{ "article": { "LEGIARTI000025787443": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5138-4", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2012-05-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025787443", "URL": "article/LEGI/ARTI/00/00/25/78/74/LEGIARTI000025787443.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": "LEGIARTI000006690173", "@num": "L5138-4", "#text": "Code de la santé publique - art. L5138-4", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000018088065", "@fin": "2999-01-01", "#text": "Section 2 : Certificat de conformité aux bonnes pratiques et banque de données communautaire.", "@debut": "2008-02-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000018088078", "@fin": "2999-01-01", "#text": "Chapitre VIII : Matières premières à usage pharmaceutique", "@debut": "2008-02-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161013", "@fin": "2999-01-01", "#text": "Titre III : Autres produits et substances pharmaceutiques réglementés", "@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": "LEGIARTI000018088058", "@fin": "2012-05-01", "@num": "R5138-4", "@etat": "MODIFIE", "@debut": "2008-02-08", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000025787443", "@fin": "2999-01-01", "@num": "R5138-4", "@etat": "VIGUEUR", "@debut": "2012-05-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

La demande de certificat prévue au deuxième alinéa de l'article L. 5138-4 est adressée à l'Agence nationale de sécurité du médicament et des produits de santé par une personne habilitée à engager l'établissement.

" } }, "LEGIARTI000006690173": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5138-4", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2002-01-01", "DATE_DEBUT": "2000-06-22" } }, "META_COMMUN": { "ID": "LEGIARTI000006690173", "URL": "article/LEGI/ARTI/00/00/06/69/01/LEGIARTI000006690173.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5138L04XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "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": "LEGIARTI000025546628", "@num": "D5321-6-1", "#text": "Code de la santé publique - art. D5321-6-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026345679", "@num": "D5321-7", "#text": "Code de la santé publique - art. D5321-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690170", "@num": "L5138-3", "#text": "Code de la santé publique - art. L5138-3 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690176", "@num": "L5138-5", "#text": "Code de la santé publique - art. L5138-5 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000047293552", "@num": "L5521-7", "#text": "Code de la santé publique - art. L5521-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694017", "@num": "L658-16", "#text": "Code de la santé publique - art. L658-16 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694017", "@num": "L658-16", "#text": "Code de la santé publique - art. L658-16 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018088061", "@num": "R5138-3", "#text": "Code de la santé publique - art. R5138-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025787443", "@num": "R5138-4", "#text": "Code de la santé publique - art. R5138-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018088090", "@num": "R5438-2", "#text": "Code de la santé publique - art. R5438-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171382", "@fin": "2999-01-01", "#text": "Chapitre VIII : Matières premières à usage pharmaceutique.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155086", "@fin": "2999-01-01", "#text": "Titre III : Autres produits et substances pharmaceutiques réglementés", "@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": "LEGIARTI000006690173", "@fin": "2002-01-01", "@num": "L5138-4", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690174", "@fin": "2007-02-27", "@num": "L5138-4", "@etat": "MODIFIE", "@debut": "2002-01-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690175", "@fin": "2012-05-01", "@num": "L5138-4", "@etat": "MODIFIE", "@debut": "2007-02-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025104733", "@fin": "2012-12-22", "@num": "L5138-4", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000026809099", "@fin": "2999-01-01", "@num": "L5138-4", "@etat": "VIGUEUR", "@debut": "2012-12-22", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Chaque demande présentée par un établissement de fabrication, d'importation ou de distribution de matières premières à usage pharmaceutique en vue d'obtenir le certificat mentionné à l'article L. 5138-3 donne lieu au versement, au profit de l'Agence française de sécurité sanitaire des produits de santé, d'un droit fixe dont le montant est fixé par décret dans la limite de 15 000 F.
\n
Ce droit est recouvré selon les modalités prévues pour le recouvrement des créances des établissements publics administratifs de l'Etat.
" } }, "LEGIARTI000006690174": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5138-4", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2007-02-27", "DATE_DEBUT": "2002-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000006690174", "URL": "article/LEGI/ARTI/00/00/06/69/01/LEGIARTI000006690174.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5138L04XXAB" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000219672", "#text": "Ordonnance 2000-916 2000-09-19 annexe II JORF 22 septembre 2000 en vigueur le 1er janvier 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000219672", "@nortexte": "JUSX0000106R", "@numtexte": "2000-916", "@typelien": "MODIFICATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2000-09-19" }, { "@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": "LEGIARTI000025546628", "@num": "D5321-6-1", "#text": "Code de la santé publique - art. D5321-6-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026345679", "@num": "D5321-7", "#text": "Code de la santé publique - art. D5321-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690170", "@num": "L5138-3", "#text": "Code de la santé publique - art. L5138-3 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690176", "@num": "L5138-5", "#text": "Code de la santé publique - art. L5138-5 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000047293552", "@num": "L5521-7", "#text": "Code de la santé publique - art. L5521-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694017", "@num": "L658-16", "#text": "Code de la santé publique - art. L658-16 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694017", "@num": "L658-16", "#text": "Code de la santé publique - art. L658-16 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018088061", "@num": "R5138-3", "#text": "Code de la santé publique - art. R5138-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025787443", "@num": "R5138-4", "#text": "Code de la santé publique - art. R5138-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018088090", "@num": "R5438-2", "#text": "Code de la santé publique - art. R5438-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171382", "@fin": "2999-01-01", "#text": "Chapitre VIII : Matières premières à usage pharmaceutique.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155086", "@fin": "2999-01-01", "#text": "Titre III : Autres produits et substances pharmaceutiques réglementés", "@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": "LEGIARTI000006690173", "@fin": "2002-01-01", "@num": "L5138-4", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690174", "@fin": "2007-02-27", "@num": "L5138-4", "@etat": "MODIFIE", "@debut": "2002-01-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690175", "@fin": "2012-05-01", "@num": "L5138-4", "@etat": "MODIFIE", "@debut": "2007-02-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025104733", "@fin": "2012-12-22", "@num": "L5138-4", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000026809099", "@fin": "2999-01-01", "@num": "L5138-4", "@etat": "VIGUEUR", "@debut": "2012-12-22", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Chaque demande présentée par un établissement de fabrication, d'importation ou de distribution de matières premières à usage pharmaceutique en vue d'obtenir le certificat mentionné à l'article L. 5138-3 donne lieu au versement, au profit de l'Agence française de sécurité sanitaire des produits de santé, d'un droit fixe dont le montant est fixé par décret dans la limite de 2 300 euros.
\n
Ce droit est recouvré selon les modalités prévues pour le recouvrement des créances des établissements publics administratifs de l'Etat.
" } }, "LEGIARTI000006690175": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5138-4", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-05-01", "DATE_DEBUT": "2007-02-27" } }, "META_COMMUN": { "ID": "LEGIARTI000006690175", "URL": "article/LEGI/ARTI/00/00/06/69/01/LEGIARTI000006690175.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5138L04XXAC" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "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": "LEGIARTI000006697033", "@num": "26", "#text": "Loi n°2007-248 du 26 février 2007 - art. 26 () JORF 27 février 2007", "@sens": "source", "@cidtexte": "JORFTEXT000000613381", "@nortexte": "SANX0600004L", "@numtexte": "2007-248", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2007-02-26" }, { "@id": "LEGIARTI000025546628", "@num": "D5321-6-1", "#text": "Code de la santé publique - art. D5321-6-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026345679", "@num": "D5321-7", "#text": "Code de la santé publique - art. D5321-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690170", "@num": "L5138-3", "#text": "Code de la santé publique - art. L5138-3 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690176", "@num": "L5138-5", "#text": "Code de la santé publique - art. L5138-5 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000047293552", "@num": "L5521-7", "#text": "Code de la santé publique - art. L5521-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694017", "@num": "L658-16", "#text": "Code de la santé publique - art. L658-16 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694017", "@num": "L658-16", "#text": "Code de la santé publique - art. L658-16 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018088061", "@num": "R5138-3", "#text": "Code de la santé publique - art. R5138-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025787443", "@num": "R5138-4", "#text": "Code de la santé publique - art. R5138-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018088090", "@num": "R5438-2", "#text": "Code de la santé publique - art. R5438-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171382", "@fin": "2999-01-01", "#text": "Chapitre VIII : Matières premières à usage pharmaceutique.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155086", "@fin": "2999-01-01", "#text": "Titre III : Autres produits et substances pharmaceutiques réglementés", "@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": "LEGIARTI000006690173", "@fin": "2002-01-01", "@num": "L5138-4", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690174", "@fin": "2007-02-27", "@num": "L5138-4", "@etat": "MODIFIE", "@debut": "2002-01-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690175", "@fin": "2012-05-01", "@num": "L5138-4", "@etat": "MODIFIE", "@debut": "2007-02-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025104733", "@fin": "2012-12-22", "@num": "L5138-4", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000026809099", "@fin": "2999-01-01", "@num": "L5138-4", "@etat": "VIGUEUR", "@debut": "2012-12-22", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Lorsque dans le cadre de ses pouvoirs d'inspection l'Agence française de sécurité sanitaire des produits de santé constate que la fabrication ou le reconditionnement et le réétiquetage en vue de la distribution des matières premières à usage pharmaceutique respectent les bonnes pratiques prévues à l'article L. 5138-3, elle délivre un certificat de conformité.
\n
Tout établissement réalisant une des activités mentionnées au premier alinéa peut demander à l'agence de certifier qu'il respecte ces bonnes pratiques.
\n
Le modèle du certificat de conformité est établi par l'agence.
" } }, "LEGIARTI000025104733": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5138-4", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-12-22", "DATE_DEBUT": "2012-05-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025104733", "URL": "article/LEGI/ARTI/00/00/25/10/47/LEGIARTI000025104733.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 mentionnée au premier alinéa du présent III, 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": "JORFTEXT000000217229", "#text": "Rapport relatif à l'ordonnance n° 2000-548 du 15 juin 2000", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi n°2002-303 du 4 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@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": "LEGIARTI000025546628", "@num": "D5321-6-1", "#text": "Code de la santé publique - art. 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L5521-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694017", "@num": "L658-16", "#text": "Code de la santé publique - art. L658-16 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694017", "@num": "L658-16", "#text": "Code de la santé publique - art. L658-16 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018088061", "@num": "R5138-3", "#text": "Code de la santé publique - art. R5138-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025787443", "@num": "R5138-4", "#text": "Code de la santé publique - art. R5138-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018088090", "@num": "R5438-2", "#text": "Code de la santé publique - art. R5438-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171382", "@fin": "2999-01-01", "#text": "Chapitre VIII : Matières premières à usage pharmaceutique.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155086", "@fin": "2999-01-01", "#text": "Titre III : Autres produits et substances pharmaceutiques réglementés", "@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": "LEGIARTI000006690173", "@fin": "2002-01-01", "@num": "L5138-4", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690174", "@fin": "2007-02-27", "@num": "L5138-4", "@etat": "MODIFIE", "@debut": "2002-01-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690175", "@fin": "2012-05-01", "@num": "L5138-4", "@etat": "MODIFIE", "@debut": "2007-02-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025104733", "@fin": "2012-12-22", "@num": "L5138-4", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000026809099", "@fin": "2999-01-01", "@num": "L5138-4", "@etat": "VIGUEUR", "@debut": "2012-12-22", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Lorsque dans le cadre de ses pouvoirs d'inspection l'Agence nationale de sécurité du médicament et des produits de santé constate que la fabrication ou le reconditionnement et le réétiquetage en vue de la distribution des matières premières à usage pharmaceutique respectent les bonnes pratiques prévues à l'article L. 5138-3, elle délivre un certificat de conformité.
\n
Tout établissement réalisant une des activités mentionnées au premier alinéa peut demander à l'agence de certifier qu'il respecte ces bonnes pratiques.
\n
Le modèle du certificat de conformité est établi par l'agence.
" } }, "LEGIARTI000025765496": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "5", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025765496", "URL": "article/LEGI/ARTI/00/00/25/76/54/LEGIARTI000025765496.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000025788792", "@num": "1", "#text": "Décret n°2003-224 du 7 mars 2003 - art. 1 (M)", "@sens": "source", "@cidtexte": "JORFTEXT000000412057", "@nortexte": "SANG0320319D", "@numtexte": "2003-224", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2003-03-07" }, { "@id": "LEGIARTI000028444959", "@num": "R523-5", "#text": "Code de l'environnement - art. R523-5 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "MODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025788955", "@num": "R613-10", "#text": "Code de la propriété intellectuelle - art. R613-10 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006069414", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025788960", "@num": "R613-25-4", "#text": "Code de la propriété intellectuelle - art. R613-25-4 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006069414", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025788947", "@num": "A1", "#text": "Code de procédure pénale - art. A1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006071154", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000025788964", "#text": "Code de la santé publique - Chapitre II : Inspecteurs de l'Agence nationale... (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000025788966", "#text": "Code de la santé publique - Livre III : Agence nationale de sécurité du méd... (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000025788971", "#text": "Code de la santé publique - Paragraphe 1 : Agence nationale de sécurité du ... (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000025788969", "#text": "Code de la santé publique - Paragraphe 1 : Agence nationale de sécurité du ... (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000025788975", "#text": "Code de la santé publique - Paragraphe 2 : Rôle de l'Agence nationale de sé... (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000025788973", "#text": "Code de la santé publique - Section 9 : Dispositifs soumis à communication ... (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000025788979", "#text": "Code de la santé publique - Sous-section 3 : Rôle de l'Agence nationale de ... (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000025788977", "#text": "Code de la santé publique - Sous-section 3 : Rôle de l'Agence nationale de ... (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000025788962", "#text": "Code de la santé publique - Titre V : Agence nationale de sécurité du médic... 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R235-6 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006074228", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025788826", "@num": "R235-8", "#text": "Code de la route. - art. R235-8 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006074228", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025788821", "@num": "R235-9", "#text": "Code de la route. - art. R235-9 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006074228", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025788805", "@num": "R244-2", "#text": "Code de la route. - art. R244-2 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006074228", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025788794", "@num": "R245-2", "#text": "Code de la route. - art. R245-2 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006074228", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000025757625", "@nor": "ETSP1206945D", "@num": "2012-597", "@nature": "DECRET", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Décret n° 2012-597 du 27 avril 2012 relatif à l'Agence nationale de sécurité du médicament et des produits de santé", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000025757625", "@c_titre_court": "Décret n°2012-597 du 27 avril 2012" }, { "@fin": "2999-01-01", "#text": "Décret n° 2012-597 du 27 avril 2012 relatif à l'Agence nationale de sécurité du médicament et des produits de santé", "@debut": "2012-05-01", "@id_txt": "LEGITEXT000025765483", "@c_titre_court": "Décret n°2012-597 du 27 avril 2012" } ], "@ministere": "Ministère du travail, de l'emploi et de la santé", "@date_publi": "2012-04-29", "@date_signature": "2012-04-27", "@num_parution_jo": "0102" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000025765496", "@fin": "2999-01-01", "@num": "5", "@debut": "2999-01-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000025757630", "@fin": "2999-01-01", "@num": "5", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
A modifié les dispositions suivantes :

- Code de la santé publique
\n Art. R1121-1, Art. R1121-12, Art. R1123-20, Art. R1123-22, Art. R1123-30, Art. R1123-31, Art. R1123-32, Art. R1123-35, Art. R1123-41, Art. R1123-47, Art. R1123-48, Art. R1123-49, Art. R1123-50, Art. R1123-51, Art. R1123-52, Art. R1123-53, Art. R1123-59, Art. R1123-60, Art. R1123-61, Art. R1125-7, Art. R1125-8, Art. R1125-9, Art. R1125-10, Art. R1125-11, Art. R1131-3, Art. R1161-8, Art. R1161-10, Art. R1161-13, Art. R1161-15, Art. R1161-17, Art. R1161-18, Art. R1161-19, Art. R1161-21, Art. R1161-25, Art. R1211-21, Art. R1211-22, Art. R1211-32, Art. R1211-33, Art. R1211-34, Art. R1211-35, Art. R1211-41, Art. R1211-42, Art. R1211-43, Art. R1211-45, Art. R1211-46, Art. R1211-47, Art. R1221-5, Art. R1221-18, Art. R1221-20-2, Art. R1221-24, Art. R1221-25, Art. R1221-26, Art. R1221-27, Art. R1221-32, Art. R1221-33, Art. R1221-34, Art. R1221-37, Art. R1221-38, Art. R1221-39, Art. R1221-40, Art. R1221-41, Art. R1221-42, Art. R1221-43, Art. R1221-47, Art. R1221-48, Art. R1221-50, Art. R1221-51, Art. D1221-58, Art. D1221-63, Art. D1221-66, Art. R1222-2, Art. R1222-9, Art. R1222-9-1, Art. R1222-9-4, Art. R1222-10, Art. R1223-3, Art. R1223-4, Art. R1223-4-1, Art. R1223-4-2, Art. R1223-5, Art. R1223-6, Art. R1223-7, Art. R1223-7-1, Art. R1223-8, Art. R1223-13, Art. R1223-31, Art. R1223-34, Art. R1235-6, Art. R1235-9, Art. R1235-10, Art. R1235-11, Art. R1243-4, Art. R1243-5, Art. R1243-6, Art. R1243-7, Art. R1243-8, Art. R1243-10, Art. R1243-11, Art. R1243-14, Art. R1243-19, Art. R1243-22, Art. R1243-23, Art. R1243-27, Art. R1243-28, Art. R1243-30, Art. R1243-33, Art. R1243-34, Art. R1243-35, Art. R1243-36, Art. R1243-37, Art. R1243-51, Art. R1245-2, Art. R1245-3, Art. R1245-4, Art. R1245-5, Art. R1245-6, Art. R1245-7, Art. R1245-11, Art. R1245-12, Art. R1245-13, Art. R1245-14, Art. R1245-16, Art. R1245-17, Art. R1245-19, Art. R1261-2, Art. R1261-4, Art. R1261-5, Art. R1261-7, Art. R1261-9, Art. R1313-3, Art. R1313-24, Art. R1323-2, Art. R1323-4, Art. R1333-28, Art. R1333-36, Art. R1413-14, Art. D1414-51, Art. R1417-9, Art. R1418-4, Art. R1418-6, Art. R1418-26, Art. R1521-3, Art. R2131-1-1, Art. R2141-1-7, Art. R2141-35, Art. R2142-24, Art. R2142-27, Art. R2142-42, Art. R2151-17, Art. R2151-21, Art. D2323-6, Art. R3114-3, Art. R3114-8, Art. R4211-1, Art. R4211-8, Art. R4211-21, Art. R4234-1, Art. R4234-5, Art. R4234-12, Art. R4234-24, Art. R5112-2, Art. R5112-5, Art. R5121-5-1, Art. R5121-5-2, Art. R5121-6, Art. R5121-11, Art. R5121-13, Art. R5121-16, Art. R5121-21, Art. R5121-21-1, Art. R5121-25, Art. R5121-29-1, Art. R5121-34, Art. R5121-35, Art. R5121-36, Art. R5121-36-1, Art. R5121-38, Art. R5121-38-1, Art. R5121-39, Art. R5121-40, Art. R5121-41, Art. R5121-41-2, Art. R5121-41-3, Art. R5121-41-4, Art. R5121-41-5, Art. R5121-41-5-1, Art. R5121-41-6, Art. R5121-41-7, Art. R5121-42, Art. R5121-43, Art. R5121-45, Art. R5121-45-1, Art. R5121-46, Art. R5121-47, Art. R5121-48, Art. R5121-50, Art. R5121-51-1, Art. R5121-51-2, Art. R5121-51-3, Art. R5121-51-4, Art. R5121-51-5, Art. R5121-51-6, Art. R5121-51-8, Art. R5121-51-9, Art. R5121-51-10, Art. R5121-51-11, Art. R5121-51-12, Art. R5121-61, Art. R5121-62, Art. R5121-68, Art. R5121-69, Art. R5121-70, Art. R5121-70-1, Art. R5121-70-2, Art. R5121-71, Art. R5121-72, Art. R5121-73, Art. R5121-75, Art. R5121-76, Art. R5121-79, Art. R5121-97, Art. R5121-108, Art. R5121-109, Art. R5121-112, Art. R5121-113, Art. R5121-114, Art. R5121-115, Art. R5121-116, Art. R5121-120, Art. R5121-122, Art. R5121-123, Art. R5121-124, Art. R5121-125, Art. R5121-126, Art. R5121-127, Art. R5121-129, Art. R5121-131, Art. R5121-132-1, Art. R5121-133, Art. R5121-134, Art. R5121-135, Art. R5121-135-1, Art. R5121-137, Art. R5121-138, Art. R5121-139, Art. R5121-140, Art. R5121-147, Art. R5121-148, Art. R5121-154, Art. R5121-155, Art. R5121-156, Art. R5121-157, Art. R5121-158, Art. R5121-167, Art. R5121-169, Art. R5121-171, Art. R5121-173, Art. R5121-174, Art. R5121-176, Art. R5121-177, Art. R5121-178, Art. R5121-179, Art. R5121-184, Art. R5121-198, Art. R5121-199, Art. R5121-200, Art. R5121-202, Art. R5121-203, Art. R5121-204, Art. R5121-206, Art. R5121-207, Art. R5122-2, Art. R5122-5, Art. R5122-7, Art. R5122-13, Art. R5122-17, Art. R5122-20, Art. R5122-22, Art. R5122-26, Art. R5124-5, Art. R5124-6, Art. R5124-9, Art. R5124-10, Art. R5124-10-1, Art. R5124-11, Art. R5124-12, Art. R5124-13, Art. R5124-15, Art. R5124-35, Art. R5124-36, Art. R5124-46, Art. R5124-47, Art. R5124-49, Art. R5124-55, Art. R5124-57-2, Art. R5124-57-5, Art. R5124-59, Art. R5124-69, Art. D5125-63, Art. R5126-10, Art. R5126-16, Art. R5126-16-1, Art. R5126-105, Art. R5127-11, Art. R5127-14, Art. R5127-15, Art. R5127-16, Art. R5127-18, Art. R5131-1, Art. R5131-3, Art. R5131-7, Art. R5131-8, Art. R5131-9, Art. R5131-10, Art. R5131-11, Art. R5132-1, Art. R5132-2, Art. R5132-5, Art. R5132-21, Art. R5132-23, Art. R5132-30, Art. R5132-31, Art. R5132-36, Art. R5132-39, Art. R5132-42, Art. R5132-44, Art. R5132-74, Art. R5132-75, Art. R5132-78, Art. R5132-80, Art. R5132-81, Art. R5132-82, Art. R5132-83, Art. R5132-84, Art. R5132-85, Art. R5132-86, Art. R5132-87, Art. R5132-88, Art. R5132-92, Art. R5132-93, Art. R5132-94, Art. R5132-95, Art. R5132-99, Art. R5132-100, Art. R5132-101, Art. R5132-102, Art. R5132-112, Art. R5132-113, Art. R5132-115, Art. R5132-116, Art. R5133-3, Art. R5133-4, Art. R5133-5, Art. R5138-1, Art. R5138-2, Art. R5138-4, Art. R5138-5, Art. R5138-6, Art. R5139-1, Art. R5139-3, Art. R5139-3-1, Art. R5139-4, Art. R5139-5, Art. R5139-6, Art. R5139-7, Art. R5139-11, Art. R5139-12, Art. R5139-13, Art. R5139-14, Art. R5139-17, Art. R5139-20, Art. R5139-24, Art. R5139-25, Art. R5139-26, Art. R5139-31, Art. R513-10-2, Art. R513-10-3, Art. R513-10-4, Art. R513-10-8, Art. R513-10-10, Art. R513-10-11, Art. R513-10-12, Art. R5141-95, Art. R5141-96, Art. R5141-122, Art. R5141-123-3, Art. R5142-6, Art. R5142-10, Art. R5142-13, Art. R5142-15, Art. R5211-5, Art. R5211-7, Art. R5211-11, Art. R5211-19, Art. R5211-22, Art. R5211-23, Art. R5211-23-2, Art. R5211-24, Art. R5211-26, Art. R5211-35, Art. R5211-37, Art. R5211-40, Art. R5211-41, Art. R5211-41-1, Art. R5211-43, Art. R5211-46, Art. R5211-53, Art. R5211-54, Art. R5211-55, Art. R5211-56, Art. R5211-57, Art. R5211-57-1, Art. R5211-58, Art. R5211-61, Art. R5211-64, Art. R5211-65, Art. R5211-65-1, Art. R5211-66, Art. R5211-67, Art. R5212-4, Art. R5212-5, Art. R5212-6, Art. R5212-12, Art. R5212-13, Art. R5212-17, Art. R5212-18, Art. R5212-19, Art. R5212-20, Art. R5212-21, Art. R5212-22, Art. R5212-23, Art. R5212-24, Art. R5212-26, Art. R5212-27, Art. R5212-28, Art. R5212-29, Art. R5212-32, Art. R5212-33, Art. R5212-34, Art. R5212-35, Art. R5212-36, Art. R5221-6, Art. R5221-7, Art. R5221-16, Art. R5221-17, Art. R5221-29, Art. R5221-32, Art. R5221-35, Art. R5221-36, Art. R5221-37, Art. R5222-3, Art. R5222-4, Art. R5222-10, Art. R5222-11, Art. R5222-12, Art. R5222-13, Art. R5222-14, Art. R5222-15, Art. R5222-16, Art. R5222-17, Art. R5222-18, Art. R5313-1, Art. R5313-3, Art. R5313-4, Art. R5313-5, Art. R5313-6, Art. R5313-7, Art. R5313-8, Art. R5433-1, Art. R5433-3, Art. R5438-3, Art. R5461-1, Art. R5461-2, Art. R5462-1, Art. R5462-2, Art. D6211-35, Art. D6213-9, Art. D6213-10, Art. D6213-14, Art. D6213-15, Art. D6213-16, Art. D6213-17, Art. D6213-18, Art. R1221-35\n
\n

\n
\n
A modifié les dispositions suivantes :

- Code de la santé publique
\n Sct. Sous-section 3 : Rôle de l'Agence nationale de sécurité du médicament et des produits de santé, Sct. Sous-section 3 : Rôle de l'Agence nationale de sécurité du médicament et des produits de santé., Sct. Paragraphe 2 : Rôle de l'Agence nationale de sécurité du médicament et des produits de santé., Sct. Section 9 : Dispositifs soumis à communication auprès de l'Agence nationale de sécurité du médicament et des produits de santé, Sct. Paragraphe 1 : Agence nationale de sécurité du médicament et des produits de santé., Sct. Paragraphe 1 : Agence nationale de sécurité du médicament et des produits de santé., Sct. Livre III : Agence nationale de sécurité du médicament et des produits de santé, Sct. Chapitre II : Inspecteurs de l'Agence nationale de sécurité du médicament et des produits de santé, Sct. Titre V : Agence nationale de sécurité du médicament et des produits de santé.\n
\n

- Code de la propriété intellectuelle
\n Art. R613-10, Art. R613-25-4\n
\n

- Code de procédure pénale
\n Art. A1\n
\n

- Code de la sécurité sociale.
\n Art. R161-72, Art. D162-2-2, Art. R163-2, Art. R163-7, Art. R163-15, Art. R163-20, Art. R163-26, Art. R163-28, Art. R165-4-1, Art. R165-5-1, Art. R165-18, Art. R165-32, Art. R165-33\n
\n

- Code de l'action sociale et des familles
\n Art. D247-5\n
\n

- Code de l'environnement
\n Art. R521-2-7, Art. R523-5\n
\n

- Code de la route.
\n Art. R235-4, Art. R235-6, Art. R235-8, Art. R235-9, Art. R235-10, Art. R244-2, Art. R245-2\n
\n

- Décret n°2003-224 du 7 mars 2003
\n Art. 1\n
\n

- Code de l'environnement
\n Art. Annexe I à l'article D523-8\n
\n

\n
" } }, "LEGIARTI000026809099": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5138-4", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2012-12-22" } }, "META_COMMUN": { "ID": "LEGIARTI000026809099", "URL": "article/LEGI/ARTI/00/00/26/80/90/LEGIARTI000026809099.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Rapport relatif à l'ordonnance n° 2000-548 du 15 juin 2000", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi n°2002-303 du 4 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000026806478", "@num": "11", "#text": "Ordonnance n°2012-1427\n du 19 décembre 2012 - art. 11", "@sens": "cible", "@cidtexte": "JORFTEXT000026805101", "@nortexte": "AFSX1240311R", "@numtexte": "2012-1427", "@typelien": "MODIFIE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2012-12-19" }, { "@id": "LEGIARTI000025546628", "@num": "D5321-6-1", "#text": "Code de la santé publique - art. D5321-6-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026345679", "@num": "D5321-7", "#text": "Code de la santé publique - art. D5321-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690170", "@num": "L5138-3", "#text": "Code de la santé publique - art. L5138-3", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690176", "@num": "L5138-5", "#text": "Code de la santé publique - art. L5138-5 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000047293552", "@num": "L5521-7", "#text": "Code de la santé publique - art. L5521-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694017", "@num": "L658-16", "#text": "Code de la santé publique - art. L658-16 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694017", "@num": "L658-16", "#text": "Code de la santé publique - art. L658-16 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018088061", "@num": "R5138-3", "#text": "Code de la santé publique - art. R5138-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025787443", "@num": "R5138-4", "#text": "Code de la santé publique - art. 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Lorsque dans le cadre de ses pouvoirs d'inspection l'Agence nationale de sécurité du médicament et des produits de santé constate que la fabrication ou le reconditionnement et le réétiquetage en vue de la distribution des matières premières à usage pharmaceutique respectent les bonnes pratiques prévues à l'article L. 5138-3, elle délivre un certificat de conformité, sauf pour les activités de distribution d'excipients.

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Tout établissement réalisant une des activités mentionnées au premier alinéa peut demander à l'agence de certifier qu'il respecte ces bonnes pratiques.

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Le modèle du certificat de conformité est établi par l'agence en coopération avec l'Agence européenne des médicaments.

" } } }, "article_lien": [ { "article_id": "LEGIARTI000026809099", "cible": true, "cidtexte": "LEGITEXT000006072665", "id": "LEGIARTI000025787443", "typelien": "CITATION" }, { "article_id": "LEGIARTI000025104733", "cible": true, "cidtexte": "LEGITEXT000006072665", "id": "LEGIARTI000025787443", "typelien": "CITATION" }, { "article_id": "LEGIARTI000025765496", "cible": false, "cidtexte": "LEGITEXT000006072665", "id": "LEGIARTI000025787443", "typelien": "MODIFIE" }, { "article_id": "LEGIARTI000006690173", "cible": true, "cidtexte": "LEGITEXT000006072665", "id": "LEGIARTI000025787443", "typelien": "CITATION" }, { "article_id": "LEGIARTI000006690174", "cible": true, "cidtexte": "LEGITEXT000006072665", "id": "LEGIARTI000025787443", "typelien": "CITATION" }, { "article_id": "LEGIARTI000006690175", "cible": true, "cidtexte": "LEGITEXT000006072665", "id": "LEGIARTI000025787443", "typelien": "CITATION" } ], "follow": [ "LIENS.LIEN[@sens=cible,@typelien=CREATION].@id" ], "id": "LEGIARTI000025787443", "liens_entrants": true }

Article R5138-4 AUTONOME VIGUEUR, en vigueur depuis le 01/05/2012 (Code de la santé publique)