{ "article": { "LEGIARTI000038432466": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "1", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000038432466", "URL": "article/LEGI/ARTI/00/00/38/43/24/LEGIARTI000038432466.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "#text": "2 de l'article 2 du règlement (CE) N° 1234/2008", "@sens": "source", "@typelien": "CITATION" }, { "#text": "2 de l'article 2 du règlement (CE) N° 1234/2008", "@sens": "source", "@typelien": "CITATION" }, { "@id": "LEGIARTI000038434515", "@num": "344 undecies A", "#text": "Code général des impôts, annexe 3, CGIAN3. - art. 344 undecies A (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006069574", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025010429", "@num": "1635 bis AE", "#text": "Code général des impôts, CGI. - art. 1635 bis AE", "@sens": "source", "@cidtexte": "LEGITEXT000006069577", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689889", "@num": "L5121-8", "#text": "Code de la santé publique - art. L5121-8", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690344", "@num": "L5311-1", "#text": "Code de la santé publique - art. L5311-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914751", "@num": "R5121-28", "#text": "Code de la santé publique - art. R5121-28", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914769", "@num": "R5121-41", "#text": "Code de la santé publique - art. R5121-41", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914781", "@num": "R5121-46", "#text": "Code de la santé publique - art. 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A modifié les dispositions suivantes :

- Code général des impôts, annexe 3, CGIAN3.
\n Art. 344 undecies A\n
\n

\n
" } }, "LEGIARTI000006689889": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5121-8", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2007-02-27", "DATE_DEBUT": "2000-06-22" } }, "META_COMMUN": { "ID": "LEGIARTI000006689889", "URL": "article/LEGI/ARTI/00/00/06/68/98/LEGIARTI000006689889.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5121L08XXAA" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006700043", "@num": "15", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 15 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000039374401", "@num": "1", "#text": "Arrêté du 20 septembre 1999 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000761570", "@nortexte": "MESP9922897A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1999-09-20" }, { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006724328", "@num": "1", "#text": "Décret n°2000-1194 du 5 décembre 2000 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000768314", "@nortexte": "MESG0022611D", "@numtexte": "2000-1194", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2000-12-05" }, { "@id": "LEGIARTI000006724332", "@num": "3", "#text": "Décret n°2000-1194 du 5 décembre 2000 - art. 3 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000000768314", "@nortexte": "MESG0022611D", "@numtexte": "2000-1194", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2000-12-05" }, { "@id": "LEGITEXT000005631695", "#text": "Arrêté du 13 novembre 2001", "@sens": "cible", "@cidtexte": "JORFTEXT000000221792", "@nortexte": "MESG0123551A", "@typelien": "TXT_ASSOCIE", "@naturetexte": "ARRETE", "@datesignatexte": "2001-11-13" }, { "@id": "LEGIARTI000006334800", "@num": "1", "#text": "Arrêté du 13 novembre 2001 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000221792", "@nortexte": "MESG0123551A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2001-11-13" }, { "@id": "LEGIARTI000006334800", "@num": "1", "#text": "Arrêté du 13 novembre 2001 - 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art. 6 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000613381", "@nortexte": "SANX0600004L", "@numtexte": "2007-248", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2007-02-26" }, { "@id": "LEGITEXT000017833546", "#text": "Décret n°2007-1860\n du 26 décembre 2007 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000017762708", "@nortexte": "SJSP0771467D", "@numtexte": "2007-1860", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-12-26" }, { "@id": "LEGIARTI000026604165", "@num": "2", "#text": "Arrêté du 6 mai 2008 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000018768299", "@nortexte": "SJSP0810423A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-05-06" }, { "@id": "LEGIARTI000025882819", "#text": "Arrêté du 1er septembre 2009 - art. 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art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036920946", "@nortexte": "SSAP1813104A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-05-14" }, { "@id": "LEGIARTI000036925435", "@num": "4", "#text": "Arrêté du 14 mai 2018 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036920946", "@nortexte": "SSAP1813104A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-05-14" }, { "@id": "LEGIARTI000037502021", "@num": "1", "#text": "Arrêté du 15 octobre 2018 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000037501422", "@nortexte": "SSAP1828085A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-10-15" }, { "@id": "LEGIARTI000037557939", "@num": "3", "#text": "Arrêté du 26 octobre 2018 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000037552934", "@nortexte": "SSAP1829446A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-10-26" }, { "@id": "LEGIARTI000038122113", "@num": "2", "#text": "Arrêté du 11 février 2019 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000038121150", "@nortexte": "SSAP1904422A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-02-11" }, { "@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": "LEGIARTI000039157836", "@num": "2", "#text": "Arrêté du 26 septembre 2019 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000039146677", "@nortexte": "SSAP1927722A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-09-26" }, { "@id": "LEGIARTI000039373779", "@num": "1", "#text": "Arrêté du 5 novembre 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000039373247", "@nortexte": "SSAP1931830A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-11-05" }, { "@id": "LEGIARTI000041493923", "@num": "1", "#text": "Arrêté du 21 janvier 2020 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041459990", "@nortexte": "SSAP2001803A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-01-21" }, { "@id": "LEGIARTI000041521988", "@num": "2", "#text": "Arrêté du 30 janvier 2020 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041514887", "@nortexte": "SSAP2000708A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-01-30" }, { "@id": "LEGIARTI000041807940", "@num": "10-4", "#text": "Arrêté du 23 mars 2020 - art. 10-4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041807774", "@num": "10-5", "#text": "Arrêté du 23 mars 2020 - art. 10-5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041920905", "@num": "6-1", "#text": "Arrêté du 23 mars 2020 - 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Toute spécialité pharmaceutique ou tout autre médicament fabriqué industriellement, ainsi que tout générateur, trousse ou précurseur qui ne fait pas l'objet d'une autorisation de mise sur le marché délivrée par la Communauté européenne en application du règlement (CEE) n° 2309/93 du Conseil du 22 juillet 1993 doit faire l'objet avant sa commercialisation ou sa distribution à titre gratuit, en gros ou en détail, d'une autorisation de mise sur le marché délivrée par l'Agence française de sécurité sanitaire des produits de santé. Cette autorisation peut être assortie de conditions adéquates.
\n
L'autorisation est délivrée pour une durée de cinq ans ; elle est ensuite renouvelable par période quinquennale. Toute modification des éléments d'une autorisation de mise sur le marché délivrée par l'Agence française de sécurité sanitaire des produits de santé, quelle que soit son importance, doit être préalablement autorisée.
\n
L'autorisation peut être modifiée, suspendue ou retirée par l'Agence française de sécurité sanitaire des produits de santé.
\n
L'accomplissement des formalités prévues au présent article n'a pas pour effet d'exonérer le fabricant ou, s'il est distinct, le titulaire de l'autorisation de mise sur le marché, de la responsabilité que l'un ou l'autre peut encourir dans les conditions du droit commun en raison de la fabrication ou de la mise sur le marché du médicament ou produit.
" } }, "LEGIARTI000006689890": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5121-8", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2010-02-26", "DATE_DEBUT": "2007-02-27" } }, "META_COMMUN": { "ID": "LEGIARTI000006689890", "URL": "article/LEGI/ARTI/00/00/06/68/98/LEGIARTI000006689890.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5121L08XXAB" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006700043", "@num": "15", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 15 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000039374401", "@num": "1", "#text": "Arrêté du 20 septembre 1999 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000761570", "@nortexte": "MESP9922897A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1999-09-20" }, { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006724328", "@num": "1", "#text": "Décret n°2000-1194 du 5 décembre 2000 - 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art. 5 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000032093358", "@nortexte": "AFSP1604649A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-02-15" }, { "@id": "LEGIARTI000032096341", "@num": "6", "#text": "Arrêté du 15 février 2016 - art. 6 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000032093358", "@nortexte": "AFSP1604649A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-02-15" }, { "@id": "LEGIARTI000032096343", "@num": "7", "#text": "Arrêté du 15 février 2016 - art. 7 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000032093358", "@nortexte": "AFSP1604649A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-02-15" }, { "@id": "LEGIARTI000033122072", "@num": "4", "#text": "Arrêté du 8 septembre 2016 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033120953", "@nortexte": "AFSP1625292A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-09-08" }, { "@id": "LEGIARTI000036925433", "@num": "3", "#text": "Arrêté du 14 mai 2018 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036920946", "@nortexte": "SSAP1813104A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-05-14" }, { "@id": "LEGIARTI000036925435", "@num": "4", "#text": "Arrêté du 14 mai 2018 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036920946", "@nortexte": "SSAP1813104A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-05-14" }, { "@id": "LEGIARTI000037502021", "@num": "1", "#text": "Arrêté du 15 octobre 2018 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000037501422", "@nortexte": "SSAP1828085A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-10-15" }, { "@id": "LEGIARTI000037557939", "@num": "3", "#text": "Arrêté du 26 octobre 2018 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000037552934", "@nortexte": "SSAP1829446A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-10-26" }, { "@id": "LEGIARTI000038122113", "@num": "2", "#text": "Arrêté du 11 février 2019 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000038121150", "@nortexte": "SSAP1904422A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-02-11" }, { "@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": "LEGIARTI000039157836", "@num": "2", "#text": "Arrêté du 26 septembre 2019 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000039146677", "@nortexte": "SSAP1927722A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-09-26" }, { "@id": "LEGIARTI000039373779", "@num": "1", "#text": "Arrêté du 5 novembre 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000039373247", "@nortexte": "SSAP1931830A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-11-05" }, { "@id": "LEGIARTI000041493923", "@num": "1", "#text": "Arrêté du 21 janvier 2020 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041459990", "@nortexte": "SSAP2001803A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-01-21" }, { "@id": "LEGIARTI000041521988", "@num": "2", "#text": "Arrêté du 30 janvier 2020 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041514887", "@nortexte": "SSAP2000708A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-01-30" }, { "@id": "LEGIARTI000041807940", "@num": "10-4", "#text": "Arrêté du 23 mars 2020 - art. 10-4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041807774", "@num": "10-5", "#text": "Arrêté du 23 mars 2020 - art. 10-5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041920905", "@num": "6-1", "#text": "Arrêté du 23 mars 2020 - art. 6-1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041760851", "@num": "12-2", "#text": "Décret n°2020-293 du 23 mars 2020 - art. 12-2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746694", "@nortexte": "SSAZ2008253D", "@numtexte": "2020-293", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041756280", "@num": "1", "#text": "Décret n°2020-314 du 25 mars 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041755775", "@nortexte": "SSAZ2008362D", "@numtexte": "2020-314", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-25" }, { "@id": "LEGIARTI000041798665", "@num": "1", "#text": "Arrêté du 14 avril 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041798289", "@nortexte": "SSAZ2009592A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-04-14" }, { "@id": "LEGIARTI000041859122", "@num": "17", "#text": "Décret n°2020-545 du 11 mai 2020 - art. 17 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041858681", "@nortexte": "SSAZ2011567D", "@numtexte": "2020-545", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041866847", "@num": "19", "#text": "Décret n°2020-548 du 11 mai 2020 - art. 19 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041865329", "@nortexte": "SSAZ2011695D", "@numtexte": "2020-548", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041920889", "@num": "1", "#text": "Arrêté du 26 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041920446", "@nortexte": "SSAZ2012694A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-26" }, { "@id": "LEGIARTI000042107205", "@num": "12", "#text": "Arrêté du 10 juillet 2020 - art. 12 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042507722", "@num": "17-2", "#text": "Arrêté du 10 juillet 2020 - art. 17-2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042362301", "@num": "2", "#text": "Arrêté du 11 septembre 2020 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042360578", "@nortexte": "SSAP2023295A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-09-11" }, { "@id": "LEGIARTI000042362303", "@num": "3", "#text": "Arrêté du 11 septembre 2020 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042360578", "@nortexte": "SSAP2023295A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-09-11" }, { "@id": "LEGIARTI000042507028", "@num": "1", "#text": "Arrêté du 7 novembre 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000042506409", "@nortexte": "SSAZ2030422A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-11-07" }, { "@id": "LEGIARTI000043507358", "@num": "1", "#text": "Arrêté du 17 mai 2021 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043507013", "@nortexte": "SSAP2115206A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-05-17" }, { "@id": "LEGIARTI000043577258", "@num": "4", "#text": "Arrêté du 1 juin 2021 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000043577276", "@num": "13", "#text": "Arrêté du 1er juin 2021 - art. 13 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000044132476", "@num": "2", "#text": "Arrêté du 28 septembre 2021 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000044126672", "@nortexte": "SSAP2129267A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-09-28" }, { "@id": "LEGIARTI000049735069", "@num": "2", "#text": "Décret n°2024-550 du 17 juin 2024 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000049734265", "@nortexte": "TSSP2411185D", "@numtexte": "2024-550", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-06-17" }, { "@id": "LEGIARTI000020529716", "@num": "D5121-64", "#text": "Code de la santé publique - art. 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Toute spécialité pharmaceutique ou tout autre médicament fabriqué industriellement ou selon une méthode dans laquelle intervient un processus industriel ainsi que tout générateur, trousse ou précurseur qui ne fait pas l'objet d'une autorisation de mise sur le marché délivrée par la Communauté européenne en application du règlement (CE) n° 726/2004 du Parlement européen et du Conseil, du 31 mars 2004, établissant des procédures communautaires pour l'autorisation et la surveillance en ce qui concerne les médicaments à usage humain et à usage vétérinaire, et instituant une Agence européenne des médicaments doit faire l'objet, avant sa mise sur le marché ou sa distribution à titre gratuit, d'une autorisation de mise sur le marché délivrée par l'Agence française de sécurité sanitaire des produits de santé. L'autorisation peut être assortie de conditions appropriées.
\n
Le demandeur de l'autorisation peut être dispensé de produire certaines données et études dans des conditions fixées par voie réglementaire.
\n
Une autorisation de mise sur le marché ne peut être délivrée qu'à un demandeur établi dans un Etat membre de la Communauté européenne ou partie à l'accord sur l'Espace économique européen.
\n
L'autorisation est délivrée pour une durée de cinq ans et peut ensuite être renouvelée, le cas échéant, sans limitation de durée, dans des conditions fixées par un décret en Conseil d'Etat, sauf si l'Agence française de sécurité sanitaire des produits de santé décide, pour des raisons justifiées ayant trait à la pharmacovigilance, de procéder à un renouvellement supplémentaire, sur la base d'une réévaluation des effets thérapeutiques positifs du médicament ou produit au regard des risques tels que définis au premier alinéa de l'article L. 5121-9. Ce décret détermine également les conditions dans lesquelles elle peut devenir caduque.
\n
L'autorisation peut être modifiée par l'Agence française de sécurité sanitaire des produits de santé.
\n
L'accomplissement des formalités prévues au présent article n'a pas pour effet d'exonérer le fabricant et, s'il est distinct, le titulaire de l'autorisation de mise sur le marché, de la responsabilité que l'un ou l'autre peut encourir dans les conditions du droit commun en raison de la fabrication ou de la mise sur le marché du médicament ou produit.
" } }, "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. 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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": "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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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 (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. (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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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.
" } }, "LEGIARTI000006914751": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5121-28", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2008-05-08", "DATE_DEBUT": "2004-08-08" } }, "META_COMMUN": { "ID": "LEGIARTI000006914751", "URL": "article/LEGI/ARTI/00/00/06/91/47/LEGIARTI000006914751.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "YXXXXXXXXXX5121R0280XX0A" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@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": "LEGIARTI000020529716", "@num": "D5121-64", "#text": "Code de la santé publique - art. D5121-64 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044944581", "@num": "R5121-138", "#text": "Code de la santé publique - art. R5121-138 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025786628", "@num": "R5121-29", "#text": "Code de la santé publique - art. R5121-29 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018776294", "@num": "R5121-29-2", "#text": "Code de la santé publique - art. R5121-29-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018776549", "@num": "R5121-31", "#text": "Code de la santé publique - art. R5121-31 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000030773843", "@num": "R5121-41-1", "#text": "Code de la santé publique - art. R5121-41-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039401753", "@num": "R5121-5", "#text": "Code de la santé publique - art. R5121-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800140", "@num": "R5132", "#text": "Code de la santé publique - art. R5132 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800138", "@num": "R5132", "#text": "Code de la santé publique - art. R5132 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000030695761", "@num": "344 undecies A", "#text": "Code général des impôts, annexe 3, CGIAN3. - art. 344 undecies A (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069574", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006196541", "@fin": "2999-01-01", "#text": "Sous-section 1 : Demande d'autorisation.", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190665", "@fin": "2999-01-01", "#text": "Section 5 : Autorisation de mise sur le marché", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178649", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161012", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006914751", "@fin": "2008-05-08", "@num": "R5121-28", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000018776287", "@fin": "2011-02-06", "@num": "R5121-28", "@etat": "MODIFIE", "@debut": "2008-05-08", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000023529857", "@fin": "2999-01-01", "@num": "R5121-28", "@etat": "VIGUEUR", "@debut": "2011-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les comptes rendus des expertises cliniques comprennent le relevé de chaque observation et les conclusions de l'expert relatives notamment :
\n
1° Aux indications et à l'effet thérapeutique ;
\n
2° A l'innocuité dans les conditions normales d'emploi ;
\n
3° A l'évaluation de l'efficacité du dosage ;
\n
4° Aux contre-indications et aux effets secondaires ;
\n
5° Aux conditions normales et particulières de prescription, de délivrance et d'emploi.
" } }, "LEGIARTI000006914769": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5121-41", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2008-05-08", "DATE_DEBUT": "2004-08-08" } }, "META_COMMUN": { "ID": "LEGIARTI000006914769", "URL": "article/LEGI/ARTI/00/00/06/91/47/LEGIARTI000006914769.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "YXXXXXXXXXX5121R0410XX0A" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000019564954", "@num": "6", "#text": "Arrêté du 8 août 2008 - art. 6 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019563838", "@nortexte": "SJSP0820078A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-08-08" }, { "@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": "LEGIARTI000020529716", "@num": "D5121-64", "#text": "Code de la santé publique - art. D5121-64 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000020529732", "@num": "D5121-65", "#text": "Code de la santé publique - art. D5121-65 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034432960", "@num": "R5121-139", "#text": "Code de la santé publique - art. R5121-139 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914746", "@num": "R5121-23", "#text": "Code de la santé publique - art. R5121-23 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914747", "@num": "R5121-24", "#text": "Code de la santé publique - art. R5121-24 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800297", "@num": "R5135-4", "#text": "Code de la santé publique - art. R5135-4 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000030695761", "@num": "344 undecies A", "#text": "Code général des impôts, annexe 3, CGIAN3. - art. 344 undecies A (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069574", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006196543", "@fin": "2999-01-01", "#text": "Sous-section 3 : Instruction et conditions de l'autorisation.", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190665", "@fin": "2999-01-01", "#text": "Section 5 : Autorisation de mise sur le marché", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178649", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161012", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006914769", "@fin": "2008-05-08", "@num": "R5121-41", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000018776331", "@fin": "2012-05-01", "@num": "R5121-41", "@etat": "MODIFIE", "@debut": "2008-05-08", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000025788129", "@fin": "2999-01-01", "@num": "R5121-41", "@etat": "VIGUEUR", "@debut": "2012-05-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le titulaire de l'autorisation de mise sur le marché soumet au directeur général de l'Agence française de sécurité sanitaire des produits de santé tout projet de modification d'un élément relatif à l'étiquetage ou à la notice, autre que les modifications du résumé des caractéristiques du produit, prévu aux articles R. 5121-23 et R. 5121-24.
\n
Si le directeur général de l'agence ne s'est pas prononcé dans un délai de quatre-vingt-dix jours à compter de la date de présentation de la demande, le demandeur peut procéder à la mise en oeuvre des modifications.
" } }, "LEGIARTI000006914781": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5121-46", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2005-02-23", "DATE_DEBUT": "2004-08-08" } }, "META_COMMUN": { "ID": "LEGIARTI000006914781", "URL": "article/LEGI/ARTI/00/00/06/91/47/LEGIARTI000006914781.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "YXXXXXXXXXX5121R0460XX0A" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@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": "LEGIARTI000020529716", "@num": "D5121-64", "#text": "Code de la santé publique - art. D5121-64 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000020529732", "@num": "D5121-65", "#text": "Code de la santé publique - art. D5121-65 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000030772878", "@num": "R5121-100-1", "#text": "Code de la santé publique - art. R5121-100-1 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018776569", "@num": "R5121-107-8", "#text": "Code de la santé publique - art. R5121-107-8 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914744", "@num": "R5121-21", "#text": "Code de la santé publique - art. R5121-21 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000030773843", "@num": "R5121-41-1", "#text": "Code de la santé publique - art. R5121-41-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025788123", "@num": "R5121-41-2", "#text": "Code de la santé publique - art. R5121-41-2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915091", "@num": "R5124-10", "#text": "Code de la santé publique - art. R5124-10 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915085", "@num": "R5124-6", "#text": "Code de la santé publique - art. R5124-6 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915086", "@num": "R5124-7", "#text": "Code de la santé publique - art. R5124-7 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800197", "@num": "R5138", "#text": "Code de la santé publique - art. R5138 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006196543", "@fin": "2999-01-01", "#text": "Sous-section 3 : Instruction et conditions de l'autorisation.", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190665", "@fin": "2999-01-01", "#text": "Section 5 : Autorisation de mise sur le marché", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178649", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161012", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006914781", "@fin": "2005-02-23", "@num": "R5121-46", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006914782", "@fin": "2008-05-08", "@num": "R5121-46", "@etat": "MODIFIE", "@debut": "2005-02-23", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000018776362", "@fin": "2012-05-01", "@num": "R5121-46", "@etat": "MODIFIE", "@debut": "2008-05-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025788087", "@fin": "2021-11-01", "@num": "R5121-46", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000043531996", "@fin": "2999-01-01", "@num": "R5121-46", "@etat": "VIGUEUR", "@debut": "2021-11-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le changement du titulaire de l'autorisation de mise sur le marché est subordonné à une autorisation du directeur général de l'Agence française de sécurité sanitaire des produits de santé.
\n
La demande comporte les mentions prévues à l'article R. 5121-21 et elle est accompagnée d'un dossier comprenant :
\n
1° Une copie, certifiée conforme par le titulaire, de l'autorisation de mise sur le marché ;
\n
2° L'accord de ce titulaire sur le transfert de l'autorisation de mise sur le marché ;
\n
3° La désignation des lieux de fabrication, de contrôle et de conditionnement ;
\n
4° L'engagement du demandeur de se soumettre à l'ensemble des conditions auxquelles a été subordonnée l'autorisation de mise sur le marché et, notamment, de respecter les méthodes de fabrication et de contrôle ;
\n
5° Les comptes rendus des contrôles, effectués par le demandeur dans le respect desdites méthodes ;
\n
6° La formule de préparation avec, notamment, toutes indications utiles sur le récipient ;
\n
7° La compétence des nouveaux modèles destinés à la vente ;
\n
8° Le projet de nouvel étiquetage et, si elle est prévue, de la notice ;
\n
9° Copie des décisions autorisant la fabrication de la spécialité concernée et délivrée selon le cas, soit en vertu de la législation nationale du fabricant, soit en application des articles R. 5124-6, R. 5124-7 et R. 5124-10 ou, le cas échéant, copie des récépissés des demandes d'autorisation si lesdites demandes n'ont pas encore donné lieu à décision.
\n
Dans le cas de fusion ou d'apport partiel d'actifs, les sociétés intéressées peuvent déposer une demande de transfert des autorisations de mise sur le marché avant que la fusion ou l'apport ne soit définitivement réalisé. Elles fournissent, à l'appui de leur demande, le protocole d'accord de principe concernant la fusion ou l'apport. Le transfert est accordé sous la condition suspensive de la réalisation définitive qui est notifiée au directeur général de l'Agence française de sécurité sanitaire des produits de santé.
\n
En cas de silence de l'administration, le transfert prévu au présent article est réputé être autorisé à l'expiration d'un délai de deux mois.
" } }, "LEGIARTI000006914782": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5121-46", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2008-05-08", "DATE_DEBUT": "2005-02-23" } }, "META_COMMUN": { "ID": "LEGIARTI000006914782", "URL": "article/LEGI/ARTI/00/00/06/91/47/LEGIARTI000006914782.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "YXXXXXXXXXX5121R0460XX0B" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006238900", "@num": "1", "#text": "Décret n°2005-156 du 18 février 2005 - art. 1 () JORF 23 février 2005", "@sens": "source", "@cidtexte": "JORFTEXT000000444606", "@nortexte": "SANP0423672D", "@numtexte": "2005-156", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2005-02-18" }, { "@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": "LEGIARTI000020529716", "@num": "D5121-64", "#text": "Code de la santé publique - art. D5121-64 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000020529732", "@num": "D5121-65", "#text": "Code de la santé publique - art. D5121-65 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000030772878", "@num": "R5121-100-1", "#text": "Code de la santé publique - art. R5121-100-1 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018776569", "@num": "R5121-107-8", "#text": "Code de la santé publique - art. R5121-107-8 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000030773843", "@num": "R5121-41-1", "#text": "Code de la santé publique - art. R5121-41-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025788123", "@num": "R5121-41-2", "#text": "Code de la santé publique - art. R5121-41-2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800197", "@num": "R5138", "#text": "Code de la santé publique - art. R5138 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006196543", "@fin": "2999-01-01", "#text": "Sous-section 3 : Instruction et conditions de l'autorisation.", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190665", "@fin": "2999-01-01", "#text": "Section 5 : Autorisation de mise sur le marché", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178649", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161012", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006914781", "@fin": "2005-02-23", "@num": "R5121-46", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006914782", "@fin": "2008-05-08", "@num": "R5121-46", "@etat": "MODIFIE", "@debut": "2005-02-23", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000018776362", "@fin": "2012-05-01", "@num": "R5121-46", "@etat": "MODIFIE", "@debut": "2008-05-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025788087", "@fin": "2021-11-01", "@num": "R5121-46", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000043531996", "@fin": "2999-01-01", "@num": "R5121-46", "@etat": "VIGUEUR", "@debut": "2021-11-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le changement du titulaire de l'autorisation de mise sur le marché est subordonné à une autorisation du directeur général de l'Agence française de sécurité sanitaire des produits de santé.
\n
La demande comporte les mentions prévues à l'article R. 5121-21 et elle est accompagnée d'un dossier comprenant :
\n
1° Une copie, certifiée conforme par le titulaire, de l'autorisation de mise sur le marché ;
\n
2° L'accord de ce titulaire sur le transfert de l'autorisation de mise sur le marché ;
\n
3° La désignation des lieux de fabrication, de contrôle et de conditionnement ;
\n
4° L'engagement du demandeur de se soumettre à l'ensemble des conditions auxquelles a été subordonnée l'autorisation de mise sur le marché et, notamment, de respecter les méthodes de fabrication et de contrôle ;
\n
5° Les comptes rendus des contrôles, effectués par le demandeur dans le respect desdites méthodes ;
\n
6° La formule de préparation avec, notamment, toutes indications utiles sur le récipient ;
\n
7° La compétence des nouveaux modèles destinés à la vente ;
\n
8° Le projet de nouvel étiquetage et, si elle est prévue, de la notice ;
\n
9° Copie des décisions autorisant la fabrication de la spécialité concernée et délivrée selon le cas, soit en vertu de la législation nationale du fabricant, soit en application des articles R. 5124-6, R. 5124-7 et R. 5124-10 ou, le cas échéant, copie des récépissés des demandes d'autorisation si lesdites demandes n'ont pas encore donné lieu à décision ;
\n
10° Le cas échéant, un extrait du registre du commerce et des sociétés relatif au demandeur.
\n
Dans le cas de fusion ou d'apport partiel d'actifs, les sociétés intéressées peuvent déposer une demande de transfert des autorisations de mise sur le marché avant que la fusion ou l'apport ne soit définitivement réalisé. Elles fournissent, à l'appui de leur demande, le protocole d'accord de principe concernant la fusion ou l'apport. Le transfert est accordé sous la condition suspensive de la réalisation définitive qui est notifiée au directeur général de l'Agence française de sécurité sanitaire des produits de santé.
\n
Le directeur général de l'Agence française de sécurité sanitaire des produits de santé notifie sa décision dans un délai de soixante jours à compter de la date de réception de la demande. A défaut, le silence gardé par le directeur général de l'Agence française de sécurité sanitaire des produits de santé vaut autorisation à l'expiration de ce délai.
" } }, "LEGIARTI000017889898": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5121-51-3", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-05-01", "DATE_DEBUT": "2007-12-31" } }, "META_COMMUN": { "ID": "LEGIARTI000017889898", "URL": "article/LEGI/ARTI/00/00/17/88/98/LEGIARTI000017889898.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000017876177", "@num": "2", "#text": "Décret n°2007-1932\n du 26 décembre 2007 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000017766993", "@nortexte": "SJSP0757795D", "@numtexte": "2007-1932", "@typelien": "CREE", "@naturetexte": "DECRET", "@datesignatexte": "2007-12-26" }, { "@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": "LEGIARTI000006914761", "@num": "R5121-34", "#text": "Code de la santé publique - art. R5121-34", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025788064", "@num": "R5121-51-4", "#text": "Code de la santé publique - art. R5121-51-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000030695761", "@num": "344 undecies A", "#text": "Code général des impôts, annexe 3, CGIAN3. - art. 344 undecies A (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069574", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000017889919", "@fin": "2999-01-01", "#text": "Paragraphe 3 : Procédure décentralisée", "@debut": "2007-12-31" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000017889925", "@fin": "2999-01-01", "#text": "Sous-section 3 bis : Procédure de reconnaissance mutuelle et procédure décentralisée", "@debut": "2007-12-31" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190665", "@fin": "2999-01-01", "#text": "Section 5 : Autorisation de mise sur le marché", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178649", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161012", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000017889898", "@fin": "2012-05-01", "@num": "R5121-51-3", "@etat": "MODIFIE", "@debut": "2007-12-31", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000025788069", "@fin": "2999-01-01", "@num": "R5121-51-3", "@etat": "VIGUEUR", "@debut": "2012-05-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Pour obtenir une autorisation de mise sur le marché en France et dans au moins un autre Etat membre de la Communauté européenne ou partie à l'accord sur l'Espace économique européen, pour un médicament qui n'est autorisé ni dans la Communauté européenne ni dans l'Espace économique européen, le demandeur adresse une demande d'autorisation de mise sur le marché au directeur général de l'Agence française de sécurité sanitaire des produits de santé.

1° Si le demandeur désigne la France comme Etat de référence, la demande est instruite dans les conditions prévues aux articles R. 5121-34 et R. 5121-35. Le directeur général de l'agence transmet aux Etats concernés et au demandeur un projet de rapport d'évaluation du médicament, le cas échéant défavorable, accompagné des projets de résumé des caractéristiques du produit, d'étiquetage et de notice, dans un délai de cent vingt jours à compter de la réception du dossier complet.

En cas d'approbation de ces documents par chacun des Etats concernés dans un délai de quatre-vingt-dix jours, le directeur général de l'agence notifie l'accord à ces Etats et au demandeur. En conformité avec le rapport d'évaluation ainsi approuvé, il délivre ou refuse l'autorisation de mise sur le marché dans un délai de trente jours à compter de cette notification.

A défaut d'accord entre les Etats concernés dans le délai de quatre-vingt-dix jours mentionné à l'alinéa précédent, le directeur général de l'agence saisit le groupe de coordination mentionné à l'article 27 de la directive 2001 / 83 / CE du Parlement européen et du Conseil.

2° Si le demandeur désigne un autre Etat membre de la Communauté européenne ou partie à l'accord sur l'Espace économique européen comme Etat de référence, le directeur général de l'agence dispose, à compter de la réception du projet de rapport d'évaluation, accompagné des projets de résumé des caractéristiques du produit, d'étiquetage et de notice transmis par l'Etat de référence, d'un délai de quatre-vingt-dix jours pour se prononcer.

Si le directeur général de l'agence approuve ces documents, il en informe l'Etat de référence. En cas d'accord entre tous les Etats concernés, notifié par l'Etat de référence, il délivre ou refuse une autorisation de mise sur le marché en conformité avec le rapport d'évaluation ainsi approuvé dans un délai de trente jours à compter de la réception de la notification.

Si le directeur général de l'agence n'approuve pas ces documents parce qu'il estime que le médicament concerné présente un risque potentiel grave pour la santé publique au sens des lignes directrices mentionnées à l'article 29. 2 de la directive 2001 / 83 / CE du Parlement européen et du Conseil, il fait immédiatement connaître son opposition motivée à l'Etat de référence, aux autres Etats concernés, au demandeur et au groupe de coordination mentionné à l'article 27 de la directive mentionnée ci-dessus.

" } }, "LEGIARTI000017889901": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5121-51-2", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-05-01", "DATE_DEBUT": "2007-12-31" } }, "META_COMMUN": { "ID": "LEGIARTI000017889901", "URL": "article/LEGI/ARTI/00/00/17/88/99/LEGIARTI000017889901.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000017876177", "@num": "2", "#text": "Décret n°2007-1932\n du 26 décembre 2007 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000017766993", "@nortexte": "SJSP0757795D", "@numtexte": "2007-1932", "@typelien": "CREE", "@naturetexte": "DECRET", "@datesignatexte": "2007-12-26" }, { "@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": "LEGIARTI000025788064", "@num": "R5121-51-4", "#text": "Code de la santé publique - art. R5121-51-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000030695761", "@num": "344 undecies A", "#text": "Code général des impôts, annexe 3, CGIAN3. - art. 344 undecies A (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069574", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000017889921", "@fin": "2999-01-01", "#text": "Paragraphe 2 : Procédure de reconnaissance mutuelle", "@debut": "2007-12-31" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000017889925", "@fin": "2999-01-01", "#text": "Sous-section 3 bis : Procédure de reconnaissance mutuelle et procédure décentralisée", "@debut": "2007-12-31" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190665", "@fin": "2999-01-01", "#text": "Section 5 : Autorisation de mise sur le marché", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178649", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161012", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000017889901", "@fin": "2012-05-01", "@num": "R5121-51-2", "@etat": "MODIFIE", "@debut": "2007-12-31", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000025788073", "@fin": "2999-01-01", "@num": "R5121-51-2", "@etat": "VIGUEUR", "@debut": "2012-05-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Pour obtenir la reconnaissance en France d'une autorisation de mise sur le marché délivrée par un autre Etat dit Etat de référence, membre de la Communauté européenne ou partie à l'accord sur l'Espace économique européen, le titulaire de cette autorisation adresse une demande d'autorisation de mise sur le marché au directeur général de l'Agence française de sécurité sanitaire des produits de santé.

A compter de la réception du rapport d'évaluation du médicament, accompagné du résumé des caractéristiques du produit, de l'étiquetage et de la notice, transmis par l'Etat de référence, le directeur général de l'agence dispose d'un délai de quatre-vingt-dix jours pour se prononcer :

1° Si le directeur général de l'agence approuve ces documents, il en informe l'Etat de référence. En cas d'accord entre tous les Etats concernés, notifié par l'Etat de référence, il délivre une autorisation de mise sur le marché en conformité avec le rapport d'évaluation ainsi approuvé dans un délai de trente jours à compter de la réception de cette notification.

2° Si le directeur général de l'agence n'approuve pas ces documents parce qu'il estime que le médicament concerné présente un risque potentiel grave pour la santé publique au sens des lignes directrices mentionnées à l'article 29.2 de la directive 2001/83/CE du Parlement européen et du Conseil, il fait immédiatement connaître son opposition motivée à l'Etat de référence, aux autres Etats concernés, au demandeur et au groupe de coordination mentionné à l'article 27 de la directive précitée.

" } }, "LEGIARTI000017889903": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5121-51-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-05-01", "DATE_DEBUT": "2007-12-31" } }, "META_COMMUN": { "ID": "LEGIARTI000017889903", "URL": "article/LEGI/ARTI/00/00/17/88/99/LEGIARTI000017889903.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000017876177", "@num": "2", "#text": "Décret n°2007-1932\n du 26 décembre 2007 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000017766993", "@nortexte": "SJSP0757795D", "@numtexte": "2007-1932", "@typelien": "CREE", "@naturetexte": "DECRET", "@datesignatexte": "2007-12-26" }, { "@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": "LEGIARTI000025788064", "@num": "R5121-51-4", "#text": "Code de la santé publique - art. R5121-51-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000030695761", "@num": "344 undecies A", "#text": "Code général des impôts, annexe 3, CGIAN3. - art. 344 undecies A (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069574", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000017889921", "@fin": "2999-01-01", "#text": "Paragraphe 2 : Procédure de reconnaissance mutuelle", "@debut": "2007-12-31" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000017889925", "@fin": "2999-01-01", "#text": "Sous-section 3 bis : Procédure de reconnaissance mutuelle et procédure décentralisée", "@debut": "2007-12-31" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190665", "@fin": "2999-01-01", "#text": "Section 5 : Autorisation de mise sur le marché", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178649", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161012", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000017889903", "@fin": "2012-05-01", "@num": "R5121-51-1", "@etat": "MODIFIE", "@debut": "2007-12-31", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000025788075", "@fin": "2999-01-01", "@num": "R5121-51-1", "@etat": "VIGUEUR", "@debut": "2012-05-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Pour obtenir la reconnaissance, par au moins un autre Etat membre de la Communauté européenne ou partie à l'accord sur l'Espace économique européen, d'une autorisation de mise sur le marché délivrée par le directeur général de l'Agence française de sécurité sanitaire des produits de santé, la France agissant alors comme Etat de référence, le titulaire de cette autorisation demande à ce dernier de mettre à jour ou d'élaborer le rapport d'évaluation du médicament ; il lui transmet les éventuels compléments au dossier dont l'agence dispose.

Le directeur général de l'agence transmet ce rapport d'évaluation, accompagné du résumé des caractéristiques du produit, de l'étiquetage et de la notice, aux Etats concernés et au titulaire de l'autorisation de mise sur le marché dans un délai de quatre-vingt-dix jours à compter de la réception du dossier complet :

1° En cas d'approbation de ces documents par chacun des Etats concernés dans un délai de quatre-vingt-dix jours, le directeur général de l'agence notifie l'accord à ces Etats et au titulaire de l'autorisation de mise sur le marché.

2° A défaut d'accord dans le délai mentionné au 1°, le directeur général de l'agence saisit le groupe de coordination mentionné à l'article 27 de la directive 2001/83/CE du Parlement européen et du Conseil.

" } }, "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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Par dérogation à l'article R. 5121-25 :
\n
1° Lorsque la demande porte sur une spécialité générique d'une spécialité de référence qui est ou a été autorisée depuis au moins huit ans en France, le dossier fourni à l'appui de la demande comprend, outre les données chimiques, pharmaceutiques et biologiques, les études de biodisponibilité démontrant la bioéquivalence à la spécialité de référence.
\n
Si cette spécialité est autorisée depuis moins de huit ans en France et qu'elle est ou a été autorisée depuis au moins huit ans dans un Etat membre de la Communauté européenne ou partie à l'accord sur l'Espace économique européen, la procédure est également applicable ;
\n
2° Lorsque la demande porte sur une spécialité qui ne répond pas à la définition de la spécialité générique parce qu'elle comporte, par rapport à une spécialité de référence qui est ou a été autorisée depuis au moins huit ans en France, des différences relatives à la substance active, aux indications thérapeutiques, au dosage, à la forme pharmaceutique ou à la voie d'administration, ou lorsque la bioéquivalence par rapport à cette spécialité de référence n'a pu être démontrée par des études de biodisponibilité et que la spécialité ne répond pas aux conditions prévues par l'article R. 5121-29-1, le dossier fourni à l'appui de la demande comporte, outre les données chimiques, pharmaceutiques et biologiques, les résultats des essais précliniques et cliniques appropriés déterminés en fonction de ces différences.
\n
Si ce médicament est autorisé depuis moins de huit ans en France et qu'il est ou a été autorisé depuis au moins huit ans dans un Etat membre de la Communauté européenne ou partie à l'accord sur l'Espace économique européen, la procédure est également applicable ;
\n
3° Lorsque la demande porte sur un médicament biologique similaire mentionné au 14° de l'article L. 5121-1 à un médicament biologique de référence autorisé en France depuis au moins huit ans, le dossier fourni à l'appui de la demande comporte, outre les données chimiques, pharmaceutiques et biologiques, les résultats des essais précliniques et cliniques appropriés notamment relatifs à la matière première ou aux procédés de fabrication du médicament biologique similaire.
\n
Si ce médicament est autorisé depuis moins de huit ans en France et qu'il est ou a été autorisé depuis au moins huit ans dans un Etat membre de la Communauté européenne ou partie à l'accord sur l'Espace économique européen, la procédure est également applicable ;
\n
4° Lorsque la demande porte sur un médicament de même composition qualitative et quantitative en substances actives et de même forme pharmaceutique qu'un médicament autorisé, dont le titulaire a consenti à ce qu'il soit fait recours à la documentation pharmaceutique, préclinique et clinique figurant au dossier de ce médicament, le dossier fourni à l'appui de la demande comporte une duplication du dossier pharmaceutique du médicament autorisé ;
\n
5° Lorsque la demande porte sur un médicament homéopathique soumis à autorisation de mise sur le marché, le dossier fourni à l'appui de la demande comporte, outre les données chimiques, pharmaceutiques et biologiques, les résultats des essais précliniques et cliniques appropriés lorsque le demandeur ne peut pas démontrer par référence détaillée à la littérature publiée et reconnue dans la tradition de la médecine homéopathique pratiquée en France que l'usage homéopathique du médicament ou des souches homéopathiques le composant est bien établi et présente toutes garanties d'innocuité.

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Le titulaire de l'autorisation de mise sur le marché soumet au directeur général de l'Agence française de sécurité sanitaire des produits de santé tout projet de modification d'un élément relatif à l'étiquetage ou à la notice, autre que les modifications du résumé des caractéristiques du produit.

Si le directeur général de l'agence ne s'est pas prononcé dans un délai de quatre-vingt-dix jours à compter de la date de présentation de la demande, le demandeur peut procéder à la mise en oeuvre des modifications.

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Le changement du titulaire de l'autorisation de mise sur le marché est subordonné à une autorisation du directeur général de l'Agence française de sécurité sanitaire des produits de santé.

La demande comporte les mentions prévues à l'article R. 5121-21 et elle est accompagnée d'un dossier comprenant :

1° Une copie, certifiée conforme par le titulaire, de l'autorisation de mise sur le marché ;

2° L'accord de ce titulaire sur le transfert de l'autorisation de mise sur le marché ;

3° La désignation des lieux de fabrication, de contrôle et de conditionnement ;

4° L'engagement du demandeur de se soumettre à l'ensemble des conditions auxquelles a été subordonnée l'autorisation de mise sur le marché et, notamment, de respecter les méthodes de fabrication et de contrôle ;

5° Les comptes rendus des contrôles, effectués par le demandeur dans le respect desdites méthodes ;

6° La formule de préparation avec, notamment, toutes indications utiles sur le récipient ;

7° La contenance des nouveaux modèles destinés à la vente ;

8° Le projet de nouvel étiquetage et, si elle est prévue, de la notice ;

9° Copie des décisions autorisant la fabrication de la spécialité concernée et délivrée selon le cas, soit en vertu de la législation nationale du fabricant, soit en application des articles R. 5124-6, R. 5124-7 et R. 5124-10 ou, le cas échéant, copie des récépissés des demandes d'autorisation si lesdites demandes n'ont pas encore donné lieu à décision ;

10° Le cas échéant, un extrait du registre du commerce et des sociétés relatif au demandeur.

Dans le cas de fusion ou d'apport partiel d'actifs, les sociétés intéressées peuvent déposer une demande de transfert des autorisations de mise sur le marché avant que la fusion ou l'apport ne soit définitivement réalisé. Elles fournissent, à l'appui de leur demande, le protocole d'accord de principe concernant la fusion ou l'apport. Le transfert est accordé sous la condition suspensive de la réalisation définitive qui est notifiée au directeur général de l'Agence française de sécurité sanitaire des produits de santé.

Le directeur général de l'Agence française de sécurité sanitaire des produits de santé notifie sa décision dans un délai de soixante jours à compter de la date de réception de la demande. A défaut, le silence gardé par le directeur général de l'Agence française de sécurité sanitaire des produits de santé vaut autorisation à l'expiration de ce délai.

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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.

" } }, "LEGIARTI000021709037": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5311-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-05-01", "DATE_DEBUT": "2010-01-16" } }, "META_COMMUN": { "ID": "LEGIARTI000021709037", "URL": "article/LEGI/ARTI/00/00/21/70/90/LEGIARTI000021709037.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006630983", "@num": "1", "#text": "Décret n°81-278 du 25 mars 1981 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000503017", "@numtexte": "81-278", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1981-03-25" }, { "@id": "LEGIARTI000006631025", "@num": "Annexe I", "#text": "Décret n°81-278 du 25 mars 1981 - art. 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Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000195660", "@nortexte": "ENVP9640024D", "@numtexte": "96-850", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1996-09-20" }, { "@id": "LEGIARTI000006506987", "@num": "3", "#text": "Décret n°98-385 du 18 mai 1998 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000571865", "@nortexte": "MESG9820693D", "@numtexte": "98-385", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1998-05-18" }, { "@id": "LEGIARTI000006724441", "@num": "5", "#text": "Décret n°2001-35 du 11 janvier 2001 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000388987", "@nortexte": "MJSK0070147D", "@numtexte": "2001-35", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2001-01-11" }, { "@id": "LEGIARTI000006254318", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254325", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639980", "@nortexte": "SANP0623382A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254307", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254319", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326653", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020320295", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326611", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254321", "@num": "4", "#text": "Arrêté du 16 août 2006 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254313", "@num": "7", "#text": "Arrêté du 16 août 2006 - art. 7 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006734099", "@num": "ANNEXE", "#text": "Arrêté du 16 août 2006 - art. ANNEXE (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639975", "@nortexte": "SANP0623370A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006255223", "@num": "1", "#text": "Arrêté du 11 septembre 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000271992", "@nortexte": "SANP0623792A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-09-11" }, { "@id": "LEGIARTI000020322856", "@num": "3", "#text": "Arrêté du 11 septembre 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000271992", "@nortexte": "SANP0623792A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-09-11" }, { "@id": "LEGIARTI000006697048", "@num": "39", "#text": "Loi n°2007-248 du 26 février 2007 - art. 39 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000613381", "@nortexte": "SANX0600004L", "@numtexte": "2007-248", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2007-02-26" }, { "@id": "LEGIARTI000006868630", "@num": "29", "#text": "Décret n° 2007-358 du 19 mars 2007 - art. 29 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000821090", "@nortexte": "AGRG0700644D", "@numtexte": "2007-358", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-19" }, { "@id": "LEGIARTI000006726837", "@num": "5", "#text": "Décret n°2007-462 du 25 mars 2007 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000466314", "@nortexte": "MJSK0770075D", "@numtexte": "2007-462", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-25" }, { "@id": "LEGIARTI000018361459", "@num": "Annexe", "#text": "Arrêté du 5 mars 2008 - art. 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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.

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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

" } }, "LEGIARTI000021941987": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5121-8", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2011-12-31", "DATE_DEBUT": "2010-02-26" } }, "META_COMMUN": { "ID": "LEGIARTI000021941987", "URL": "article/LEGI/ARTI/00/00/21/94/19/LEGIARTI000021941987.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006700043", "@num": "15", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 15 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000039374401", "@num": "1", "#text": "Arrêté du 20 septembre 1999 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000761570", "@nortexte": "MESP9922897A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1999-09-20" }, { "@id": "LEGIARTI000006724328", "@num": "1", "#text": "Décret n°2000-1194 du 5 décembre 2000 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000768314", "@nortexte": "MESG0022611D", "@numtexte": "2000-1194", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2000-12-05" }, { "@id": "LEGIARTI000006724332", "@num": "3", "#text": "Décret n°2000-1194 du 5 décembre 2000 - art. 3 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000000768314", "@nortexte": "MESG0022611D", "@numtexte": "2000-1194", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2000-12-05" }, { "@id": "LEGITEXT000005631695", "#text": "Arrêté du 13 novembre 2001", "@sens": "cible", "@cidtexte": "JORFTEXT000000221792", "@nortexte": "MESG0123551A", "@typelien": "TXT_ASSOCIE", "@naturetexte": "ARRETE", "@datesignatexte": "2001-11-13" }, { "@id": "LEGIARTI000006334800", "@num": "1", "#text": "Arrêté du 13 novembre 2001 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000221792", "@nortexte": "MESG0123551A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2001-11-13" }, { "@id": "LEGIARTI000006334800", "@num": "1", "#text": "Arrêté du 13 novembre 2001 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000221792", "@nortexte": "MESG0123551A", "@typelien": "TXT_ASSOCIE", "@naturetexte": "ARRETE", "@datesignatexte": "2001-11-13" }, { "@id": "LEGIARTI000006334802", "@num": "3", "#text": "Arrêté du 13 novembre 2001 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000221792", "@nortexte": "MESG0123551A", "@typelien": "TXT_ASSOCIE", "@naturetexte": "ARRETE", "@datesignatexte": "2001-11-13" }, { "@id": "LEGIARTI000022158895", "@num": "1", "#text": "Arrêté du 23 avril 2004 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000436679", "@nortexte": "SANP0421445A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2004-04-23" }, { "@id": "LEGIARTI000006231372", "@num": "1", "#text": "Arrêté du 26 mai 2004 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000235408", "@nortexte": "SANG0420602A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2004-05-26" }, { "@id": "LEGIARTI000006231373", "@num": "2", "#text": "Arrêté du 26 mai 2004 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000235408", "@nortexte": "SANG0420602A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2004-05-26" }, { "@id": "LEGIARTI000006232079", "@num": "1", "#text": "Décret n°2004-651 du 2 juillet 2004 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000436350", "@nortexte": "SANG0421846D", "@numtexte": "2004-651", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-02" }, { "@id": "LEGIARTI000006256800", "@num": "1", "#text": "Arrêté du 8 novembre 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000641558", "@nortexte": "SANP0624618A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-11-08" }, { "@id": "LEGIARTI000006697010", "@num": "6", "#text": "Loi n°2007-248 du 26 février 2007 - art. 6 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000613381", "@nortexte": "SANX0600004L", "@numtexte": "2007-248", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2007-02-26" }, { "@id": "LEGITEXT000017833546", "#text": "Décret n°2007-1860\n du 26 décembre 2007 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000017762708", "@nortexte": "SJSP0771467D", "@numtexte": "2007-1860", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-12-26" }, { "@id": "LEGIARTI000026604165", "@num": "2", "#text": "Arrêté du 6 mai 2008 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000018768299", "@nortexte": "SJSP0810423A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-05-06" }, { "@id": "LEGIARTI000025882819", "#text": "Arrêté du 1er septembre 2009 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000021021310", "@nortexte": "SASP0920309A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-09-01" }, { "@id": "LEGIARTI000021869972", "@num": "26", "#text": "Ordonnance n°2010-177\n du 23 février 2010 - art. 26", "@sens": "cible", "@cidtexte": "JORFTEXT000021868310", "@nortexte": "SASX0930688R", "@numtexte": "2010-177", "@typelien": "MODIFIE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2010-02-23" }, { "@id": "LEGIARTI000048060675", "@num": "4", "#text": "Arrêté du 5 mars 2010 - art. 4 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000021954715", "@nortexte": "BCFR1004493A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-03-05" }, { "@id": "LEGIARTI000050315041", "@num": "6", "#text": "Arrêté du 5 mars 2010 - art. 6 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000021954715", "@nortexte": "BCFR1004493A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-03-05" }, { "@id": "LEGITEXT000022158905", "#text": "Arrêté du 26 avril 2010 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000022149910", "@nortexte": "SASP1011405A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-04-26" }, { "@id": "LEGIARTI000024630541", "@num": "1", "#text": "Arrêté du 22 septembre 2011 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000024629129", "@nortexte": "ETSP1125976A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-09-22" }, { "@id": "LEGIARTI000025832877", "@num": "1", "#text": "Arrêté du 7 mai 2012 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000025824505", "@nortexte": "ETSS1209429A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-05-07" }, { "@id": "LEGITEXT000026054718", "#text": "Arrêté du 12 juin 2012 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000026052302", "@nortexte": "AFSP1226069A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-06-12" }, { "@id": "LEGITEXT000028414510", "#text": "Arrêté du 20 décembre 2013 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000028398405", "@nortexte": "AFSS1331706A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-12-20" }, { "@id": "LEGIARTI000028414521", "@num": "1", "#text": "Arrêté du 20 décembre 2013 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000028398405", "@nortexte": "AFSS1331706A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-12-20" }, { "@id": "LEGIARTI000029270949", "@num": "1", "#text": "ARRÊTÉ du 11 juillet 2014 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029270263", "@nortexte": "AFSP1416909A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2014-07-11" }, { "@id": "LEGIARTI000029449716", "@num": "1", "#text": "ARRÊTÉ du 25 juillet 2014 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000029449036", "@nortexte": "FCPE1418309A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2014-07-25" }, { "@id": "LEGIARTI000042293117", "#text": "DÉCRET n°2014-1288 du 23 octobre 2014 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029676038", "@nortexte": "AFSX1419044D", "@numtexte": "2014-1288", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000030457713", "@num": "3", "#text": "ARRÊTÉ du 30 mars 2015 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000030456816", "@nortexte": "AFSP1508194A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2015-03-30" }, { "@id": "LEGIARTI000032096337", "@num": "3", "#text": "Arrêté du 15 février 2016 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000032093358", "@nortexte": "AFSP1604649A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-02-15" }, { "@id": "LEGIARTI000032096334", "@num": "4", "#text": "Arrêté du 15 février 2016 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000032093358", "@nortexte": "AFSP1604649A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-02-15" }, { "@id": "LEGIARTI000032096339", "@num": "5", "#text": "Arrêté du 15 février 2016 - art. 5 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000032093358", "@nortexte": "AFSP1604649A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-02-15" }, { "@id": "LEGIARTI000032096341", "@num": "6", "#text": "Arrêté du 15 février 2016 - art. 6 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000032093358", "@nortexte": "AFSP1604649A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-02-15" }, { "@id": "LEGIARTI000032096343", "@num": "7", "#text": "Arrêté du 15 février 2016 - art. 7 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000032093358", "@nortexte": "AFSP1604649A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-02-15" }, { "@id": "LEGIARTI000033122072", "@num": "4", "#text": "Arrêté du 8 septembre 2016 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033120953", "@nortexte": "AFSP1625292A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-09-08" }, { "@id": "LEGIARTI000036925433", "@num": "3", "#text": "Arrêté du 14 mai 2018 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036920946", "@nortexte": "SSAP1813104A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-05-14" }, { "@id": "LEGIARTI000036925435", "@num": "4", "#text": "Arrêté du 14 mai 2018 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036920946", "@nortexte": "SSAP1813104A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-05-14" }, { "@id": "LEGIARTI000037502021", "@num": "1", "#text": "Arrêté du 15 octobre 2018 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000037501422", "@nortexte": "SSAP1828085A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-10-15" }, { "@id": "LEGIARTI000037557939", "@num": "3", "#text": "Arrêté du 26 octobre 2018 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000037552934", "@nortexte": "SSAP1829446A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-10-26" }, { "@id": "LEGIARTI000038122113", "@num": "2", "#text": "Arrêté du 11 février 2019 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000038121150", "@nortexte": "SSAP1904422A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-02-11" }, { "@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": "LEGIARTI000039157836", "@num": "2", "#text": "Arrêté du 26 septembre 2019 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000039146677", "@nortexte": "SSAP1927722A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-09-26" }, { "@id": "LEGIARTI000039373779", "@num": "1", "#text": "Arrêté du 5 novembre 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000039373247", "@nortexte": "SSAP1931830A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-11-05" }, { "@id": "LEGIARTI000041493923", "@num": "1", "#text": "Arrêté du 21 janvier 2020 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041459990", "@nortexte": "SSAP2001803A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-01-21" }, { "@id": "LEGIARTI000041521988", "@num": "2", "#text": "Arrêté du 30 janvier 2020 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041514887", "@nortexte": "SSAP2000708A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-01-30" }, { "@id": "LEGIARTI000041807940", "@num": "10-4", "#text": "Arrêté du 23 mars 2020 - art. 10-4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041807774", "@num": "10-5", "#text": "Arrêté du 23 mars 2020 - art. 10-5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041920905", "@num": "6-1", "#text": "Arrêté du 23 mars 2020 - art. 6-1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041760851", "@num": "12-2", "#text": "Décret n°2020-293 du 23 mars 2020 - art. 12-2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746694", "@nortexte": "SSAZ2008253D", "@numtexte": "2020-293", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041756280", "@num": "1", "#text": "Décret n°2020-314 du 25 mars 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041755775", "@nortexte": "SSAZ2008362D", "@numtexte": "2020-314", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-25" }, { "@id": "LEGIARTI000041798665", "@num": "1", "#text": "Arrêté du 14 avril 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041798289", "@nortexte": "SSAZ2009592A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-04-14" }, { "@id": "LEGIARTI000041859122", "@num": "17", "#text": "Décret n°2020-545 du 11 mai 2020 - art. 17 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041858681", "@nortexte": "SSAZ2011567D", "@numtexte": "2020-545", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041866847", "@num": "19", "#text": "Décret n°2020-548 du 11 mai 2020 - art. 19 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041865329", "@nortexte": "SSAZ2011695D", "@numtexte": "2020-548", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041920889", "@num": "1", "#text": "Arrêté du 26 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041920446", "@nortexte": "SSAZ2012694A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-26" }, { "@id": "LEGIARTI000042107205", "@num": "12", "#text": "Arrêté du 10 juillet 2020 - art. 12 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042507722", "@num": "17-2", "#text": "Arrêté du 10 juillet 2020 - art. 17-2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042362301", "@num": "2", "#text": "Arrêté du 11 septembre 2020 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042360578", "@nortexte": "SSAP2023295A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-09-11" }, { "@id": "LEGIARTI000042362303", "@num": "3", "#text": "Arrêté du 11 septembre 2020 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042360578", "@nortexte": "SSAP2023295A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-09-11" }, { "@id": "LEGIARTI000042507028", "@num": "1", "#text": "Arrêté du 7 novembre 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000042506409", "@nortexte": "SSAZ2030422A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-11-07" }, { "@id": "LEGIARTI000043507358", "@num": "1", "#text": "Arrêté du 17 mai 2021 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043507013", "@nortexte": "SSAP2115206A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-05-17" }, { "@id": "LEGIARTI000043577258", "@num": "4", "#text": "Arrêté du 1 juin 2021 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000043577276", "@num": "13", "#text": "Arrêté du 1er juin 2021 - art. 13 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000044132476", "@num": "2", "#text": "Arrêté du 28 septembre 2021 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000044126672", "@nortexte": "SSAP2129267A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-09-28" }, { "@id": "LEGIARTI000049735069", "@num": "2", "#text": "Décret n°2024-550 du 17 juin 2024 - 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Toute spécialité pharmaceutique ou tout autre médicament fabriqué industriellement ou selon une méthode dans laquelle intervient un processus industriel ainsi que tout générateur, trousse ou précurseur qui ne fait pas l'objet d'une autorisation de mise sur le marché délivrée par l'Union européenne en application du règlement (CE) n° 726 / 2004 du Parlement européen et du Conseil, du 31 mars 2004, établissant des procédures communautaires pour l'autorisation et la surveillance en ce qui concerne les médicaments à usage humain et à usage vétérinaire, et instituant une Agence européenne des médicaments doit faire l'objet, avant sa mise sur le marché ou sa distribution à titre gratuit, d'une autorisation de mise sur le marché délivrée par l'Agence française de sécurité sanitaire des produits de santé.L'autorisation peut être assortie de conditions appropriées.
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Le demandeur de l'autorisation peut être dispensé de produire certaines données et études dans des conditions fixées par voie réglementaire.
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Une autorisation de mise sur le marché ne peut être délivrée qu'à un demandeur établi dans un Etat membre de l'Union européenne ou partie à l'accord sur l'Espace économique européen.
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L'autorisation est délivrée pour une durée de cinq ans et peut ensuite être renouvelée, le cas échéant, sans limitation de durée, dans des conditions fixées par un décret en Conseil d'Etat, sauf si l'Agence française de sécurité sanitaire des produits de santé décide, pour des raisons justifiées ayant trait à la pharmacovigilance, de procéder à un renouvellement supplémentaire, sur la base d'une réévaluation des effets thérapeutiques positifs du médicament ou produit au regard des risques tels que définis au premier alinéa de l'article L. 5121-9. Ce décret détermine également les conditions dans lesquelles elle peut devenir caduque.
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L'autorisation peut être modifiée par l'Agence française de sécurité sanitaire des produits de santé.
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L'accomplissement des formalités prévues au présent article n'a pas pour effet d'exonérer le fabricant et, s'il est distinct, le titulaire de l'autorisation de mise sur le marché, de la responsabilité que l'un ou l'autre peut encourir dans les conditions du droit commun en raison de la fabrication ou de la mise sur le marché du médicament ou produit.
" } }, "LEGIARTI000023529857": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5121-28", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2011-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000023529857", "URL": "article/LEGI/ARTI/00/00/23/52/98/LEGIARTI000023529857.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000023529061", "@num": "3", "#text": "Décret n°2011-149\n du 3 février 2011 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000023528170", "@nortexte": "ETSP1028649D", "@numtexte": "2011-149", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2011-02-03" }, { "@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": "LEGIARTI000020529716", "@num": "D5121-64", "#text": "Code de la santé publique - art. 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R5121-29 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018774269", "@num": "R5121-29-1", "#text": "Code de la santé publique - art. R5121-29-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018776294", "@num": "R5121-29-2", "#text": "Code de la santé publique - art. R5121-29-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018776549", "@num": "R5121-31", "#text": "Code de la santé publique - art. R5121-31 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000030773843", "@num": "R5121-41-1", "#text": "Code de la santé publique - art. R5121-41-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039401753", "@num": "R5121-5", "#text": "Code de la santé publique - art. R5121-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800140", "@num": "R5132", "#text": "Code de la santé publique - art. R5132 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800138", "@num": "R5132", "#text": "Code de la santé publique - art. R5132 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000030695761", "@num": "344 undecies A", "#text": "Code général des impôts, annexe 3, CGIAN3. - art. 344 undecies A (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069574", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006196541", "@fin": "2999-01-01", "#text": "Sous-section 1 : Demande d'autorisation.", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190665", "@fin": "2999-01-01", "#text": "Section 5 : Autorisation de mise sur le marché", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178649", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161012", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006914751", "@fin": "2008-05-08", "@num": "R5121-28", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000018776287", "@fin": "2011-02-06", "@num": "R5121-28", "@etat": "MODIFIE", "@debut": "2008-05-08", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000023529857", "@fin": "2999-01-01", "@num": "R5121-28", "@etat": "VIGUEUR", "@debut": "2011-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Par dérogation au 2° de l'article R. 5121-25, pour les médicaments mentionnés au présent article, le dossier joint à la demande d'autorisation de mise sur le marché est constitué dans les conditions suivantes :

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1° Lorsque la demande porte sur une spécialité générique d'une spécialité de référence qui est ou a été autorisée depuis au moins huit ans en France, le dossier fourni à l'appui de la demande comprend, outre les données chimiques, pharmaceutiques et biologiques, les études de biodisponibilité démontrant la bioéquivalence à la spécialité de référence.

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Si cette spécialité est autorisée depuis moins de huit ans en France et qu'elle est ou a été autorisée depuis au moins huit ans dans un Etat membre de la Communauté européenne ou partie à l'accord sur l'Espace économique européen, la procédure est également applicable ;

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2° Lorsque la demande porte sur une spécialité qui ne répond pas à la définition de la spécialité générique parce qu'elle comporte, par rapport à une spécialité de référence qui est ou a été autorisée depuis au moins huit ans en France, des différences relatives à la substance active, aux indications thérapeutiques, au dosage, à la forme pharmaceutique ou à la voie d'administration, ou lorsque la bioéquivalence par rapport à cette spécialité de référence n'a pu être démontrée par des études de biodisponibilité et que la spécialité ne répond pas aux conditions prévues par l'article R. 5121-29-1, le dossier fourni à l'appui de la demande comporte, outre les données chimiques, pharmaceutiques et biologiques, les résultats des essais précliniques et cliniques appropriés déterminés en fonction de ces différences.

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Si ce médicament est autorisé depuis moins de huit ans en France et qu'il est ou a été autorisé depuis au moins huit ans dans un Etat membre de la Communauté européenne ou partie à l'accord sur l'Espace économique européen, la procédure est également applicable ;

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3° Lorsque la demande porte sur un médicament biologique similaire mentionné au 14° de l'article L. 5121-1 à un médicament biologique de référence autorisé en France depuis au moins huit ans, le dossier fourni à l'appui de la demande comporte, outre les données chimiques, pharmaceutiques et biologiques, les résultats des essais précliniques et cliniques appropriés notamment relatifs à la matière première ou aux procédés de fabrication du médicament biologique similaire.

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4° Lorsque la demande porte sur un médicament de même composition qualitative et quantitative en substances actives et de même forme pharmaceutique qu'un médicament autorisé, dont le titulaire a consenti à ce qu'il soit fait recours à la documentation pharmaceutique, préclinique et clinique figurant au dossier de ce médicament, le dossier fourni à l'appui de la demande comporte une duplication du dossier pharmaceutique du médicament autorisé ;

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5° Lorsque la demande porte sur un médicament homéopathique soumis à autorisation de mise sur le marché, le dossier fourni à l'appui de la demande comporte, outre les données chimiques, pharmaceutiques et biologiques, les résultats des essais précliniques et cliniques appropriés lorsque le demandeur ne peut pas démontrer par référence détaillée à la littérature publiée et reconnue dans la tradition de la médecine homéopathique pratiquée en France que l'usage homéopathique du médicament ou des souches homéopathiques le composant est bien établi et présente toutes garanties d'innocuité.

" } }, "LEGIARTI000025010429": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "1635 bis AE", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-12-19", "DATE_DEBUT": "2012-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025010429", "URL": "article/LEGI/ARTI/00/00/25/01/04/LEGIARTI000025010429.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000048060675", "@num": "4", "#text": "Arrêté du 5 mars 2010 - art. 4 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000021954715", "@nortexte": "BCFR1004493A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-03-05" }, { "@id": "LEGIARTI000050315041", "@num": "6", "#text": "Arrêté du 5 mars 2010 - art. 6 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000021954715", "@nortexte": "BCFR1004493A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-03-05" }, { "@id": "LEGIARTI000025007638", "@num": "26", "#text": "LOI n°2011-1906\n du 21 décembre 2011 - art. 26 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025005833", "@nortexte": "BCRX1125833L", "@numtexte": "2011-1906", "@typelien": "CREE", "@naturetexte": "LOI", "@datesignatexte": "2011-12-21" }, { "@id": "LEGITEXT000025085054", "#text": "Arrêté du 22 décembre 2011 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025055918", "@nortexte": "BCRE1134340A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-12-22" }, { "@id": "LEGIARTI000029449716", "@num": "1", "#text": "ARRÊTÉ du 25 juillet 2014 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000029449036", "@nortexte": "FCPE1418309A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2014-07-25" }, { "@id": "LEGITEXT000038433940", "#text": "Décret n°2019-388 du 30 avril 2019 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000038431230", "@nortexte": "SSAS1906323D", "@numtexte": "2019-388", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-04-30" }, { "@id": "LEGIARTI000038433946", "@num": "1", "#text": "Décret n°2019-388 du 30 avril 2019 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000038431230", "@nortexte": "SSAS1906323D", "@numtexte": "2019-388", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-04-30" }, { "@id": "LEGITEXT000038432458", "#text": "Décret n°2019-389 du 30 avril 2019 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000038431240", "@nortexte": "SSAS1906324D", "@numtexte": "2019-389", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-04-30" }, { "@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": "LEGITEXT000039393836", "#text": "Décret n°2019-1189 du 15 novembre 2019 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000039393107", "@nortexte": "SSAS1929960D", "@numtexte": "2019-1189", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-11-15" }, { "@id": "LEGIARTI000046805562", "@num": "L241-2", "#text": "Code de la sécurité sociale. - art. L241-2 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048637972", "@num": "1647", "#text": "Code général des impôts, CGI. - art. 1647 (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" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000025013697", "@fin": "2018-06-14", "#text": "Section V quinquies : Droits perçus au profit de la Caisse nationale de l'assurance maladie des travailleurs salariés", "@debut": "2012-01-01" }, { "@id": "LEGISCTA000037065048", "@fin": "2999-01-01", "#text": "Section V quinquies : Droits perçus au profit de la Caisse nationale de l'assurance maladie", "@debut": "2018-06-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006147086", "@fin": "2999-01-01", "#text": "Chapitre III : Enregistrement, publicité foncière et timbre", "@debut": "1979-07-01" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006133856", "@fin": "2999-01-01", "#text": "Titre III : Impositions perçues au profit de certains établissements publics et d'organismes divers", "@debut": "1977-12-31" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006114497", "@fin": "2999-01-01", "#text": "Deuxième Partie : Impositions perçues au profit des collectivités locales et de divers organismes", "@debut": "1967-12-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006084232", "@fin": "2999-01-01", "#text": "Livre premier : Assiette et liquidation de l'impôt", "@debut": "1952-02-14" } ] }, "@cid": "LEGITEXT000006069577", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code général des impôts", "@debut": "1952-02-14", "@id_txt": "LEGITEXT000006069577", "@c_titre_court": "Code général des impôts, CGI." } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025010429", "@fin": "2012-12-19", "@num": "1635 bis AE", "@etat": "MODIFIE", "@debut": "2012-01-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026798822", "@fin": "2015-06-06", "@num": "1635 bis AE", "@etat": "MODIFIE", "@debut": "2012-12-19", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000030702259", "@fin": "2016-01-01", "@num": "1635 bis AE", "@etat": "MODIFIE", "@debut": "2015-06-06", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000030752191", "@fin": "2017-01-01", "@num": "1635 bis AE", "@etat": "MODIFIE", "@debut": "2016-01-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000033813273", "@fin": "2018-06-14", "@num": "1635 bis AE", "@etat": "MODIFIE", "@debut": "2017-01-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000037065063", "@fin": "2019-01-01", "@num": "1635 bis AE", "@etat": "MODIFIE", "@debut": "2018-06-14", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000037947963", "@fin": "2999-01-01", "@num": "1635 bis AE", "@etat": "VIGUEUR", "@debut": "2019-01-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "I. ― Est subordonné au paiement d'un droit perçu au profit de la Caisse nationale de l'assurance maladie des travailleurs salariés le dépôt auprès de l'agence mentionnée à l'article L. 5311-1 du code de la santé publique de chaque :
\n
1° Demande d'enregistrement mentionnée aux articles L. 5121-13 et L. 5121-14 du même code, de chaque demande de renouvellement ou de modification de cet enregistrement ;
\n
2° Demande d'enregistrement mentionnée à l'article L. 5121-14-1 du même code, de chaque demande de renouvellement ou de modification de cet enregistrement ;
\n
3° Demande d'autorisation de mise sur le marché mentionnée à l'article L. 5121-8 du même code ou de chaque demande de renouvellement ou de chaque demande ou notification de modification de cette autorisation ;
\n
4° Demande de reconnaissance par au moins un autre Etat membre de l'Union européenne ou partie à l'accord sur l'Espace économique européen d'une autorisation de mise sur le marché, délivrée par le directeur général de l'agence mentionnée à l'article L. 5311-1, mentionnée à l'article L. 5121-8 du même code ou de chaque demande de modification de cette autorisation ;
\n
5° Demande d'autorisation d'importation parallèle conformément à l'article L. 5124-13 du même code et de chaque demande de modification ou de renouvellement de cette autorisation ;
\n
6° Demande de visa ou de renouvellement de visa de publicité mentionné aux articles L. 5122-8 et L. 5122-14 du même code ;
\n
7° Dépôt de publicité mentionné aux articles L. 5122-9 et L. 5122-14 du même code.
\n
II. ― Le montant du droit dû à raison des dépôts mentionnés au I est fixé par décret dans la limite maximale de :
\n
a) 7 600 € pour les demandes mentionnées au 1° du I ;
\n
b) 21 000 € pour les demandes mentionnées au 2° du I ;
\n
c) 50 000 € pour les demandes mentionnées aux 3° à 5° du I ;
\n
d) 1 200 € pour les demandes mentionnées aux 6° et 7° du I.
\n
III. ― Le versement du droit est accompagné d'une déclaration dont le modèle est fixé par l'administration. Le droit est recouvré et contrôlé selon les mêmes garanties et sanctions qu'en matière de droits d'enregistrement. Il est donné quittance de son versement. A défaut de production de la quittance à l'appui de son dépôt à l'agence ou en cas de versement d'un montant insuffisant, le dossier de la demande est réputé incomplet et la publicité mentionnée au 7° du I est réputée non déposée.
\n
Lorsque le dossier d'une demande mentionnée au I est complet ou que la publicité mentionnée au 7° du même I est déposée, le droit versé n'est restituable qu'à concurrence de la fraction de son montant dont l'agence a antérieurement constaté l'insuffisance de versement." } }, "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. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000050407232", "@nortexte": "MSAP2428789A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-10-24" }, { "@id": "LEGIARTI000043545974", "@num": "Annexe I à l'article D523-8", "#text": "Code de l'environnement - art. Annexe I à l'article D523-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000027912149", "@num": "D523-8", "#text": "Code de l'environnement - art. D523-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000042654871", "@num": "L521-2", "#text": "Code de l'environnement - art. L521-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021666283", "@num": "L531-3", "#text": "Code de l'environnement - art. L531-3 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028749087", "@num": "L221-10", "#text": "Code de la consommation - art. L221-10 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069565", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000041985451", "@num": "L511-22", "#text": "Code de la consommation - art. L511-22 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069565", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000046012786", "@num": "R422-1", "#text": "Code de la consommation - art. R422-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069565", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006574178", "@num": "R*1142-25", "#text": "Code de la défense. - art. R*1142-25 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006071307", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006574182", "@num": "R*1142-29", "#text": "Code de la défense. - art. R*1142-29 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006071307", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049599041", "@num": "D1413-58", "#text": "Code de la santé publique - art. D1413-58 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033642702", "@num": "D6141-42", "#text": "Code de la santé publique - art. 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"2021-08-04", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000045630379", "@fin": "2022-07-31", "@num": "L5311-1", "@etat": "MODIFIE", "@debut": "2022-04-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000046126182", "@fin": "2024-01-01", "@num": "L5311-1", "@etat": "MODIFIE", "@debut": "2022-07-31", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000046871876", "@fin": "2999-01-01", "@num": "L5311-1", "@etat": "VIGUEUR", "@debut": "2024-01-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

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

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

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

2° Les produits contraceptifs et contragestifs ;

3° Les biomatériaux et les dispositifs médicaux ;

4° Les dispositifs médicaux de diagnostic in vitro ;

5° Les produits sanguins labiles ;

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

7° Les produits cellulaires à finalité thérapeutique ;

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

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

10° (Abrogé) ;

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

12° Les produits thérapeutiques annexes ;

13° (Abrogé) ;

14° Les lentilles oculaires non correctrices ;

15° Les produits cosmétiques ;

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

17° Les produits de tatouage ;

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

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

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

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

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

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

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

" } }, "LEGIARTI000025104474": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5121-8", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2012-05-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025104474", "URL": "article/LEGI/ARTI/00/00/25/10/44/LEGIARTI000025104474.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": "LEGIARTI000006700043", "@num": "15", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 15 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000039374401", "@num": "1", "#text": "Arrêté du 20 septembre 1999 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000761570", "@nortexte": "MESP9922897A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1999-09-20" }, { "@id": "LEGIARTI000006724328", "@num": "1", "#text": "Décret n°2000-1194 du 5 décembre 2000 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000768314", "@nortexte": "MESG0022611D", "@numtexte": "2000-1194", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2000-12-05" }, { "@id": "LEGIARTI000006724332", "@num": "3", "#text": "Décret n°2000-1194 du 5 décembre 2000 - art. 3 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000000768314", "@nortexte": "MESG0022611D", "@numtexte": "2000-1194", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2000-12-05" }, { "@id": "LEGITEXT000005631695", "#text": "Arrêté du 13 novembre 2001", "@sens": "cible", "@cidtexte": "JORFTEXT000000221792", "@nortexte": "MESG0123551A", "@typelien": "TXT_ASSOCIE", "@naturetexte": "ARRETE", "@datesignatexte": "2001-11-13" }, { "@id": "LEGIARTI000006334800", "@num": "1", "#text": "Arrêté du 13 novembre 2001 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000221792", "@nortexte": "MESG0123551A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2001-11-13" }, { "@id": "LEGIARTI000006334800", "@num": "1", "#text": "Arrêté du 13 novembre 2001 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000221792", "@nortexte": "MESG0123551A", "@typelien": "TXT_ASSOCIE", "@naturetexte": "ARRETE", "@datesignatexte": "2001-11-13" }, { "@id": "LEGIARTI000006334802", "@num": "3", "#text": "Arrêté du 13 novembre 2001 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000221792", "@nortexte": "MESG0123551A", "@typelien": "TXT_ASSOCIE", "@naturetexte": "ARRETE", "@datesignatexte": "2001-11-13" }, { "@id": "LEGIARTI000022158895", "@num": "1", "#text": "Arrêté du 23 avril 2004 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000436679", "@nortexte": "SANP0421445A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2004-04-23" }, { "@id": "LEGIARTI000006231372", "@num": "1", "#text": "Arrêté du 26 mai 2004 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000235408", "@nortexte": "SANG0420602A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2004-05-26" }, { "@id": "LEGIARTI000006231373", "@num": "2", "#text": "Arrêté du 26 mai 2004 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000235408", "@nortexte": "SANG0420602A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2004-05-26" }, { "@id": "LEGIARTI000006232079", "@num": "1", "#text": "Décret n°2004-651 du 2 juillet 2004 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000436350", "@nortexte": "SANG0421846D", "@numtexte": "2004-651", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-02" }, { "@id": "LEGIARTI000006256800", "@num": "1", "#text": "Arrêté du 8 novembre 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000641558", "@nortexte": "SANP0624618A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-11-08" }, { "@id": "LEGIARTI000006697010", "@num": "6", "#text": "Loi n°2007-248 du 26 février 2007 - art. 6 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000613381", "@nortexte": "SANX0600004L", "@numtexte": "2007-248", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2007-02-26" }, { "@id": "LEGITEXT000017833546", "#text": "Décret n°2007-1860\n du 26 décembre 2007 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000017762708", "@nortexte": "SJSP0771467D", "@numtexte": "2007-1860", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-12-26" }, { "@id": "LEGIARTI000026604165", "@num": "2", "#text": "Arrêté du 6 mai 2008 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000018768299", "@nortexte": "SJSP0810423A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-05-06" }, { "@id": "LEGIARTI000025882819", "#text": "Arrêté du 1er septembre 2009 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000021021310", "@nortexte": "SASP0920309A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-09-01" }, { "@id": "LEGIARTI000048060675", "@num": "4", "#text": "Arrêté du 5 mars 2010 - art. 4 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000021954715", "@nortexte": "BCFR1004493A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-03-05" }, { "@id": "LEGIARTI000050315041", "@num": "6", "#text": "Arrêté du 5 mars 2010 - art. 6 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000021954715", "@nortexte": "BCFR1004493A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-03-05" }, { "@id": "LEGITEXT000022158905", "#text": "Arrêté du 26 avril 2010 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000022149910", "@nortexte": "SASP1011405A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-04-26" }, { "@id": "LEGIARTI000024630541", "@num": "1", "#text": "Arrêté du 22 septembre 2011 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000024629129", "@nortexte": "ETSP1125976A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-09-22" }, { "@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": "LEGIARTI000025832877", "@num": "1", "#text": "Arrêté du 7 mai 2012 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000025824505", "@nortexte": "ETSS1209429A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-05-07" }, { "@id": "LEGITEXT000026054718", "#text": "Arrêté du 12 juin 2012 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000026052302", "@nortexte": "AFSP1226069A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-06-12" }, { "@id": "LEGITEXT000028414510", "#text": "Arrêté du 20 décembre 2013 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000028398405", "@nortexte": "AFSS1331706A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-12-20" }, { "@id": "LEGIARTI000028414521", "@num": "1", "#text": "Arrêté du 20 décembre 2013 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000028398405", "@nortexte": "AFSS1331706A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-12-20" }, { "@id": "LEGIARTI000029270949", "@num": "1", "#text": "ARRÊTÉ du 11 juillet 2014 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029270263", "@nortexte": "AFSP1416909A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2014-07-11" }, { "@id": "LEGIARTI000029449716", "@num": "1", "#text": "ARRÊTÉ du 25 juillet 2014 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000029449036", "@nortexte": "FCPE1418309A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2014-07-25" }, { "@id": "LEGIARTI000042293117", "#text": "DÉCRET n°2014-1288 du 23 octobre 2014 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029676038", "@nortexte": "AFSX1419044D", "@numtexte": "2014-1288", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000030457713", "@num": "3", "#text": "ARRÊTÉ du 30 mars 2015 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000030456816", "@nortexte": "AFSP1508194A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2015-03-30" }, { "@id": "LEGIARTI000032096337", "@num": "3", "#text": "Arrêté du 15 février 2016 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000032093358", "@nortexte": "AFSP1604649A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-02-15" }, { "@id": "LEGIARTI000032096334", "@num": "4", "#text": "Arrêté du 15 février 2016 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000032093358", "@nortexte": "AFSP1604649A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-02-15" }, { "@id": "LEGIARTI000032096339", "@num": "5", "#text": "Arrêté du 15 février 2016 - art. 5 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000032093358", "@nortexte": "AFSP1604649A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-02-15" }, { "@id": "LEGIARTI000032096341", "@num": "6", "#text": "Arrêté du 15 février 2016 - art. 6 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000032093358", "@nortexte": "AFSP1604649A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-02-15" }, { "@id": "LEGIARTI000032096343", "@num": "7", "#text": "Arrêté du 15 février 2016 - art. 7 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000032093358", "@nortexte": "AFSP1604649A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-02-15" }, { "@id": "LEGIARTI000033122072", "@num": "4", "#text": "Arrêté du 8 septembre 2016 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033120953", "@nortexte": "AFSP1625292A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-09-08" }, { "@id": "LEGIARTI000036925433", "@num": "3", "#text": "Arrêté du 14 mai 2018 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036920946", "@nortexte": "SSAP1813104A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-05-14" }, { "@id": "LEGIARTI000036925435", "@num": "4", "#text": "Arrêté du 14 mai 2018 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036920946", "@nortexte": "SSAP1813104A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-05-14" }, { "@id": "LEGIARTI000037502021", "@num": "1", "#text": "Arrêté du 15 octobre 2018 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000037501422", "@nortexte": "SSAP1828085A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-10-15" }, { "@id": "LEGIARTI000037557939", "@num": "3", "#text": "Arrêté du 26 octobre 2018 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000037552934", "@nortexte": "SSAP1829446A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-10-26" }, { "@id": "LEGIARTI000038122113", "@num": "2", "#text": "Arrêté du 11 février 2019 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000038121150", "@nortexte": "SSAP1904422A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-02-11" }, { "@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": "LEGIARTI000039157836", "@num": "2", "#text": "Arrêté du 26 septembre 2019 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000039146677", "@nortexte": "SSAP1927722A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-09-26" }, { "@id": "LEGIARTI000039373779", "@num": "1", "#text": "Arrêté du 5 novembre 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000039373247", "@nortexte": "SSAP1931830A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-11-05" }, { "@id": "LEGIARTI000041493923", "@num": "1", "#text": "Arrêté du 21 janvier 2020 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041459990", "@nortexte": "SSAP2001803A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-01-21" }, { "@id": "LEGIARTI000041521988", "@num": "2", "#text": "Arrêté du 30 janvier 2020 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041514887", "@nortexte": "SSAP2000708A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-01-30" }, { "@id": "LEGIARTI000041807940", "@num": "10-4", "#text": "Arrêté du 23 mars 2020 - art. 10-4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041807774", "@num": "10-5", "#text": "Arrêté du 23 mars 2020 - art. 10-5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041920905", "@num": "6-1", "#text": "Arrêté du 23 mars 2020 - art. 6-1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041760851", "@num": "12-2", "#text": "Décret n°2020-293 du 23 mars 2020 - art. 12-2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746694", "@nortexte": "SSAZ2008253D", "@numtexte": "2020-293", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041756280", "@num": "1", "#text": "Décret n°2020-314 du 25 mars 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041755775", "@nortexte": "SSAZ2008362D", "@numtexte": "2020-314", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-25" }, { "@id": "LEGIARTI000041798665", "@num": "1", "#text": "Arrêté du 14 avril 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041798289", "@nortexte": "SSAZ2009592A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-04-14" }, { "@id": "LEGIARTI000041859122", "@num": "17", "#text": "Décret n°2020-545 du 11 mai 2020 - art. 17 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041858681", "@nortexte": "SSAZ2011567D", "@numtexte": "2020-545", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041866847", "@num": "19", "#text": "Décret n°2020-548 du 11 mai 2020 - art. 19 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041865329", "@nortexte": "SSAZ2011695D", "@numtexte": "2020-548", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041920889", "@num": "1", "#text": "Arrêté du 26 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041920446", "@nortexte": "SSAZ2012694A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-26" }, { "@id": "LEGIARTI000042107205", "@num": "12", "#text": "Arrêté du 10 juillet 2020 - art. 12 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042507722", "@num": "17-2", "#text": "Arrêté du 10 juillet 2020 - art. 17-2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042362301", "@num": "2", "#text": "Arrêté du 11 septembre 2020 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042360578", "@nortexte": "SSAP2023295A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-09-11" }, { "@id": "LEGIARTI000042362303", "@num": "3", "#text": "Arrêté du 11 septembre 2020 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042360578", "@nortexte": "SSAP2023295A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-09-11" }, { "@id": "LEGIARTI000042507028", "@num": "1", "#text": "Arrêté du 7 novembre 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000042506409", "@nortexte": "SSAZ2030422A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-11-07" }, { "@id": "LEGIARTI000043507358", "@num": "1", "#text": "Arrêté du 17 mai 2021 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043507013", "@nortexte": "SSAP2115206A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-05-17" }, { "@id": "LEGIARTI000043577258", "@num": "4", "#text": "Arrêté du 1 juin 2021 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000043577276", "@num": "13", "#text": "Arrêté du 1er juin 2021 - art. 13 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000044132476", "@num": "2", "#text": "Arrêté du 28 septembre 2021 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000044126672", "@nortexte": "SSAP2129267A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-09-28" }, { "@id": "LEGIARTI000049735069", "@num": "2", "#text": "Décret n°2024-550 du 17 juin 2024 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000049734265", "@nortexte": "TSSP2411185D", "@numtexte": "2024-550", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-06-17" }, { "@id": "LEGIARTI000020529716", "@num": "D5121-64", "#text": "Code de la santé publique - art. 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Toute spécialité pharmaceutique ou tout autre médicament fabriqué industriellement ou selon une méthode dans laquelle intervient un processus industriel ainsi que tout générateur, trousse ou précurseur qui ne fait pas l'objet d'une autorisation de mise sur le marché délivrée par l'Union européenne en application du règlement (CE) n° 726/2004 du Parlement européen et du Conseil, du 31 mars 2004, établissant des procédures communautaires pour l'autorisation et la surveillance en ce qui concerne les médicaments à usage humain et à usage vétérinaire, et instituant une Agence européenne des médicaments doit faire l'objet, avant sa mise sur le marché ou sa distribution à titre gratuit, d'une autorisation de mise sur le marché délivrée par l'Agence nationale de sécurité du médicament et des produits de santé. L'autorisation peut être assortie de conditions appropriées, notamment l'obligation de réaliser des études de sécurité ou d'efficacité post-autorisation.

Le demandeur de l'autorisation peut être dispensé de produire certaines données et études dans des conditions fixées par voie réglementaire.

Une autorisation de mise sur le marché ne peut être délivrée qu'à un demandeur établi dans un Etat membre de l'Union européenne ou partie à l'accord sur l'Espace économique européen.

L'autorisation est délivrée pour une durée de cinq ans et peut ensuite être renouvelée, le cas échéant, sans limitation de durée, dans des conditions fixées par un décret en Conseil d'Etat, sauf si l'Agence nationale de sécurité du médicament et des produits de santé décide de procéder à un renouvellement quinquennal, sur la base d'une réévaluation des effets thérapeutiques positifs du médicament ou produit au regard des risques tels que définis au premier alinéa de l'article L. 5121-9. Ce décret détermine également les conditions dans lesquelles elle peut devenir caduque.

L'autorisation peut être modifiée par l'Agence nationale de sécurité du médicament et des produits de santé.

L'accomplissement des formalités prévues au présent article n'a pas pour effet d'exonérer le fabricant et, s'il est distinct, le titulaire de l'autorisation de mise sur le marché, de la responsabilité que l'un ou l'autre peut encourir dans les conditions du droit commun en raison de la fabrication ou de la mise sur le marché du médicament ou produit.

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Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000195660", "@nortexte": "ENVP9640024D", "@numtexte": "96-850", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1996-09-20" }, { "@id": "LEGIARTI000006506987", "@num": "3", "#text": "Décret n°98-385 du 18 mai 1998 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000571865", "@nortexte": "MESG9820693D", "@numtexte": "98-385", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1998-05-18" }, { "@id": "LEGIARTI000006724441", "@num": "5", "#text": "Décret n°2001-35 du 11 janvier 2001 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000388987", "@nortexte": "MJSK0070147D", "@numtexte": "2001-35", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2001-01-11" }, { "@id": "LEGIARTI000006254318", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254325", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639980", "@nortexte": "SANP0623382A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254307", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254319", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326653", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020320295", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326611", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254321", "@num": "4", "#text": "Arrêté du 16 août 2006 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254313", "@num": "7", "#text": "Arrêté du 16 août 2006 - art. 7 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006734099", "@num": "ANNEXE", "#text": "Arrêté du 16 août 2006 - art. ANNEXE (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639975", "@nortexte": "SANP0623370A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006255223", "@num": "1", "#text": "Arrêté du 11 septembre 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000271992", "@nortexte": "SANP0623792A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-09-11" }, { "@id": "LEGIARTI000020322856", "@num": "3", "#text": "Arrêté du 11 septembre 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000271992", "@nortexte": "SANP0623792A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-09-11" }, { "@id": "LEGIARTI000006697048", "@num": "39", "#text": "Loi n°2007-248 du 26 février 2007 - art. 39 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000613381", "@nortexte": "SANX0600004L", "@numtexte": "2007-248", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2007-02-26" }, { "@id": "LEGIARTI000006868630", "@num": "29", "#text": "Décret n° 2007-358 du 19 mars 2007 - art. 29 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000821090", "@nortexte": "AGRG0700644D", "@numtexte": "2007-358", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-19" }, { "@id": "LEGIARTI000006726837", "@num": "5", "#text": "Décret n°2007-462 du 25 mars 2007 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000466314", "@nortexte": "MJSK0770075D", "@numtexte": "2007-462", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-25" }, { "@id": "LEGIARTI000018361459", "@num": "Annexe", "#text": "Arrêté du 5 mars 2008 - art. Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000018360158", "@nortexte": "SJSP0805973A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-03-05" }, { "@id": "LEGIARTI000019382668", "@num": "2", "#text": "Arrêté du 11 août 2008 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019381783", "@nortexte": "SJSP0820319A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-08-11" }, { "@id": "LEGIARTI000034448482", "@num": "7", "#text": "Arrêté du 6 février 2009 - art. 7 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000020234297", "@nortexte": "SJSG0824493A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-06" }, { "@id": "LEGITEXT000020319418", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318429", "@nortexte": "SASP0904387A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319427", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318439", "@nortexte": "SASP0904427A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319436", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318449", "@nortexte": "SASP0904394A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "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. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000050407232", "@nortexte": "MSAP2428789A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-10-24" }, { "@id": "LEGIARTI000043545974", "@num": "Annexe I à l'article D523-8", "#text": "Code de l'environnement - art. Annexe I à l'article D523-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000027912149", "@num": "D523-8", "#text": "Code de l'environnement - art. D523-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000042654871", "@num": "L521-2", "#text": "Code de l'environnement - art. 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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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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

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Pour obtenir une autorisation de mise sur le marché en France et dans au moins un autre Etat membre de la Communauté européenne ou partie à l'accord sur l'Espace économique européen, pour un médicament qui n'est autorisé ni dans la Communauté européenne ni dans l'Espace économique européen, le demandeur adresse une demande d'autorisation de mise sur le marché au directeur général de l'Agence nationale de sécurité du médicament et des produits de santé.

Si le directeur général de l'agence n'approuve pas ces documents parce qu'il estime que le médicament concerné présente un risque potentiel grave pour la santé publique au sens des lignes directrices mentionnées à l'article 29.2 de la directive 2001/83/ CE du Parlement européen et du Conseil, il fait immédiatement connaître son opposition motivée à l'Etat de référence, aux autres Etats concernés, au demandeur et au groupe de coordination mentionné à l'article 27 de la directive mentionnée ci-dessus.

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Pour obtenir la reconnaissance en France d'une autorisation de mise sur le marché délivrée par un autre Etat dit Etat de référence, membre de la Communauté européenne ou partie à l'accord sur l'Espace économique européen, le titulaire de cette autorisation adresse une demande d'autorisation de mise sur le marché au directeur général de l'Agence nationale de sécurité du médicament et des produits de santé.

2° Si le directeur général de l'agence n'approuve pas ces documents parce qu'il estime que le médicament concerné présente un risque potentiel grave pour la santé publique au sens des lignes directrices mentionnées à l'article 29.2 de la directive 2001/83/ CE du Parlement européen et du Conseil, il fait immédiatement connaître son opposition motivée à l'Etat de référence, aux autres Etats concernés, au demandeur et au groupe de coordination mentionné à l'article 27 de la directive précitée.

" } }, "LEGIARTI000025788075": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5121-51-1", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2012-05-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025788075", "URL": "article/LEGI/ARTI/00/00/25/78/80/LEGIARTI000025788075.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000025765496", "@num": "5", "#text": "Décret n°2012-597\n du 27 avril 2012 - art. 5", "@sens": "cible", "@cidtexte": "JORFTEXT000025757625", "@nortexte": "ETSP1206945D", "@numtexte": "2012-597", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2012-04-27" }, { "@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": "LEGIARTI000025788064", "@num": "R5121-51-4", "#text": "Code de la santé publique - art. R5121-51-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000030695761", "@num": "344 undecies A", "#text": "Code général des impôts, annexe 3, CGIAN3. - art. 344 undecies A (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069574", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000017889921", "@fin": "2999-01-01", "#text": "Paragraphe 2 : Procédure de reconnaissance mutuelle", "@debut": "2007-12-31" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000017889925", "@fin": "2999-01-01", "#text": "Sous-section 3 bis : Procédure de reconnaissance mutuelle et procédure décentralisée", "@debut": "2007-12-31" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190665", "@fin": "2999-01-01", "#text": "Section 5 : Autorisation de mise sur le marché", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178649", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161012", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000017889903", "@fin": "2012-05-01", "@num": "R5121-51-1", "@etat": "MODIFIE", "@debut": "2007-12-31", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000025788075", "@fin": "2999-01-01", "@num": "R5121-51-1", "@etat": "VIGUEUR", "@debut": "2012-05-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Pour obtenir la reconnaissance, par au moins un autre Etat membre de la Communauté européenne ou partie à l'accord sur l'Espace économique européen, d'une autorisation de mise sur le marché délivrée par le directeur général de l'Agence nationale de sécurité du médicament et des produits de santé, la France agissant alors comme Etat de référence, le titulaire de cette autorisation demande à ce dernier de mettre à jour ou d'élaborer le rapport d'évaluation du médicament ; il lui transmet les éventuels compléments au dossier dont l'agence dispose.

" } }, "LEGIARTI000025788087": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5121-46", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2021-11-01", "DATE_DEBUT": "2012-05-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025788087", "URL": "article/LEGI/ARTI/00/00/25/78/80/LEGIARTI000025788087.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000025765496", "@num": "5", "#text": "Décret n°2012-597\n du 27 avril 2012 - art. 5", "@sens": "cible", "@cidtexte": "JORFTEXT000025757625", "@nortexte": "ETSP1206945D", "@numtexte": "2012-597", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2012-04-27" }, { "@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": "LEGIARTI000020529716", "@num": "D5121-64", "#text": "Code de la santé publique - art. D5121-64 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000020529732", "@num": "D5121-65", "#text": "Code de la santé publique - art. D5121-65 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000030772878", "@num": "R5121-100-1", "#text": "Code de la santé publique - art. R5121-100-1 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018776569", "@num": "R5121-107-8", "#text": "Code de la santé publique - art. R5121-107-8 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914744", "@num": "R5121-21", "#text": "Code de la santé publique - art. R5121-21", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000030773843", "@num": "R5121-41-1", "#text": "Code de la santé publique - art. R5121-41-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025788123", "@num": "R5121-41-2", "#text": "Code de la santé publique - art. R5121-41-2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915091", "@num": "R5124-10", "#text": "Code de la santé publique - art. R5124-10", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915085", "@num": "R5124-6", "#text": "Code de la santé publique - art. R5124-6", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800197", "@num": "R5138", "#text": "Code de la santé publique - art. R5138 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006196543", "@fin": "2999-01-01", "#text": "Sous-section 3 : Instruction et conditions de l'autorisation.", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190665", "@fin": "2999-01-01", "#text": "Section 5 : Autorisation de mise sur le marché", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178649", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161012", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006914781", "@fin": "2005-02-23", "@num": "R5121-46", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006914782", "@fin": "2008-05-08", "@num": "R5121-46", "@etat": "MODIFIE", "@debut": "2005-02-23", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000018776362", "@fin": "2012-05-01", "@num": "R5121-46", "@etat": "MODIFIE", "@debut": "2008-05-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025788087", "@fin": "2021-11-01", "@num": "R5121-46", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000043531996", "@fin": "2999-01-01", "@num": "R5121-46", "@etat": "VIGUEUR", "@debut": "2021-11-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Le changement du titulaire de l'autorisation de mise sur le marché est subordonné à une autorisation du directeur général de l'Agence nationale de sécurité du médicament et des produits de santé.

La demande comporte les mentions prévues à l'article R. 5121-21 et elle est accompagnée d'un dossier comprenant :

1° Une copie, certifiée conforme par le titulaire, de l'autorisation de mise sur le marché ;

2° L'accord de ce titulaire sur le transfert de l'autorisation de mise sur le marché ;

3° La désignation des lieux de fabrication, de contrôle et de conditionnement ;

5° Les comptes rendus des contrôles, effectués par le demandeur dans le respect desdites méthodes ;

6° La formule de préparation avec, notamment, toutes indications utiles sur le récipient ;

7° La contenance des nouveaux modèles destinés à la vente ;

8° Le projet de nouvel étiquetage et, si elle est prévue, de la notice ;

10° Le cas échéant, un extrait du registre du commerce et des sociétés relatif au demandeur.

Dans le cas de fusion ou d'apport partiel d'actifs, les sociétés intéressées peuvent déposer une demande de transfert des autorisations de mise sur le marché avant que la fusion ou l'apport ne soit définitivement réalisé. Elles fournissent, à l'appui de leur demande, le protocole d'accord de principe concernant la fusion ou l'apport. Le transfert est accordé sous la condition suspensive de la réalisation définitive qui est notifiée au directeur général de l'Agence nationale de sécurité du médicament et des produits de santé.

Le directeur général de l'Agence nationale de sécurité du médicament et des produits de santé notifie sa décision dans un délai de soixante jours à compter de la date de réception de la demande. A défaut, le silence gardé par le directeur général de l'Agence nationale de sécurité du médicament et des produits de santé vaut autorisation à l'expiration de ce délai.

" } }, "LEGIARTI000025788129": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5121-41", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2012-05-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025788129", "URL": "article/LEGI/ARTI/00/00/25/78/81/LEGIARTI000025788129.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000019564954", "@num": "6", "#text": "Arrêté du 8 août 2008 - art. 6 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019563838", "@nortexte": "SJSP0820078A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-08-08" }, { "@id": "LEGIARTI000025765496", "@num": "5", "#text": "Décret n°2012-597\n du 27 avril 2012 - art. 5", "@sens": "cible", "@cidtexte": "JORFTEXT000025757625", "@nortexte": "ETSP1206945D", "@numtexte": "2012-597", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2012-04-27" }, { "@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": "LEGIARTI000020529716", "@num": "D5121-64", "#text": "Code de la santé publique - art. D5121-64 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000020529732", "@num": "D5121-65", "#text": "Code de la santé publique - art. D5121-65 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034432960", "@num": "R5121-139", "#text": "Code de la santé publique - art. R5121-139 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800297", "@num": "R5135-4", "#text": "Code de la santé publique - art. R5135-4 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000030695761", "@num": "344 undecies A", "#text": "Code général des impôts, annexe 3, CGIAN3. - art. 344 undecies A (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069574", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006196543", "@fin": "2999-01-01", "#text": "Sous-section 3 : Instruction et conditions de l'autorisation.", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190665", "@fin": "2999-01-01", "#text": "Section 5 : Autorisation de mise sur le marché", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178649", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161012", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006914769", "@fin": "2008-05-08", "@num": "R5121-41", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000018776331", "@fin": "2012-05-01", "@num": "R5121-41", "@etat": "MODIFIE", "@debut": "2008-05-08", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000025788129", "@fin": "2999-01-01", "@num": "R5121-41", "@etat": "VIGUEUR", "@debut": "2012-05-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Le titulaire de l'autorisation de mise sur le marché soumet au directeur général de l'Agence nationale de sécurité du médicament et des produits de santé tout projet de modification d'un élément relatif à l'étiquetage ou à la notice, autre que les modifications du résumé des caractéristiques du produit.

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art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036920946", "@nortexte": "SSAP1813104A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-05-14" }, { "@id": "LEGIARTI000036925435", "@num": "4", "#text": "Arrêté du 14 mai 2018 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036920946", "@nortexte": "SSAP1813104A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-05-14" }, { "@id": "LEGIARTI000037502021", "@num": "1", "#text": "Arrêté du 15 octobre 2018 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000037501422", "@nortexte": "SSAP1828085A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-10-15" }, { "@id": "LEGIARTI000037557939", "@num": "3", "#text": "Arrêté du 26 octobre 2018 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000037552934", "@nortexte": "SSAP1829446A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-10-26" }, { "@id": "LEGIARTI000038122113", "@num": "2", "#text": "Arrêté du 11 février 2019 - 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art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041459990", "@nortexte": "SSAP2001803A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-01-21" }, { "@id": "LEGIARTI000041521988", "@num": "2", "#text": "Arrêté du 30 janvier 2020 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041514887", "@nortexte": "SSAP2000708A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-01-30" }, { "@id": "LEGIARTI000041807940", "@num": "10-4", "#text": "Arrêté du 23 mars 2020 - art. 10-4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041807774", "@num": "10-5", "#text": "Arrêté du 23 mars 2020 - art. 10-5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041920905", "@num": "6-1", "#text": "Arrêté du 23 mars 2020 - 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Toute spécialité pharmaceutique ou tout autre médicament fabriqué industriellement ou selon une méthode dans laquelle intervient un processus industriel ainsi que tout générateur, trousse ou précurseur qui ne fait pas l'objet d'une autorisation de mise sur le marché délivrée par l'Union européenne en application du règlement (CE) n° 726 / 2004 du Parlement européen et du Conseil, du 31 mars 2004, établissant des procédures communautaires pour l'autorisation et la surveillance en ce qui concerne les médicaments à usage humain et à usage vétérinaire, et instituant une Agence européenne des médicaments doit faire l'objet, avant sa mise sur le marché ou sa distribution à titre gratuit, d'une autorisation de mise sur le marché délivrée par l'Agence française de sécurité sanitaire des produits de santé. L'autorisation peut être assortie de conditions appropriées, notamment l'obligation de réaliser des études de sécurité ou d'efficacité post-autorisation.

Le demandeur de l'autorisation peut être dispensé de produire certaines données et études dans des conditions fixées par voie réglementaire.

Une autorisation de mise sur le marché ne peut être délivrée qu'à un demandeur établi dans un Etat membre de l'Union européenne ou partie à l'accord sur l'Espace économique européen.

L'autorisation est délivrée pour une durée de cinq ans et peut ensuite être renouvelée, le cas échéant, sans limitation de durée, dans des conditions fixées par un décret en Conseil d'Etat, sauf si l'Agence française de sécurité sanitaire des produits de santé décide, pour des raisons justifiées ayant trait à la pharmacovigilance, de procéder à un renouvellement supplémentaire, sur la base d'une réévaluation des effets thérapeutiques positifs du médicament ou produit au regard des risques tels que définis au premier alinéa de l'article L. 5121-9. Ce décret détermine également les conditions dans lesquelles elle peut devenir caduque.

L'autorisation peut être modifiée par l'Agence française de sécurité sanitaire des produits de santé.

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I. ― Est subordonné au paiement d'un droit perçu au profit de la Caisse nationale de l'assurance maladie des travailleurs salariés le dépôt auprès de l'agence mentionnée à l'article L. 5311-1 du code de la santé publique de chaque :

1° Demande d'enregistrement mentionnée aux articles L. 5121-13 et L. 5121-14 du même code, de chaque demande de renouvellement ou de modification de cet enregistrement ;

2° Demande d'enregistrement mentionnée à l'article L. 5121-14-1 du même code, de chaque demande de renouvellement ou de modification de cet enregistrement ;

3° Demande d'autorisation de mise sur le marché mentionnée à l'article L. 5121-8 du même code ou de chaque demande de renouvellement ou de chaque demande ou notification de modification de cette autorisation ;

4° Demande de reconnaissance par au moins un autre Etat membre de l'Union européenne ou partie à l'accord sur l'Espace économique européen d'une autorisation de mise sur le marché, délivrée par le directeur général de l'agence mentionnée à l'article L. 5311-1, mentionnée à l'article L. 5121-8 du même code ou de chaque demande de modification de cette autorisation ;

5° Demande d'autorisation d'importation parallèle conformément à l'article L. 5124-13 du même code et de chaque demande de modification ou de renouvellement de cette autorisation ;

6° Demande de visa ou de renouvellement de visa de publicité, mentionné aux articles L. 5122-8, L. 5122-9 et L. 5122-14 du même code ;

7° Demande d'autorisation ou de renouvellement d'autorisation de publicité, mentionnée aux articles L. 5213-4 et L. 5223-3 du même code.

II. ― Le montant du droit dû à raison des dépôts mentionnés au I est fixé par décret dans la limite maximale de :

a) 7 600 € pour les demandes mentionnées au 1° du I ;

b) 21 000 € pour les demandes mentionnées au 2° du I ;

c) 50 000 € pour les demandes mentionnées aux 3° à 5° du I ;

d) 1 200 € pour les demandes mentionnées aux 6° et 7° du I.

III. ― Le versement du droit est accompagné d'une déclaration dont le modèle est fixé par l'administration. Le droit est recouvré et contrôlé selon les mêmes garanties et sanctions qu'en matière de droits d'enregistrement. Il est donné quittance de son versement. A défaut de production de la quittance à l'appui de son dépôt à l'agence ou en cas de versement d'un montant insuffisant, le dossier de la demande est réputé incomplet.

Lorsque le dossier d'une demande mentionnée au I est complet, le droit versé n'est restituable qu'à concurrence de la fraction de son montant dont l'agence a antérieurement constaté l'insuffisance de versement.

" } }, "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. 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Article 1 ENTIEREMENT_MODIF (Décret n° 2019-389 du 30 avril 2019 pris pour l'application de l'article 1635 bis AE du code général des impôts relatif aux droits perçus à l'occasion de demandes déposées à l'Agence nationale de sécurité du médicament et des produits de santé)