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La demande d'autorisation de mise sur le marché est adressée au directeur général de l'Agence française de sécurité sanitaire des produits de santé. Elle mentionne :
\n
1° Le nom et l'adresse du responsable de la mise sur le marché et, lorsque celui-ci ne fabrique pas la spécialité pharmaceutique, le nom et l'adresse du fabricant ;
\n
2° La dénomination du médicament, qui est conforme aux dispositions des articles R. 5121-2 à R. 5121-4 ;
\n
3° La composition intégrale du médicament soit par unité de prise, soit par unité de poids ou de volume, énoncée en termes usuels pour le produit concerné à l'exclusion des formules chimiques brutes, avec recours à la dénomination commune internationale des composants, chaque fois que celle-ci a été recommandée par l'Organisation mondiale de la santé.
\n
La demande est accompagnée du résumé des caractéristiques du produit défini aux articles R. 5121-23 et R. 5121-24.
" } }, "LEGIARTI000018776266": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5121-21", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-05-01", "DATE_DEBUT": "2008-05-08" } }, "META_COMMUN": { "ID": "LEGIARTI000018776266", "URL": "article/LEGI/ARTI/00/00/18/77/62/LEGIARTI000018776266.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006700047", "@num": "17", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 17 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000026602958", "@num": "1", "#text": "Arrêté du 6 mai 2008 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000018768294", "@nortexte": "SJSP0810431A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-05-06" }, { "@id": "LEGIARTI000018770523", "@num": "11", "#text": "Décret n°2008-435 du 6 mai 2008 - art. 11", "@sens": "cible", "@cidtexte": "JORFTEXT000018767820", "@nortexte": "SJSP0807671D", "@numtexte": "2008-435", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2008-05-06" }, { "@id": "LEGIARTI000024687204", "@num": "1", "#text": "Arrêté du 12 octobre 2011 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000024686131", "@nortexte": "ETSH1127808A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-10-12" }, { "@id": "LEGITEXT000026594841", "#text": "Arrêté du 8 novembre 2012 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000026592768", "@nortexte": "AFSP1238370A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-11-08" }, { "@id": "LEGITEXT000030772618", "#text": "DÉCRET n°2015-709 du 22 juin 2015 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000030769177", "@nortexte": "AFSP1507766D", "@numtexte": "2015-709", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2015-06-22" }, { "@id": "LEGIARTI000045290161", "@num": "4", "#text": "Arrêté du 1er mars 2022 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000045287964", "@nortexte": "SSAH2202554A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-03-01" }, { "@id": "LEGIARTI000045650100", "@num": "D4151-25", "#text": "Code de la santé publique - art. 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R5121-41-5 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043531996", "@num": "R5121-46", "#text": "Code de la santé publique - art. R5121-46 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043761549", "@num": "R5121-68", "#text": "Code de la santé publique - art. R5121-68 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018776657", "@num": "R5122-1", "#text": "Code de la santé publique - art. R5122-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914992", "@num": "R5122-11", "#text": "Code de la santé publique - art. R5122-11 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025853198", "@num": "R5122-17", "#text": "Code de la santé publique - art. R5122-17 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800122", "@num": "R5128", "#text": "Code de la santé publique - art. R5128 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000037269752", "@num": "R5521-1", "#text": "Code de la santé publique - art. R5521-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique R5128 al. 1 à 5", "@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": "LEGIARTI000006914744", "@fin": "2008-05-08", "@num": "R5121-21", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000018776266", "@fin": "2012-05-01", "@num": "R5121-21", "@etat": "MODIFIE", "@debut": "2008-05-08", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000025788171", "@fin": "2999-01-01", "@num": "R5121-21", "@etat": "VIGUEUR", "@debut": "2012-05-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

La demande d'autorisation de mise sur le marché est adressée au directeur général de l'Agence française de sécurité sanitaire des produits de santé. Elle mentionne :

1° Le nom et l'adresse du futur titulaire de l'autorisation de mise sur le marché et, le cas échéant, ceux de l'entreprise exploitant la spécialité pharmaceutique, ainsi que ceux du fabricant lorsque ni le futur titulaire de l'autorisation ni l'entreprise exploitant la spécialité n'assure la fabrication ;

2° Le nom du médicament ;

3° La composition intégrale du médicament, soit par unité de prise, soit par unité de poids ou de volume, comportant la mention de la dénomination commune de ses composants.

La demande est accompagnée du projet de résumé des caractéristiques du produit dont la présentation et le contenu sont fixés conformément à l'article 11 de la directive 2001 / 83 / CE du 6 novembre 2001 par arrêté du ministre chargé de la santé, pris sur proposition du directeur général de l'agence.

" } }, "LEGIARTI000025788171": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5121-21", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2012-05-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025788171", "URL": "article/LEGI/ARTI/00/00/25/78/81/LEGIARTI000025788171.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006700047", "@num": "17", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 17 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000026602958", "@num": "1", "#text": "Arrêté du 6 mai 2008 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000018768294", "@nortexte": "SJSP0810431A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-05-06" }, { "@id": "LEGIARTI000024687204", "@num": "1", "#text": "Arrêté du 12 octobre 2011 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000024686131", "@nortexte": "ETSH1127808A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-10-12" }, { "@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": "LEGITEXT000026594841", "#text": "Arrêté du 8 novembre 2012 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000026592768", "@nortexte": "AFSP1238370A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-11-08" }, { "@id": "LEGITEXT000030772618", "#text": "DÉCRET n°2015-709 du 22 juin 2015 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000030769177", "@nortexte": "AFSP1507766D", "@numtexte": "2015-709", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2015-06-22" }, { "@id": "LEGIARTI000045290161", "@num": "4", "#text": "Arrêté du 1er mars 2022 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000045287964", "@nortexte": "SSAH2202554A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-03-01" }, { "@id": "LEGIARTI000045650100", "@num": "D4151-25", "#text": "Code de la santé publique - art. D4151-25 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@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": "LEGIARTI000030772762", "@num": "R5121-107-15", "#text": "Code de la santé publique - art. R5121-107-15 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018776582", "@num": "R5121-107-4", "#text": "Code de la santé publique - art. R5121-107-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028083982", "@num": "R5121-152", "#text": "Code de la santé publique - art. R5121-152 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914905", "@num": "R5121-153", "#text": "Code de la santé publique - art. R5121-153 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026903038", "@num": "R5121-25", "#text": "Code de la santé publique - art. R5121-25 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914753", "@num": "R5121-29", "#text": "Code de la santé publique - art. R5121-29 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044944636", "@num": "R5121-36", "#text": "Code de la santé publique - art. R5121-36 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025788113", "@num": "R5121-41-5", "#text": "Code de la santé publique - art. R5121-41-5 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043531996", "@num": "R5121-46", "#text": "Code de la santé publique - art. R5121-46 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043761549", "@num": "R5121-68", "#text": "Code de la santé publique - art. R5121-68 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018776657", "@num": "R5122-1", "#text": "Code de la santé publique - art. R5122-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914992", "@num": "R5122-11", "#text": "Code de la santé publique - art. R5122-11 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025853198", "@num": "R5122-17", "#text": "Code de la santé publique - art. R5122-17 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800122", "@num": "R5128", "#text": "Code de la santé publique - art. R5128 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000037269752", "@num": "R5521-1", "#text": "Code de la santé publique - art. R5521-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique R5128 al. 1 à 5", "@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": "LEGIARTI000006914744", "@fin": "2008-05-08", "@num": "R5121-21", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000018776266", "@fin": "2012-05-01", "@num": "R5121-21", "@etat": "MODIFIE", "@debut": "2008-05-08", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000025788171", "@fin": "2999-01-01", "@num": "R5121-21", "@etat": "VIGUEUR", "@debut": "2012-05-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

La demande d'autorisation de mise sur le marché est adressée au directeur général de l'Agence nationale de sécurité du médicament et des produits de santé. Elle mentionne :

2° Le nom du médicament ;

3° La composition intégrale du médicament, soit par unité de prise, soit par unité de poids ou de volume, comportant la mention de la dénomination commune de ses composants.

La demande est accompagnée du projet de résumé des caractéristiques du produit dont la présentation et le contenu sont fixés conformément à l'article 11 de la directive 2001/83/ CE du 6 novembre 2001 par arrêté du ministre chargé de la santé, pris sur proposition du directeur général de l'agence.

" } } }, "article_lien": [ { "article_id": "LEGIARTI000025788171", "cible": true, "cidtexte": "JORFTEXT000026592768", "id": "LEGITEXT000026594841", "typelien": "CITATION" }, { "article_id": "LEGIARTI000018776266", "cible": true, "cidtexte": "JORFTEXT000026592768", "id": "LEGITEXT000026594841", "typelien": "CITATION" }, { "article_id": "LEGIARTI000006914744", "cible": true, "cidtexte": "JORFTEXT000026592768", "id": "LEGITEXT000026594841", "typelien": "CITATION" } ], "texte_version": { "LEGITEXT000026594841": { "META": { "META_SPEC": { "META_TEXTE_VERSION": { "ETAT": "VIGUEUR", "LIENS": { "LIEN": [ { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914744", "@num": "R5121-21", "#text": "Code de la santé publique - art. R5121-21 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "règlement CE n° 726/2004", "@sens": "source", "@typelien": "CITATION" } ] }, "TITRE": "Arrêté du 8 novembre 2012", "DATE_FIN": "2999-01-01", "TITREFULL": "Arrêté du 8 novembre 2012 modifiant l'arrêté du 6 mai 2008 pris pour l'application de l'article R. 5121-21 du code de la santé publique", "DATE_DEBUT": "2012-11-10" }, "META_TEXTE_CHRONICLE": { "CID": "JORFTEXT000026592768", "NOR": "AFSP1238370A", "DATE_PUBLI": "2012-11-09", "DATE_TEXTE": "2012-11-08", "NUM_SEQUENCE": 18, "ORIGINE_PUBLI": "JORF n°0261 du 9 novembre 2012", "PAGE_DEB_PUBLI": 17625, "PAGE_FIN_PUBLI": 17626, "DERNIERE_MODIFICATION": "2012-11-10" } }, "META_COMMUN": { "ID": "LEGITEXT000026594841", "URL": "texte/version/LEGI/TEXT/00/00/26/59/48/LEGITEXT000026594841.xml", "NATURE": "ARRETE", "ORIGINE": "LEGI" } }, "VISAS": { "CONTENU": "

\n
La ministre des affaires sociales et de la santé,
Vu le 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, modifié par le règlement (UE) n° 1235/2010 du Parlement européen et du Conseil du 15 décembre 2010 ;
Vu la directive 2010/84/UE du Parlement européen et du Conseil du 15 décembre 2010 modifiant, en ce qui concerne la pharmacovigilance, la directive 2001/83/CE du 6 novembre 2001 instituant un code communautaire relatif aux médicaments à usage humain ;
Vu le code de la santé publique, notamment l'article R. 5121-21 ;
Vu l'arrêté du 6 mai 2008 pris pour l'application de l'article R. 5121-21 du code de la santé publique ;
Sur la proposition du directeur général de l'Agence nationale de sécurité du médicament et des produits de santé en date du 18 juin 2012,
Arrête :

" }, "SIGNATAIRES": { "CONTENU": "

Fait le 8 novembre 2012.

Pour la ministre et par délégation :

Le directeur général de la santé,

J.-Y. Grall

" } } }, "textelr": { "LEGITEXT000026594841": { "META": { "META_SPEC": { "META_TEXTE_CHRONICLE": { "CID": "JORFTEXT000026592768", "NOR": "AFSP1238370A", "DATE_PUBLI": "2012-11-09", "DATE_TEXTE": "2012-11-08", "NUM_SEQUENCE": 18, "ORIGINE_PUBLI": "JORF n°0261 du 9 novembre 2012", "PAGE_DEB_PUBLI": 17625, "PAGE_FIN_PUBLI": 17626, "DERNIERE_MODIFICATION": "2012-11-10" } }, "META_COMMUN": { "ID": "LEGITEXT000026594841", "URL": "texte/struct/LEGI/TEXT/00/00/26/59/48/LEGITEXT000026594841.xml", "NATURE": "ARRETE", "ORIGINE": "LEGI" } }, "STRUCT": { "LIEN_ART": [ { "@id": "LEGIARTI000026594849", "@fin": "2999-01-01", "@num": "1", "@debut": "2999-01-01", "@origine": "LEGI" }, { "@id": "LEGIARTI000026594845", "@fin": "2999-01-01", "@num": "2", "@etat": "VIGUEUR", "@debut": "2012-11-10", "@origine": "LEGI" }, { "@id": "LEGIARTI000026594847", "@fin": "2999-01-01", "@num": "3", "@etat": "VIGUEUR", "@debut": "2012-11-10", "@origine": "LEGI" } ] }, "VERSIONS": { "VERSION": [ { "LIEN_TXT": { "@id": "JORFTEXT000026592768", "@fin": "2999-01-01", "@debut": "2999-01-01" } }, { "@etat": "VIGUEUR", "LIEN_TXT": { "@id": "LEGITEXT000026594841", "@fin": "2999-01-01", "@debut": "2012-11-10" } } ] } } }, "follow": [ "STRUCT.LIEN_SECTION_TA.@id", "STRUCTURE_TA.LIEN_SECTION_TA.@id", "TEXTEKALI", "TEXTELR" ], "id": "LEGITEXT000026594841", "liens_entrants": true }