{ "article": { "LEGIARTI000033851884": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5313-6-3", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2017-03-26", "DATE_DEBUT": "2017-01-12" } }, "META_COMMUN": { "ID": "LEGIARTI000033851884", "URL": "article/LEGI/ARTI/00/00/33/85/18/LEGIARTI000033851884.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000033851321", "@num": "1", "#text": "Décret n°2017-20 du 9 janvier 2017 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000033850698", "@nortexte": "AFSP1622630D", "@numtexte": "2017-20", "@typelien": "CREE", "@naturetexte": "DECRET", "@datesignatexte": "2017-01-09" }, { "@id": "LEGIARTI000006686215", "@num": "L1243-2", "#text": "Code de la santé publique - art. L1243-2 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000047923142", "@num": "R1243-23", "#text": "Code de la santé publique - art. R1243-23 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006190768", "@fin": "2999-01-01", "#text": "Section 1 : Dispositions générales", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178672", "@fin": "2999-01-01", "#text": "Chapitre III : Inspection", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161018", "@fin": "2999-01-01", "#text": "Titre Ier : Missions et prérogatives", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145491", "@fin": "2012-05-01", "#text": "Livre III : Agence française de sécurité sanitaire des produits de santé", "@debut": "2004-08-08" }, { "@id": "LEGISCTA000025788966", "@fin": "2999-01-01", "#text": "Livre III : Agence nationale de sécurité du médicament et des produits de santé", "@debut": "2012-05-01" } ] }, "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": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000033851884", "@fin": "2017-03-26", "@num": "R5313-6-3", "@etat": "MODIFIE", "@debut": "2017-01-12", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000034288100", "@fin": "2999-01-01", "@num": "R5313-6-3", "@etat": "VIGUEUR", "@debut": "2017-03-26", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

L'Agence nationale de sécurité du médicament et des produits de santé diligente au moins une fois tous les deux ans, dans les conditions prévues au présent chapitre, des inspections sur dossier ou sur site au sein de chaque établissement et organisme autorisé en application de l'article L. 1243-2.

" } }, "LEGIARTI000033851321": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "1", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000033851321", "URL": "article/LEGI/ARTI/00/00/33/85/13/LEGIARTI000033851321.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000029460533", "@num": "R1223-31", "#text": "Code de la santé publique - art. R1223-31 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000029460452", "@num": "R1223-7-1", "#text": "Code de la santé publique - art. R1223-7-1 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033857061", "@num": "R1243-22", "#text": "Code de la santé publique - art. R1243-22 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025788393", "@num": "R1243-28", "#text": "Code de la santé publique - art. R1243-28 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033857047", "@num": "R1245-19", "#text": "Code de la santé publique - art. R1245-19 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856921", "@num": "R5124-10", "#text": "Code de la santé publique - art. R5124-10 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856916", "@num": "R5124-10-1", "#text": "Code de la santé publique - art. R5124-10-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856911", "@num": "R5124-13", "#text": "Code de la santé publique - art. R5124-13 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856899", "@num": "R5124-14", "#text": "Code de la santé publique - art. R5124-14 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033857013", "@num": "R5124-2", "#text": "Code de la santé publique - art. R5124-2 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915111", "@num": "R5124-25", "#text": "Code de la santé publique - art. R5124-25 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033857003", "@num": "R5124-3", "#text": "Code de la santé publique - art. R5124-3 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856986", "@num": "R5124-3-1", "#text": "Code de la santé publique - art. R5124-3-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856881", "@num": "R5124-34", "#text": "Code de la santé publique - art. R5124-34 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856873", "@num": "R5124-35", "#text": "Code de la santé publique - art. R5124-35 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856976", "@num": "R5124-4", "#text": "Code de la santé publique - art. R5124-4 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856858", "@num": "R5124-43", "#text": "Code de la santé publique - art. R5124-43 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856806", "@num": "R5124-45", "#text": "Code de la santé publique - art. R5124-45 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856800", "@num": "R5124-46", "#text": "Code de la santé publique - art. R5124-46 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856780", "@num": "R5124-47", "#text": "Code de la santé publique - art. R5124-47 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856959", "@num": "R5124-5", "#text": "Code de la santé publique - art. R5124-5 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856771", "@num": "R5124-53", "#text": "Code de la santé publique - art. R5124-53 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856695", "@num": "R5124-6", "#text": "Code de la santé publique - art. R5124-6 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856760", "@num": "R5124-61", "#text": "Code de la santé publique - art. R5124-61 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856952", "@num": "R5124-7", "#text": "Code de la santé publique - art. R5124-7 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856943", "@num": "R5124-8", "#text": "Code de la santé publique - art. R5124-8 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856936", "@num": "R5124-9", "#text": "Code de la santé publique - art. R5124-9 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033851841", "@num": "R5124-9-1", "#text": "Code de la santé publique - art. R5124-9-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856753", "@num": "R5313-1", "#text": "Code de la santé publique - art. R5313-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026595976", "@num": "R5313-2-1", "#text": "Code de la santé publique - art. R5313-2-1 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856747", "@num": "R5313-3", "#text": "Code de la santé publique - art. R5313-3 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033851855", "@num": "R5313-3-1", "#text": "Code de la santé publique - art. R5313-3-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033851857", "@num": "R5313-3-2", "#text": "Code de la santé publique - art. R5313-3-2 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856733", "@num": "R5313-4", "#text": "Code de la santé publique - art. R5313-4 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856706", "@num": "R5313-5", "#text": "Code de la santé publique - art. R5313-5 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033851866", "@num": "R5313-5-1", "#text": "Code de la santé publique - art. R5313-5-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033851879", "@num": "R5313-6-1", "#text": "Code de la santé publique - art. R5313-6-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033851881", "@num": "R5313-6-2", "#text": "Code de la santé publique - art. R5313-6-2 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033851884", "@num": "R5313-6-3", "#text": "Code de la santé publique - art. R5313-6-3 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000033850698", "@nor": "AFSP1622630D", "@num": "2017-20", "@nature": "DECRET", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Décret n° 2017-20 du 9 janvier 2017 relatif aux établissements pharmaceutiques et à l'inspection par l'Agence nationale de sécurité du médicament et des produits de santé et portant simplification de procédures mises en œuvre par cette agence", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000033850698", "@c_titre_court": "Décret n°2017-20 du 9 janvier 2017" }, { "@fin": "2999-01-01", "#text": "Décret n° 2017-20 du 9 janvier 2017 relatif aux établissements pharmaceutiques et à l'inspection par l'Agence nationale de sécurité du médicament et des produits de santé et portant simplification de procédures mises en œuvre par cette agence", "@debut": "2017-01-12", "@id_txt": "LEGITEXT000033851310", "@c_titre_court": "Décret n°2017-20 du 9 janvier 2017" } ], "@ministere": "Ministère des affaires sociales et de la santé", "@date_publi": "2017-01-11", "@date_signature": "2017-01-09", "@num_parution_jo": "0009" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000033851321", "@fin": "2999-01-01", "@num": "1", "@debut": "2999-01-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000033850705", "@fin": "2999-01-01", "@num": "1", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

\n
A abrogé les dispositions suivantes :

-Code de la santé publique
\nArt. R1243-28, Art. R5124-25, Art. R5313-2-1, Art. R1223-7-1, Art. R1223-31 \n
\n

A créé les dispositions suivantes :

-Code de la santé publique
\nArt. R5124-9-1 \n
\n

A créé les dispositions suivantes :

-Code de la santé publique
\nArt. R5313-6-1, Art. R5313-6-2, Art. R5313-6-3 \n
\n

A créé les dispositions suivantes :

-Code de la santé publique
\nArt. R5313-3-1, Art. R5313-3-2 \n
\n

A créé les dispositions suivantes :

-Code de la santé publique
\nArt. R5313-5-1 \n
\n

A modifié les dispositions suivantes :

-Code de la santé publique
\nArt. R1243-22, Art. R1245-19, Art. R5124-2, Art. R5124-3, Art. R5124-3-1, Art. R5124-4, Art. R5124-5, Art. R5124-6, Art. R5124-7, Art. R5124-8, Art. R5124-9, Art. R5124-10, Art. R5124-10-1, Art. R5124-13, Art. R5124-14, Art. R5124-34, Art. R5124-35, Art. R5124-43, Art. R5124-45, Art. R5124-46, Art. R5124-47, Art. R5124-53, Art. R5124-61, Art. R5313-1, Art. R5313-3, Art. R5313-4, Art. R5313-5\n
\n

\n
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Les établissements ou organismes autorisés tiennent à la disposition de l'Agence nationale de sécurité du médicament et des produits de santé les données actualisées concernant les personnels, les équipements et toute information nécessaire à l'évaluation de l'ensemble des activités pour lesquelles ils sont autorisés, y compris celles prévues par l'article R. 1243-3-1. Ils établissent et tiennent à jour la liste des conventions qu'ils concluent avec les tiers dont l'intervention a une influence sur la qualité et la sécurité des tissus ou de leurs dérivés ou des préparations de thérapie cellulaire. Cette liste et ces conventions sont tenues à la disposition de l'Agence nationale de sécurité du médicament et des produits de santé et des personnes chargées d'effectuer les inspections, conformément aux dispositions de l'article R. 5313-6-3.

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Article R5313-6-3 AUTONOME MODIFIE, en vigueur du 12/01/2017 au 26/03/2017 (Code de la santé publique)