{ "article": { "LEGIARTI000018088090": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5438-2", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2008-02-08" } }, "META_COMMUN": { "ID": "LEGIARTI000018088090", "URL": "article/LEGI/ARTI/00/00/18/08/80/LEGIARTI000018088090.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000018081928", "@num": "19", "#text": "Décret n°2008-109 du 5 février 2008 - art. 19", "@sens": "cible", "@cidtexte": "JORFTEXT000018081221", "@nortexte": "SJSP0762724D", "@numtexte": "2008-109", "@typelien": "CREE", "@naturetexte": "DECRET", "@datesignatexte": "2008-02-05" }, { "@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" }, { "@id": "LEGIARTI000018083335", "@num": "R5138-5", "#text": "Code de la santé publique - art. R5138-5", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000018088098", "@fin": "2999-01-01", "#text": "Section unique", "@debut": "2008-02-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000018088100", "@fin": "2999-01-01", "#text": "Chapitre VIII : Matières premières à usage pharmaceutique.", "@debut": "2008-02-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161021", "@fin": "2999-01-01", "#text": "Titre III : Autres produits et substances pharmaceutiques réglementés", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145492", "@fin": "2014-02-01", "#text": "Livre IV : Dispositions pénales", "@debut": "2004-08-08" }, { "@id": "LEGISCTA000028542295", "@fin": "2999-01-01", "#text": "Livre IV : Sanctions pénales et financières", "@debut": "2014-02-01" } ] }, "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": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000018088090", "@fin": "2999-01-01", "@num": "R5438-2", "@etat": "VIGUEUR", "@debut": "2008-02-08", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Est puni de l'amende prévue pour les contraventions de la 5e classe le fait d'utiliser le certificat de conformité mentionné à l'article L. 5138-4 alors qu'il a été mis fin à la validité de celui-ci en application de l'article R. 5138-5.\n

\n
\n
" } }, "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.
" } }, "LEGIARTI000018081928": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "19", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000018081928", "URL": "article/LEGI/ARTI/00/00/18/08/19/LEGIARTI000018081928.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006417368", "@num": "132-11", "#text": "Code pénal - art. 132-11", "@sens": "source", "@cidtexte": "LEGITEXT000006070719", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000018088100", "#text": "Code de la santé publique - Chapitre VIII : Matières premières à usage phar... (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000018088098", "#text": "Code de la santé publique - Section unique (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018088094", "@num": "R5438-1", "#text": "Code de la santé publique - art. R5438-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018088090", "@num": "R5438-2", "#text": "Code de la santé publique - art. R5438-2 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018088086", "@num": "R5438-3", "#text": "Code de la santé publique - art. R5438-3 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018088081", "@num": "R5438-4", "#text": "Code de la santé publique - art. R5438-4 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000018081893", "@fin": "2999-01-01", "#text": "Chapitre III : Matières premières à usage pharmaceutique", "@debut": "2008-02-08" } ] }, "@cid": "JORFTEXT000018081221", "@nor": "SJSP0762724D", "@num": "2008-109", "@nature": "DECRET", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Décret n° 2008-109 du 5 février 2008 relatif aux insecticides et acaricides, aux aliments diététiques destinés à des fins médicales spéciales et aux matières premières à usage pharmaceutique et modifiant le code de la santé publique (dispositions réglementaires)", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000018081221", "@c_titre_court": "Décret n°2008-109 du 5 février 2008" }, { "@fin": "2999-01-01", "#text": "Décret n° 2008-109 du 5 février 2008 relatif aux insecticides et acaricides, aux aliments diététiques destinés à des fins médicales spéciales et aux matières premières à usage pharmaceutique et modifiant le code de la santé publique (dispositions réglementaires)", "@debut": "2008-02-08", "@id_txt": "LEGITEXT000018081887", "@c_titre_court": "Décret n°2008-109 du 5 février 2008" } ], "@ministere": "Ministère de la santé, de la jeunesse et des sports", "@date_publi": "2008-02-07", "@date_signature": "2008-02-05" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000018081928", "@fin": "2999-01-01", "@num": "19", "@debut": "2999-01-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000018081266", "@fin": "2999-01-01", "@num": "19", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
A modifié les dispositions suivantes :

Code de la santé publique
Sct. Chapitre, Sct. Chapitre VIII : Matières premières à usage pharmaceutique., Sct. Section unique, Art. , Art. R5438-1, Art. R5438-2, Art. R5438-3, Art. R5438-4\n
\n

" } }, "LEGIARTI000018088055": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5138-5", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-05-01", "DATE_DEBUT": "2008-02-08" } }, "META_COMMUN": { "ID": "LEGIARTI000018088055", "URL": "article/LEGI/ARTI/00/00/18/08/80/LEGIARTI000018088055.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000018081926", "@num": "18", "#text": "Décret n°2008-109 du 5 février 2008 - art. 18", "@sens": "cible", "@cidtexte": "JORFTEXT000018081221", "@nortexte": "SJSP0762724D", "@numtexte": "2008-109", "@typelien": "CREE", "@naturetexte": "DECRET", "@datesignatexte": "2008-02-05" }, { "@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": "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": { "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": "LEGIARTI000018088055", "@fin": "2012-05-01", "@num": "R5138-5", "@etat": "MODIFIE", "@debut": "2008-02-08", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000025787440", "@fin": "2999-01-01", "@num": "R5138-5", "@etat": "VIGUEUR", "@debut": "2012-05-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Lorsque l'inspection fait apparaître que la fabrication ou le reconditionnement et le réétiquetage effectués dans le cadre de la distribution d'une matière première à usage pharmaceutique ne respectent pas les bonnes pratiques prévues à l'article L. 5138-3, l'établissement inspecté en informe immédiatement les fabricants des médicaments dans la composition desquels entre cette matière première.

Si un certificat a été précédemment délivré à cet établissement, le directeur général de l'Agence française de sécurité sanitaire des produits de santé met fin à sa validité. Les exemplaires de ce certificat détenus par le titulaire sont immédiatement retournés à l'agence.

\n
" } }, "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. 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. 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.
" } }, "LEGIARTI000025787440": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5138-5", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2012-05-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025787440", "URL": "article/LEGI/ARTI/00/00/25/78/74/LEGIARTI000025787440.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": "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": "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": { "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": "LEGIARTI000018088055", "@fin": "2012-05-01", "@num": "R5138-5", "@etat": "MODIFIE", "@debut": "2008-02-08", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000025787440", "@fin": "2999-01-01", "@num": "R5138-5", "@etat": "VIGUEUR", "@debut": "2012-05-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Si un certificat a été précédemment délivré à cet établissement, le directeur général de l'Agence nationale de sécurité du médicament et des produits de santé met fin à sa validité. Les exemplaires de ce certificat détenus par le titulaire sont immédiatement retournés à l'agence.

\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. 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, 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": "LEGIARTI000018088090", "typelien": "CITATION" }, { "article_id": "LEGIARTI000025104733", "cible": true, "cidtexte": "LEGITEXT000006072665", "id": "LEGIARTI000018088090", "typelien": "CITATION" }, { "article_id": "LEGIARTI000025787440", "cible": true, "cidtexte": "LEGITEXT000006072665", "id": "LEGIARTI000018088090", "typelien": "CITATION" }, { "article_id": "LEGIARTI000018088055", "cible": true, "cidtexte": "LEGITEXT000006072665", "id": "LEGIARTI000018088090", "typelien": "CITATION" }, { "article_id": "LEGIARTI000018081928", "cible": false, "cidtexte": "LEGITEXT000006072665", "id": "LEGIARTI000018088090", "typelien": "CREE" }, { "article_id": "LEGIARTI000006690173", "cible": true, "cidtexte": "LEGITEXT000006072665", "id": "LEGIARTI000018088090", "typelien": "CITATION" }, { "article_id": "LEGIARTI000006690174", "cible": true, "cidtexte": "LEGITEXT000006072665", "id": "LEGIARTI000018088090", "typelien": "CITATION" }, { "article_id": "LEGIARTI000006690175", "cible": true, "cidtexte": "LEGITEXT000006072665", "id": "LEGIARTI000018088090", "typelien": "CITATION" } ], "follow": [ "LIENS.LIEN[@sens=cible,@typelien=CREATION].@id" ], "id": "LEGIARTI000018088090", "liens_entrants": true }

Article R5438-2 AUTONOME VIGUEUR, en vigueur depuis le 08/02/2008 (Code de la santé publique)