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Conformément à l'article 2 du décret n° 2019-1306 du 6 décembre 2019, ces dispositions entrent en vigueur à une date fixée par arrêté et au plus tard le 1er janvier 2021.

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Les centres régionaux de pharmacovigilance exercent les missions de vigilance relatives aux produits de santé dans les conditions définies à l'article R. 1413-61-4.

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R5144-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800542", "@num": "R5144-1", "#text": "Code de la santé publique - art. R5144-1 (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": "LEGISCTA000006196559", "@fin": "2999-01-01", "#text": "Sous-section 1 : Dispositions générales.", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190672", "@fin": "2999-01-01", "#text": "Section 13 : Pharmacovigilance", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178649", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161012", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "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": "LEGIARTI000006914902", "@fin": "2007-12-30", "@num": "R5121-150", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000017841575", "@fin": "2012-11-10", "@num": "R5121-150", "@etat": "MODIFIE", "@debut": "2007-12-30", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026596752", "@fin": "2021-07-02", "@num": "R5121-150", "@etat": "MODIFIE", "@debut": "2012-11-10", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000043761864", "@fin": "2999-01-01", "@num": "R5121-150", "@etat": "VIGUEUR", "@debut": "2021-07-02", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
La pharmacovigilance a pour objet la surveillance du risque d'effet indésirable résultant de l'utilisation des médicaments et produits à usage humain mentionnés aux articles L. 5111-2 et L. 5121-1, des produits mentionnés à l'article L. 5136-1 et des contraceptifs mentionnés à l'article L. 5134-1.
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Les sous-sections 1 à 4 de la présente section définissent des règles générales relatives à la pharmacovigilance exercée sur l'ensemble des médicaments et produits mentionnés au précédent alinéa. Ces règles s'appliquent à la pharmacovigilance exercée sur les médicaments dérivés du sang et sur les autres médicaments d'origine humaine sous réserve des règles particulières prévues pour ces médicaments par le 14° de l'article L. 5121-20.
" } }, "LEGIARTI000006914914": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5121-161", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2005-07-26", "DATE_DEBUT": "2004-08-08" } }, "META_COMMUN": { "ID": "LEGIARTI000006914914", "URL": "article/LEGI/ARTI/00/00/06/91/49/LEGIARTI000006914914.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "YXXXXXXXXXX5121R1610XX0A" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000043196022", "@num": "Annexe", "#text": "Arrêté du 28 novembre 2016 - art. Annexe (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033507633", "@nortexte": "AFSP1633476A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-11-28" }, { "@id": "LEGIARTI000034152829", "@num": "1", "#text": "Arrêté du 27 février 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150863", "@nortexte": "AFSP1706243A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000043194559", "#text": "Arrêté du 26 février 2021 - art.", "@sens": "cible", "@cidtexte": "JORFTEXT000043189686", "@nortexte": "SSAP2105925A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-02-26" }, { "@id": "LEGIARTI000033993561", "@num": "R1413-68", "#text": "Code de la santé publique - art. 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R5121-158 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026596802", "@num": "R5121-173", "#text": "Code de la santé publique - art. R5121-173 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800580", "@num": "R5144-10", "#text": "Code de la santé publique - art. R5144-10 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique R5144-10 al. 18", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006198810", "@fin": "2012-05-01", "#text": "Paragraphe 3 : Commission nationale de pharmacovigilance.", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006196560", "@fin": "2999-01-01", "#text": "Sous-section 2 : Organisation", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190672", "@fin": "2999-01-01", "#text": "Section 13 : Pharmacovigilance", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178649", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161012", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "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": "LEGIARTI000006914914", "@fin": "2005-07-26", "@num": "R5121-161", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006914915", "@fin": "2012-05-01", "@num": "R5121-161", "@etat": "ABROGE", "@debut": "2005-07-26", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026596852", "@fin": "2023-08-10", "@num": "R5121-161", "@etat": "MODIFIE", "@debut": "2012-11-10", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000047950830", "@fin": "2999-01-01", "@num": "R5121-161", "@etat": "VIGUEUR", "@debut": "2023-08-10", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Trente-deux suppléants sont désignés dans les mêmes conditions que les membres titulaires. Ils remplacent ces derniers en cas d'empêchement. Ils leur succèdent s'il se produit une vacance en cours de mandat, pour la durée du mandat restant à courir.
\n
" } }, "LEGIARTI000006914915": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5121-161", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2012-05-01", "DATE_DEBUT": "2005-07-26" } }, "META_COMMUN": { "ID": "LEGIARTI000006914915", "URL": "article/LEGI/ARTI/00/00/06/91/49/LEGIARTI000006914915.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "YXXXXXXXXXX5121R1610XX0B" } }, "NOTA": { "CONTENU": "

Décret n° 2009-631 du 6 juin 2009 article 1 : Les dispositions réglementaires instituant les commissions administratives à caractère consultatif dont la liste est annexée au présent décret sont prorogées pour une durée de cinq ans. (Commission nationale de pharmacovigilance vétérinaire).

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" }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "JORFTEXT000000814956", "#text": "Décret 2005-840 2005-07-20 art. 12 4° JORF 26 juillet 2005", "@sens": "source", "@cidtexte": "JORFTEXT000000814956", "@nortexte": "SANP0522707D", "@numtexte": "2005-840", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2005-07-20" }, { "@id": "LEGIARTI000025765488", "@num": "4", "#text": "Décret n°2012-597\n du 27 avril 2012 - art. 4", "@sens": "cible", "@cidtexte": "JORFTEXT000025757625", "@nortexte": "ETSP1206945D", "@numtexte": "2012-597", "@typelien": "ABROGE", "@naturetexte": "DECRET", "@datesignatexte": "2012-04-27" }, { "@id": "LEGIARTI000043196022", "@num": "Annexe", "#text": "Arrêté du 28 novembre 2016 - art. Annexe (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033507633", "@nortexte": "AFSP1633476A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-11-28" }, { "@id": "LEGIARTI000034152829", "@num": "1", "#text": "Arrêté du 27 février 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150863", "@nortexte": "AFSP1706243A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000043194559", "#text": "Arrêté du 26 février 2021 - art.", "@sens": "cible", "@cidtexte": "JORFTEXT000043189686", "@nortexte": "SSAP2105925A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-02-26" }, { "@id": "LEGIARTI000033993561", "@num": "R1413-68", "#text": "Code de la santé publique - art. R1413-68 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026596733", "@num": "R5121-153", "#text": "Code de la santé publique - art. R5121-153 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034687102", "@num": "R5121-155", "#text": "Code de la santé publique - art. R5121-155 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039659066", "@num": "R5121-158", "#text": "Code de la santé publique - art. R5121-158 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914913", "@num": "R5121-160", "#text": "Code de la santé publique - art. R5121-160", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026596802", "@num": "R5121-173", "#text": "Code de la santé publique - art. R5121-173 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800580", "@num": "R5144-10", "#text": "Code de la santé publique - art. R5144-10 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique R5144-10 al. 18", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006198810", "@fin": "2012-05-01", "#text": "Paragraphe 3 : Commission nationale de pharmacovigilance.", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006196560", "@fin": "2999-01-01", "#text": "Sous-section 2 : Organisation", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190672", "@fin": "2999-01-01", "#text": "Section 13 : Pharmacovigilance", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178649", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161012", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "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": "LEGIARTI000006914914", "@fin": "2005-07-26", "@num": "R5121-161", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006914915", "@fin": "2012-05-01", "@num": "R5121-161", "@etat": "ABROGE", "@debut": "2005-07-26", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026596852", "@fin": "2023-08-10", "@num": "R5121-161", "@etat": "MODIFIE", "@debut": "2012-11-10", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000047950830", "@fin": "2999-01-01", "@num": "R5121-161", "@etat": "VIGUEUR", "@debut": "2023-08-10", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Des membres suppléants sont désignés dans les mêmes conditions que les membres titulaires mentionnés au 2° de l'article R. 5121-160. Ils remplacent ces derniers en cas d'empêchement. Ils leur succèdent s'il se produit une vacance en cours de mandat, pour la durée du mandat restant à courir.
\n
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La pharmacovigilance a pour objet la surveillance du risque d'effet indésirable résultant de l'utilisation des médicaments et produits à usage humain mentionnés à l'article L. 5121-1.
\n
Les sous-sections 1 à 4 de la présente section définissent des règles générales relatives à la pharmacovigilance exercée sur l'ensemble des médicaments et produits mentionnés au précédent alinéa. Ces règles s'appliquent à la pharmacovigilance exercée sur les médicaments dérivés du sang et sur les autres médicaments d'origine humaine sous réserve des règles particulières prévues pour ces médicaments par le 14° de l'article L. 5121-20.
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R6133-4 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171459", "@fin": "2999-01-01", "#text": "Chapitre III : Groupements de coopération sanitaire.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155108", "@fin": "2999-01-01", "#text": "Titre III : Coopération", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140636", "@fin": "2999-01-01", "#text": "Livre Ier : Etablissements de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125350", "@fin": "2999-01-01", "#text": "Sixième partie : Etablissements et services de 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": "LEGIARTI000020892305", "@fin": "2010-02-26", "@num": "L6133-7", "@etat": "MODIFIE", "@debut": "2009-07-23", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000021940263", "@fin": "2017-01-14", "@num": "L6133-7", "@etat": "MODIFIE", "@debut": "2010-02-26", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000033862913", "@fin": "2019-08-08", "@num": "L6133-7", "@etat": "MODIFIE", "@debut": "2017-01-14", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000038921958", "@fin": "2023-12-29", "@num": "L6133-7", "@etat": "MODIFIE", "@debut": "2019-08-08", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000048690971", "@fin": "2999-01-01", "@num": "L6133-7", "@etat": "VIGUEUR", "@debut": "2023-12-29", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Lorsqu'il est titulaire d'une ou plusieurs autorisations d'activités de soins, le groupement de coopération sanitaire est un établissement de santé avec les droits et obligations afférents. Le groupement de coopération sanitaire de droit privé est érigé en établissement de santé privé et le groupement de coopération sanitaire de droit public est érigé en établissement public de santé, par décision du directeur général de l'agence régionale de santé.
\n
Lorsque le groupement de coopération sanitaire est un établissement public de santé, les règles de fonctionnement et de gouvernance des établissements publics de santé s'appliquent, sous les réserves suivantes :
\n
1° Les fonctions de l'administrateur du groupement sont exercées en sus des fonctions du directeur mentionnées à l'article L. 6143-7 ;
\n
2° Le conseil de surveillance est composé comme suit :
\n
a) Cinq représentants des collectivités territoriales ou de leurs groupements, désignés par les assemblées délibérantes des collectivités territoriales ou de leurs groupements sur le territoire desquels les établissements membres sont implantés ;
\n
b) Cinq représentants du personnel médical et non médical du groupement de coopération sanitaire qualifié d'établissement public de santé, dont trois désignés par le comité technique d'établissement et deux désignés par la commission médicale d'établissement ;
\n
c) Cinq personnalités qualifiées, parmi lesquelles deux désignées par le directeur général de l'agence régionale de santé et trois, dont deux représentants des usagers au sens de l'article L. 1114-1, désignées par le représentant de l'Etat dans le département.

" } }, "LEGIARTI000021940263": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L6133-7", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2017-01-14", "DATE_DEBUT": "2010-02-26" } }, "META_COMMUN": { "ID": "LEGIARTI000021940263", "URL": "article/LEGI/ARTI/00/00/21/94/02/LEGIARTI000021940263.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000025500368", "@num": "23", "#text": "LOI n° 2009-879 du 21 juillet 2009 - art. 23 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020879475", "@nortexte": "SASX0822640L", "@numtexte": "2009-879", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2009-07-21" }, { "@id": "LEGIARTI000021869992", "@num": "6", "#text": "Ordonnance n°2010-177\n du 23 février 2010 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000021868310", "@nortexte": "SASX0930688R", "@numtexte": "2010-177", "@typelien": "MODIFIE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2010-02-23" }, { "@id": "LEGIARTI000047009511", "@num": "1", "#text": "Décret n°2012-1246\n du 7 novembre 2012 - art. 1 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000026597003", "@nortexte": "EFIX1205948D", "@numtexte": "2012-1246", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2012-11-07" }, { "@id": "LEGIARTI000037280868", "@num": "4", "#text": "Décret n°2018-689 du 1er août 2018 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000037277851", "@nortexte": "CPAE1815650D", "@numtexte": "2018-689", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2018-08-01" }, { "@id": "LEGITEXT000050919372", "#text": "Décret n°2024-1235 du 30 décembre 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000050871356", "@nortexte": "TSSH2414989D", "@numtexte": "2024-1235", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-12-30" }, { "@id": "LEGIARTI000044634640", "@num": "D1432-38", "#text": "Code de la santé publique - art. D1432-38 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685816", "@num": "L1114-1", "#text": "Code de la santé publique - art. L1114-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033620969", "@num": "L5126-10", "#text": "Code de la santé publique - art. L5126-10 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044317184", "@num": "L6113-4", "#text": "Code de la santé publique - art. L6113-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690983", "@num": "L6143-7", "#text": "Code de la santé publique - art. L6143-7", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039659066", "@num": "R5121-158", "#text": "Code de la santé publique - art. R5121-158 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025787852", "@num": "R5121-167", "#text": "Code de la santé publique - art. R5121-167 (T)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000038598402", "@num": "R5121-181", "#text": "Code de la santé publique - art. R5121-181 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026886518", "@num": "R5121-191", "#text": "Code de la santé publique - art. R5121-191 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034102382", "@num": "R5121-83", "#text": "Code de la santé publique - art. R5121-83 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043761956", "@num": "R5121-88", "#text": "Code de la santé publique - art. R5121-88 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000038597085", "@num": "R5126-111", "#text": "Code de la santé publique - art. R5126-111 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000041963168", "@num": "R5126-4", "#text": "Code de la santé publique - art. R5126-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026886414", "@num": "R5212-37", "#text": "Code de la santé publique - art. R5212-37 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000022055186", "@num": "R6111-1", "#text": "Code de la santé publique - art. R6111-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026886398", "@num": "R6111-12", "#text": "Code de la santé publique - art. R6111-12 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000022055178", "@num": "R6111-8", "#text": "Code de la santé publique - art. R6111-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000022517301", "@num": "R6133-12", "#text": "Code de la santé publique - art. R6133-12 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034502012", "@num": "R6133-15", "#text": "Code de la santé publique - art. R6133-15 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000047009499", "@num": "R6133-4", "#text": "Code de la santé publique - art. R6133-4 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171459", "@fin": "2999-01-01", "#text": "Chapitre III : Groupements de coopération sanitaire.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155108", "@fin": "2999-01-01", "#text": "Titre III : Coopération", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140636", "@fin": "2999-01-01", "#text": "Livre Ier : Etablissements de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125350", "@fin": "2999-01-01", "#text": "Sixième partie : Etablissements et services de 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": "LEGIARTI000020892305", "@fin": "2010-02-26", "@num": "L6133-7", "@etat": "MODIFIE", "@debut": "2009-07-23", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000021940263", "@fin": "2017-01-14", "@num": "L6133-7", "@etat": "MODIFIE", "@debut": "2010-02-26", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000033862913", "@fin": "2019-08-08", "@num": "L6133-7", "@etat": "MODIFIE", "@debut": "2017-01-14", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000038921958", "@fin": "2023-12-29", "@num": "L6133-7", "@etat": "MODIFIE", "@debut": "2019-08-08", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000048690971", "@fin": "2999-01-01", "@num": "L6133-7", "@etat": "VIGUEUR", "@debut": "2023-12-29", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Lorsque le groupement de coopération sanitaire est un établissement public de santé, les règles de fonctionnement et de gouvernance des établissements publics de santé s'appliquent, sous les réserves suivantes :

1° Les fonctions de l'administrateur du groupement sont exercées en sus des fonctions du directeur mentionnées à l'article L. 6143-7 ;

2° Le conseil de surveillance est composé comme suit :

a) Cinq représentants des collectivités territoriales ou de leurs groupements, désignés par les assemblées délibérantes des collectivités territoriales ou de leurs groupements sur le territoire desquels les établissements membres sont implantés ;

b) Cinq représentants du personnel médical et non médical du groupement de coopération sanitaire érigé en établissement public de santé, dont trois désignés par le comité technique d'établissement et deux désignés par la commission médicale d'établissement ;

c) Cinq personnalités qualifiées, parmi lesquelles deux désignées par le directeur général de l'agence régionale de santé et trois, dont deux représentants des usagers au sens de l'article L. 1114-1, désignées par le représentant de l'Etat dans le département.

" } }, "LEGIARTI000026596752": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5121-150", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2021-07-02", "DATE_DEBUT": "2012-11-10" } }, "META_COMMUN": { "ID": "LEGIARTI000026596752", "URL": "article/LEGI/ARTI/00/00/26/59/67/LEGIARTI000026596752.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000046423274", "#text": "Arrêté du 6 avril 2011 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023865866", "@nortexte": "ETSH1109848A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-04-06" }, { "@id": "LEGITEXT000026593781", "#text": "Décret n°2012-1244\n du 8 novembre 2012 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000026592596", "@nortexte": "AFSP1232131D", "@numtexte": "2012-1244", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2012-11-08" }, { "@id": "LEGIARTI000026593806", "@num": "5", "#text": "Décret n°2012-1244\n du 8 novembre 2012 - art. 5", "@sens": "cible", "@cidtexte": "JORFTEXT000026592596", "@nortexte": "AFSP1232131D", "@numtexte": "2012-1244", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2012-11-08" }, { "@id": "LEGITEXT000027514577", "#text": "Décret n°2013-473\n du 5 juin 2013 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027513604", "@nortexte": "AFSP1308402D", "@numtexte": "2013-473", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2013-06-05" }, { "@id": "LEGITEXT000028083099", "#text": "Décret n°2013-923\n du 16 octobre 2013 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000028081088", "@nortexte": "AFSP1320840D", "@numtexte": "2013-923", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2013-10-16" }, { "@id": "LEGITEXT000032102397", "#text": "Décret n°2016-183 du 23 février 2016 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000032101471", "@nortexte": "AFSP1528786D", "@numtexte": "2016-183", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2016-02-23" }, { "@id": "LEGITEXT000032924021", "#text": "Décret n°2016-993 du 20 juillet 2016 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000032922434", "@nortexte": "AFSP1605997D", "@numtexte": "2016-993", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2016-07-20" }, { "@id": "LEGIARTI000045400745", "@num": "4", "#text": "Arrêté du 21 février 2022 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000045398455", "@nortexte": "SSAP2201963A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-02-21" }, { "@id": "LEGIARTI000033642723", "@num": "D6141-37", "#text": "Code de la santé publique - art. D6141-37 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689013", "@num": "L4211-6", "#text": "Code de la santé publique - art. L4211-6", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689870", "@num": "L5121-1", "#text": "Code de la santé publique - art. L5121-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689900", "@num": "L5121-12", "#text": "Code de la santé publique - art. L5121-12", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689906", "@num": "L5121-14-1", "#text": "Code de la santé publique - art. L5121-14-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689921", "@num": "L5121-20", "#text": "Code de la santé publique - art. L5121-20", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689889", "@num": "L5121-8", "#text": "Code de la santé publique - art. L5121-8 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689893", "@num": "L5121-9-1", "#text": "Code de la santé publique - art. L5121-9-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026596747", "@num": "R5121-151", "#text": "Code de la santé publique - art. R5121-151 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028083982", "@num": "R5121-152", "#text": "Code de la santé publique - art. R5121-152 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026596733", "@num": "R5121-153", "#text": "Code de la santé publique - art. R5121-153 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039659081", "@num": "R5121-154", "#text": "Code de la santé publique - art. R5121-154 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034687102", "@num": "R5121-155", "#text": "Code de la santé publique - art. R5121-155 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026596709", "@num": "R5121-156", "#text": "Code de la santé publique - art. R5121-156 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028083986", "@num": "R5121-157", "#text": "Code de la santé publique - art. R5121-157 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039659066", "@num": "R5121-158", "#text": "Code de la santé publique - art. R5121-158 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914912", "@num": "R5121-159", "#text": "Code de la santé publique - art. R5121-159 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000024555562", "@num": "R5121-160", "#text": "Code de la santé publique - art. R5121-160 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000047950830", "@num": "R5121-161", "#text": "Code de la santé publique - art. R5121-161 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026596847", "@num": "R5121-162", "#text": "Code de la santé publique - art. R5121-162 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026596841", "@num": "R5121-163", "#text": "Code de la santé publique - art. R5121-163 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034687077", "@num": "R5121-164", "#text": "Code de la santé publique - art. R5121-164 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026596829", "@num": "R5121-165", "#text": "Code de la santé publique - art. R5121-165 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026596825", "@num": "R5121-166", "#text": "Code de la santé publique - art. 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R5121-168 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914926", "@num": "R5121-169", "#text": "Code de la santé publique - art. R5121-169", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000024166844", "@num": "R5121-170", "#text": "Code de la santé publique - art. R5121-170 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000017841601", "@num": "R5121-171", "#text": "Code de la santé publique - art. 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La pharmacovigilance s'exerce :
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1° Pour les médicaments et pour les produits devant faire l'objet de l'autorisation de mise sur le marché prévue par l'article L. 5121-8, après la délivrance de cette autorisation ;
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2° Pour les médicaments mentionnés à l'article L. 5121-12, après la délivrance de l'autorisation temporaire d'utilisation, sous réserve des règles particulières prévues pour ces médicaments à l'article R. 5121-169 ;
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3° Pour les médicaments homéopathiques mentionnés à l'article L. 5121-13, après l'enregistrement prévu par cet article ;
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4° Pour les médicaments traditionnels à base de plantes mentionnés à l'article L. 5121-14-1, après l'enregistrement prévu à cet article ;
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5° Pour les autres produits mentionnés à l'article L. 5121-1 après leur délivrance ;
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6° Pour les allergènes, préparés spécialement pour un seul individu, mentionnés à l'article L. 4211-6, après la délivrance de l'autorisation prévue par cet article ;
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7° Pour les médicaments dérivés du sang et pour les autres médicaments d'origine humaine, sous réserve des règles particulières prévues pour ces médicaments par le 14° de l'article L. 5121-20 ;
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8° Pour les médicaments mentionnés à l'article L. 5121-9-1 après la délivrance de l'autorisation prévue à ce même article.
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" }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000787339", "#text": "Décret n°2004-802 du 29 juillet 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000026593806", "@num": "5", "#text": "Décret n°2012-1244\n du 8 novembre 2012 - art. 5", "@sens": "cible", "@cidtexte": "JORFTEXT000026592596", "@nortexte": "AFSP1232131D", "@numtexte": "2012-1244", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2012-11-08" }, { "@id": "LEGIARTI000043196022", "@num": "Annexe", "#text": "Arrêté du 28 novembre 2016 - art. 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Le médecin, le chirurgien-dentiste, la sage-femme ou le pharmacien déclare immédiatement tout effet indésirable suspecté d'être dû à un médicament ou à un produit mentionné à l'article R. 5121-150, dont il a connaissance, au centre régional de pharmacovigilance.
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Les autres professionnels de santé, les patients et les associations agréées de patients peuvent déclarer tout effet indésirable suspecté d'être dû à un médicament ou à un produit mentionné à l'article R. 5121-150, dont ils ont connaissance, au centre régional de pharmacovigilance.
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Le directeur général de l'Agence nationale de sécurité du médicament et des produits de santé rend publics, sur le site internet de l'agence, les informations relatives aux différents modes de notification des effets indésirables suspectés d'être dus à un médicament ou à un produit mentionné à l'article R. 5121-150 par les professionnels de santé et les patients ainsi que le formulaire de déclaration de ces effets indésirables.

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Le directeur général de l'agence régionale de santé organise, en lien avec les personnes et structures mentionnées à l'article R. 1413-62 et les cellules d'intervention en région mentionnées à l'article L. 1413-2, le recueil et la transmission vers l'agence, et le traitement partagé :
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1° Des données relatives aux maladies notifiées ou signalées dans les conditions prévues par les articles R. 3113-2 et R. 3113-4 ;
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2° Des déclarations d'infections associées aux soins et d'événements indésirables graves liés aux soins, mentionnés à l'article L. 1413-14 ;
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3° Des signalements effectués en application de l'article L. 1413-15.
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Les structures mentionnées au premier alinéa de l'article R. 1413-62 transmettent en outre au directeur général de l'agence régionale de santé les signalements recueillis dans l'exercice de leurs missions de sécurité sanitaire qui sont de nature à rendre nécessaire une intervention de l'agence régionale de santé dans l'exercice de ses missions et qui répondent à des critères définis par un arrêté du ministre chargé de la santé.
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En application de l'article L. 1435-12, le directeur général de l'agence régionale de santé constitue et anime un réseau régional de vigilances et d'appui comprenant les personnes et les représentants des structures mentionnées aux articles R. 1221-32, R. 1341-26, R. 5121-158 et R. 5132-112. Il associe au réseau toute autre structure chargée d'améliorer la qualité et la sécurité des prises en charge en santé dans la région. Il coordonne l'activité régionale de ces structures dans le respect de leurs missions et leurs obligations respectives.
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Dans le cadre de ce réseau, le directeur général de l'agence régionale de santé, en lien avec les agences et autorités nationales compétentes :
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1° Définit le programme de travail auquel contribuent les membres du réseau régional de vigilances et d'appui pour la mise en œuvre, dans le ressort territorial de l'agence régionale de santé, de la politique de développement de la qualité et de la sécurité des prises en charge en santé, et organise, dans ce champ, la coordination de leurs actions ;
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2° Favorise les mutualisations entre membres du réseau régional de vigilances et d'appui, portant notamment sur les outils, les méthodes et les moyens.
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Les cellules d'intervention en région mentionnées à l'article L. 1413-2 apportent leur concours au réseau régional de vigilances et d'appui dans les conditions prévues à l'article R. 1413-44.
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R1413-59 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000050932880", "@num": "R1413-61", "#text": "Code de la santé publique - art. R1413-61 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034686992", "@num": "R1413-77", "#text": "Code de la santé publique - art. R1413-77 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033992118", "@num": "R1413-83", "#text": "Code de la santé publique - art. 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En application de l'article L. 1435-12, le directeur général de l'agence régionale de santé constitue et anime un réseau régional de vigilances et d'appui comprenant les personnes et les représentants des structures mentionnées aux articles R. 1221-32, R. 1340-4, R. 5121-158 et R. 5132-112. Il associe au réseau toute autre structure chargée d'améliorer la qualité et la sécurité des prises en charge en santé dans la région. Il coordonne l'activité régionale de ces structures dans le respect de leurs missions et leurs obligations respectives.
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Dans le cadre de ce réseau, le directeur général de l'agence régionale de santé, en lien avec les agences et autorités nationales compétentes :
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1° Définit le programme de travail auquel contribuent les membres du réseau régional de vigilances et d'appui pour la mise en œuvre, dans le ressort territorial de l'agence régionale de santé, de la politique de développement de la qualité et de la sécurité des prises en charge en santé, et organise, dans ce champ, la coordination de leurs actions ;
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2° Favorise les mutualisations entre membres du réseau régional de vigilances et d'appui, portant notamment sur les outils, les méthodes et les moyens.
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Les cellules d'intervention en région mentionnées à l'article L. 1413-2 apportent leur concours au réseau régional de vigilances et d'appui dans les conditions prévues à l'article R. 1413-44.
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\n

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1° Les fonctions de l'administrateur du groupement sont exercées en sus des fonctions du directeur mentionnées à l'article L. 6143-7 ;

2° Le conseil de surveillance est composé comme suit :

Par dérogation aux dispositions du premier alinéa, un groupement de coopération sanitaire de moyens dont la seule autorisation d'activité de soins dont il est titulaire est une autorisation d'activité biologique d'assistance médicale à la procréation n'est pas érigé en établissement de santé.

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Conformément à l'article 4 du décret n° 2017-129 du 3 février 2017, ces dispositions entrent en vigueur le 1er avril 2017.

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(V)", "@sens": "cible", "@cidtexte": "JORFTEXT000046566303", "@nortexte": "SPRP2231874A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-11-14" }, { "@id": "LEGIARTI000049976728", "@num": "Annexe 1", "#text": "Arrêté du 14 novembre 2022 - art. Annexe 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000046566303", "@nortexte": "SPRP2231874A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-11-14" }, { "@id": "LEGIARTI000006686953", "@num": "L1413-2", "#text": "Code de la santé publique - art. L1413-2", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000031921206", "@num": "L1435-12", "#text": "Code de la santé publique - art. L1435-12", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034686880", "@num": "R1221-32", "#text": "Code de la santé publique - art. R1221-32 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033626679", "@num": "R1340-4", "#text": "Code de la santé publique - art. R1340-4 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034686911", "@num": "R1340-5", "#text": "Code de la santé publique - art. R1340-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000032475567", "@num": "R1413-44", "#text": "Code de la santé publique - art. R1413-44", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000047913673", "@num": "R1413-59", "#text": "Code de la santé publique - art. R1413-59 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000050932880", "@num": "R1413-61", "#text": "Code de la santé publique - art. R1413-61 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034686992", "@num": "R1413-77", "#text": "Code de la santé publique - art. R1413-77 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033992118", "@num": "R1413-83", "#text": "Code de la santé publique - art. R1413-83 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039659066", "@num": "R5121-158", "#text": "Code de la santé publique - art. R5121-158 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034687207", "@num": "R5132-112", "#text": "Code de la santé publique - art. R5132-112 (T)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000035838233", "@num": "D162-6", "#text": "Code de la sécurité sociale. - art. D162-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000033522392", "@fin": "2021-01-01", "#text": "Sous-section 2 : Réseau régional de vigilances et d'appui", "@debut": "2017-04-01" }, { "@id": "LEGISCTA000039658989", "@fin": "2999-01-01", "#text": "Sous-section 3 : Réseau régional de vigilances et d'appui", "@debut": "2021-01-01" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000033522382", "@fin": "2999-01-01", "#text": "Section 4 : Veille et sécurité sanitaire", "@debut": "2017-04-01" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178523", "@fin": "2016-05-01", "#text": "Chapitre III : Sécurité, veille et alerte sanitaires", "@debut": "2003-05-27" }, { "@id": "LEGISCTA000032481161", "@fin": "2999-01-01", "#text": "Chapitre III : Veille sanitaire, urgence sanitaire et promotion de la santé", "@debut": "2016-05-01" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006160962", "@fin": "2999-01-01", "#text": "Titre Ier : Institutions", "@debut": "2003-05-27" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145470", "@fin": "2999-01-01", "#text": "Livre IV : Administration générale de la santé", "@debut": "2000-12-23" } ] }, "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": "LEGIARTI000033992574", "@fin": "2017-05-11", "@num": "R1413-62", "@etat": "MODIFIE", "@debut": "2017-04-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE_MORT_NE", "LIEN_ART": { "@id": "LEGIARTI000033627752", "@fin": "2017-02-06", "@num": "R1413-62", "@etat": "MODIFIE_MORT_NE", "@debut": "2017-04-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE_MORT_NE", "LIEN_ART": { "@id": "LEGIARTI000033522394", "@fin": "2016-12-18", "@num": "R1413-62", "@etat": "MODIFIE_MORT_NE", "@debut": "2017-04-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000034687046", "@fin": "2017-10-21", "@num": "R1413-62", "@etat": "MODIFIE", "@debut": "2017-05-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000035838208", "@fin": "2021-01-01", "@num": "R1413-62", "@etat": "MODIFIE", "@debut": "2017-10-21", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000039658991", "@fin": "2022-11-21", "@num": "R1413-62", "@etat": "MODIFIE", "@debut": "2021-01-01", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000046581336", "@fin": "2999-01-01", "@num": "R1413-62", "@etat": "VIGUEUR", "@debut": "2022-11-21", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
\n

Dans le cadre de ce réseau, le directeur général de l'agence régionale de santé, en lien avec les agences et autorités nationales compétentes :

1° Définit le programme de travail auquel contribuent les membres du réseau régional de vigilances et d'appui pour la mise en œuvre, dans le ressort territorial de l'agence régionale de santé, de la politique de développement de la qualité et de la sécurité des prises en charge en santé, et organise, dans ce champ, la coordination de leurs actions ;

2° Favorise les mutualisations entre membres du réseau régional de vigilances et d'appui, portant notamment sur les outils, les méthodes et les moyens.

Les cellules d'intervention en région mentionnées à l'article L. 1413-2 apportent leur concours au réseau régional de vigilances et d'appui dans les conditions prévues à l'article R. 1413-44.

\n
\n

\n
" } }, "LEGIARTI000034687046": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R1413-62", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2017-10-21", "DATE_DEBUT": "2017-05-11" } }, "META_COMMUN": { "ID": "LEGIARTI000034687046", "URL": "article/LEGI/ARTI/00/00/34/68/70/LEGIARTI000034687046.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Conformément à l'article 4 du décret n° 2017-129 du 3 février 2017, ces dispositions entrent en vigueur le 1er avril 2017.

" }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000034078013", "@num": "1", "#text": "Arrêté du 20 février 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034074178", "@nortexte": "AFSP1705441A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-20" }, { "@id": "LEGIARTI000034668031", "@num": "4", "#text": "Décret n°2017-885 du 9 mai 2017 - art. 4", "@sens": "cible", "@cidtexte": "JORFTEXT000034634287", "@nortexte": "AFSP1706658D", "@numtexte": "2017-885", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2017-05-09" }, { "@id": "LEGIARTI000046567251", "@num": "Annexe 2", "#text": "Arrêté du 14 novembre 2022 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000046566303", "@nortexte": "SPRP2231874A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-11-14" }, { "@id": "LEGIARTI000049976728", "@num": "Annexe 1", "#text": "Arrêté du 14 novembre 2022 - art. Annexe 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000046566303", "@nortexte": "SPRP2231874A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-11-14" }, { "@id": "LEGIARTI000006686953", "@num": "L1413-2", "#text": "Code de la santé publique - art. L1413-2", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000031921206", "@num": "L1435-12", "#text": "Code de la santé publique - art. L1435-12", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034686880", "@num": "R1221-32", "#text": "Code de la santé publique - art. R1221-32 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033626679", "@num": "R1340-4", "#text": "Code de la santé publique - art. R1340-4", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034686911", "@num": "R1340-5", "#text": "Code de la santé publique - art. R1340-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000032475567", "@num": "R1413-44", "#text": "Code de la santé publique - art. R1413-44", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000047913673", "@num": "R1413-59", "#text": "Code de la santé publique - art. R1413-59 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000050932880", "@num": "R1413-61", "#text": "Code de la santé publique - art. R1413-61 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033496391", "@num": "R1413-75", "#text": "Code de la santé publique - art. R1413-75 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034686992", "@num": "R1413-77", "#text": "Code de la santé publique - art. 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R5132-112 (T)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000035838233", "@num": "D162-6", "#text": "Code de la sécurité sociale. - art. D162-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000033522392", "@fin": "2021-01-01", "#text": "Sous-section 2 : Réseau régional de vigilances et d'appui", "@debut": "2017-04-01" }, { "@id": "LEGISCTA000039658989", "@fin": "2999-01-01", "#text": "Sous-section 3 : Réseau régional de vigilances et d'appui", "@debut": "2021-01-01" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000033522382", "@fin": "2999-01-01", "#text": "Section 4 : Veille et sécurité sanitaire", "@debut": "2017-04-01" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178523", "@fin": "2016-05-01", "#text": "Chapitre III : Sécurité, veille et alerte sanitaires", "@debut": "2003-05-27" }, { "@id": "LEGISCTA000032481161", "@fin": "2999-01-01", "#text": "Chapitre III : Veille sanitaire, urgence sanitaire et promotion de la santé", "@debut": "2016-05-01" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006160962", "@fin": "2999-01-01", "#text": "Titre Ier : Institutions", "@debut": "2003-05-27" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145470", "@fin": "2999-01-01", "#text": "Livre IV : Administration générale de la santé", "@debut": "2000-12-23" } ] }, "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": "LEGIARTI000033992574", "@fin": "2017-05-11", "@num": "R1413-62", "@etat": "MODIFIE", "@debut": "2017-04-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE_MORT_NE", "LIEN_ART": { "@id": "LEGIARTI000033627752", "@fin": "2017-02-06", "@num": "R1413-62", "@etat": "MODIFIE_MORT_NE", "@debut": "2017-04-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE_MORT_NE", "LIEN_ART": { "@id": "LEGIARTI000033522394", "@fin": "2016-12-18", "@num": "R1413-62", "@etat": "MODIFIE_MORT_NE", "@debut": "2017-04-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000034687046", "@fin": "2017-10-21", "@num": "R1413-62", "@etat": "MODIFIE", "@debut": "2017-05-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000035838208", "@fin": "2021-01-01", "@num": "R1413-62", "@etat": "MODIFIE", "@debut": "2017-10-21", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000039658991", "@fin": "2022-11-21", "@num": "R1413-62", "@etat": "MODIFIE", "@debut": "2021-01-01", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000046581336", "@fin": "2999-01-01", "@num": "R1413-62", "@etat": "VIGUEUR", "@debut": "2022-11-21", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Dans le cadre de ce réseau, le directeur général de l'agence régionale de santé, en lien avec les agences et autorités nationales compétentes :

2° Favorise les mutualisations entre membres du réseau régional de vigilances et d'appui, portant notamment sur les outils, les méthodes et les moyens.

Les cellules d'intervention en région mentionnées à l'article L. 1413-2 apportent leur concours au réseau régional de vigilances et d'appui dans les conditions prévues à l'article R. 1413-44.

" } }, "LEGIARTI000034687057": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R1413-59", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2023-08-02", "DATE_DEBUT": "2017-05-11" } }, "META_COMMUN": { "ID": "LEGIARTI000034687057", "URL": "article/LEGI/ARTI/00/00/34/68/70/LEGIARTI000034687057.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000034668031", "@num": "4", "#text": "Décret n°2017-885 du 9 mai 2017 - art. 4", "@sens": "cible", "@cidtexte": "JORFTEXT000034634287", "@nortexte": "AFSP1706658D", "@numtexte": "2017-885", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2017-05-09" }, { "@id": "LEGIARTI000006686977", "@num": "L1413-14", "#text": "Code de la santé publique - art. 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\n

\n
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1° Des données relatives aux maladies notifiées ou signalées dans les conditions prévues par les articles R. 3113-2 et R. 3113-4 ;

2° Des déclarations d'infections associées aux soins et d'événements indésirables graves associés à des soins, mentionnés à l'article L. 1413-14 ;

3° Des signalements effectués en application de l'article L. 1413-15.

Les structures mentionnées au premier alinéa de l'article R. 1413-62 transmettent en outre au directeur général de l'agence régionale de santé les signalements recueillis dans l'exercice de leurs missions de sécurité sanitaire qui sont de nature à rendre nécessaire une intervention de l'agence régionale de santé dans l'exercice de ses missions et qui répondent à des critères définis par un arrêté du ministre chargé de la santé.

\n
\n
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Dans le cadre de ce réseau, le directeur général de l'agence régionale de santé, en lien avec les agences et autorités nationales compétentes :

2° Favorise les mutualisations entre membres du réseau régional de vigilances et d'appui, portant notamment sur les outils, les méthodes et les moyens.

Les cellules d'intervention en région mentionnées à l'article L. 1413-2 apportent leur concours au réseau régional de vigilances et d'appui dans les conditions prévues à l'article R. 1413-44.

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Conformément au A du II de l'article 94 de la loi n° 2019-828 du 6 août 2019, ces dispositions entrent en vigueur en vue du prochain renouvellement général des instances dans la fonction publique.

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1° Les fonctions de l'administrateur du groupement sont exercées en sus des fonctions du directeur mentionnées à l'article L. 6143-7 ;

2° Le conseil de surveillance est composé comme suit :

b) Cinq représentants du personnel médical et non médical du groupement de coopération sanitaire érigé en établissement public de santé, dont trois désignés par le comité social d'établissement et deux désignés par la commission médicale d'établissement ;

" } }, "LEGIARTI000039458786": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "1", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000039458786", "URL": "article/LEGI/ARTI/00/00/39/45/87/LEGIARTI000039458786.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGISCTA000025788971", "#text": "Code de la santé publique - Paragraphe 1 : Agence nationale de sécurité du ... (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000025788969", "#text": "Code de la santé publique - Paragraphe 1 : Agence nationale de sécurité du ... 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R5132-104 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039659123", "@num": "R5132-105", "#text": "Code de la santé publique - art. R5132-105 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034687207", "@num": "R5132-112", "#text": "Code de la santé publique - art. R5132-112 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "TRANSFERE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034687202", "@num": "R5132-113", "#text": "Code de la santé publique - art. R5132-113 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "TRANSFERE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034687195", "@num": "R5132-114", "#text": "Code de la santé publique - art. R5132-114 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "TRANSFERE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034687188", "@num": "R5132-115", "#text": "Code de la santé publique - art. R5132-115 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "TRANSFERE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025787465", "@num": "R5132-116", "#text": "Code de la santé publique - art. R5132-116 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039659171", "@num": "R5132-97", "#text": "Code de la santé publique - art. R5132-97 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "DEPLACE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039659165", "@num": "R5132-98", "#text": "Code de la santé publique - art. R5132-98 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "DEPLACE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039659101", "@num": "R5132-99", "#text": "Code de la santé publique - art. R5132-99 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039659181", "@num": "R5212-12", "#text": "Code de la santé publique - art. R5212-12 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039659186", "@num": "R5212-13", "#text": "Code de la santé publique - art. R5212-13 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "DEPLACE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039659230", "@num": "R5212-17", "#text": "Code de la santé publique - art. R5212-17 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025787197", "@num": "R5212-18", "#text": "Code de la santé publique - art. R5212-18 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039659221", "@num": "R5212-22", "#text": "Code de la santé publique - art. R5212-22 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025786496", "@num": "R5212-4", "#text": "Code de la santé publique - art. R5212-4 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039659193", "@num": "R5212-5", "#text": "Code de la santé publique - art. R5212-5 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039659205", "@num": "R5212-6", "#text": "Code de la santé publique - art. R5212-6 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "DEPLACE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039659191", "@num": "R5212-7", "#text": "Code de la santé publique - art. R5212-7 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039659245", "@num": "R5222-10", "#text": "Code de la santé publique - art. R5222-10 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039659252", "@num": "R5222-11", "#text": "Code de la santé publique - art. R5222-11 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "DEPLACE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026886411", "@num": "R5222-3", "#text": "Code de la santé publique - art. R5222-3 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039659264", "@num": "R5222-4", "#text": "Code de la santé publique - art. R5222-4 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039659257", "@num": "R5222-5", "#text": "Code de la santé publique - art. R5222-5 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039469863", "@num": "R5311-2", "#text": "Code de la santé publique - art. R5311-2 (VD)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039659297", "@num": "R6111-1", "#text": "Code de la santé publique - art. R6111-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039659289", "@num": "R6111-2", "#text": "Code de la santé publique - art. R6111-2 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000039457239", "@nor": "SSAP1918839D", "@num": "2019-1306", "@nature": "DECRET", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Décret n° 2019-1306 du 6 décembre 2019 sur les vigilances relatives aux produits de santé et les événements indésirables associés aux soins", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000039457239", "@c_titre_court": "Décret n°2019-1306 du 6 décembre 2019" }, { "@fin": "2999-01-01", "#text": "Décret n° 2019-1306 du 6 décembre 2019 sur les vigilances relatives aux produits de santé et les événements indésirables associés aux soins", "@debut": "2019-12-09", "@id_txt": "LEGITEXT000039458783", "@c_titre_court": "Décret n°2019-1306 du 6 décembre 2019" } ], "@ministere": "Ministère des solidarités et de la santé", "@date_publi": "2019-12-08", "@date_signature": "2019-12-06", "@num_parution_jo": "0285" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000039458786", "@fin": "2999-01-01", "@num": "1", "@debut": "2999-01-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000039457243", "@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
Sct. Sous-section 2 : Vigilances relatives aux produits de santé, Art. R1413-61-1, Art. R1413-61-2, Art. R1413-61-3, Art. R1413-61-4, Art. R1413-61-5, Art. R1413-61-6, Art. R1413-61-7, Art. R1413-62\n
\n

\n
\n
A modifié les dispositions suivantes :

- Code de la santé publique
\n Sct. Paragraphe 3 : Professionnels de santé et patients, Sct. Paragraphe 4 : Entreprises ou organismes exploitant un médicament ou un produit mentionné à l'article R. 5121-150\n
\n

\n
\n
A modifié les dispositions suivantes :

- Code de la santé publique
Sct. Section 5 : Evènements indésirables associés aux soins, Art. R1413-66-1
\n

\n
\n
A modifié les dispositions suivantes :

- Code de la santé publique
Art. R5132-99
\n

\n
\n
A modifié les dispositions suivantes :

- Code de la santé publique
Art. R5132-101, Art. R5132-100, Art. R5132-102
\n

\n
\n
A abrogé les dispositions suivantes :

- Code de la santé publique
Sct. Paragraphe 1 : Système national., Art. R5121-153, Art. R5121-159, Art. R5121-160\n
\n

\n
\n
A modifié les dispositions suivantes :

- Code de la santé publique
\n Art. R5121-154, Sct. Paragraphe 2 : Centres régionaux de pharmacovigilance, Art. R5121-158, Art. R5121-179\n
\n

\n
\n
A modifié les dispositions suivantes :

- Code de la santé publique
\n Sct. Section 2 : Organisation de la réactovigilance, Art. R5222-4, Art. R5222-5, Art. R5222-10, Art. R5222-11\n
\n

\n
\n
A modifié les dispositions suivantes :

- Code de la santé publique
\n Art. R5212-17, Art. R5212-22\n
\n

\n
\n
A modifié les dispositions suivantes :

- Code de la santé publique
Art. R5311-2
\n

\n
\n
A abrogé les dispositions suivantes :

- Code de la santé publique
\n Sct. Sous-section 1 : Organisation générale., Art. R5212-4, Sct. Sous-section 2 : Echelon national, Sct. Paragraphe 1 : Agence nationale de sécurité du médicament et des produits de santé., Sct. Sous-section 3 : Echelon local.\n
\n

\n
\n
A abrogé les dispositions suivantes :

- Code de la santé publique
\n Sct. Sous-section 1 : Organisation générale., Art. R5222-3, Sct. Sous-section 2 : Echelon national, Sct. Paragraphe 1 : Agence nationale de sécurité du médicament et des produits de santé., Sct. Sous-section 3 : Echelon local.\n
\n

\n
\n
A modifié les dispositions suivantes :

- Code de la santé publique
\n Art. R1221-26, Sct. Sous-section 5 : Coordonnateurs régionaux d'hémovigilance et de sécurité transfusionnelle, Art. R1221-32, Art. R1221-39\n
\n

\n
\n
A modifié les dispositions suivantes :

- Code de la santé publique
\n Sct. Section 6 : Déclaration des événements indésirables graves associés à des soins, Sct. Section 7 : Structures régionales d'appui à la qualité des soins et à la sécurité des patients, Sct. Section 8 : Prévention des infections associées aux soins, Sct. Section 9 : Adaptation aux outre-mer, Sct. Section 10 : Observatoires du médicament, des dispositifs médicaux et de l'innovation thérapeutique\n
\n

\n
\n
A modifié les dispositions suivantes :

- Code de la santé publique
\n Art. R5132-114, Art. R5132-102, Art. R5132-115, Art. R5132-103, Art. R5132-112, Art. R5132-104, Art. R5132-113, Art. R5132-105
\n

\n
\n
A abrogé les dispositions suivantes :

- Code de la santé publique
\n Sct. Sous-section 1 : Dispositions générales., Sct. Sous-section 2 : Système national d'addictovigilance, Sct. Sous-section 4 : Centres d'évaluation et d'information sur la pharmacodépendance et d'addictovigilance, Art. R5132-104, Art. R5132-105
\n

\n
\n
A modifié les dispositions suivantes :

- Code de la santé publique
\n Sct. Paragraphe 1 : Rôle de l'Agence nationale de sécurité du médicament et des produits de santé.\n
\n

\n
\n
A abrogé les dispositions suivantes :

- Code de la santé publique
\n Sct. Paragraphe 1 : Système national., Art. R5121-153\n
\n

\n
\n
A abrogé les dispositions suivantes :

- Code de la santé publique
\n Art. R5132-116\n
\n

\n
\n
A modifié les dispositions suivantes :

- Code de la santé publique
\n Art. R5132-97, Art. R5132-98, Art. R5132-99, Art. R5132-100, Art. R5132-101, Art. R5132-102, Art. R5132-103, Art. R5132-104, Art. R5132-105\n
\n

\n
\n
A abrogé les dispositions suivantes :

- Code de la santé publique
\n Art. R1221-34, Art. R1221-35\n
\n

\n
\n
A modifié les dispositions suivantes :

- Code de la santé publique
\n Sct. Sous-section 3 : Réseau régional de vigilances et d'appui, Sct. Sous-section 4 : Adaptation aux outre-mer\n
\n

\n
\n
A abrogé les dispositions suivantes :

- Code de la santé publique
\n Art. R5212-18\n
\n

\n
\n
\n
A modifié les dispositions suivantes :

- Code de la santé publique
\n Art. R6111-1, Art. R6111-2\n
\n

\n
\n
\n
\n
\n
\n
A abrogé les dispositions suivantes :

- Code de la santé publique
\n Sct. Sous-section 2 : Système national d'hémovigilance, Art. R1221-24\n
\n

\n
\n
A modifié les dispositions suivantes :

- Code de la santé publique
\n Sct. Section 2 : Organisation de la matériovigilance, Art. R5212-5, Art. R5212-6, Art. R5212-7, Art. R5212-12, Art. R5212-13\n
\n

\n
" } }, "LEGIARTI000039658991": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R1413-62", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2022-11-21", "DATE_DEBUT": "2021-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000039658991", "URL": "article/LEGI/ARTI/00/00/39/65/89/LEGIARTI000039658991.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Conformément à l'article 2 du décret n° 2019-1306 du 6 décembre 2019, ces dispositions entrent en vigueur à une date fixée par arrêté et au plus tard le 1er janvier 2021.

" }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000034078013", "@num": "1", "#text": "Arrêté du 20 février 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034074178", "@nortexte": "AFSP1705441A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-20" }, { "@id": "LEGIARTI000039458786", "@num": "1", "#text": "Décret n°2019-1306 du 6 décembre 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000039457239", "@nortexte": "SSAP1918839D", "@numtexte": "2019-1306", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2019-12-06" }, { "@id": "LEGIARTI000046567251", "@num": "Annexe 2", "#text": "Arrêté du 14 novembre 2022 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000046566303", "@nortexte": "SPRP2231874A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-11-14" }, { "@id": "LEGIARTI000049976728", "@num": "Annexe 1", "#text": "Arrêté du 14 novembre 2022 - art. Annexe 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000046566303", "@nortexte": "SPRP2231874A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-11-14" }, { "@id": "LEGIARTI000006686953", "@num": "L1413-2", "#text": "Code de la santé publique - art. L1413-2", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000031921206", "@num": "L1435-12", "#text": "Code de la santé publique - art. L1435-12", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039658956", "@num": "R1221-32", "#text": "Code de la santé publique - art. R1221-32 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033626679", "@num": "R1340-4", "#text": "Code de la santé publique - art. R1340-4", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034686911", "@num": "R1340-5", "#text": "Code de la santé publique - art. R1340-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000032475567", "@num": "R1413-44", "#text": "Code de la santé publique - art. R1413-44", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000047913673", "@num": "R1413-59", "#text": "Code de la santé publique - art. 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Dans le cadre de ce réseau, le directeur général de l'agence régionale de santé, en lien avec les agences et autorités nationales compétentes :

2° Favorise les mutualisations entre membres du réseau régional de vigilances et d'appui, portant notamment sur les outils, les méthodes et les moyens.

Les cellules d'intervention en région mentionnées à l'article L. 1413-2 apportent leur concours au réseau régional de vigilances et d'appui dans les conditions prévues à l'article R. 1413-44.

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La pharmacovigilance s'exerce :

1° Pour les médicaments et pour les produits devant faire l'objet de l'autorisation de mise sur le marché prévue par l'article L. 5121-8, après la délivrance de cette autorisation ;

2° Pour les médicaments mentionnés à l'article L. 5121-12 et au II de l'article L. 5121-12-1, après la délivrance de l'autorisation d'accès précoce ou de l'autorisation d'accès compassionnel, sous réserve des règles particulières prévues pour ces médicaments à l'article R. 5121-172 ;

3° Pour les médicaments homéopathiques mentionnés à l'article L. 5121-13, après l'enregistrement prévu par cet article ;

4° Pour les médicaments traditionnels à base de plantes mentionnés à l'article L. 5121-14-1, après l'enregistrement prévu à cet article ;

5° Pour les autres produits mentionnés à l'article L. 5121-1 après leur délivrance ;

6° Pour les allergènes, préparés spécialement pour un seul individu, mentionnés à l'article L. 4211-6, après la délivrance de l'autorisation prévue par cet article ;

7° Pour les médicaments dérivés du sang et pour les autres médicaments d'origine humaine, sous réserve des règles particulières prévues pour ces médicaments par le 14° de l'article L. 5121-20 ;

8° Pour les médicaments mentionnés à l'article L. 5121-9-1 après la délivrance de l'autorisation prévue à ce même article.

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Dans le cadre de ce réseau, le directeur général de l'agence régionale de santé, en lien avec les agences et autorités nationales compétentes :

2° Favorise les mutualisations entre membres du réseau régional de vigilances et d'appui, portant notamment sur les outils, les méthodes et les moyens.

Les cellules d'intervention en région mentionnées à l'article L. 1413-2 apportent leur concours au réseau régional de vigilances et d'appui dans les conditions prévues à l'article R. 1413-44.

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\n

1° Des données relatives aux cas de maladies signalés dans les conditions prévues aux articles R. 3113-2 et R. 3113-3 ;

2° Des déclarations d'infections associées aux soins et d'événements indésirables graves associés à des soins, mentionnés à l'article L. 1413-14 ;

3° Des signalements effectués en application de l'article L. 1413-15.

\n
" } }, "LEGIARTI000047950830": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5121-161", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2023-08-10" } }, "META_COMMUN": { "ID": "LEGIARTI000047950830", "URL": "article/LEGI/ARTI/00/00/47/95/08/LEGIARTI000047950830.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "
\n
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Le médecin, le chirurgien-dentiste, la sage-femme, le pharmacien ou l'infirmier déclare immédiatement tout effet indésirable suspecté d'être dû à un médicament ou à un produit mentionné à l'article R. 5121-150, dont il a connaissance, au centre régional de pharmacovigilance.

Les autres professionnels de santé, les patients et les associations agréées de patients peuvent déclarer tout effet indésirable suspecté d'être dû à un médicament ou à un produit mentionné à l'article R. 5121-150, dont ils ont connaissance, au centre régional de pharmacovigilance.

Le directeur général de l'Agence nationale de sécurité du médicament et des produits de santé rend publics, sur le site internet de l'agence, les informations relatives aux différents modes de notification des effets indésirables suspectés d'être dus à un médicament ou à un produit mentionné à l'article R. 5121-150 par les professionnels de santé et les patients ainsi que le formulaire de déclaration de ces effets indésirables.

" } }, "LEGIARTI000048690971": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L6133-7", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2023-12-29" } }, "META_COMMUN": { "ID": "LEGIARTI000048690971", "URL": "article/LEGI/ARTI/00/00/48/69/09/LEGIARTI000048690971.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Conformément au IV de l'article 9 de la loi n° 2023-1268 du 27 décembre 2023, l'article L. 6133-7 du code de la santé publique, dans sa rédaction antérieure à la présente loi, reste applicable jusqu'à la publication du décret en Conseil d'Etat mentionné au dernier alinéa de l'article L. 6133-7 du code de la santé publique, dans sa rédaction résultant du III du présent article, et au plus tard deux mois après la publication de la présente loi.

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1° Les fonctions de l'administrateur du groupement sont exercées en sus des fonctions du directeur mentionnées à l'article L. 6143-7 ;

2° Le conseil de surveillance est composé comme suit :

Par dérogation aux dispositions du premier alinéa, un groupement de coopération sanitaire de moyens autorisé à pratiquer les seules activités de soins dont la liste est fixée par décret en Conseil d'Etat n'est pas érigé en établissement de santé.

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Article R5121-158 AUTONOME VIGUEUR, en vigueur depuis le 01/01/2021 (Code de la santé publique)