{ "article": { "LEGIARTI000019497964": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R1243-2", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2008-09-19" } }, "META_COMMUN": { "ID": "LEGIARTI000019497964", "URL": "article/LEGI/ARTI/00/00/19/49/79/LEGIARTI000019497964.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": "LEGIARTI000006686215", "@num": "L1243-2", "#text": "Code de la santé publique - art. L1243-2", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006802004", "@num": "R672-13", "#text": "Code de la santé publique - art. R672-13 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006196880", "@fin": "2999-01-01", "#text": "Sous-section 1 : Dispositions générales.", "@debut": "2007-08-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190960", "@fin": "2008-09-19", "#text": "Section 1 : Autorisation concernant la conservation et l'utilisation à des fins thérapeuthiques des tissus et de leurs dérivés", "@debut": "2007-08-14" }, { "@id": "LEGISCTA000019497791", "@fin": "2999-01-01", "#text": "Section 1 : 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.", "@debut": "2008-09-19" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178493", "@fin": "2008-09-19", "#text": "Chapitre III : Conservation et utilisation des tissus et cellules", "@debut": "2003-05-27" }, { "@id": "LEGISCTA000019497971", "@fin": "2999-01-01", "#text": "Chapitre III : Préparation, conservation, distribution et cession des tissus, de leurs dérivés, des cellules et des préparations de thérapie cellulaire", "@debut": "2008-09-19" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006160954", "@fin": "2999-01-01", "#text": "Titre IV : Tissus, cellules et produits", "@debut": "2003-05-27" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145468", "@fin": "2999-01-01", "#text": "Livre II : Don et utilisation des éléments et produits du corps humain", "@debut": "2003-05-27" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132378", "@fin": "2999-01-01", "#text": "Première partie : Protection générale de la santé", "@debut": "2000-12-23" } ] }, "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": "LEGIARTI000006909200", "@fin": "2007-08-14", "@num": "R1243-2", "@etat": "MODIFIE", "@debut": "2003-05-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006909201", "@fin": "2008-09-19", "@num": "R1243-2", "@etat": "MODIFIE", "@debut": "2007-08-14", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000019497964", "@fin": "2999-01-01", "@num": "R1243-2", "@etat": "VIGUEUR", "@debut": "2008-09-19", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

L'autorisation prévue à l'article L. 1243-2 peut porter sur une ou plusieurs des activités mentionnées à cet article.

\n
" } }, "LEGIARTI000006686215": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1243-2", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-07", "DATE_DEBUT": "2000-06-22" } }, "META_COMMUN": { "ID": "LEGIARTI000006686215", "URL": "article/LEGI/ARTI/00/00/06/68/62/LEGIARTI000006686215.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X1243L02XXAA" } }, "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": "LEGIARTI000006697606", "@num": "35", "#text": "Loi n°2004-800 du 6 août 2004 - art. 35 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000441469", "@nortexte": "SANX0100053L", "@numtexte": "2004-800", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-06" }, { "@id": "LEGIARTI000025577319", "@num": "37", "#text": "Loi n°2004-800 du 6 août 2004 - art. 37 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000441469", "@nortexte": "SANX0100053L", "@numtexte": "2004-800", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-06" }, { "@id": "LEGIARTI000006726301", "@num": "12", "#text": "Décret n°2004-1024 du 28 septembre 2004 - art. 12 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000624750", "@nortexte": "MENR0401951D", "@numtexte": "2004-1024", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-09-28" }, { "@id": "LEGIARTI000006726294", "@num": "5", "#text": "Décret n°2004-1024 du 28 septembre 2004 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000624750", "@nortexte": "MENR0401951D", "@numtexte": "2004-1024", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-09-28" }, { "@id": "LEGIARTI000006726296", "@num": "7", "#text": "Décret n°2004-1024 du 28 septembre 2004 - art. 7 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000624750", "@nortexte": "MENR0401951D", "@numtexte": "2004-1024", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-09-28" }, { "@id": "LEGIARTI000020330568", "@num": "3", "#text": "Arrêté du 13 novembre 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000645015", "@nortexte": "SANP0624637A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-11-13" }, { "@id": "LEGIARTI000019422927", "@num": "3", "#text": "Décret n°2008-891\n du 2 septembre 2008 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019420616", "@nortexte": "SJSP0814140D", "@numtexte": "2008-891", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2008-09-02" }, { "@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": "LEGIARTI000019753833", "@num": "Annexe 1", "#text": "Arrêté du 28 octobre 2008 - art. 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Un organisme public ou privé peut, à des fins scientifiques, pour les besoins de ses propres programmes de recherche, assurer la conservation et la transformation de tissus et de cellules issus du corps humain, sous réserve d'en avoir fait la déclaration préalable auprès du ministre chargé de la recherche.
\n
Celui-ci peut s'opposer dans un délai de trois mois à l'exercice des activités ainsi déclarées si les conditions d'approvisionnement, de conservation et d'utilisation des tissus et cellules issus du corps humain ne présentent pas les garanties suffisantes pour assurer le respect des dispositions du titre Ier du présent livre et des règles applicables en matière de sécurité des travailleurs et de protection de l'environnement.
\n
Le ministre chargé de la recherche peut à tout moment suspendre ou interdire les activités qui ne répondent pas à ces exigences.
\n
L'Agence française de sécurité sanitaire des produits de santé est informée des activités de conservation ou de transformation à des fins scientifiques de tissus et cellules du corps humain réalisées sur le même site que des activités de même nature exercées à des fins thérapeutiques. Dans ce cas la suspension ou l'interdiction de l'exercice des activités déclarées est de droit quand elle est demandée par l'Agence française de sécurité sanitaire des produits de santé pour des raisons de sécurité sanitaire.
\n
Les organismes mentionnés au premier alinéa ne peuvent céder les tissus et cellules du corps humain qu'ils conservent ou transforment qu'à un autre établissement ou organisme qui a lui-même déclaré des activités similaires.
\n
La déclaration effectuée en application de l'article L. 1131-4 se substitue pour les collections d'échantillons biologiques humains à la déclaration prévue au premier alinéa.
" } }, "LEGIARTI000006686216": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1243-2", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2007-04-27", "DATE_DEBUT": "2004-08-07" } }, "META_COMMUN": { "ID": "LEGIARTI000006686216", "URL": "article/LEGI/ARTI/00/00/06/68/62/LEGIARTI000006686216.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X1243L02XXAB" } }, "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": "LEGIARTI000006697580", "@num": "12", "#text": "Loi n°2004-800 du 6 août 2004 - art. 12 () JORF 7 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000441469", "@nortexte": "SANX0100053L", "@numtexte": "2004-800", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-06" }, { "@id": "LEGIARTI000006697606", "@num": "35", "#text": "Loi n°2004-800 du 6 août 2004 - art. 35 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000441469", "@nortexte": "SANX0100053L", "@numtexte": "2004-800", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-06" }, { "@id": "LEGIARTI000025577319", "@num": "37", "#text": "Loi n°2004-800 du 6 août 2004 - art. 37 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000441469", "@nortexte": "SANX0100053L", "@numtexte": "2004-800", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-06" }, { "@id": "LEGIARTI000006726301", "@num": "12", "#text": "Décret n°2004-1024 du 28 septembre 2004 - art. 12 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000624750", "@nortexte": "MENR0401951D", "@numtexte": "2004-1024", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-09-28" }, { "@id": "LEGIARTI000006726294", "@num": "5", "#text": "Décret n°2004-1024 du 28 septembre 2004 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000624750", "@nortexte": "MENR0401951D", "@numtexte": "2004-1024", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-09-28" }, { "@id": "LEGIARTI000006726296", "@num": "7", "#text": "Décret n°2004-1024 du 28 septembre 2004 - art. 7 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000624750", "@nortexte": "MENR0401951D", "@numtexte": "2004-1024", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-09-28" }, { "@id": "LEGIARTI000020330568", "@num": "3", "#text": "Arrêté du 13 novembre 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000645015", "@nortexte": "SANP0624637A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-11-13" }, { "@id": "LEGIARTI000019422927", "@num": "3", "#text": "Décret n°2008-891\n du 2 septembre 2008 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019420616", "@nortexte": "SJSP0814140D", "@numtexte": "2008-891", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2008-09-02" }, { "@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": "LEGIARTI000019753833", "@num": "Annexe 1", "#text": "Arrêté du 28 octobre 2008 - art. 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Peuvent assurer la préparation, la conservation, la distribution et la cession, à des fins thérapeutiques autologues ou allogéniques, des tissus et de leurs dérivés et des préparations de thérapie cellulaire, les établissements et les organismes autorisés à cet effet, après avis de l'Agence de la biomédecine, par l'Agence française de sécurité sanitaire des produits de santé qui s'assure du respect des dispositions du titre Ier du présent livre.
\n
L'autorisation est accordée pour une durée de cinq ans. Elle est renouvelable.
\n
Toute modification des éléments figurant dans l'autorisation initiale doit faire l'objet d'une nouvelle autorisation.
" } }, "LEGIARTI000006686217": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1243-2", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2011-07-09", "DATE_DEBUT": "2007-04-27" } }, "META_COMMUN": { "ID": "LEGIARTI000006686217", "URL": "article/LEGI/ARTI/00/00/06/68/62/LEGIARTI000006686217.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X1243L02XXAC" } }, "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": "LEGIARTI000006697606", "@num": "35", "#text": "Loi n°2004-800 du 6 août 2004 - art. 35 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000441469", "@nortexte": "SANX0100053L", "@numtexte": "2004-800", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-06" }, { "@id": "LEGIARTI000025577319", "@num": "37", "#text": "Loi n°2004-800 du 6 août 2004 - art. 37 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000441469", "@nortexte": "SANX0100053L", "@numtexte": "2004-800", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-06" }, { "@id": "LEGIARTI000006726301", "@num": "12", "#text": "Décret n°2004-1024 du 28 septembre 2004 - art. 12 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000624750", "@nortexte": "MENR0401951D", "@numtexte": "2004-1024", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-09-28" }, { "@id": "LEGIARTI000006726294", "@num": "5", "#text": "Décret n°2004-1024 du 28 septembre 2004 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000624750", "@nortexte": "MENR0401951D", "@numtexte": "2004-1024", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-09-28" }, { "@id": "LEGIARTI000006726296", "@num": "7", "#text": "Décret n°2004-1024 du 28 septembre 2004 - art. 7 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000624750", "@nortexte": "MENR0401951D", "@numtexte": "2004-1024", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-09-28" }, { "@id": "LEGIARTI000020330568", "@num": "3", "#text": "Arrêté du 13 novembre 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000645015", "@nortexte": "SANP0624637A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-11-13" }, { "@id": "LEGIARTI000006698424", "@num": "8", "#text": "Ordonnance n°2007-613 du 26 avril 2007 - art. 8 () JORF 27 avril 2007", "@sens": "source", "@cidtexte": "JORFTEXT000000646989", "@nortexte": "SANX0700046R", "@numtexte": "2007-613", "@typelien": "MODIFICATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2007-04-26" }, { "@id": "LEGIARTI000019422927", "@num": "3", "#text": "Décret n°2008-891\n du 2 septembre 2008 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019420616", "@nortexte": "SJSP0814140D", "@numtexte": "2008-891", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2008-09-02" }, { "@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": "LEGIARTI000019753833", "@num": "Annexe 1", "#text": "Arrêté du 28 octobre 2008 - art. 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Peuvent assurer la préparation, la conservation, la distribution et la cession, à des fins thérapeutiques autologues ou allogéniques, des tissus et de leurs dérivés et des préparations de thérapie cellulaire, les établissements et les organismes autorisés à cet effet, après avis de l'Agence de la biomédecine, par l'Agence française de sécurité sanitaire des produits de santé qui s'assure du respect des dispositions du titre Ier du présent livre.
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L'autorisation est accordée pour une durée de cinq ans. Elle est renouvelable.
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Toute modification substantielle dont la liste est fixée par décret en Conseil d'Etat affectant une ou plusieurs des activités exercées par l'établissement ou l'organisme autorisé doit faire l'objet d'une nouvelle autorisation. Les autres modifications sont soumises à une déclaration auprès du directeur général de l'Agence française de sécurité sanitaire des produits de santé.
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Par dérogation aux dispositions du premier alinéa, les établissements de santé autorisés à prélever des cellules hématopoïétiques issues de la moelle osseuse peuvent distribuer des cellules hématopoïétiques issues de la moelle osseuse non transformées en vue d'une greffe immédiate.
" } }, "LEGIARTI000019495361": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "1", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000019495361", "URL": "article/LEGI/ARTI/00/00/19/49/53/LEGIARTI000019495361.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGISCTA000019497971", "#text": "Code de la santé publique - Chapitre III : Préparation, conservation, distr... (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000006198941", "#text": "Code de la santé publique - Paragraphe 1 : Procédure d'autorisation. 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R1243-13 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497921", "@num": "R1243-14", "#text": "Code de la santé publique - art. R1243-14 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497917", "@num": "R1243-15", "#text": "Code de la santé publique - art. R1243-15 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497914", "@num": "R1243-16", "#text": "Code de la santé publique - art. R1243-16 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497912", "@num": "R1243-17", "#text": "Code de la santé publique - art. R1243-17 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497909", "@num": "R1243-18", "#text": "Code de la santé publique - art. R1243-18 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497905", "@num": "R1243-19", "#text": "Code de la santé publique - art. R1243-19 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006909240", "@num": "R1243-19-1", "#text": "Code de la santé publique - art. R1243-19-1 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497964", "@num": "R1243-2", "#text": "Code de la santé publique - art. R1243-2 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497903", "@num": "R1243-20", "#text": "Code de la santé publique - art. R1243-20 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497900", "@num": "R1243-21", "#text": "Code de la santé publique - art. R1243-21 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497897", "@num": "R1243-22", "#text": "Code de la santé publique - art. R1243-22 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497894", "@num": "R1243-23", "#text": "Code de la santé publique - art. R1243-23 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497889", "@num": "R1243-24", "#text": "Code de la santé publique - art. R1243-24 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497884", "@num": "R1243-25", "#text": "Code de la santé publique - art. R1243-25 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497880", "@num": "R1243-26", "#text": "Code de la santé publique - art. R1243-26 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497876", "@num": "R1243-27", "#text": "Code de la santé publique - art. R1243-27 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497872", "@num": "R1243-28", "#text": "Code de la santé publique - art. R1243-28 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497867", "@num": "R1243-29", "#text": "Code de la santé publique - art. R1243-29 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497959", "@num": "R1243-3", "#text": "Code de la santé publique - art. R1243-3 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497864", "@num": "R1243-30", "#text": "Code de la santé publique - art. R1243-30 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497860", "@num": "R1243-31", "#text": "Code de la santé publique - art. R1243-31 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497852", "@num": "R1243-32", "#text": "Code de la santé publique - art. R1243-32 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497848", "@num": "R1243-33", "#text": "Code de la santé publique - art. 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R1243-38 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497825", "@num": "R1243-39", "#text": "Code de la santé publique - art. R1243-39 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497955", "@num": "R1243-4", "#text": "Code de la santé publique - art. R1243-4 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497822", "@num": "R1243-40", "#text": "Code de la santé publique - art. R1243-40 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497819", "@num": "R1243-41", "#text": "Code de la santé publique - art. R1243-41 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497816", "@num": "R1243-42", "#text": "Code de la santé publique - art. R1243-42 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006909291", "@num": "R1243-42-1", "#text": "Code de la santé publique - art. R1243-42-1 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497808", "@num": "R1243-43", "#text": "Code de la santé publique - art. R1243-43 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497806", "@num": "R1243-44", "#text": "Code de la santé publique - art. R1243-44 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497803", "@num": "R1243-45", "#text": "Code de la santé publique - art. R1243-45 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497801", "@num": "R1243-46", "#text": "Code de la santé publique - art. 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. R1243-6 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497948", "@num": "R1243-7", "#text": "Code de la santé publique - art. R1243-7 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497944", "@num": "R1243-8", "#text": "Code de la santé publique - art. R1243-8 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019497939", "@num": "R1243-9", "#text": "Code de la santé publique - art. 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
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R6123-77 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique L672-11 I", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006418883", "@num": "511-7", "#text": "Code pénal - art. 511-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006070719", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025577309", "@num": "511-8-1", "#text": "Code pénal - art. 511-8-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006070719", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171034", "@fin": "2999-01-01", "#text": "Chapitre III : Préparation, conservation et utilisation des tissus, des cellules et de leurs dérivés.", "@debut": "2004-08-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006154988", "@fin": "2999-01-01", "#text": "Titre IV : Tissus, cellules, produits du corps humain et leurs dérivés", "@debut": "2004-08-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140604", "@fin": "2999-01-01", "#text": "Livre II : Don et utilisation des éléments et produits du corps humain", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125345", "@fin": "2999-01-01", "#text": "Première partie : Protection générale de la 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": "LEGIARTI000006686215", "@fin": "2004-08-07", "@num": "L1243-2", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686216", "@fin": "2007-04-27", "@num": "L1243-2", "@etat": "MODIFIE", "@debut": "2004-08-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686217", "@fin": "2011-07-09", "@num": "L1243-2", "@etat": "MODIFIE", "@debut": "2007-04-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000024325413", "@fin": "2012-03-24", "@num": "L1243-2", "@etat": "MODIFIE", "@debut": "2011-07-09", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025577351", "@fin": "2012-05-01", "@num": "L1243-2", "@etat": "MODIFIE", "@debut": "2012-03-24", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000025104376", "@fin": "2999-01-01", "@num": "L1243-2", "@etat": "VIGUEUR", "@debut": "2012-05-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Peuvent assurer la préparation, la conservation, la distribution et la cession, à des fins thérapeutiques autologues ou allogéniques, des tissus et de leurs dérivés et des préparations de thérapie cellulaire, les établissements et les organismes autorisés à cet effet, après avis de l'Agence de la biomédecine, par l'Agence française de sécurité sanitaire des produits de santé qui s'assure du respect des dispositions du titre Ier du présent livre.

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L'autorisation est accordée pour une durée de cinq ans. Elle est renouvelable.

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Toute modification substantielle dont la liste est fixée par décret en Conseil d'Etat affectant une ou plusieurs des activités exercées par l'établissement ou l'organisme autorisé doit faire l'objet d'une nouvelle autorisation. Les autres modifications sont soumises à une déclaration auprès du directeur général de l'Agence française de sécurité sanitaire des produits de santé.

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Seules peuvent être préparées, conservées, distribuées ou cédées les cellules du sang de cordon et du sang placentaire ainsi que les cellules du cordon et du placenta prélevées dans les conditions mentionnées au dernier alinéa de l'article L. 1241-1. Chacun de ces établissements consacre une part de son stockage au don dédié mentionné à ce même dernier alinéa.

" } }, "LEGIARTI000025104376": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1243-2", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2012-05-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025104376", "URL": "article/LEGI/ARTI/00/00/25/10/43/LEGIARTI000025104376.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.

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\n
" }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Rapport relatif à l'ordonnance n° 2000-548 du 15 juin 2000", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi n°2002-303 du 4 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000006697606", "@num": "35", "#text": "Loi n°2004-800 du 6 août 2004 - art. 35 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000441469", "@nortexte": "SANX0100053L", "@numtexte": "2004-800", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-06" }, { "@id": "LEGIARTI000025577319", "@num": "37", "#text": "Loi n°2004-800 du 6 août 2004 - art. 37 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000441469", "@nortexte": "SANX0100053L", "@numtexte": "2004-800", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-06" }, { "@id": "LEGIARTI000006726301", "@num": "12", "#text": "Décret n°2004-1024 du 28 septembre 2004 - art. 12 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000624750", "@nortexte": "MENR0401951D", "@numtexte": "2004-1024", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-09-28" }, { "@id": "LEGIARTI000006726294", "@num": "5", "#text": "Décret n°2004-1024 du 28 septembre 2004 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000624750", "@nortexte": "MENR0401951D", "@numtexte": "2004-1024", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-09-28" }, { "@id": "LEGIARTI000006726296", "@num": "7", "#text": "Décret n°2004-1024 du 28 septembre 2004 - art. 7 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000624750", "@nortexte": "MENR0401951D", "@numtexte": "2004-1024", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-09-28" }, { "@id": "LEGIARTI000020330568", "@num": "3", "#text": "Arrêté du 13 novembre 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000645015", "@nortexte": "SANP0624637A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-11-13" }, { "@id": "LEGIARTI000019422927", "@num": "3", "#text": "Décret n°2008-891\n du 2 septembre 2008 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019420616", "@nortexte": "SJSP0814140D", "@numtexte": "2008-891", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2008-09-02" }, { "@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": "LEGIARTI000019753833", "@num": "Annexe 1", "#text": "Arrêté du 28 octobre 2008 - art. 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Peuvent assurer la préparation, la conservation, la distribution et la cession, à des fins thérapeutiques autologues ou allogéniques, des tissus et de leurs dérivés et des préparations de thérapie cellulaire, les établissements et les organismes autorisés à cet effet, après avis de l'Agence de la biomédecine, par l'Agence nationale de sécurité du médicament et des produits de santé qui s'assure du respect des dispositions du titre Ier du présent livre.

L'autorisation délivrée par l'Agence nationale de sécurité du médicament et des produits de santé, conformément à l'article 6 de la directive 2004/23/ CE du Parlement européen et du Conseil du 31 mars 2004 relative à l'établissement de normes de qualité et de sécurité pour le don, l'obtention, le contrôle, la transformation, la conservation, le stockage et la distribution des tissus et cellules humains, précise la catégorie de tissus et leurs dérivés ou de préparations de thérapie cellulaire et mentionne les accords passés entre un établissement et des tiers pour la réalisation de ces activités, les procédés de préparation et de conservation mis en œuvre ainsi que les indications thérapeutiques reconnues.

Toute modification substantielle des éléments figurant dans l'autorisation initiale qui affecte une ou plusieurs des activités exercées par l'établissement ou l'organisme autorisé doit faire l'objet d'une nouvelle autorisation. Les autres modifications sont soumises à une déclaration auprès du directeur général de l'Agence nationale de sécurité du médicament et des produits de santé.

L'Agence de la biomédecine est informée des autorisations délivrées en application du présent article.

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Toute modification substantielle des éléments figurant dans l'autorisation initiale qui affecte une ou plusieurs des activités exercées par l'établissement ou l'organisme autorisé doit faire l'objet d'une nouvelle autorisation. Les autres modifications sont soumises à une déclaration auprès du directeur général de l'Agence française de sécurité sanitaire des produits de santé.

L'Agence de la biomédecine est informée des autorisations délivrées en application du présent article.

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Article R1243-2 AUTONOME VIGUEUR, en vigueur depuis le 19/09/2008 (Code de la santé publique)