{ "article": { "LEGIARTI000026897141": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5124-49-3", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2013-01-02" } }, "META_COMMUN": { "ID": "LEGIARTI000026897141", "URL": "article/LEGI/ARTI/00/00/26/89/71/LEGIARTI000026897141.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000026896768", "@num": "2", "#text": "Décret n°2012-1562 du 31 décembre 2012 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000026871417", "@nortexte": "AFSP1240709D", "@numtexte": "2012-1562", "@typelien": "CREE", "@naturetexte": "DECRET", "@datesignatexte": "2012-12-31" }, { "@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" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006196945", "@fin": "2999-01-01", "#text": "Sous-section 1 : Dispositions générales applicables à la fabrication et l'importation.", "@debut": "2006-04-27" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190681", "@fin": "2999-01-01", "#text": "Section 4 : Fabrication et importation.", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178652", "@fin": "2999-01-01", "#text": "Chapitre IV : Fabrication et distribution en gros", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161012", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000026897141", "@fin": "2999-01-01", "@num": "R5124-49-3", "@etat": "VIGUEUR", "@debut": "2013-01-02", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Les fabricants de médicaments doivent être en mesure de documenter les mesures qu'ils ont prises pour s'assurer du respect, par leur fournisseur d'excipients, des bonnes pratiques dans les conditions prévues à l'article L. 5138-3.

" } }, "LEGIARTI000006690170": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5138-3", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2005-09-02", "DATE_DEBUT": "2000-06-22" } }, "META_COMMUN": { "ID": "LEGIARTI000006690170", "URL": "article/LEGI/ARTI/00/00/06/69/01/LEGIARTI000006690170.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5138L03XXAA" } }, "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": "LEGIARTI000018393724", "@num": "2", "#text": "Arrêté du 6 mars 2008 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000018392379", "@nortexte": "SJSP0806021A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-03-06" }, { "@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": "LEGIARTI000006690167", "@num": "L5138-2", "#text": "Code de la santé publique - art. L5138-2 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026808100", "@num": "L5138-3-1", "#text": "Code de la santé publique - art. L5138-3-1 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026809099", "@num": "L5138-4", "#text": "Code de la santé publique - art. L5138-4 (V)", "@sens": "cible", "@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": "LEGIARTI000045405397", "@num": "L5438-1", "#text": "Code de la santé publique - art. L5438-1 (V)", "@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": "LEGIARTI000006694016", "@num": "L658-15", "#text": "Code de la santé publique - art. L658-15 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694016", "@num": "L658-15", "#text": "Code de la santé publique - art. L658-15 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026897141", "@num": "R5124-49-3", "#text": "Code de la santé publique - art. R5124-49-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@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": "LEGIARTI000025787440", "@num": "R5138-5", "#text": "Code de la santé publique - art. R5138-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026903142", "@num": "R5313-5", "#text": "Code de la santé publique - art. R5313-5 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033851866", "@num": "R5313-5-1", "#text": "Code de la santé publique - art. R5313-5-1 (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": "LEGIARTI000006690170", "@fin": "2005-09-02", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690171", "@fin": "2007-02-27", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2005-09-02", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690172", "@fin": "2010-07-01", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2007-02-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000021666244", "@fin": "2012-05-01", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2010-07-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025104608", "@fin": "2012-12-22", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026809093", "@fin": "2022-03-25", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2012-12-22", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000045404937", "@fin": "2999-01-01", "@num": "L5138-3", "@etat": "VIGUEUR", "@debut": "2022-03-25", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Tout établissement de fabrication, d'importation ou de distribution de matières premières à usage pharmaceutique peut demander à l'Agence française de sécurité sanitaire des produits de santé de certifier que l'établissement qui produit les matières premières respecte les bonnes pratiques mentionnées à l'article L. 5138-2.
\n
Le contenu de ce certificat est fixé par arrêté du ministre chargé de la santé, pris sur proposition de l'Agence française de sécurité sanitaire des produits de santé.
" } }, "LEGIARTI000006690171": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5138-3", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2007-02-27", "DATE_DEBUT": "2005-09-02" } }, "META_COMMUN": { "ID": "LEGIARTI000006690171", "URL": "article/LEGI/ARTI/00/00/06/69/01/LEGIARTI000006690171.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5138L03XXAB" } }, "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": "LEGIARTI000006698387", "@num": "4", "#text": "Ordonnance n°2005-1087 du 1 septembre 2005 - art. 4 () JORF 2 septembre 2005", "@sens": "source", "@cidtexte": "JORFTEXT000000261711", "@nortexte": "SANX0500159R", "@numtexte": "2005-1087", "@typelien": "MODIFICATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2005-09-01" }, { "@id": "LEGIARTI000018393724", "@num": "2", "#text": "Arrêté du 6 mars 2008 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000018392379", "@nortexte": "SJSP0806021A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-03-06" }, { "@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": "LEGIARTI000006690167", "@num": "L5138-2", "#text": "Code de la santé publique - art. L5138-2 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026808100", "@num": "L5138-3-1", "#text": "Code de la santé publique - art. L5138-3-1 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026809099", "@num": "L5138-4", "#text": "Code de la santé publique - art. L5138-4 (V)", "@sens": "cible", "@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": "LEGIARTI000045405397", "@num": "L5438-1", "#text": "Code de la santé publique - art. L5438-1 (V)", "@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": "LEGIARTI000006694016", "@num": "L658-15", "#text": "Code de la santé publique - art. L658-15 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694016", "@num": "L658-15", "#text": "Code de la santé publique - art. L658-15 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026897141", "@num": "R5124-49-3", "#text": "Code de la santé publique - art. R5124-49-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@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": "LEGIARTI000025787440", "@num": "R5138-5", "#text": "Code de la santé publique - art. R5138-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026903142", "@num": "R5313-5", "#text": "Code de la santé publique - art. R5313-5 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033851866", "@num": "R5313-5-1", "#text": "Code de la santé publique - art. R5313-5-1 (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": "LEGIARTI000006690170", "@fin": "2005-09-02", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690171", "@fin": "2007-02-27", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2005-09-02", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690172", "@fin": "2010-07-01", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2007-02-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000021666244", "@fin": "2012-05-01", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2010-07-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025104608", "@fin": "2012-12-22", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026809093", "@fin": "2022-03-25", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2012-12-22", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000045404937", "@fin": "2999-01-01", "@num": "L5138-3", "@etat": "VIGUEUR", "@debut": "2022-03-25", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Tout établissement de fabrication, d'importation ou de distribution de matières premières à usage pharmaceutique peut demander à l'Agence française de sécurité sanitaire des produits de santé de certifier que l'établissement qui produit les matières premières respecte les bonnes pratiques mentionnées à l'article L. 5138-2.
\n
Le contenu de ce certificat est fixé par décision de l'Agence française de sécurité sanitaire des produits de santé.
" } }, "LEGIARTI000006690172": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5138-3", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2010-07-01", "DATE_DEBUT": "2007-02-27" } }, "META_COMMUN": { "ID": "LEGIARTI000006690172", "URL": "article/LEGI/ARTI/00/00/06/69/01/LEGIARTI000006690172.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5138L03XXAC" } }, "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": "LEGIARTI000006697032", "@num": "25", "#text": "Loi n°2007-248 du 26 février 2007 - art. 25 () JORF 27 février 2007", "@sens": "source", "@cidtexte": "JORFTEXT000000613381", "@nortexte": "SANX0600004L", "@numtexte": "2007-248", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2007-02-26" }, { "@id": "LEGIARTI000018393724", "@num": "2", "#text": "Arrêté du 6 mars 2008 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000018392379", "@nortexte": "SJSP0806021A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-03-06" }, { "@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": "LEGIARTI000006689973", "@num": "L5124-1", "#text": "Code de la santé publique - art. L5124-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026808100", "@num": "L5138-3-1", "#text": "Code de la santé publique - art. L5138-3-1 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026809099", "@num": "L5138-4", "#text": "Code de la santé publique - art. L5138-4 (V)", "@sens": "cible", "@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": "LEGIARTI000006690231", "@num": "L5142-1", "#text": "Code de la santé publique - art. L5142-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045405397", "@num": "L5438-1", "#text": "Code de la santé publique - art. L5438-1 (V)", "@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": "LEGIARTI000006694016", "@num": "L658-15", "#text": "Code de la santé publique - art. L658-15 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694016", "@num": "L658-15", "#text": "Code de la santé publique - art. L658-15 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026897141", "@num": "R5124-49-3", "#text": "Code de la santé publique - art. R5124-49-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@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": "LEGIARTI000025787440", "@num": "R5138-5", "#text": "Code de la santé publique - art. R5138-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026903142", "@num": "R5313-5", "#text": "Code de la santé publique - art. R5313-5 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033851866", "@num": "R5313-5-1", "#text": "Code de la santé publique - art. R5313-5-1 (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": "LEGIARTI000006690170", "@fin": "2005-09-02", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690171", "@fin": "2007-02-27", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2005-09-02", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690172", "@fin": "2010-07-01", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2007-02-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000021666244", "@fin": "2012-05-01", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2010-07-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025104608", "@fin": "2012-12-22", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026809093", "@fin": "2022-03-25", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2012-12-22", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000045404937", "@fin": "2999-01-01", "@num": "L5138-3", "@etat": "VIGUEUR", "@debut": "2022-03-25", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les matières premières à usage pharmaceutique répondent aux spécifications de la pharmacopée quand elles existent.
\n
Pour la fabrication de médicaments, les établissements pharmaceutiques mentionnés à l'article L. 5124-1 ou à l'article L. 5142-1, les pharmacies à usage intérieur, les pharmacies d'officine, les médecins, les vétérinaires et les personnes autorisées à préparer des autovaccins à usage vétérinaire utilisent, en tant que matières premières à usage pharmaceutique, des substances actives fabriquées et distribuées conformément à des bonnes pratiques, y compris lorsqu'elles sont importées, dont les principes sont définis conformément au droit communautaire par décision de l'Agence française de sécurité sanitaire des produits de santé, après avis de l'Agence française de sécurité sanitaire des aliments. Ce dispositif est également applicable aux excipients entrant dans la fabrication des médicaments à usage humain, dont la liste et les conditions spécifiques qui leur sont applicables sont fixées par décision de l'Agence française de sécurité sanitaire des produits de santé conformément au droit communautaire.
" } }, "LEGIARTI000021666244": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5138-3", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-05-01", "DATE_DEBUT": "2010-07-01" } }, "META_COMMUN": { "ID": "LEGIARTI000021666244", "URL": "article/LEGI/ARTI/00/00/21/66/62/LEGIARTI000021666244.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "
" }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000018393724", "@num": "2", "#text": "Arrêté du 6 mars 2008 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000018392379", "@nortexte": "SJSP0806021A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-03-06" }, { "@id": "LEGIARTI000021661274", "@num": "3", "#text": "Ordonnance n°2010-18\n du 7 janvier 2010 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000021637409", "@nortexte": "SASX0928345R", "@numtexte": "2010-18", "@typelien": "MODIFIE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2010-01-07" }, { "@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": "LEGIARTI000006689973", "@num": "L5124-1", "#text": "Code de la santé publique - art. L5124-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026808100", "@num": "L5138-3-1", "#text": "Code de la santé publique - art. L5138-3-1 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026809099", "@num": "L5138-4", "#text": "Code de la santé publique - art. L5138-4 (V)", "@sens": "cible", "@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": "LEGIARTI000006690231", "@num": "L5142-1", "#text": "Code de la santé publique - art. L5142-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045405397", "@num": "L5438-1", "#text": "Code de la santé publique - art. L5438-1 (V)", "@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": "LEGIARTI000006694016", "@num": "L658-15", "#text": "Code de la santé publique - art. L658-15 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694016", "@num": "L658-15", "#text": "Code de la santé publique - art. L658-15 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026897141", "@num": "R5124-49-3", "#text": "Code de la santé publique - art. R5124-49-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@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": "LEGIARTI000025787440", "@num": "R5138-5", "#text": "Code de la santé publique - art. R5138-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026903142", "@num": "R5313-5", "#text": "Code de la santé publique - art. R5313-5 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033851866", "@num": "R5313-5-1", "#text": "Code de la santé publique - art. R5313-5-1 (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": "LEGIARTI000006690170", "@fin": "2005-09-02", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690171", "@fin": "2007-02-27", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2005-09-02", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690172", "@fin": "2010-07-01", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2007-02-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000021666244", "@fin": "2012-05-01", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2010-07-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025104608", "@fin": "2012-12-22", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026809093", "@fin": "2022-03-25", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2012-12-22", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000045404937", "@fin": "2999-01-01", "@num": "L5138-3", "@etat": "VIGUEUR", "@debut": "2022-03-25", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Les matières premières à usage pharmaceutique répondent aux spécifications de la pharmacopée quand elles existent.

Pour la fabrication de médicaments, les établissements pharmaceutiques mentionnés à l'article L. 5124-1 ou à l'article L. 5142-1, les pharmacies à usage intérieur, les pharmacies d'officine, les médecins, les vétérinaires et les personnes autorisées à préparer des autovaccins à usage vétérinaire utilisent, en tant que matières premières à usage pharmaceutique, des substances actives fabriquées et distribuées conformément à des bonnes pratiques, y compris lorsqu'elles sont importées, dont les principes sont définis conformément au droit communautaire par décision de l'Agence française de sécurité sanitaire des produits de santé, après avis de l'Agence nationale chargée de la sécurité sanitaire de l'alimentation, de l'environnement et du travail. Ce dispositif est également applicable aux excipients entrant dans la fabrication des médicaments à usage humain, dont la liste et les conditions spécifiques qui leur sont applicables sont fixées par décision de l'Agence française de sécurité sanitaire des produits de santé conformément au droit communautaire.

" } }, "LEGIARTI000025104608": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5138-3", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-12-22", "DATE_DEBUT": "2012-05-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025104608", "URL": "article/LEGI/ARTI/00/00/25/10/46/LEGIARTI000025104608.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": "LEGIARTI000018393724", "@num": "2", "#text": "Arrêté du 6 mars 2008 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000018392379", "@nortexte": "SJSP0806021A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-03-06" }, { "@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": "LEGIARTI000006689973", "@num": "L5124-1", "#text": "Code de la santé publique - art. L5124-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026808100", "@num": "L5138-3-1", "#text": "Code de la santé publique - art. L5138-3-1 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026809099", "@num": "L5138-4", "#text": "Code de la santé publique - art. L5138-4 (V)", "@sens": "cible", "@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": "LEGIARTI000006690231", "@num": "L5142-1", "#text": "Code de la santé publique - art. L5142-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045405397", "@num": "L5438-1", "#text": "Code de la santé publique - art. L5438-1 (V)", "@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": "LEGIARTI000006694016", "@num": "L658-15", "#text": "Code de la santé publique - art. L658-15 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694016", "@num": "L658-15", "#text": "Code de la santé publique - art. L658-15 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026897141", "@num": "R5124-49-3", "#text": "Code de la santé publique - art. R5124-49-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@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": "LEGIARTI000025787440", "@num": "R5138-5", "#text": "Code de la santé publique - art. R5138-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026903142", "@num": "R5313-5", "#text": "Code de la santé publique - art. R5313-5 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033851866", "@num": "R5313-5-1", "#text": "Code de la santé publique - art. R5313-5-1 (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": "LEGIARTI000006690170", "@fin": "2005-09-02", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690171", "@fin": "2007-02-27", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2005-09-02", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690172", "@fin": "2010-07-01", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2007-02-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000021666244", "@fin": "2012-05-01", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2010-07-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025104608", "@fin": "2012-12-22", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026809093", "@fin": "2022-03-25", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2012-12-22", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000045404937", "@fin": "2999-01-01", "@num": "L5138-3", "@etat": "VIGUEUR", "@debut": "2022-03-25", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Les matières premières à usage pharmaceutique répondent aux spécifications de la pharmacopée quand elles existent.

Pour la fabrication de médicaments, les établissements pharmaceutiques mentionnés à l'article L. 5124-1 ou à l'article L. 5142-1, les pharmacies à usage intérieur, les pharmacies d'officine, les médecins, les vétérinaires et les personnes autorisées à préparer des autovaccins à usage vétérinaire utilisent, en tant que matières premières à usage pharmaceutique, des substances actives fabriquées et distribuées conformément à des bonnes pratiques, y compris lorsqu'elles sont importées, dont les principes sont définis conformément au droit communautaire par décision de l'Agence nationale de sécurité du médicament et des produits de santé , après avis de l'Agence nationale chargée de la sécurité sanitaire de l'alimentation, de l'environnement et du travail. Ce dispositif est également applicable aux excipients entrant dans la fabrication des médicaments à usage humain, dont la liste et les conditions spécifiques qui leur sont applicables sont fixées par décision de l'Agence nationale de sécurité du médicament et des produits de santé conformément au droit communautaire.

" } }, "LEGIARTI000026809093": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5138-3", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2022-03-25", "DATE_DEBUT": "2012-12-22" } }, "META_COMMUN": { "ID": "LEGIARTI000026809093", "URL": "article/LEGI/ARTI/00/00/26/80/90/LEGIARTI000026809093.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000018393724", "@num": "2", "#text": "Arrêté du 6 mars 2008 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000018392379", "@nortexte": "SJSP0806021A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-03-06" }, { "@id": "LEGIARTI000026806476", "@num": "10", "#text": "Ordonnance n°2012-1427\n du 19 décembre 2012 - art. 10", "@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": "LEGIARTI000006689973", "@num": "L5124-1", "#text": "Code de la santé publique - art. L5124-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026808100", "@num": "L5138-3-1", "#text": "Code de la santé publique - art. L5138-3-1 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026809099", "@num": "L5138-4", "#text": "Code de la santé publique - art. L5138-4 (V)", "@sens": "cible", "@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": "LEGIARTI000045405397", "@num": "L5438-1", "#text": "Code de la santé publique - art. L5438-1 (V)", "@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": "LEGIARTI000006694016", "@num": "L658-15", "#text": "Code de la santé publique - art. L658-15 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694016", "@num": "L658-15", "#text": "Code de la santé publique - art. L658-15 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026897141", "@num": "R5124-49-3", "#text": "Code de la santé publique - art. R5124-49-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@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": "LEGIARTI000025787440", "@num": "R5138-5", "#text": "Code de la santé publique - art. R5138-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026903142", "@num": "R5313-5", "#text": "Code de la santé publique - art. R5313-5 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033851866", "@num": "R5313-5-1", "#text": "Code de la santé publique - art. R5313-5-1 (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": "LEGIARTI000006690170", "@fin": "2005-09-02", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690171", "@fin": "2007-02-27", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2005-09-02", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690172", "@fin": "2010-07-01", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2007-02-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000021666244", "@fin": "2012-05-01", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2010-07-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025104608", "@fin": "2012-12-22", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026809093", "@fin": "2022-03-25", "@num": "L5138-3", "@etat": "MODIFIE", "@debut": "2012-12-22", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000045404937", "@fin": "2999-01-01", "@num": "L5138-3", "@etat": "VIGUEUR", "@debut": "2022-03-25", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Les matières premières à usage pharmaceutique répondent aux spécifications de la pharmacopée quand elles existent. Les substances actives sont fabriquées et distribuées conformément à des bonnes pratiques dont les principes sont définis par le directeur général de l'Agence nationale de sécurité du médicament et des produits de santé, après avis de l'Agence nationale chargée de la sécurité sanitaire de l'alimentation, de l'environnement et du travail.

\n
\n

Pour la fabrication de médicaments à usage humain, les établissements pharmaceutiques mentionnés à l'article L. 5124-1, les pharmacies à usage intérieur, les pharmacies d'officine ainsi que les médecins :

\n
\n
1° Vérifient la qualité et l'authenticité des matières premières qu'ils utilisent ;

\n
\n
2° Veillent à n'utiliser que des substances actives fabriquées et distribuées, y compris lorsqu'elles sont importées, conformément aux bonnes pratiques de fabrication et de distribution mentionnées au premier alinéa.

\n
\n
Les établissements pharmaceutiques de fabrication de médicaments à usage humain mentionnés à l'article L. 5124-1 se conforment à l'obligation résultant du 2° notamment en réalisant, par eux-mêmes ou par l'intermédiaire d'un organisme tiers avec lequel ils concluent un contrat écrit, des audits sur les sites de fabrication et de distribution des substances actives.

\n
\n
Ces mêmes établissements utilisent des excipients appropriés pour lesquels ils déterminent, sur la base d'une évaluation formalisée du risque conforme aux lignes directrices de la Commission européenne, les bonnes pratiques de fabrication adéquates. Cette évaluation du risque tient compte des exigences imposées par d'autres systèmes de qualité pertinents, de la source et de l'utilisation prévue de ces excipients, ainsi que de précédents cas de défaut de qualité.

" } }, "LEGIARTI000026896768": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "2", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000026896768", "URL": "article/LEGI/ARTI/00/00/26/89/67/LEGIARTI000026896768.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGISCTA000026897379", "#text": "Code de la santé publique - Chapitre IV bis - Courtage de médicaments (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026903078", "@num": "R5124-3", "#text": "Code de la santé publique - art. R5124-3 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026903068", "@num": "R5124-36", "#text": "Code de la santé publique - art. R5124-36 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026897100", "@num": "R5124-48-2", "#text": "Code de la santé publique - art. R5124-48-2 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026897126", "@num": "R5124-49-2", "#text": "Code de la santé publique - art. R5124-49-2 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026897141", "@num": "R5124-49-3", "#text": "Code de la santé publique - art. R5124-49-3 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026897199", "@num": "R5124-54-1", "#text": "Code de la santé publique - art. R5124-54-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026903086", "@num": "R5124-58", "#text": "Code de la santé publique - art. R5124-58 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026903073", "@num": "R5124-6", "#text": "Code de la santé publique - art. R5124-6 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026897293", "@num": "R5124-60-1", "#text": "Code de la santé publique - art. R5124-60-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026899041", "@num": "R5124-74", "#text": "Code de la santé publique - art. R5124-74 (VD)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026899045", "@num": "R5124-75", "#text": "Code de la santé publique - art. R5124-75 (VD)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026899048", "@num": "R5124-76", "#text": "Code de la santé publique - art. R5124-76 (VD)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026897363", "@num": "R5124-77", "#text": "Code de la santé publique - art. R5124-77 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000026871417", "@nor": "AFSP1240709D", "@num": "2012-1562", "@nature": "DECRET", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Décret n° 2012-1562 du 31 décembre 2012 relatif au renforcement de la sécurité de la chaîne d'approvisionnement des médicaments et à l'encadrement de la vente de médicaments sur internet", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000026871417", "@c_titre_court": "Décret n° 2012-1562 du 31 décembre 2012" }, { "@fin": "2999-01-01", "#text": "Décret n° 2012-1562 du 31 décembre 2012 relatif au renforcement de la sécurité de la chaîne d'approvisionnement des médicaments et à l'encadrement de la vente de médicaments sur internet", "@debut": "2013-01-02", "@id_txt": "LEGITEXT000026896754", "@c_titre_court": "Décret n°2012-1562 du 31 décembre 2012" } ], "@ministere": "Ministère des affaires sociales et de la santé", "@date_publi": "2013-01-01", "@date_signature": "2012-12-31", "@num_parution_jo": "0001" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000026896768", "@fin": "2999-01-01", "@num": "2", "@debut": "2999-01-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000026871438", "@fin": "2999-01-01", "@num": "2", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
A modifié les dispositions suivantes :

- Code de la santé publique
Art. R5124-3
\n

\n
\n
A modifié les dispositions suivantes :

- Code de la santé publique
\n Art. R5124-3, Art. R5124-6, Art. R5124-36, Art. R5124-48-2
\n

\n
\n
\n
A créé les dispositions suivantes :

- Code de la santé publique
\n Sct. Chapitre IV bis - Courtage de médicaments, Art. R5124-74, Art. R5124-75, Art. R5124-76, Art. R5124-77\n
\n

\n
\n
A modifié les dispositions suivantes :

- Code de la santé publique
Art. R5124-49-2, Art. R5124-49-3, Art. R5124-54-1, Art. R5124-58, Art. R5124-60-1
\n

\n
" } }, "LEGIARTI000045404937": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5138-3", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2022-03-25" } }, "META_COMMUN": { "ID": "LEGIARTI000045404937", "URL": "article/LEGI/ARTI/00/00/45/40/49/LEGIARTI000045404937.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000018393724", "@num": "2", "#text": "Arrêté du 6 mars 2008 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000018392379", "@nortexte": "SJSP0806021A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-03-06" }, { "@id": "LEGIARTI000045398873", "@num": "2", "#text": "Ordonnance n°2022-414 du 23 mars 2022 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000045398547", "@nortexte": "AGRG2202804R", "@numtexte": "2022-414", "@typelien": "MODIFIE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2022-03-23" }, { "@id": "LEGIARTI000025546628", "@num": "D5321-6-1", "#text": "Code de la santé publique - art. 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\n

Les matières premières à usage pharmaceutique répondent aux spécifications de la pharmacopée quand elles existent. Les substances actives utilisées comme matières premières dans les médicaments à usage humain sont fabriquées et distribuées conformément à des bonnes pratiques dont les principes sont définis par le directeur général de l'Agence nationale de sécurité du médicament et des produits de santé.

Les substances actives utilisées comme matières premières dans les médicaments vétérinaires sont fabriquées et distribuées conformément aux bonnes pratiques de fabrication visées au point 2 de l'article 93 du règlement (UE) 2019/6 du 11 décembre 2018 et aux bonnes pratiques de distribution visées au point 8 de l'article 95 du même règlement.

1° Vérifient la qualité et l'authenticité des matières premières qu'ils utilisent ;

2° Veillent à n'utiliser que des substances actives fabriquées et distribuées, y compris lorsqu'elles sont importées, conformément aux bonnes pratiques de fabrication et de distribution mentionnées au premier alinéa.

Les établissements pharmaceutiques de fabrication de médicaments à usage humain mentionnés à l'article L. 5124-1 se conforment à l'obligation résultant du 2° notamment en réalisant, par eux-mêmes ou par l'intermédiaire d'un organisme tiers avec lequel ils concluent un contrat écrit, des audits sur les sites de fabrication et de distribution des substances actives.

Ces mêmes établissements utilisent des excipients appropriés pour lesquels ils déterminent, sur la base d'une évaluation formalisée du risque conforme aux lignes directrices de la Commission européenne, les bonnes pratiques de fabrication adéquates. Cette évaluation du risque tient compte des exigences imposées par d'autres systèmes de qualité pertinents, de la source et de l'utilisation prévue de ces excipients, ainsi que de précédents cas de défaut de qualité.

\n
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Article R5124-49-3 AUTONOME VIGUEUR, en vigueur depuis le 02/01/2013 (Code de la santé publique)