{ "article": { "LEGIARTI000006908372": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R1123-17", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2006-04-27", "DATE_DEBUT": "2003-05-27" } }, "META_COMMUN": { "ID": "LEGIARTI000006908372", "URL": "article/LEGI/ARTI/00/00/06/90/83/LEGIARTI000006908372.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "YXXXXXXXXXX1123R0170XX0A" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000412528", "#text": "Décret 2003-462 2003-05-21", "@sens": "source", "@cidtexte": "JORFTEXT000000412528", "@nortexte": "SANP0321523D", "@numtexte": "2003-462", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2003-05-21" }, { "@id": "LEGIARTI000044296012", "@num": "ANNEXE 2", "#text": "Arrêté du 25 octobre 2021 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000044294342", "@nortexte": "SSAP2132225A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-10-25" }, { "@id": "LEGIARTI000044296010", "@num": "ANNEXE 1", "#text": "Arrêté du 25 octobre 2021 - art. ANNEXE 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000044294342", "@nortexte": "SSAP2132225A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-10-25" }, { "@id": "LEGITEXT000047264603", "#text": "Arrêté du 2 mars 2023 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000047260256", "@nortexte": "SPRH2300610A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2023-03-02" }, { "@id": "LEGITEXT000047262969", "#text": "Décret n°2023-156 du 2 mars 2023 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000047260205", "@nortexte": "SPRH2300606D", "@numtexte": "2023-156", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2023-03-02" }, { "@id": "LEGIARTI000047262979", "@num": "1", "#text": "Décret n°2023-156 du 2 mars 2023 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000047260205", "@nortexte": "SPRH2300606D", "@numtexte": "2023-156", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2023-03-02" }, { "@id": "LEGIARTI000006690344", "@num": "L5311-1", "#text": "Code de la santé publique - art. L5311-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798922", "@num": "R2018-1", "#text": "Code de la santé publique - art. R2018-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798921", "@num": "R2018-1", "#text": "Code de la santé publique - art. R2018-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006196152", "@fin": "2006-04-27", "#text": "Sous-section 3 : Organisation et fonctionnement.", "@debut": "2003-05-27" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190192", "@fin": "2006-04-27", "#text": "Section 1 : Dispositions générales", "@debut": "2003-05-27" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178471", "@fin": "2006-04-27", "#text": "Chapitre III : Comités consultatifs de protection des personnes", "@debut": "2003-05-27" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006160948", "@fin": "2017-05-11", "#text": "Titre II : Recherches biomédicales", "@debut": "2003-05-27" }, { "@id": "LEGISCTA000034773672", "@fin": "2999-01-01", "#text": "Titre II : Recherches impliquant la personne humaine", "@debut": "2017-05-11" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145467", "@fin": "2999-01-01", "#text": "Livre Ier : Protection des personnes en matière de santé", "@debut": "2003-05-27" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132378", "@fin": "2999-01-01", "#text": "Première partie : Protection générale de la santé", "@debut": "2000-12-23" } ] }, "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": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006908372", "@fin": "2006-04-27", "@num": "R1123-17", "@etat": "MODIFIE", "@debut": "2003-05-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006908373", "@fin": "2010-04-01", "@num": "R1123-17", "@etat": "MODIFIE", "@debut": "2006-04-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000022049503", "@fin": "2016-11-18", "@num": "R1123-17", "@etat": "MODIFIE", "@debut": "2010-04-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000033417905", "@fin": "2017-05-11", "@num": "R1123-17", "@etat": "MODIFIE", "@debut": "2016-11-18", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000034696978", "@fin": "2999-01-01", "@num": "R1123-17", "@etat": "VIGUEUR", "@debut": "2017-05-11", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le comité communique tout avis défavorable donné à un projet de recherche au ministre chargé de la santé. Toutefois, lorsqu'il s'agit d'une recherche biomédicale portant sur des produits mentionnés à l'article L. 5311-1, le comité communique cet avis au directeur général de l'Agence française de sécurité sanitaire des produits de santé.
\n
" } }, "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. 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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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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° 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.
\n
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.
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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": "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. 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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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.
\n
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.
\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 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.
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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": "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 (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 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 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": "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. (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 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.
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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.
" } }, "LEGIARTI000006798922": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R2018-1", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2003-05-27", "DATE_DEBUT": "1999-03-05" } }, "META_COMMUN": { "ID": "LEGIARTI000006798922", "URL": "article/LEGI/ARTI/00/00/06/79/89/LEGIARTI000006798922.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX2018R0010XXAB" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006723529", "@num": "2", "#text": "Décret n°99-146 du 4 mars 1999 - art. 2 () JORF 5 mars 1999", "@sens": "source", "@cidtexte": "JORFTEXT000000575200", "@nortexte": "MESP9824095D", "@numtexte": "99-146", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1999-03-04" }, { "@id": "JORFTEXT000000412528", "#text": "Décret 2003-462 2003-05-21 art. 4 2° JORF 27 mai 2003", "@sens": "source", "@cidtexte": "JORFTEXT000000412528", "@nortexte": "SANP0321523D", "@numtexte": "2003-462", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2003-05-21" }, { "@id": "LEGIARTI000006695238", "@num": "L793-1", "#text": "Code de la santé publique - art. L793-1 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908372", "@num": "R1123-17", "#text": "Code de la santé publique - art. R1123-17 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908373", "@num": "R1123-17", "#text": "Code de la santé publique - art. R1123-17 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "LOI 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006157730", "@fin": "2003-05-27", "#text": "Chapitre 3 : Financement et fonctionnement.", "@debut": "1990-09-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142882", "@fin": "2003-05-27", "#text": "Titre 1 : Comités consultatifs de protection des personnes dans la recherche biomédicale", "@debut": "1990-09-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128468", "@fin": "2003-05-27", "#text": "Livre 2 bis : Protection des personnes qui se prêtent à des recherches biomédicales", "@debut": "1990-09-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@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": "LEGIARTI000006798921", "@fin": "1999-03-05", "@num": "R2018-1", "@etat": "MODIFIE", "@debut": "1997-10-02", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006798922", "@fin": "2003-05-27", "@num": "R2018-1", "@etat": "ABROGE", "@debut": "1999-03-05", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le comité communique tout avis défavorable donné à un projet de recherche au ministre chargé de la santé. Toutefois, lorsqu'il s'agit d'une recherche biomédicale portant, sur des produits mentionnés à l'article L. 793-1, le comité communique son avis au directeur général de l'Agence française de sécurité sanitaire des produits de santé.
\n
" } }, "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. 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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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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 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.

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": "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 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.

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

" } }, "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.

" }, "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": "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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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

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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": "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. (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° (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. (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

" } }, "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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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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"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.

" }, "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": "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": "LEGIARTI000033894823", "@num": "1", "#text": "Ordonnance n°2017-51 du 19 janvier 2017 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000033893453", "@nortexte": "AFSP1632580R", "@numtexte": "2017-51", "@typelien": "MODIFIE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2017-01-19" }, { "@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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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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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. 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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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"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.

\n
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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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 cellulaires à finalité thérapeutique ;

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

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

\n
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 ;

\n
12° (Abrogé) ;

\n
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 ;

\n
17° Les produits de tatouage ;

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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, portant sur les produits mentionnés au II, à l'exception de la biovigilance et du dispositif de vigilance relatif à l'assistance médicale à la procréation, et élabore la pharmacopée.

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

\n
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.

" } }, "LEGIARTI000042654751": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5311-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2021-08-04", "DATE_DEBUT": "2021-06-01" } }, "META_COMMUN": { "ID": "LEGIARTI000042654751", "URL": "article/LEGI/ARTI/00/00/42/65/47/LEGIARTI000042654751.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Conformément au III de l’article 148 de la loi n° 2020-1525 du 7 décembre 2020, les présentes dispositions entrent en vigueur le premier jour du sixième mois qui suit celui de la publication de la présente loi.

Article R1123-17 AUTONOME MODIFIE, en vigueur du 27/05/2003 au 27/04/2006 (Code de la santé publique)