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Se reporter aux modalités d'application prévues aux I, II et III de l'article 17 de l'ordonnance n° 2022-582 du 20 avril 2022.
\n

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Le promoteur dont la responsabilité civile n'est pas garantie par l'assurance prévue au troisième alinéa de l'article L. 1125-9 est puni d'un an d'emprisonnement et de 15 000 euros d'amende.

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L1126-4 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000032723021", "@num": "L1126-5", "#text": "Code de la santé publique - art. L1126-5 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "TRANSFERE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685934", "@num": "L1126-6", "#text": "Code de la santé publique - art. L1126-6 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "TRANSFERE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039279733", "@num": "L1126-7", "#text": "Code de la santé publique - art. L1126-7 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "TRANSFERE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019227420", "@num": "L1126-8", "#text": "Code de la santé publique - art. L1126-8 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "TRANSFERE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019227418", "@num": "L1126-9", "#text": "Code de la santé publique - art. L1126-9 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "TRANSFERE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045618765", "@num": "L1127-1", "#text": "Code de la santé publique - art. L1127-1 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045618840", "@num": "L1127-10", "#text": "Code de la santé publique - art. L1127-10 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045618849", "@num": "L1127-11", "#text": "Code de la santé publique - art. L1127-11 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045618858", "@num": "L1127-12", "#text": "Code de la santé publique - art. L1127-12 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045618774", "@num": "L1127-2", "#text": "Code de la santé publique - art. L1127-2 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045618784", "@num": "L1127-3", "#text": "Code de la santé publique - art. L1127-3 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045618793", "@num": "L1127-4", "#text": "Code de la santé publique - art. L1127-4 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045618793", "@num": "L1127-4", "#text": "Code de la santé publique - art. L1127-4 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045618802", "@num": "L1127-5", "#text": "Code de la santé publique - art. L1127-5 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045618813", "@num": "L1127-6", "#text": "Code de la santé publique - art. L1127-6 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045618821", "@num": "L1127-7", "#text": "Code de la santé publique - art. L1127-7 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045618830", "@num": "L1127-8", "#text": "Code de la santé publique - art. L1127-8 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045618835", "@num": "L1127-9", "#text": "Code de la santé publique - art. L1127-9 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000045614779", "@nor": "SSAP2205263R", "@num": "2022-582", "@nature": "ORDONNANCE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Ordonnance n° 2022-582 du 20 avril 2022 portant adaptation du droit français au règlement (UE) 2017/745 du Parlement européen et du Conseil du 5 avril 2017 relatif aux dispositifs médicaux", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000045614779", "@c_titre_court": "Ordonnance n°2022-582 du 20 avril 2022" }, { "@fin": "2999-01-01", "#text": "Ordonnance n° 2022-582 du 20 avril 2022 portant adaptation du droit français au règlement (UE) 2017/745 du Parlement européen et du Conseil du 5 avril 2017 relatif aux dispositifs médicaux", "@debut": "2022-04-22", "@id_txt": "LEGITEXT000045615350", "@c_titre_court": "Ordonnance n°2022-582 du 20 avril 2022" } ], "@ministere": "Ministère des solidarités et de la santé", "@date_publi": "2022-04-21", "@date_signature": "2022-04-20", "@num_parution_jo": "0093" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000045615363", "@fin": "2999-01-01", "@num": "2", "@debut": "2999-01-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000045614781", "@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\n
\nArt. L1121-1, Sct. Chapitre III bis : Recherches et investigations cliniques relevant du secret de la défense nationale, Art. L1123-15, Art. L1123-16, Art. L1123-17, Art. L1123-18, Art. L1123-19, Art. L1123-20, Art. L1124-1 \n
\n

A modifié les dispositions suivantes :

-Code de la santé publique\n
\nArt. L1125-1, Art. L1125-1, Art. L1126-1, Art. L1125-2, Art. L1125-2, Art. L1126-2, Art. L1125-3, Art. L1125-3, Art. L1126-3, Art. L1125-4, Art. L1125-4, Art. L1125-5, Art. L1126-4, Art. L. 1127-4\n
\n

A créé les dispositions suivantes :

-Code de la santé publique\n
\nSct. Chapitre V : Dispositions particulières applicables aux investigations cliniques de dispositifs mentionnés à l'article premier du règlement (UE) 2017/745 du Parlement européen et du Conseil du 5 avril 2017, Art. L1125-6, Art. L1125-7, Art. L1125-8, Art. L1125-9, Art. L1125-10, Art. L1125-11, Art. L1125-12, Art. L1125-13, Art. L1125-14, Art. L1125-15, Art. L1125-16, Art. L1125-17, Art. L1125-18, Art. L1125-19, Art. L1125-20, Art. L1125-21, Art. L1125-22, Art. L1125-23, Art. L1125-24, Art. L1125-25, Art. L1125-26, Art. L1125-27, Art. L1125-28, Art. L1125-29, Art. L1125-30, Art. L1125-31, Art. L1125-32 \n
\n

A modifié les dispositions suivantes :

-Code de la santé publique\n
\nArt. L1126-1, Art. L1127-1, Art. L1126-2, Art. L1127-2, Art. L1126-3, Art. L1127-3, Art. L1126-4, Art. L1127-4, Art. L1126-5, Art. L1127-5, Art. L1126-6, Art. L1127-6, Art. L1126-7, Art. L1127-7, Art. L1126-8, Art. L1127-8, Art. L1126-9, Art. L1127-9, Art. L1126-10, Art. L1127-10, Art. L1126-11, Art. L1127-11, Art. L1126-12, Art. L1127-12 \n
\n

A modifié les dispositions suivantes :

-Code de la santé publique\n
\nSct. Chapitre VI : Dispositions particulières à certaines recherches, Sct. Chapitre VII : Dispositions pénales\n
\n

" } }, "LEGIARTI000045619869": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1125-24", "ETAT": "TRANSFERE", "TYPE": "AUTONOME", "DATE_FIN": "2022-07-31", "DATE_DEBUT": "2022-04-22" } }, "META_COMMUN": { "ID": "LEGIARTI000045619869", "URL": "article/LEGI/ARTI/00/00/45/61/98/LEGIARTI000045619869.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Se reporter aux modalités d'application prévues aux I, II et III de l'article 17 de l'ordonnance n° 2022-582 du 20 avril 2022.
\n

" }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000045615363", "@num": "2", "#text": "Ordonnance n°2022-582 du 20 avril 2022 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000045614779", "@nortexte": "SSAP2205263R", "@numtexte": "2022-582", "@typelien": "CREE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2022-04-20" }, { "@id": "LEGIARTI000046118710", "@num": "1", "#text": "Ordonnance n°2022-1086 du 29 juillet 2022 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000046113837", "@nortexte": "SPRP2217455R", "@numtexte": "2022-1086", "@typelien": "TRANSFERE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2022-07-29" }, { "@id": "LEGIARTI000006685907", "@num": "L1125-1", "#text": "Code de la santé publique - art. L1125-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045619843", "@num": "L1125-11", "#text": "Code de la santé publique - art. L1125-11", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045619845", "@num": "L1125-12", "#text": "Code de la santé publique - art. L1125-12", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000046125757", "@num": "L1125-23", "#text": "Code de la santé publique - art. L1125-23 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045619871", "@num": "L1125-25", "#text": "Code de la santé publique - art. L1125-25 (T)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000045619831", "@fin": "2999-01-01", "#text": "Chapitre V : Dispositions particulières applicables aux investigations cliniques de dispositifs mentionnés à l'article premier du règlement (UE) 2017/745 du Parlement européen et du Conseil du 5 avril 2017", "@debut": "2022-04-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006154978", "@fin": "2012-03-07", "#text": "Titre II : Recherches biomédicales", "@debut": "2000-06-22" }, { "@id": "LEGISCTA000025457387", "@fin": "2999-01-01", "#text": "Titre II : Recherches impliquant la personne humaine", "@debut": "2012-03-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140603", "@fin": "2999-01-01", "#text": "Livre Ier : Protection des personnes en matière de santé", "@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": "TRANSFERE", "LIEN_ART": { "@id": "LEGIARTI000045619869", "@fin": "2022-07-31", "@num": "L1125-24", "@etat": "TRANSFERE", "@debut": "2022-04-22", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000046125801", "@fin": "2999-01-01", "@num": "L1125-24", "@etat": "VIGUEUR", "@debut": "2022-07-31", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Est puni d'un an d'emprisonnement et de 15 000 euros d'amende le fait de pratiquer ou de faire pratiquer une investigation clinique :
\n
1° Sans avoir obtenu l'avis favorable d'un comité de protection des personnes et, dans les cas d'investigations cliniques mentionnées aux deuxième et troisième alinéas du II de l'article L. 1125-1, l'autorisation de l'autorité compétente ;
\n
2° Dans des conditions contraires aux dispositions de l'article L. 1125-11 ;
\n
3° Dont la réalisation a été interdite ou suspendue par l'autorité compétente.
\n
L'investigateur qui réalise une telle investigation clinique en méconnaissance des dispositions de l'article L. 1125-12 est puni des mêmes peines.

" } }, "LEGIARTI000046118710": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "1", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000046118710", "URL": "article/LEGI/ARTI/00/00/46/11/87/LEGIARTI000046118710.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGISCTA000046125743", "#text": "Code de la santé publique - Chapitre III bis : Recherches, investigations c... (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000046122391", "#text": "Code de la santé publique - Chapitre VI : Dispositions particulières applic... 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L1121-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000046125738", "@num": "L1123-15", "#text": "Code de la santé publique - art. L1123-15 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000046125731", "@num": "L1123-16", "#text": "Code de la santé publique - art. L1123-16 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000046125724", "@num": "L1123-17", "#text": "Code de la santé publique - art. L1123-17 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000046125715", "@num": "L1123-18", "#text": "Code de la santé publique - art. 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A modifié les dispositions suivantes :

- Code de la santé publique
\n Art. L1121-1, Sct. Chapitre III bis : Recherches, investigations cliniques et études des performances relevant du secret de la défense nationale, Art. L1123-15, Art. L1123-16, Art. L1123-17, Art. L1123-18, Art. L1123-19, Art. L1123-20, Art. L1124-1, Art. L1125-1, Art. L1125-5, Art. L1125-6, Art. L1125-21, Art. L1125-22, Art. L1126-1, Art. L1126-2, Art. L1126-3, Art. L1126-4
\n

Article L1125-25 AUTONOME TRANSFERE, en vigueur du 22/04/2022 au 31/07/2022 (Code de la santé publique)