{ "article": { "LEGIARTI000025071092": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "9", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025071092", "URL": "article/LEGI/ARTI/00/00/25/07/10/LEGIARTI000025071092.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000026499689", "@num": "L5121-8", "#text": "Code de la santé publique - art. L5121-8 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025085935", "@num": "L5121-8-1", "#text": "Code de la santé publique - art. L5121-8-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000025071043", "@fin": "2999-01-01", "#text": "Chapitre Ier : L'autorisation de mise sur le marché", "@debut": "2011-12-31" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000025071054", "@fin": "2999-01-01", "#text": "TITRE III : LE MÉDICAMENT À USAGE HUMAIN", "@debut": "2011-12-31" } ] }, "@cid": "JORFTEXT000025053440", "@nor": "ETSX1119227L", "@num": "2011-2012", "@nature": "LOI", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "LOI n° 2011-2012 du 29 décembre 2011 relative au renforcement de la sécurité sanitaire du médicament et des produits de santé", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000025053440", "@c_titre_court": "LOI n° 2011-2012 du 29 décembre 2011" }, { "@fin": "2999-01-01", "#text": "LOI n° 2011-2012 du 29 décembre 2011 relative au renforcement de la sécurité sanitaire du médicament et des produits de santé (1)", "@debut": "2011-12-31", "@id_txt": "LEGITEXT000025071038", "@c_titre_court": "LOI n°2011-2012 du 29 décembre 2011" } ], "@date_publi": "2011-12-30", "@date_signature": "2011-12-29", "@num_parution_jo": "0302" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000025071092", "@fin": "2999-01-01", "@num": "9", "@debut": "2999-01-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000025053654", "@fin": "2999-01-01", "@num": "9", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
A modifié les dispositions suivantes :

-Code de la santé publique
\nArt. L5121-8\n
\n

\n
\n
A créé les dispositions suivantes :

-Code de la santé publique
\nArt. L5121-8-1\n
\n

\n
\n
\n
" } }, "LEGIARTI000025085935": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5121-8-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2023-12-28", "DATE_DEBUT": "2011-12-31" } }, "META_COMMUN": { "ID": "LEGIARTI000025085935", "URL": "article/LEGI/ARTI/00/00/25/08/59/LEGIARTI000025085935.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000025071092", "@num": "9", "#text": "LOI n°2011-2012 du 29 décembre 2011 - art. 9 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CREATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000025086411", "@num": "L5121-24", "#text": "Code de la santé publique - art. L5121-24 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026594734", "@num": "R5121-37-3", "#text": "Code de la santé publique - art. R5121-37-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171366", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155085", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140630", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025085935", "@fin": "2023-12-28", "@num": "L5121-8-1", "@etat": "MODIFIE", "@debut": "2011-12-31", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000048703419", "@fin": "2999-01-01", "@num": "L5121-8-1", "@etat": "VIGUEUR", "@debut": "2023-12-28", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "Après délivrance de l'autorisation prévue à l'article L. 5121-8, l'Agence nationale de sécurité du médicament et des produits de santé peut, dans des conditions fixées par décret en Conseil d'Etat, exiger du titulaire de l'autorisation qu'il effectue, dans un délai qu'elle fixe :
\n
1° Des études de sécurité post-autorisation s'il existe des craintes quant aux risques de sécurité présentés par un médicament autorisé ;
\n
2° Des études d'efficacité post-autorisation lorsque la compréhension de la maladie ou la méthodologie clinique fait apparaître que les évaluations d'efficacité antérieures pourraient devoir être revues de manière significative ;
\n
3° Un suivi spécifique du risque, de ses complications et de sa prise en charge médico-sociale, au travers d'un registre de patients atteints, lorsque le médicament, bien que retiré, est susceptible de provoquer un effet indésirable grave.
\n
Les études mentionnées aux 1° et 2° sont faites au plus près des conditions réelles de soins, c'est-à-dire en comparaison avec les traitements de référence disponibles lorsqu'ils existent." } }, "LEGIARTI000026499689": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5121-8", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-05-01", "DATE_DEBUT": "2011-12-31" } }, "META_COMMUN": { "ID": "LEGIARTI000026499689", "URL": "article/LEGI/ARTI/00/00/26/49/96/LEGIARTI000026499689.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": "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": "LEGIARTI000025071092", "@num": "9", "#text": "LOI n°2011-2012 du 29 décembre 2011 - art. 9", "@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": "LEGIARTI000043577276", "@num": "13", "#text": "Arrêté du 1 juin 2021 - art. 13 (VT)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@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": "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 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.

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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Article 9 ENTIEREMENT_MODIF (LOI n° 2011-2012 du 29 décembre 2011 relative au renforcement de la sécurité sanitaire du médicament et des produits de santé)