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La commission est réunie sur convocation du directeur général de l'Agence française de sécurité sanitaire des produits de santé, qui en fixe l'ordre du jour.

" } }, "LEGIARTI000006909198": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R1243-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2007-08-14", "DATE_DEBUT": "2003-05-27" } }, "META_COMMUN": { "ID": "LEGIARTI000006909198", "URL": "article/LEGI/ARTI/00/00/06/90/91/LEGIARTI000006909198.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "YXXXXXXXXXX1243R0010XX0A" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000412528", "#text": "Décret 2003-462 2003-05-21", "@sens": "source", "@cidtexte": "JORFTEXT000000412528", "@nortexte": "SANP0321523D", "@numtexte": "2003-462", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2003-05-21" }, { "@id": "LEGIARTI000019495367", "@num": "4", "#text": "Décret n°2008-968\n du 16 septembre 2008 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019494693", "@nortexte": "SJSP0813071D", "@numtexte": "2008-968", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2008-09-16" }, { "@id": "LEGIARTI000024853977", "@num": "Annexe II", "#text": "Arrêté du 27 octobre 2011 - art. 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Les dispositions du présent chapitre s'appliquent aux activités mentionnées par l'article L. 1243-1 relatives à la transformation, la conservation, la distribution et la cession de tissus et de leurs dérivés, quel qu'en soit le niveau de transformation, à l'exclusion des préparations cellulaires, utilisés à des fins thérapeutiques chez l'homme. L'utilisation à des fins thérapeutiques comprend les recherches biomédicales au sens de l'article L. 1121-1.
\n
" } }, "LEGIARTI000006909199": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R1243-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2008-09-19", "DATE_DEBUT": "2007-08-14" } }, "META_COMMUN": { "ID": "LEGIARTI000006909199", "URL": "article/LEGI/ARTI/00/00/06/90/91/LEGIARTI000006909199.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "YXXXXXXXXXX1243R0010XX0B" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000412528", "#text": "Décret 2003-462 2003-05-21", "@sens": "source", "@cidtexte": "JORFTEXT000000412528", "@nortexte": "SANP0321523D", "@numtexte": "2003-462", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2003-05-21" }, { "@id": "LEGIARTI000006722601", "@num": "4", "#text": "Décret n°2007-1220 du 10 août 2007 - art. 4 () JORF 14 août 2007", "@sens": "source", "@cidtexte": "JORFTEXT000000829163", "@nortexte": "ESRR0757103D", "@numtexte": "2007-1220", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-08-10" }, { "@id": "LEGIARTI000019495367", "@num": "4", "#text": "Décret n°2008-968\n du 16 septembre 2008 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019494693", "@nortexte": "SJSP0813071D", "@numtexte": "2008-968", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2008-09-16" }, { "@id": "LEGIARTI000024853977", "@num": "Annexe II", "#text": "Arrêté du 27 octobre 2011 - art. 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Les dispositions des sections 1 à 4 du présent chapitre s'appliquent aux activités mentionnées par l'article L. 1243-1 relatives à la transformation, la conservation, la distribution et la cession de tissus et de leurs dérivés, quel qu'en soit le niveau de transformation, à l'exclusion des préparations cellulaires, utilisés à des fins thérapeutiques chez l'homme. L'utilisation à des fins thérapeutiques comprend les recherches biomédicales au sens de l'article L. 1121-1.
\n
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R1243-46 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497797", "@num": "R1243-47", "#text": "Code de la santé publique - art. R1243-47 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497793", "@num": "R1243-48", "#text": "Code de la santé publique - art. R1243-48 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497953", "@num": "R1243-5", "#text": "Code de la santé publique - art. R1243-5 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497951", "@num": "R1243-6", "#text": "Code de la santé publique - art. 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R1243-9 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000019494693", "@nor": "SJSP0813071D", "@num": "2008-968", "@nature": "DECRET", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Décret n° 2008-968 du 16 septembre 2008 relatif aux conditions d'autorisation des activités portant sur les tissus et leurs dérivés, les préparations de thérapie cellulaire, de thérapie génique et de thérapie cellulaire xénogénique, et aux conditions d'autorisation de ces produits", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000019494693", "@c_titre_court": "Décret n°2008-968 du 16 septembre 2008" }, { "@fin": "2999-01-01", "#text": "Décret n° 2008-968 du 16 septembre 2008 relatif aux conditions d'autorisation des activités portant sur les tissus et leurs dérivés, les préparations de thérapie cellulaire, de thérapie génique et de thérapie cellulaire xénogénique, et aux conditions d'autorisation de ces produits", "@debut": "2008-09-19", "@id_txt": "LEGITEXT000019495356", "@c_titre_court": "Décret n°2008-968 du 16 septembre 2008" } ], "@ministere": "Ministère de la santé, de la jeunesse, des sports et de la vie associative", "@date_publi": "2008-09-18", "@date_signature": "2008-09-16", "@num_parution_jo": "0218" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000019495361", "@fin": "2999-01-01", "@num": "1", "@debut": "2999-01-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000019494698", "@fin": "2999-01-01", "@num": "1", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
\n
A modifié les dispositions suivantes :

- Code de la santé publique
\n Sct. Chapitre III : Préparation, conservation, distribution et cession des tissus, de leurs dérivés, des cellules et des préparations de thérapie cellulaire., Sct. Autorisation des activités de préparation, de conservation, de distribution et de cession des tissus, de leurs dérivés, des cellules et des préparations de thérapie cellulaire., Art. R1243-1, Art. R1243-2, Art. R1243-3, Art. R1243-4, Art. R1243-5, Art. R1243-6, Art. R1243-7, Art. R1243-8, Art. R1243-9, Art. R1243-10, Art. R1243-11, Art. R1243-12, Art. R1243-13, Art. R1243-14, Art. R1243-15, Art. R1243-16, Art. R1243-17, Art. R1243-18, Art. R1243-19, Art. R1243-19-1, Art. R1243-20, Art. R1243-21, Art. R1243-22, Art. R1243-23, Art. R1243-24, Art. R1243-25, Art. R1243-26, Art. R1243-27, Art. R1243-28, Art. R1243-29, Art. R1243-30, Art. R1243-31, Sct. Sous-section 5 : Modalités d'application au service de santé des armées., Sct. Section 2 : Autorisation de procédés concernant les tissus, leurs dérivés et les préparations de thérapie cellulaire., Sct. Sous-section 1 : Conditions d'autorisation., Art. R1243-32, Art. R1243-33, Art. R1243-34, Art. R1243-35, Art. R1243-36, Art. R1243-37, Art. R1243-38, Art. R1243-39, Art. R1243-40, Art. R1243-41, Art. R1243-42, Art. R1243-35-1, Sct. Sous-section 2 : Commission de thérapie génique et cellulaire., Art. R1243-42-1, Art. R1243-43, Art. R1243-44, Art. R1243-45, Art. R1243-46, Art. R1243-47, Sct. Paragraphe 1 : Procédure d'autorisation., Sct. Paragraphe 2 : Conditions d'octroi de l'autorisation., Sct. Paragraphe 3 : Règles applicables aux établissements ou organismes autorisés., Sct. Paragraphe 4 : Modalités d'application au service de santé des armées., Sct. Sous-section 3 : Modalités d'application aux hôpitaux des armées et au centre de transfusion sanguine des armées., Art. R1243-48, Sct. Section 3 : Autorisation des procédés de transformation, préparation et conservation à des fins thérapeuthiques des cellules et de leurs dérivés., Sct. Section 4 : Autorisation des procédés de transformation, préparation et conservation à des fins thérapeuthiques des tissus et de leurs dérivés., Sct. Section 5 : Conservation et préparation à des fins scientifiques de tissus et cellules issus du corps humain, Sct. Sous-section 1 : Organismes assurant la conservation et la préparation de tissus et de cellules issus du corps humain pour les besoins de leurs propres programmes de recherche, Art. R1243-49, Art. R1243-50, Art. R1243-51, Art. R1243-52, Art. R1243-53, Art. R1243-54, Art. R1243-55, Art. R1243-56, Art. R1243-57, Art. R1243-58, Art. R1243-59, Art. R1243-60, Sct. Sous-section 2 : Organismes assurant la conservation et la préparation de tissus et de cellules issus du corps humain en vue de leur cession pour un usage scientifique, Art. R1243-61, Art. R1243-62, Art. R1243-63, Art. R1243-64, Art. R1243-65, Art. R1243-66, Art. R1243-67, Art. R1243-68, Art. R1243-69, Art. R1243-70, Art. R1243-71, Art. R1243-72, Sct. Sous-section 3 : Application aux hôpitaux des armées., Art. R1243-73
\n

\n
" } }, "LEGIARTI000019497967": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R1243-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2015-05-09", "DATE_DEBUT": "2008-09-19" } }, "META_COMMUN": { "ID": "LEGIARTI000019497967", "URL": "article/LEGI/ARTI/00/00/19/49/79/LEGIARTI000019497967.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000019495361", "@num": "1", "#text": "Décret n°2008-968\n du 16 septembre 2008 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000019494693", "@nortexte": "SJSP0813071D", "@numtexte": "2008-968", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2008-09-16" }, { "@id": "LEGIARTI000019495367", "@num": "4", "#text": "Décret n°2008-968\n du 16 septembre 2008 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019494693", "@nortexte": "SJSP0813071D", "@numtexte": "2008-968", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2008-09-16" }, { "@id": "LEGIARTI000024853977", "@num": "Annexe II", "#text": "Arrêté du 27 octobre 2011 - art. 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Les dispositions de la présente section s'appliquent aux activités mentionnées à l'article L. 1243-2 relatives à la préparation, la conservation, la distribution ou la cession de tissus, de leurs dérivés, de cellules ou de préparations de thérapie cellulaire, quel qu'en soit le niveau de transformation, utilisés à des fins thérapeutiques chez l'homme.
\n
L'utilisation à des fins thérapeutiques inclut notamment les recherches biomédicales au sens de l'article L. 1121-1.
\n
Pour l'application de la présente section on entend par :
\n
1° Cession : le transfert de tissus, de leurs dérivés ou de cellules ou de préparations de thérapie cellulaire d'un établissement ou d'un organisme autorisé en application de l'article L. 1243-2 vers un autre établissement ou organisme autorisé en application de ce même article ou vers un fabricant de dispositifs médicaux de diagnostic in vitro ou de spécialités pharmaceutiques ou de médicaments fabriqués industriellement ou de produits thérapeutiques annexes.
\n
2° Distribution : la mise à disposition d'un tissu ou de son dérivé ou d'une préparation de thérapie cellulaire sur prescription médicale en vue de sa greffe ou de son administration à un patient déterminé.

\n
" } }, "LEGIARTI000025765486": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "3", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025765486", "URL": "article/LEGI/ARTI/00/00/25/76/54/LEGIARTI000025765486.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGISCTA000019497831", "#text": "Code de la santé publique - Sous-section 2 : Commission de thérapie génique... (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000006196874", "#text": "Code de la santé publique - Sous-section 4 : Commission nationale d'hémovig... 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A abrogé les dispositions suivantes :

- Code de la santé publique
\n Sct. Sous-section 4 : Commission nationale de biovigilance, Art. R1211-36, Art. R1211-37, Art. R1211-38, Art. R1211-39, Sct. Sous-section 4 : Commission nationale d'hémovigilance, Art. R1221-28, Art. R1221-29, Art. R1221-30, Art. R1221-31, Sct. Sous-section 2 : Commission de thérapie génique et cellulaire., Art. R1243-38, Art. R1243-39, Art. R1243-40, Art. R1243-41, Art. R1243-42, Art. R1243-43, Art. R1243-44, Art. R1243-45, Art. R1243-46, Art. R1243-47\n
\n

\n
\n
A modifié les dispositions suivantes :

- Code de la santé publique
\n Art. R1125-2, Art. R1125-9, Art. R1161-17, Art. R1161-18, Art. R1161-19, Art. R1211-32, Art. R1221-24, Art. R1243-34, Art. R1261-3, Art. R1341-20\n
\n

\n
" } }, "LEGIARTI000030589908": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R1243-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2023-08-03", "DATE_DEBUT": "2015-05-09" } }, "META_COMMUN": { "ID": "LEGIARTI000030589908", "URL": "article/LEGI/ARTI/00/00/30/58/99/LEGIARTI000030589908.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000019495367", "@num": "4", "#text": "Décret n°2008-968\n du 16 septembre 2008 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019494693", "@nortexte": "SJSP0813071D", "@numtexte": "2008-968", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2008-09-16" }, { "@id": "LEGIARTI000024853977", "@num": "Annexe II", "#text": "Arrêté du 27 octobre 2011 - art. 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R1245-31 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006802003", "@num": "R672-12", "#text": "Code de la santé publique - art. R672-12 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006802003", "@num": "R672-12", "#text": "Code de la santé publique - art. 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I. - Les dispositions de la présente section s'appliquent aux activités mentionnées à l'article L. 1243-2 relatives à la préparation, la conservation, la distribution ou la cession de tissus, de leurs dérivés, de cellules ou de préparations de thérapie cellulaire, quel qu'en soit le niveau de transformation, utilisés à des fins thérapeutiques chez l'homme.

II. - L'utilisation à des fins thérapeutiques inclut notamment les recherches mentionnées à l'article L. 1121-1. En application de l'article L. 1245-4, les dispositions des sous-sections 3 et 4 de la présente section sont applicables à ces recherches.

III. - Pour l'application de la présente section on entend par :

1° Cession : le transfert de tissus, de leurs dérivés ou de cellules ou de préparations de thérapie cellulaire d'un établissement ou d'un organisme autorisé en application de l'article L. 1243-2 vers un autre établissement ou organisme autorisé en application de ce même article ou vers un fabricant de dispositifs médicaux de diagnostic in vitro ou de spécialités pharmaceutiques ou de médicaments fabriqués industriellement ou de produits thérapeutiques annexes.

2° Distribution : la mise à disposition d'un tissu ou de son dérivé ou d'une préparation de thérapie cellulaire sur prescription médicale en vue de sa greffe ou de son administration à un patient déterminé.

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I.-Les dispositions de la présente section s'appliquent aux activités mentionnées à l'article L. 1243-2 relatives à la préparation, la conservation, la distribution ou la cession de tissus, de leurs dérivés, de cellules ou de préparations de thérapie cellulaire, quel qu'en soit le niveau de transformation, utilisés à des fins thérapeutiques chez l'homme.

II.-L'utilisation à des fins thérapeutiques inclut notamment les recherches mentionnées à l'article L. 1121-1. En application de l'article L. 1245-4, les dispositions des sous-sections 3 et 4 de la présente section sont applicables à ces recherches.

III.-Pour l'application de la présente section on entend par :

3° Stockage : le maintien, dans le cadre de l'activité de conservation, d'un tissu ou de son dérivé sous des conditions contrôlées et appropriées jusqu'à la distribution.

\n
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Article R1243-45 AUTONOME ABROGE, en vigueur du 19/09/2008 au 01/05/2012 (Code de la santé publique)