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Le fait pour le promoteur de ne pas communiquer aux investigateurs les informations réglementairement prescrites et relatives à l'essai et aux médicaments expérimentaux est puni de deux ans d'emprisonnement et de 30 000 euros d'amende.

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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

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L1128-9 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000046113837", "@nor": "SPRP2217455R", "@num": "2022-1086", "@nature": "ORDONNANCE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Ordonnance n° 2022-1086 du 29 juillet 2022 portant adaptation du droit français au règlement (UE) 2017/746 du Parlement européen et du Conseil du 5 avril 2017 relatif aux dispositifs médicaux de diagnostic in vitro", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000046113837", "@c_titre_court": "Ordonnance n°2022-1086 du 29 juillet 2022" }, { "@fin": "2999-01-01", "#text": "Ordonnance n° 2022-1086 du 29 juillet 2022 portant adaptation du droit français au règlement (UE) 2017/746 du Parlement européen et du Conseil du 5 avril 2017 relatif aux dispositifs médicaux de diagnostic in vitro", "@debut": "2022-07-31", "@id_txt": "LEGITEXT000046118709", "@c_titre_court": "Ordonnance n°2022-1086 du 29 juillet 2022" } ], "@ministere": "Ministère de la santé et de la prévention", "@date_publi": "2022-07-30", "@date_signature": "2022-07-29", "@num_parution_jo": "0175" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000046118710", "@fin": "2999-01-01", "@num": "1", "@debut": "2999-01-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000046113838", "@fin": "2999-01-01", "@num": "1", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
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 L1127-9 AUTONOME TRANSFERE, en vigueur du 22/04/2022 au 31/07/2022 (Code de la santé publique)