017-220 du 23 février 2017 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034078423", "@nortexte": "AFSP1622342L", "@numtexte": "2017-220", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2017-02-23" }, { "@id": "LEGIARTI000034152829", "@num": "1", "#text": "Arrêté du 27 février 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150863", "@nortexte": "AFSP1706243A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000035988048", "@num": "3", "#text": "Arrêté du 27 février 2017 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150842", "@nortexte": "AFSP1706241A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000035269375", "@num": "1", "#text": "Arrêté du 17 juillet 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000035268202", "@nortexte": "SSAE1720859A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-07-17" }, { "@id": "LEGITEXT000036406189", "#text": "Décret n°2017-1781 du 27 décembre 2017 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036299141", "@nortexte": "SSAP1728401D", "@numtexte": "2017-1781", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-12-27" }, { "@id": "LEGIARTI000038432466", "@num": "1", "#text": "Décret n°2019-389 du 30 avril 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000038431240", "@nortexte": "SSAS1906324D", "@numtexte": "2019-389", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-04-30" }, { "@id": "LEGITEXT000039664011", "#text": "Arrêté du 20 décembre 2019 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000039663324", "@nortexte": "SSAP1936730A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-12-20" }, { "@id": "LEGIARTI000041898595", "@num": "10-3-1", "#text": "Arrêté du 23 mars 2020 - art. 10-3-1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000042645749", "@num": "17", "#text": "Ordonnance n°2020-460 du 22 avril 2020 - art. 17 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041814597", "@nortexte": "ECOX2009794R", "@numtexte": "2020-460", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2020-04-22" }, { "@id": "LEGIARTI000041890409", "@num": "1", "#text": "Arrêté du 18 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041889362", "@nortexte": "SSAZ2011564A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-18" }, { "@id": "LEGIARTI000041898504", "@num": "1", "#text": "Arrêté du 20 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041897919", "@nortexte": "SSAZ2012596A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-20" }, { "@id": "LEGIARTI000043298218", "@num": "25", "#text": "Arrêté du 10 juillet 2020 - art. 25 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042609739", "@num": "26", "#text": "Arrêté du 10 juillet 2020 - art. 26 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000043103458", "#text": "Arrêté du 5 février 2021 - art. (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000043100729", "@nortexte": "SSAP2104251A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-02-05" }, { "@id": "LEGIARTI000043298491", "@num": "3", "#text": "Décret n°2021-331 du 26 mars 2021 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000043297285", "@nortexte": "SSAS2034156D", "@numtexte": "2021-331", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-03-26" }, { "@id": "LEGITEXT000043543262", "#text": "Décret n°2021-662 du 26 mai 2021 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043541690", "@nortexte": "ECOI2106880D", "@numtexte": "2021-662", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-05-26" }, { "@id": "LEGIARTI000043543283", "#text": "Décret n°2021-662 du 26 mai 2021 - art.", "@sens": "cible", "@cidtexte": "JORFTEXT000043541690", "@nortexte": "ECOI2106880D", "@numtexte": "2021-662", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-05-26" }, { "@id": "LEGIARTI000047779186", "@num": "25", "#text": "Arrêté du 1 juin 2021 - art. 25 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000043770220", "@num": "27", "#text": "Arrêté du 1er juin 2021 - art. 27 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000046567251", "@num": "Annexe 2", "#text": "Arrêté du 14 novembre 2022 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000046566303", "@nortexte": "SPRP2231874A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-11-14" }, { "@id": "LEGIARTI000049976728", "@num": "Annexe 1", "#text": "Arrêté du 14 novembre 2022 - art. Annexe 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000046566303", "@nortexte": "SPRP2231874A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-11-14" }, { "@id": "LEGIARTI000050409030", "#text": "Arrêté du 24 octobre 2024 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000050407232", "@nortexte": "MSAP2428789A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-10-24" }, { "@id": "LEGIARTI000050409032", "#text": "Arrêté du 24 octobre 2024 - art. 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I.-L'Agence nationale de sécurité du médicament et des produits de santé est un établissement public de l'Etat, placé sous la tutelle du ministre chargé de la santé.

II.-L'agence procède à l'évaluation des bénéfices et des risques liés à l'utilisation des produits à finalité sanitaire destinés à l'homme et des produits à finalité cosmétique. Elle surveille le risque lié à ces produits et effectue des réévaluations des bénéfices et des risques.

L'agence participe à l'application des lois et règlements et prend, dans les cas prévus par des dispositions particulières, des décisions relatives à l'évaluation, aux essais, à la fabrication, à la préparation, à l'importation, à l'exportation, à la distribution en gros, au courtage, au conditionnement, à la conservation, à l'exploitation, à la mise sur le marché, à la publicité, à la mise en service ou à l'utilisation des produits à finalité sanitaire destinés à l'homme et des produits à finalité cosmétique, et notamment :

2° Les produits contraceptifs et contragestifs ;

3° Les biomatériaux et les dispositifs médicaux ;

4° Les dispositifs médicaux de diagnostic in vitro ;

5° Les produits sanguins labiles ;

6° Les organes, tissus, cellules et produits d'origine humaine ou animale, y compris lorsqu'ils sont prélevés à l'occasion d'une intervention chirurgicale ;

7° Les produits cellulaires à finalité thérapeutique ;

8° Le lait maternel collecté, qualifié, préparé et conservé par les lactariums ;

9° Les produits destinés à l'entretien ou à l'application des lentilles de contact ;

10° (Abrogé) ;

11° Les procédés et appareils destinés à la désinfection des locaux et des véhicules dans les cas prévus à l'article L. 3114-1 ;

12° (Abrogé) ;

13° (Abrogé) ;

14° Les lentilles oculaires non correctrices ;

15° Les produits cosmétiques ;

16° Les micro-organismes et toxines mentionnés à l'article L. 5139-1 ;

17° Les produits de tatouage ;

19° Les dispositifs à finalité non strictement médicale utilisés dans les laboratoires de biologie médicale pour la réalisation des examens de biologie médicale ;

20° Les logiciels d'aide à la prescription et les logiciels d'aide à la dispensation.

III.-L'agence participe à l'application des lois et règlements relatifs aux recherches biomédicales et prend, dans les cas prévus par des dispositions particulières, des décisions relatives aux recherches biomédicales.

Elle contrôle la publicité en faveur de tous les produits, objets, appareils et méthodes revendiquant une finalité sanitaire.

Elle organise des auditions publiques sur des thèmes de santé publique.

L'agence est également chargée du contrôle du respect des dispositions des autorisations délivrées en application de l'article L. 1161-5.\n

" } }, "LEGIARTI000032908924": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5311-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2017-07-01", "DATE_DEBUT": "2016-07-17" } }, "META_COMMUN": { "ID": "LEGIARTI000032908924", "URL": "article/LEGI/ARTI/00/00/32/90/89/LEGIARTI000032908924.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006630983", "@num": "1", "#text": "Décret n°81-278 du 25 mars 1981 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000503017", "@numtexte": "81-278", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1981-03-25" }, { "@id": "LEGIARTI000006631025", "@num": "Annexe I", "#text": "Décret n°81-278 du 25 mars 1981 - art. Annexe I (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000503017", "@numtexte": "81-278", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1981-03-25" }, { "@id": "LEGIARTI000035606736", "@num": "2-1", "#text": "Décret n°90-975 du 30 octobre 1990 - art. 2-1 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000000160314", "@nortexte": "SPSG9001546D", "@numtexte": "90-975", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1990-10-30" }, { "@id": "LEGIARTI000006712582", "@num": "2", "#text": "Décret n°92-1432 du 30 décembre 1992 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000726011", "@nortexte": "SPSG9202710D", "@numtexte": "92-1432", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1992-12-30" }, { "@id": "LEGIARTI000006355280", "@num": "87", "#text": "Loi n°93-122 du 29 janvier 1993 - art. 87 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000711604", "@nortexte": "PRMX9200148L", "@numtexte": "93-122", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "1993-01-29" }, { "@id": "LEGIARTI000006865783", "@num": "Annexe", "#text": "Décret n°96-850 du 20 septembre 1996 - art. Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000195660", "@nortexte": "ENVP9640024D", "@numtexte": "96-850", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1996-09-20" }, { "@id": "LEGIARTI000006506987", "@num": "3", "#text": "Décret n°98-385 du 18 mai 1998 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000571865", "@nortexte": "MESG9820693D", "@numtexte": "98-385", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1998-05-18" }, { "@id": "LEGIARTI000006724441", "@num": "5", "#text": "Décret n°2001-35 du 11 janvier 2001 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000388987", "@nortexte": "MJSK0070147D", "@numtexte": "2001-35", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2001-01-11" }, { "@id": "LEGIARTI000006254318", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254325", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639980", "@nortexte": "SANP0623382A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254307", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254319", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326653", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020320295", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326611", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254321", "@num": "4", "#text": "Arrêté du 16 août 2006 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254313", "@num": "7", "#text": "Arrêté du 16 août 2006 - art. 7 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006734099", "@num": "ANNEXE", "#text": "Arrêté du 16 août 2006 - art. ANNEXE (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639975", "@nortexte": "SANP0623370A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006255223", "@num": "1", "#text": "Arrêté du 11 septembre 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000271992", "@nortexte": "SANP0623792A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-09-11" }, { "@id": "LEGIARTI000020322856", "@num": "3", "#text": "Arrêté du 11 septembre 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000271992", "@nortexte": "SANP0623792A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-09-11" }, { "@id": "LEGIARTI000006697048", "@num": "39", "#text": "Loi n°2007-248 du 26 février 2007 - art. 39 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000613381", "@nortexte": "SANX0600004L", "@numtexte": "2007-248", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2007-02-26" }, { "@id": "LEGIARTI000006868630", "@num": "29", "#text": "Décret n° 2007-358 du 19 mars 2007 - art. 29 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000821090", "@nortexte": "AGRG0700644D", "@numtexte": "2007-358", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-19" }, { "@id": "LEGIARTI000006726837", "@num": "5", "#text": "Décret n°2007-462 du 25 mars 2007 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000466314", "@nortexte": "MJSK0770075D", "@numtexte": "2007-462", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-25" }, { "@id": "LEGIARTI000018361459", "@num": "Annexe", "#text": "Arrêté du 5 mars 2008 - art. Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000018360158", "@nortexte": "SJSP0805973A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-03-05" }, { "@id": "LEGIARTI000019382668", "@num": "2", "#text": "Arrêté du 11 août 2008 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019381783", "@nortexte": "SJSP0820319A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-08-11" }, { "@id": "LEGIARTI000034448482", "@num": "7", "#text": "Arrêté du 6 février 2009 - art. 7 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000020234297", "@nortexte": "SJSG0824493A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-06" }, { "@id": "LEGITEXT000020319418", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318429", "@nortexte": "SASP0904387A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319427", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318439", "@nortexte": "SASP0904427A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319436", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318449", "@nortexte": "SASP0904394A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGIARTI000021782780", "@num": "Annexe au règlement intérieur", "#text": "Arrêté du 13 janvier 2010 - art. Annexe au règlement intérieur (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000021782073", "@nortexte": "SASP1001133A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-01-13" }, { "@id": "LEGITEXT000022416787", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415149", "@nortexte": "SASP1017123A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416463", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415125", "@nortexte": "SASP1017105A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416472", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415141", "@nortexte": "SASP1017114A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGIARTI000023430029", "@num": "6", "#text": "Décret n°2011-57\n du 13 janvier 2011 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000023428330", "@nortexte": "SPOV1017553D", "@numtexte": "2011-57", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-01-13" }, { "@id": "LEGITEXT000023778069", "#text": "Arrêté du 17 mars 2011 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000023776935", "@nortexte": "ETSP1108041A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-03-17" }, { "@id": "LEGIARTI000025071143", "@num": "38", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 38 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000025071141", "@num": "39", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 39 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000026480621", "@num": "4", "#text": "Arrêté du 10 octobre 2012 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000026479723", "@nortexte": "AFSP1221372A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-10-10" }, { "@id": "LEGIARTI000027648252", "#text": "Arrêté du 23 janvier 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027047902", "@nortexte": "AFSP1228322A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-01-23" }, { "@id": "LEGITEXT000027434552", "#text": "Décret n°2013-414\n du 21 mai 2013 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027434029", "@nortexte": "AFSP1304115D", "@numtexte": "2013-414", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2013-05-21" }, { "@id": "LEGIARTI000027594512", "#text": "Arrêté du 20 juin 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027592947", "@nortexte": "AFSP1313848A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-20" }, { "@id": "LEGIARTI000027699119", "@num": "1", "#text": "Arrêté du 17 juin 2013 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027697076", "@nortexte": "AFSP1301854A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-17" }, { "@id": "LEGIARTI000033202304", "#text": "Arrêté du 29 août 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027910341", "@nortexte": "PROI1311061A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-08-29" }, { "@id": "LEGIARTI000035971526", "#text": "DÉCRET n°2014-1286 du 23 octobre 2014 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029675991", "@nortexte": "AFSX1419046D", "@numtexte": "2014-1286", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000036393921", "@num": "166", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 166 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000031916570", "@num": "169", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 169 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000032896542", "@num": "2", "#text": "Ordonnance n°2016-966 du 15 juillet 2016 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000032894018", "@nortexte": "AFSP1611753R", "@numtexte": "2016-966", "@typelien": "MODIFIE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2016-07-15" }, { "@id": "LEGIARTI000043508038", "#text": "Arrêté du 28 novembre 2016 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033507693", "@nortexte": "AFSP1633477A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-11-28" }, { "@id": "LEGIARTI000033554483", "@num": "3", "#text": "Arrêté du 2 décembre 2016 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033553349", "@nortexte": "AFSP1635656A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000038887172", "@num": "2", "#text": "LOI n°2017-220 du 23 février 2017 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034078423", "@nortexte": "AFSP1622342L", "@numtexte": "2017-220", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2017-02-23" }, { "@id": "LEGIARTI000034152829", "@num": "1", "#text": "Arrêté du 27 février 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150863", "@nortexte": "AFSP1706243A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000035988048", "@num": "3", "#text": "Arrêté du 27 février 2017 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150842", "@nortexte": "AFSP1706241A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000035269375", "@num": "1", "#text": "Arrêté du 17 juillet 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000035268202", "@nortexte": "SSAE1720859A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-07-17" }, { "@id": "LEGITEXT000036406189", "#text": "Décret n°2017-1781 du 27 décembre 2017 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036299141", "@nortexte": "SSAP1728401D", "@numtexte": "2017-1781", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-12-27" }, { "@id": "LEGIARTI000038432466", "@num": "1", "#text": "Décret n°2019-389 du 30 avril 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000038431240", "@nortexte": "SSAS1906324D", "@numtexte": "2019-389", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-04-30" }, { "@id": "LEGITEXT000039664011", "#text": "Arrêté du 20 décembre 2019 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000039663324", "@nortexte": "SSAP1936730A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-12-20" }, { "@id": "LEGIARTI000041898595", "@num": "10-3-1", "#text": "Arrêté du 23 mars 2020 - art. 10-3-1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000042645749", "@num": "17", "#text": "Ordonnance n°2020-460 du 22 avril 2020 - art. 17 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041814597", "@nortexte": "ECOX2009794R", "@numtexte": "2020-460", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2020-04-22" }, { "@id": "LEGIARTI000041890409", "@num": "1", "#text": "Arrêté du 18 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041889362", "@nortexte": "SSAZ2011564A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-18" }, { "@id": "LEGIARTI000041898504", "@num": "1", "#text": "Arrêté du 20 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041897919", "@nortexte": "SSAZ2012596A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-20" }, { "@id": "LEGIARTI000043298218", "@num": "25", "#text": "Arrêté du 10 juillet 2020 - art. 25 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042609739", "@num": "26", "#text": "Arrêté du 10 juillet 2020 - art. 26 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000043103458", "#text": "Arrêté du 5 février 2021 - art. (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000043100729", "@nortexte": "SSAP2104251A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-02-05" }, { "@id": "LEGIARTI000043298491", "@num": "3", "#text": "Décret n°2021-331 du 26 mars 2021 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000043297285", "@nortexte": "SSAS2034156D", "@numtexte": "2021-331", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-03-26" }, { "@id": "LEGITEXT000043543262", "#text": "Décret n°2021-662 du 26 mai 2021 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043541690", "@nortexte": "ECOI2106880D", "@numtexte": "2021-662", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-05-26" }, { "@id": "LEGIARTI000043543283", "#text": "Décret n°2021-662 du 26 mai 2021 - art.", "@sens": "cible", "@cidtexte": "JORFTEXT000043541690", "@nortexte": "ECOI2106880D", "@numtexte": "2021-662", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-05-26" }, { "@id": "LEGIARTI000047779186", "@num": "25", "#text": "Arrêté du 1 juin 2021 - art. 25 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000043770220", "@num": "27", "#text": "Arrêté du 1er juin 2021 - art. 27 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000046567251", "@num": "Annexe 2", "#text": "Arrêté du 14 novembre 2022 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000046566303", "@nortexte": "SPRP2231874A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-11-14" }, { "@id": "LEGIARTI000049976728", "@num": "Annexe 1", "#text": "Arrêté du 14 novembre 2022 - art. Annexe 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000046566303", "@nortexte": "SPRP2231874A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-11-14" }, { "@id": "LEGIARTI000050409030", "#text": "Arrêté du 24 octobre 2024 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000050407232", "@nortexte": "MSAP2428789A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-10-24" }, { "@id": "LEGIARTI000050409032", "#text": "Arrêté du 24 octobre 2024 - art. 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"2021-08-04", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000045630379", "@fin": "2022-07-31", "@num": "L5311-1", "@etat": "MODIFIE", "@debut": "2022-04-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000046126182", "@fin": "2024-01-01", "@num": "L5311-1", "@etat": "MODIFIE", "@debut": "2022-07-31", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000046871876", "@fin": "2999-01-01", "@num": "L5311-1", "@etat": "VIGUEUR", "@debut": "2024-01-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "I. - L'Agence nationale de sécurité du médicament et des produits de santé est un établissement public de l'Etat, placé sous la tutelle du ministre chargé de la santé.

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II. - L'agence procède à l'évaluation des bénéfices et des risques liés à l'utilisation des produits à finalité sanitaire destinés à l'homme et des produits à finalité cosmétique. Elle surveille le risque lié à ces produits et effectue des réévaluations des bénéfices et des risques.

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L'agence peut demander que les essais cliniques portant sur des médicaments soient effectués sous forme d'essais contre comparateurs actifs et contre placebo. Si la personne produisant ou exploitant un médicament s'oppose aux essais contre comparateurs actifs, elle doit le justifier.

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L'agence participe à l'application des lois et règlements et prend, dans les cas prévus par des dispositions particulières, des décisions relatives à l'évaluation, aux essais, à la fabrication, à la préparation, à l'importation, à l'exportation, à la distribution en gros, au courtage, au conditionnement, à la conservation, à l'exploitation, à la mise sur le marché, à la publicité, à la mise en service ou à l'utilisation des produits à finalité sanitaire destinés à l'homme et des produits à finalité cosmétique, et notamment :

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1° Les médicaments, y compris les insecticides, acaricides et antiparasitaires à usage humain, les préparations magistrales, hospitalières et officinales, les substances stupéfiantes, psychotropes ou autres substances vénéneuses utilisées en médecine, les huiles essentielles et plantes médicinales, les matières premières à usage pharmaceutique ;

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2° Les produits contraceptifs et contragestifs ;

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3° Les biomatériaux et les dispositifs médicaux ;

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4° Les dispositifs médicaux de diagnostic in vitro ;

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5° Les produits sanguins labiles ;

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6° Les organes, tissus, cellules et produits d'origine humaine ou animale, y compris lorsqu'ils sont prélevés à l'occasion d'une intervention chirurgicale ;

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7° Les produits cellulaires à finalité thérapeutique ;

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8° Le lait maternel collecté, qualifié, préparé et conservé par les lactariums ;

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9° Les produits destinés à l'entretien ou à l'application des lentilles de contact ;

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10° (Abrogé) ;

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11° Les procédés et appareils destinés à la désinfection des locaux et des véhicules dans les cas prévus à l'article L. 3114-1 ;

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12° (Abrogé) ;

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13° (Abrogé) ;

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14° Les lentilles oculaires non correctrices ;

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15° Les produits cosmétiques ;

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16° Les micro-organismes et toxines mentionnés à l'article L. 5139-1 ;

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17° Les produits de tatouage ;

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18° Les logiciels qui ne sont pas des dispositifs médicaux et qui sont utilisés par les laboratoires de biologie médicale, pour la gestion des examens de biologie médicale et lors de la validation, de l'interprétation, de la communication appropriée en application du 3° de l'article L. 6211-2 et de l'archivage des résultats ;

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19° Les dispositifs à finalité non strictement médicale utilisés dans les laboratoires de biologie médicale pour la réalisation des examens de biologie médicale ;

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20° Les logiciels d'aide à la prescription et les logiciels d'aide à la dispensation.

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III. - L'agence participe à l'application des lois et règlements relatifs aux recherches impliquant la personne humaine et prend, dans les cas prévus par des dispositions particulières, des décisions relatives aux recherches impliquant la personne humaine.

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Elle assure la mise en œuvre des systèmes de vigilance, à l'exception de ceux portant sur le lait maternel, les organes, les tissus, les cellules et les préparations de thérapie cellulaire, et élabore la pharmacopée.

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Elle rend publics un rapport de synthèse de l'évaluation effectuée pour tout nouveau médicament dans des conditions déterminées par voie réglementaire, ainsi que les décisions d'octroi, de suspension et de retrait de l'autorisation de mise sur le marché mentionnées aux articles L. 5121-8 et L. 5121-9. Elle organise des réunions régulières d'information avec des associations agréées de personnes malades et d'usagers du système de santé mentionnées à l'article L. 1114-1 sur les problèmes de sécurité sanitaire des produits de santé, notamment sur les actions entreprises dans le domaine de la prévention et de la répression de la falsification des médicaments.

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Elle contrôle la publicité en faveur de tous les produits, objets, appareils et méthodes revendiquant une finalité sanitaire.

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Elle prend ou demande aux autorités compétentes de prendre les mesures de police sanitaire nécessaires lorsque la santé de la population est menacée, dans les conditions prévues au présent code ou par toute autre disposition législative ou réglementaire visant à préserver la santé humaine.

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Elle établit un rapport annuel d'activité adressé au Gouvernement et au Parlement. Ce rapport est rendu public. Le rapport comporte le bilan annuel de la réévaluation du rapport entre les bénéfices et les risques des médicaments à usage humain mentionnés à l'article L. 5121-8.

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Elle organise des auditions publiques sur des thèmes de santé publique.

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L'agence est également chargée du contrôle du respect des dispositions des autorisations délivrées en application de l'article L. 1161-5.

" } }, "LEGIARTI000033897163": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5311-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2021-06-01", "DATE_DEBUT": "2017-07-01" } }, "META_COMMUN": { "ID": "LEGIARTI000033897163", "URL": "article/LEGI/ARTI/00/00/33/89/71/LEGIARTI000033897163.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Conformément à l'article 7 de l'ordonnance n° 2017-51 du 19 janvier 2017, les présentes dispositions entrent en application à la date d'entrée en vigueur du décret en Conseil d'Etat pris pour son application, et au plus tard le 1er juillet 2017.

Article R5161-1 AUTONOME VIGUEUR, en vigueur depuis le 20/02/2012 (Code de la santé publique)