{ "article": { "LEGIARTI000049967621": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "3", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000049967621", "URL": "article/LEGI/ARTI/00/00/49/96/76/LEGIARTI000049967621.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGISCTA000033416938", "#text": "Code de la santé publique", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033416943", "@num": "R1124-1", "#text": "Code de la santé publique - art. R1124-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049974107", "@num": "R1124-1-1", "#text": "Code de la santé publique - art. R1124-1-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049986836", "@num": "R1124-15", "#text": "Code de la santé publique - art. R1124-15 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049986831", "@num": "R1124-16", "#text": "Code de la santé publique - art. R1124-16 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049986841", "@num": "R1124-7", "#text": "Code de la santé publique - art. R1124-7 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000049962633", "@nor": "TSSP2329890D", "@num": "2024-795", "@nature": "DECRET", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Décret n° 2024-795 du 8 juillet 2024 relatif aux investigations cliniques et aux études des performances", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000049962633", "@c_titre_court": "Décret n°2024-795 du 8 juillet 2024" }, { "@fin": "2999-01-01", "#text": "Décret n° 2024-795 du 8 juillet 2024 relatif aux investigations cliniques et aux études des performances", "@debut": "2024-07-14", "@id_txt": "LEGITEXT000049967604", "@c_titre_court": "Décret n°2024-795 du 8 juillet 2024" } ], "@ministere": "Ministère du travail, de la santé et des solidarités", "@date_publi": "2024-07-13", "@date_signature": "2024-07-08", "@num_parution_jo": "0166" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000049967621", "@fin": "2999-01-01", "@num": "3", "@debut": "2999-01-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000049962650", "@fin": "2999-01-01", "@num": "3", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
A créé les dispositions suivantes :

- Code de la santé publique
\n Art. R1124-1-1\n
\n

\n
\n
A modifié les dispositions suivantes :

- Code de la santé publique
\n Art. R1124-7, Art. R1124-15, Art. R1124-16\n
\n

\n
" } }, "LEGIARTI000033416948": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R1124-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2022-01-01", "DATE_DEBUT": "2016-11-18" } }, "META_COMMUN": { "ID": "LEGIARTI000033416948", "URL": "article/LEGI/ARTI/00/00/33/41/69/LEGIARTI000033416948.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000033396115", "@num": "18", "#text": "Décret n°2016-1537 du 16 novembre 2016 - art. 18", "@sens": "cible", "@cidtexte": "JORFTEXT000033394083", "@nortexte": "AFSP1621392D", "@numtexte": "2016-1537", "@typelien": "CREE", "@naturetexte": "DECRET", "@datesignatexte": "2016-11-16" }, { "@id": "LEGIARTI000049967621", "@num": "3", "#text": "Décret n°2024-795 du 8 juillet 2024 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000049962633", "@nortexte": "TSSP2329890D", "@numtexte": "2024-795", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-07-08" }, { "@id": "LEGIARTI000006838977", "@num": "R533-1", "#text": "Code de l'environnement - art. R533-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006838994", "@num": "R533-17", "#text": "Code de l'environnement - art. R533-17 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000033416941", "@fin": "2999-01-01", "#text": "Chapitre IV : Dispositions particulières relatives aux essais cliniques portant sur le médicament", "@debut": "2016-11-18" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006160948", "@fin": "2017-05-11", "#text": "Titre II : Recherches biomédicales", "@debut": "2003-05-27" }, { "@id": "LEGISCTA000034773672", "@fin": "2999-01-01", "#text": "Titre II : Recherches impliquant la personne humaine", "@debut": "2017-05-11" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145467", "@fin": "2999-01-01", "#text": "Livre Ier : Protection des personnes en matière de santé", "@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": "LEGIARTI000033416948", "@fin": "2022-01-01", "@num": "R1124-1", "@etat": "MODIFIE", "@debut": "2016-11-18", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000045303539", "@fin": "2999-01-01", "@num": "R1124-1", "@etat": "VIGUEUR", "@debut": "2022-03-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000044962563", "@fin": "2022-03-07", "@num": "R1124-1", "@etat": "MODIFIE", "@debut": "2022-01-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Lorsque la recherche porte sur un médicament composé en tout ou partie d'organismes génétiquement modifiés, les dispositions des articles R. 533-1 à R. 533-17 du code de l'environnement sont applicables.

" } }, "LEGIARTI000044962563": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R1124-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2022-03-07", "DATE_DEBUT": "2022-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000044962563", "URL": "article/LEGI/ARTI/00/00/44/96/25/LEGIARTI000044962563.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Conformément au I de l'article 10 du décret n° 2021-1905 du 30 décembre 2021, ces dispositions entrent en vigueur le 1er janvier 2022, sous les réserves énoncées au II et dans les conditions précisées au III dudit article 10 auquel il convient de se reporter.

" }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000044941356", "@num": "5", "#text": "Décret n°2021-1905 du 30 décembre 2021 - art. 5", "@sens": "cible", "@cidtexte": "JORFTEXT000044638030", "@nortexte": "TREP2130559D", "@numtexte": "2021-1905", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2021-12-30" }, { "@id": "LEGIARTI000049967621", "@num": "3", "#text": "Décret n°2024-795 du 8 juillet 2024 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000049962633", "@nortexte": "TSSP2329890D", "@numtexte": "2024-795", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-07-08" }, { "@id": "LEGIARTI000044946490", "@num": "R532-35", "#text": "Code de l'environnement - art. R532-35", "@sens": "source", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044962646", "@num": "R533-21", "#text": "Code de l'environnement - art. R533-21 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000033416941", "@fin": "2999-01-01", "#text": "Chapitre IV : Dispositions particulières relatives aux essais cliniques portant sur le médicament", "@debut": "2016-11-18" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006160948", "@fin": "2017-05-11", "#text": "Titre II : Recherches biomédicales", "@debut": "2003-05-27" }, { "@id": "LEGISCTA000034773672", "@fin": "2999-01-01", "#text": "Titre II : Recherches impliquant la personne humaine", "@debut": "2017-05-11" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145467", "@fin": "2999-01-01", "#text": "Livre Ier : Protection des personnes en matière de santé", "@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": "LEGIARTI000033416948", "@fin": "2022-01-01", "@num": "R1124-1", "@etat": "MODIFIE", "@debut": "2016-11-18", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000045303539", "@fin": "2999-01-01", "@num": "R1124-1", "@etat": "VIGUEUR", "@debut": "2022-03-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000044962563", "@fin": "2022-03-07", "@num": "R1124-1", "@etat": "MODIFIE", "@debut": "2022-01-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Lorsque la recherche porte sur un médicament composé en tout ou partie d'organismes génétiquement modifiés, les dispositions des articles R. 532-35 à R. 532-44 et R. 533-21 du code de l'environnement sont applicables.

" } }, "LEGIARTI000045303539": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R1124-1", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2022-03-07" } }, "META_COMMUN": { "ID": "LEGIARTI000045303539", "URL": "article/LEGI/ARTI/00/00/45/30/35/LEGIARTI000045303539.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

" }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000045300781", "@num": "1", "#text": "Décret n°2022-323 du 4 mars 2022 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000045300029", "@nortexte": "SSAP2138405D", "@numtexte": "2022-323", "@typelien": "DEPLACE", "@naturetexte": "DECRET", "@datesignatexte": "2022-03-04" }, { "@id": "LEGIARTI000049967621", "@num": "3", "#text": "Décret n°2024-795 du 8 juillet 2024 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000049962633", "@nortexte": "TSSP2329890D", "@numtexte": "2024-795", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-07-08" }, { "@id": "LEGIARTI000044946490", "@num": "R532-35", "#text": "Code de l'environnement - art. R532-35", "@sens": "source", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006838998", "@num": "R533-21", "#text": "Code de l'environnement - art. R533-21", "@sens": "source", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000045301426", "@fin": "2999-01-01", "#text": "Section 1 : Dispositions diverses", "@debut": "2022-03-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000033416941", "@fin": "2999-01-01", "#text": "Chapitre IV : Dispositions particulières relatives aux essais cliniques portant sur le médicament", "@debut": "2016-11-18" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006160948", "@fin": "2017-05-11", "#text": "Titre II : Recherches biomédicales", "@debut": "2003-05-27" }, { "@id": "LEGISCTA000034773672", "@fin": "2999-01-01", "#text": "Titre II : Recherches impliquant la personne humaine", "@debut": "2017-05-11" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145467", "@fin": "2999-01-01", "#text": "Livre Ier : Protection des personnes en matière de santé", "@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": "LEGIARTI000033416948", "@fin": "2022-01-01", "@num": "R1124-1", "@etat": "MODIFIE", "@debut": "2016-11-18", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000045303539", "@fin": "2999-01-01", "@num": "R1124-1", "@etat": "VIGUEUR", "@debut": "2022-03-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000044962563", "@fin": "2022-03-07", "@num": "R1124-1", "@etat": "MODIFIE", "@debut": "2022-01-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

" } }, "LEGIARTI000049974107": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R1124-1-1", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2024-07-14" } }, "META_COMMUN": { "ID": "LEGIARTI000049974107", "URL": "article/LEGI/ARTI/00/00/49/97/41/LEGIARTI000049974107.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000049967621", "@num": "3", "#text": "Décret n°2024-795 du 8 juillet 2024 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000049962633", "@nortexte": "TSSP2329890D", "@numtexte": "2024-795", "@typelien": "CREE", "@naturetexte": "DECRET", "@datesignatexte": "2024-07-08" }, { "@id": "LEGIARTI000023753593", "@num": "L4211-9-1", "#text": "Code de la santé publique - art. L4211-9-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000045301426", "@fin": "2999-01-01", "#text": "Section 1 : Dispositions diverses", "@debut": "2022-03-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000033416941", "@fin": "2999-01-01", "#text": "Chapitre IV : Dispositions particulières relatives aux essais cliniques portant sur le médicament", "@debut": "2016-11-18" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006160948", "@fin": "2017-05-11", "#text": "Titre II : Recherches biomédicales", "@debut": "2003-05-27" }, { "@id": "LEGISCTA000034773672", "@fin": "2999-01-01", "#text": "Titre II : Recherches impliquant la personne humaine", "@debut": "2017-05-11" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145467", "@fin": "2999-01-01", "#text": "Livre Ier : Protection des personnes en matière de santé", "@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": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000049974107", "@fin": "2999-01-01", "@num": "R1124-1-1", "@etat": "VIGUEUR", "@debut": "2024-07-14", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Pour l'application du II de l'article L. 4211-9-1 aux recherches impliquant la personne humaine, y compris les essais cliniques de médicaments, seuls les médicaments expérimentaux autologues de thérapie innovante préparés ponctuellement, y compris lorsqu'ils répondent à la définition des médicaments de thérapie innovante combinés, et ne faisant pas l'objet d'une manipulation substantielle au sens de l'annexe I du règlement (CE) n° 1394/2007 du Parlement européen et du Conseil du 13 novembre 2007 concernant les médicaments de thérapie innovante et modifiant la directive 2001/83/ CE ainsi que le règlement (CE) n° 726/2004, peuvent être préparés et distribués dans le cadre de la même intervention médicale que celle du prélèvement des tissus ou des cellules autologues entrant dans leur composition.

" } }, "LEGIARTI000049986831": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R1124-16", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2024-07-14" } }, "META_COMMUN": { "ID": "LEGIARTI000049986831", "URL": "article/LEGI/ARTI/00/00/49/98/68/LEGIARTI000049986831.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000412528", "#text": "Décret n°2003-462 du 21 mai 2003", "@sens": "source", "@cidtexte": "JORFTEXT000000412528", "@nortexte": "SANP0321523D", "@numtexte": "2003-462", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2003-05-21" }, { "@id": "LEGIARTI000049967621", "@num": "3", "#text": "Décret n°2024-795 du 8 juillet 2024 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000049962633", "@nortexte": "TSSP2329890D", "@numtexte": "2024-795", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2024-07-08" }, { "@id": "LEGIARTI000043272670", "@num": "R1123-20-1", "#text": "Code de la santé publique - art. R1123-20-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908460", "@num": "R1124-11", "#text": "Code de la santé publique - art. R1124-11 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908463", "@num": "R1124-14", "#text": "Code de la santé publique - art. R1124-14 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908466", "@num": "R1124-17", "#text": "Code de la santé publique - art. R1124-17 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798936", "@num": "R2028", "#text": "Code de la santé publique - art. R2028 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798936", "@num": "R2028", "#text": "Code de la santé publique - art. R2028 (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": "LEGISCTA000045301436", "@fin": "2999-01-01", "#text": "Sous-section 4 : Procédure de réexamen", "@debut": "2022-03-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000045301428", "@fin": "2999-01-01", "#text": "Section 2 : Evaluation par les comités de protection des personnes", "@debut": "2022-03-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000033416941", "@fin": "2999-01-01", "#text": "Chapitre IV : Dispositions particulières relatives aux essais cliniques portant sur le médicament", "@debut": "2016-11-18" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006160948", "@fin": "2017-05-11", "#text": "Titre II : Recherches biomédicales", "@debut": "2003-05-27" }, { "@id": "LEGISCTA000034773672", "@fin": "2999-01-01", "#text": "Titre II : Recherches impliquant la personne humaine", "@debut": "2017-05-11" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145467", "@fin": "2999-01-01", "#text": "Livre Ier : Protection des personnes en matière de santé", "@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": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006908465", "@fin": "2006-04-27", "@num": "R1124-16", "@etat": "ABROGE", "@debut": "2003-05-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000045303493", "@fin": "2024-07-14", "@num": "R1124-16", "@etat": "MODIFIE", "@debut": "2022-03-07", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000049986831", "@fin": "2999-01-01", "@num": "R1124-16", "@etat": "VIGUEUR", "@debut": "2024-07-14", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

La demande de réexamen portant sur des éléments relevant de la partie II des demandes de modification substantielle prévues à l'article 20 du règlement européen du 16 avril 2014 susmentionné est adressée par le promoteur, dans le délai d'un mois suivant la notification de l'avis défavorable du comité de la demande de modifications substantielles au ministre chargé de la santé au moyen du système d'information prévu à l'article R. 1123-20-1.

Un comité de protection des personnes est désigné selon les modalités définies au premier alinéa du II de l'article R. 1123-20-1. La demande de réexamen ne peut être attribuée au comité qui a émis le premier avis défavorable.

Le comité évalue la demande conformément aux dispositions prévues aux articles R. 1124-11 à R. 1124-12 et R. 1124-14.

" } }, "LEGIARTI000049986836": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R1124-15", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2024-07-14" } }, "META_COMMUN": { "ID": "LEGIARTI000049986836", "URL": "article/LEGI/ARTI/00/00/49/98/68/LEGIARTI000049986836.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000412528", "#text": "Décret n°2003-462 du 21 mai 2003", "@sens": "source", "@cidtexte": "JORFTEXT000000412528", "@nortexte": "SANP0321523D", "@numtexte": "2003-462", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2003-05-21" }, { "@id": "LEGIARTI000049967621", "@num": "3", "#text": "Décret n°2024-795 du 8 juillet 2024 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000049962633", "@nortexte": "TSSP2329890D", "@numtexte": "2024-795", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2024-07-08" }, { "@id": "LEGIARTI000043272670", "@num": "R1123-20-1", "#text": "Code de la santé publique - art. R1123-20-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908466", "@num": "R1124-17", "#text": "Code de la santé publique - art. R1124-17 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908453", "@num": "R1124-6", "#text": "Code de la santé publique - art. R1124-6 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798935", "@num": "R2027", "#text": "Code de la santé publique - art. R2027 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798934", "@num": "R2027", "#text": "Code de la santé publique - art. R2027 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000045301436", "@fin": "2999-01-01", "#text": "Sous-section 4 : Procédure de réexamen", "@debut": "2022-03-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000045301428", "@fin": "2999-01-01", "#text": "Section 2 : Evaluation par les comités de protection des personnes", "@debut": "2022-03-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000033416941", "@fin": "2999-01-01", "#text": "Chapitre IV : Dispositions particulières relatives aux essais cliniques portant sur le médicament", "@debut": "2016-11-18" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006160948", "@fin": "2017-05-11", "#text": "Titre II : Recherches biomédicales", "@debut": "2003-05-27" }, { "@id": "LEGISCTA000034773672", "@fin": "2999-01-01", "#text": "Titre II : Recherches impliquant la personne humaine", "@debut": "2017-05-11" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145467", "@fin": "2999-01-01", "#text": "Livre Ier : Protection des personnes en matière de santé", "@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": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006908464", "@fin": "2006-04-27", "@num": "R1124-15", "@etat": "ABROGE", "@debut": "2003-05-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000045303496", "@fin": "2024-07-14", "@num": "R1124-15", "@etat": "MODIFIE", "@debut": "2022-03-07", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000049986836", "@fin": "2999-01-01", "@num": "R1124-15", "@etat": "VIGUEUR", "@debut": "2024-07-14", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

La demande de réexamen portant sur des éléments relevant de la partie II des demandes initiales prévue à l'article 7 du règlement européen du 16 avril 2014 susmentionnée est adressée par le promoteur, dans le délai d'un mois suivant la notification de l'avis défavorable du comité au ministre chargé de la santé au moyen du système d'information prévu à l'article R. 1123-20-1.

Le comité évalue la demande conformément aux dispositions prévues aux articles R. 1124-6 à R. 1124-10.

" } }, "LEGIARTI000049986841": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R1124-7", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2024-07-14" } }, "META_COMMUN": { "ID": "LEGIARTI000049986841", "URL": "article/LEGI/ARTI/00/00/49/98/68/LEGIARTI000049986841.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000412528", "#text": "Décret n°2003-462 du 21 mai 2003", "@sens": "source", "@cidtexte": "JORFTEXT000000412528", "@nortexte": "SANP0321523D", "@numtexte": "2003-462", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2003-05-21" }, { "@id": "LEGIARTI000049967621", "@num": "3", "#text": "Décret n°2024-795 du 8 juillet 2024 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000049962633", "@nortexte": "TSSP2329890D", "@numtexte": "2024-795", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2024-07-08" }, { "@id": "LEGIARTI000043272670", "@num": "R1123-20-1", "#text": "Code de la santé publique - art. R1123-20-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908456", "@num": "R1124-8", "#text": "Code de la santé publique - art. R1124-8 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798974", "@num": "R2045", "#text": "Code de la santé publique - art. R2045 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798974", "@num": "R2045", "#text": "Code de la santé publique - art. R2045 (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": "LEGISCTA000045301432", "@fin": "2999-01-01", "#text": "Sous-section 2 : Procédure relative aux demandes initiales d'essai clinique de médicaments", "@debut": "2022-03-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000045301428", "@fin": "2999-01-01", "#text": "Section 2 : Evaluation par les comités de protection des personnes", "@debut": "2022-03-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000033416941", "@fin": "2999-01-01", "#text": "Chapitre IV : Dispositions particulières relatives aux essais cliniques portant sur le médicament", "@debut": "2016-11-18" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006160948", "@fin": "2017-05-11", "#text": "Titre II : Recherches biomédicales", "@debut": "2003-05-27" }, { "@id": "LEGISCTA000034773672", "@fin": "2999-01-01", "#text": "Titre II : Recherches impliquant la personne humaine", "@debut": "2017-05-11" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145467", "@fin": "2999-01-01", "#text": "Livre Ier : Protection des personnes en matière de santé", "@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": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006908455", "@fin": "2006-04-27", "@num": "R1124-7", "@etat": "ABROGE", "@debut": "2003-05-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000045303520", "@fin": "2024-07-14", "@num": "R1124-7", "@etat": "MODIFIE", "@debut": "2022-03-07", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000049986841", "@fin": "2999-01-01", "@num": "R1124-7", "@etat": "VIGUEUR", "@debut": "2024-07-14", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Les comités consultent les avis défavorables au moyen du système d'information mentionné à l'article R. 1123-20-1.

" } } }, "article_lien": [ { "article_id": "LEGIARTI000033416948", "cible": true, "cidtexte": "JORFTEXT000049962633", "id": "LEGIARTI000049967621", "typelien": "CITATION" }, { "article_id": "LEGIARTI000044962563", "cible": true, "cidtexte": "JORFTEXT000049962633", "id": "LEGIARTI000049967621", "typelien": "CITATION" }, { "article_id": "LEGIARTI000049974107", "cible": true, "cidtexte": "JORFTEXT000049962633", "id": "LEGIARTI000049967621", "typelien": "CREE" }, { "article_id": "LEGIARTI000045303539", "cible": true, "cidtexte": "JORFTEXT000049962633", "id": "LEGIARTI000049967621", "typelien": "CITATION" }, { "article_id": "LEGIARTI000049986831", "cible": true, "cidtexte": "JORFTEXT000049962633", "id": "LEGIARTI000049967621", "typelien": "MODIFIE" }, { "article_id": "LEGIARTI000049986836", "cible": true, "cidtexte": "JORFTEXT000049962633", "id": "LEGIARTI000049967621", "typelien": "MODIFIE" }, { "article_id": "LEGIARTI000049986841", "cible": true, "cidtexte": "JORFTEXT000049962633", "id": "LEGIARTI000049967621", "typelien": "MODIFIE" } ], "follow": [ "LIENS.LIEN[@sens=cible,@typelien=CREATION].@id" ], "id": "LEGIARTI000049967621", "liens_entrants": true }

Article 3 ENTIEREMENT_MODIF (Décret n° 2024-795 du 8 juillet 2024 relatif aux investigations cliniques et aux études des performances)