{ "article": { "LEGIARTI000039459172": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R1413-61-1", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2021-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000039459172", "URL": "article/LEGI/ARTI/00/00/39/45/91/LEGIARTI000039459172.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": "LEGIARTI000039458786", "@num": "1", "#text": "Décret n°2019-1306 du 6 décembre 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000039457239", "@nortexte": "SSAP1918839D", "@numtexte": "2019-1306", "@typelien": "CREE", "@naturetexte": "DECRET", "@datesignatexte": "2019-12-06" }, { "@id": "LEGIARTI000043103458", "#text": "Arrêté du 5 février 2021 - art. (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000043100729", "@nortexte": "SSAP2104251A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-02-05" }, { "@id": "LEGIARTI000043103478", "@num": "1", "#text": "Arrêté du 5 février 2021 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000043100729", "@nortexte": "SSAP2104251A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-02-05" }, { "@id": "LEGIARTI000046567255", "@num": "1", "#text": "Arrêté du 14 novembre 2022 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000046566303", "@nortexte": "SPRP2231874A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-11-14" }, { "@id": "LEGITEXT000049975311", "#text": "Arrêté du 8 juillet 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049962783", "@nortexte": "TSSP2417338A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-07-08" }, { "@id": "LEGIARTI000006686103", "@num": "L1221-13", "#text": "Code de la santé publique - art. L1221-13", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025086407", "@num": "L5121-22", "#text": "Code de la santé publique - art. L5121-22", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690138", "@num": "L5133-1", "#text": "Code de la santé publique - art. L5133-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690308", "@num": "L5212-2", "#text": "Code de la santé publique - art. L5212-2", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690330", "@num": "L5222-3", "#text": "Code de la santé publique - art. L5222-3", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000046554047", "@num": "R5311-2", "#text": "Code de la santé publique - art. R5311-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000039459168", "@fin": "2999-01-01", "#text": "Sous-section 2 : Vigilances relatives aux produits de santé", "@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": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000039459172", "@fin": "2999-01-01", "@num": "R1413-61-1", "@etat": "VIGUEUR", "@debut": "2021-01-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Les vigilances relatives aux produits de santé sont l'hémovigilance, la pharmacovigilance, l'addictovigilance, la matériovigilance et la réactovigilance prévues respectivement aux articles L. 1221-13, L. 5121-22, L. 5133-1, L. 5212-2 et L. 5222-3.

" } }, "LEGIARTI000006686103": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1221-13", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-11", "DATE_DEBUT": "2000-06-22" } }, "META_COMMUN": { "ID": "LEGIARTI000006686103", "URL": "article/LEGI/ARTI/00/00/06/68/61/LEGIARTI000006686103.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X1221L13XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "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": "LEGIARTI000006417944", "@num": "226-13", "#text": "Code pénal - art. 226-13 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006070719", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006417946", "@num": "226-14", "#text": "Code pénal - art. 226-14 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006070719", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708723", "@num": "L6221-7", "#text": "Code de la santé publique - art. L6221-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000027480644", "@num": "L6221-9", "#text": "Code de la santé publique - art. L6221-9 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694212", "@num": "L666-12", "#text": "Code de la santé publique - art. L666-12 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694210", "@num": "L666-12", "#text": "Code de la santé publique - art. L666-12 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039459172", "@num": "R1413-61-1", "#text": "Code de la santé publique - art. R1413-61-1 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034687007", "@num": "R1413-68", "#text": "Code de la santé publique - art. R1413-68 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034686956", "@num": "R1413-79", "#text": "Code de la santé publique - art. R1413-79 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034682983", "@num": "R1524-5", "#text": "Code de la santé publique - art. R1524-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034687243", "@num": "R1524-6", "#text": "Code de la santé publique - art. R1524-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006802537", "@num": "R711-1-11", "#text": "Code de la santé publique - art. R711-1-11 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171018", "@fin": "2999-01-01", "#text": "Chapitre Ier : Collecte, préparation et conservation du sang, de ses composants et des produits sanguins labiles.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006154985", "@fin": "2999-01-01", "#text": "Titre II : Sang humain", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140604", "@fin": "2999-01-01", "#text": "Livre II : Don et utilisation des éléments et produits du corps humain", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125345", "@fin": "2999-01-01", "#text": "Première partie : Protection générale de la santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686103", "@fin": "2004-08-11", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686104", "@fin": "2005-09-02", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686105", "@fin": "2012-05-01", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2005-09-02", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025139304", "@fin": "2014-12-25", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000029962861", "@fin": "2016-01-28", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2014-12-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000031931400", "@fin": "2017-07-01", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2016-01-28", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000033897135", "@fin": "2999-01-01", "@num": "L1221-13", "@etat": "VIGUEUR", "@debut": "2017-07-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
On entend par hémovigilance l'ensemble des procédures de surveillance organisées depuis la collecte du sang et de ses composants jusqu'au suivi des receveurs, en vue de recueillir et d'évaluer les informations sur les effets inattendus ou indésirables résultant de l'utilisation thérapeutique des produits sanguins labiles et d'en prévenir l'apparition.
\n
Les personnes qui ont à connaître de ces informations sont tenues au secret professionnel dans les conditions et sous les peines prévues aux articles 226-13 et 226-14 du code pénal.
\n
Un décret en Conseil d'Etat, pris après avis de l'Agence française de sécurité sanitaire des produits de santé, fixe les règles d'hémovigilance, et notamment la nature des informations nécessaires à la surveillance des effets de l'utilisation des produits sanguins labiles que les praticiens sont tenus de fournir, ainsi que les conditions d'exercice de cette surveillance.
" } }, "LEGIARTI000006686104": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1221-13", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2005-09-02", "DATE_DEBUT": "2004-08-11" } }, "META_COMMUN": { "ID": "LEGIARTI000006686104", "URL": "article/LEGI/ARTI/00/00/06/68/61/LEGIARTI000006686104.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X1221L13XXAB" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000006697740", "@num": "116", "#text": "Loi n°2004-806 du 9 août 2004 - art. 116 () JORF 11 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787078", "@nortexte": "SANX0300055L", "@numtexte": "2004-806", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-09" }, { "@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": "LEGIARTI000006417944", "@num": "226-13", "#text": "Code pénal - art. 226-13 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006070719", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006417946", "@num": "226-14", "#text": "Code pénal - art. 226-14 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006070719", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708723", "@num": "L6221-7", "#text": "Code de la santé publique - art. L6221-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000027480644", "@num": "L6221-9", "#text": "Code de la santé publique - art. L6221-9 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694212", "@num": "L666-12", "#text": "Code de la santé publique - art. L666-12 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694210", "@num": "L666-12", "#text": "Code de la santé publique - art. L666-12 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039459172", "@num": "R1413-61-1", "#text": "Code de la santé publique - art. R1413-61-1 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034687007", "@num": "R1413-68", "#text": "Code de la santé publique - art. R1413-68 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034686956", "@num": "R1413-79", "#text": "Code de la santé publique - art. R1413-79 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034682983", "@num": "R1524-5", "#text": "Code de la santé publique - art. R1524-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034687243", "@num": "R1524-6", "#text": "Code de la santé publique - art. R1524-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006802537", "@num": "R711-1-11", "#text": "Code de la santé publique - art. R711-1-11 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171018", "@fin": "2999-01-01", "#text": "Chapitre Ier : Collecte, préparation et conservation du sang, de ses composants et des produits sanguins labiles.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006154985", "@fin": "2999-01-01", "#text": "Titre II : Sang humain", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140604", "@fin": "2999-01-01", "#text": "Livre II : Don et utilisation des éléments et produits du corps humain", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125345", "@fin": "2999-01-01", "#text": "Première partie : Protection générale de la santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686103", "@fin": "2004-08-11", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686104", "@fin": "2005-09-02", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686105", "@fin": "2012-05-01", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2005-09-02", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025139304", "@fin": "2014-12-25", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000029962861", "@fin": "2016-01-28", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2014-12-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000031931400", "@fin": "2017-07-01", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2016-01-28", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000033897135", "@fin": "2999-01-01", "@num": "L1221-13", "@etat": "VIGUEUR", "@debut": "2017-07-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
On entend par hémovigilance l'ensemble des procédures de surveillance organisées depuis la collecte du sang et de ses composants jusqu'au suivi des receveurs, en vue de recueillir et d'évaluer les informations sur les effets inattendus ou indésirables résultant de l'utilisation thérapeutique des produits sanguins labiles en vue d'en prévenir l'apparition, ainsi que les informations sur les incidents graves ou inattendus survenus chez les donneurs. L'hémovigilance comprend également le suivi épidémiologique des donneurs.
\n
Les personnes qui ont à connaître de ces informations sont tenues au secret professionnel dans les conditions et sous les peines prévues aux articles 226-13 et 226-14 du code pénal.
\n
Un décret en Conseil d'Etat, pris après avis de l'Agence française de sécurité sanitaire des produits de santé, fixe les règles d'hémovigilance, et notamment la nature des informations nécessaires à la surveillance des effets de l'utilisation des produits sanguins labiles que les praticiens sont tenus de fournir, ainsi que les conditions d'exercice de cette surveillance.
" } }, "LEGIARTI000006686105": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1221-13", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-05-01", "DATE_DEBUT": "2005-09-02" } }, "META_COMMUN": { "ID": "LEGIARTI000006686105", "URL": "article/LEGI/ARTI/00/00/06/68/61/LEGIARTI000006686105.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X1221L13XXAC" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000006698394", "@num": "10", "#text": "Ordonnance n°2005-1087 du 1 septembre 2005 - art. 10 () JORF 2 septembre 2005", "@sens": "source", "@cidtexte": "JORFTEXT000000261711", "@nortexte": "SANX0500159R", "@numtexte": "2005-1087", "@typelien": "MODIFICATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2005-09-01" }, { "@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": "LEGIARTI000006417944", "@num": "226-13", "#text": "Code pénal - art. 226-13 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006070719", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006417946", "@num": "226-14", "#text": "Code pénal - art. 226-14 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006070719", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708723", "@num": "L6221-7", "#text": "Code de la santé publique - art. L6221-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000027480644", "@num": "L6221-9", "#text": "Code de la santé publique - art. L6221-9 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694212", "@num": "L666-12", "#text": "Code de la santé publique - art. L666-12 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694210", "@num": "L666-12", "#text": "Code de la santé publique - art. L666-12 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039459172", "@num": "R1413-61-1", "#text": "Code de la santé publique - art. R1413-61-1 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034687007", "@num": "R1413-68", "#text": "Code de la santé publique - art. R1413-68 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034686956", "@num": "R1413-79", "#text": "Code de la santé publique - art. R1413-79 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034682983", "@num": "R1524-5", "#text": "Code de la santé publique - art. R1524-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034687243", "@num": "R1524-6", "#text": "Code de la santé publique - art. R1524-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006802537", "@num": "R711-1-11", "#text": "Code de la santé publique - art. R711-1-11 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171018", "@fin": "2999-01-01", "#text": "Chapitre Ier : Collecte, préparation et conservation du sang, de ses composants et des produits sanguins labiles.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006154985", "@fin": "2999-01-01", "#text": "Titre II : Sang humain", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140604", "@fin": "2999-01-01", "#text": "Livre II : Don et utilisation des éléments et produits du corps humain", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125345", "@fin": "2999-01-01", "#text": "Première partie : Protection générale de la santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686103", "@fin": "2004-08-11", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686104", "@fin": "2005-09-02", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686105", "@fin": "2012-05-01", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2005-09-02", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025139304", "@fin": "2014-12-25", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000029962861", "@fin": "2016-01-28", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2014-12-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000031931400", "@fin": "2017-07-01", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2016-01-28", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000033897135", "@fin": "2999-01-01", "@num": "L1221-13", "@etat": "VIGUEUR", "@debut": "2017-07-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
L'hémovigilance a pour objet l'ensemble des procédures de surveillance et d'évaluation des incidents, ainsi que des effets indésirables survenant chez les donneurs ou les receveurs de produits sanguins labiles. Elle porte sur l'ensemble de la chaîne transfusionnelle allant de la collecte des produits sanguins labiles jusqu'au suivi des receveurs. L'hémovigilance comprend également le suivi épidémiologique des donneurs.
\n
Les personnes qui ont à connaître de ces informations sont tenues au secret professionnel dans les conditions et sous les peines prévues aux articles 226-13 et 226-14 du code pénal.
\n
Un décret en Conseil d'Etat, pris après avis de l'Agence française de sécurité sanitaire des produits de santé, fixe les règles d'hémovigilance, et notamment la nature des informations nécessaires à la surveillance des effets de l'utilisation des produits sanguins labiles que les praticiens sont tenus de fournir, ainsi que les conditions d'exercice de cette surveillance.
" } }, "LEGIARTI000006690138": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5133-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2003-12-07", "DATE_DEBUT": "2000-06-22" } }, "META_COMMUN": { "ID": "LEGIARTI000006690138", "URL": "article/LEGI/ARTI/00/00/06/69/01/LEGIARTI000006690138.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5133L01XXAA" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006696640", "@num": "19", "#text": "Loi n°93-5 du 4 janvier 1993 - art. 19 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000178299", "@nortexte": "SPSX9200032L", "@numtexte": "93-5", "@typelien": "CONCORDE", "@naturetexte": "LOI", "@datesignatexte": "1993-01-04" }, { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006698250", "@num": "10", "#text": "n°2001-198 du 1 mars 2001 - art. 10 (V) JORF 3 mars 2001 en vigueur le 7 décembre 2003", "@sens": "source", "@cidtexte": "JORFTEXT000000588097", "@nortexte": "MESX0100017R", "@numtexte": "2001-198", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2001-03-01" }, { "@id": "LEGIARTI000006698248", "@num": "9", "#text": "n°2001-198 du 1 mars 2001 - art. 9 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000000588097", "@nortexte": "MESX0100017R", "@numtexte": "2001-198", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2001-03-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000006228008", "@num": "1", "#text": "Arrêté du 15 janvier 2004 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000415652", "@nortexte": "SANP0420224A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2004-01-15" }, { "@id": "LEGIARTI000025860019", "@num": "1", "#text": "Arrêté du 30 juillet 2004 - art. 1 (VT)", "@sens": "cible", "@cidtexte": "JORFTEXT000000806957", "@nortexte": "SANP0422322A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2004-07-30" }, { "@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": "LEGIARTI000043103478", "@num": "1", "#text": "Arrêté du 5 février 2021 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000043100729", "@nortexte": "SSAP2104251A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-02-05" }, { "@id": "LEGIARTI000046567255", "@num": "1", "#text": "Arrêté du 14 novembre 2022 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000046566303", "@nortexte": "SPRP2231874A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-11-14" }, { "@id": "LEGIARTI000006689004", "@num": "L4211-1", "#text": "Code de la santé publique - art. L4211-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691221", "@num": "L6211-1", "#text": "Code de la santé publique - art. L6211-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908671", "@num": "R1211-12", "#text": "Code de la santé publique - art. R1211-12 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039459172", "@num": "R1413-61-1", "#text": "Code de la santé publique - art. R1413-61-1 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000046554047", "@num": "R5311-2", "#text": "Code de la santé publique - art. R5311-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 93-05 1993-01-04 art. 19 alinéa 3", "@sens": "source", "@typelien": "CONCORDANCE" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171377", "@fin": "2003-12-07", "#text": "Chapitre III : Réactifs.", "@debut": "2000-06-22" }, { "@id": "LEGISCTA000033897156", "@fin": "2999-01-01", "#text": "Chapitre III : Addictovigilance", "@debut": "2017-07-01" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155086", "@fin": "2999-01-01", "#text": "Titre III : Autres produits et substances pharmaceutiques réglementés", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140630", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits 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": "LEGIARTI000006690138", "@fin": "2003-12-07", "@num": "L5133-1", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000033897144", "@fin": "2999-01-01", "@num": "L5133-1", "@etat": "VIGUEUR", "@debut": "2017-07-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
On entend par réactifs :
\n
1° Les réactifs destinés aux laboratoires d'analyses de biologie médicale, c'est-à-dire toutes substances chimiques ou biologiques spécialement préparées pour leur utilisation in vitro, isolément ou en association, en vue d'analyses de biologie médicale au sens de l'article L. 6211-1 ;
\n
2° Les réactifs conditionnés en vue de la vente au public et destinés au diagnostic médical ou à celui de la grossesse, au sens du 2° de l'article L. 4211-1 ;
\n
3° Les réactifs utilisés pour les examens d'anatomie et de cytologie pathologiques.
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Le fabricant, les utilisateurs d'un dispositif et les tiers ayant connaissance d'un incident ou d'un risque d'incident mettant en cause un dispositif ayant entraîné ou susceptible d'entraîner la mort ou la dégradation grave de l'état de santé d'un patient, d'un utilisateur ou d'un tiers doivent le signaler sans délai à l'Agence française de sécurité sanitaire des produits de santé.
\n
Le fabricant d'un dispositif ou son mandataire est tenu d'informer l'Agence française de sécurité sanitaire des produits de santé de tout rappel de ce dispositif du marché, motivé par une raison technique ou médicale.
" } }, "LEGIARTI000006690309": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5212-2", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-05-01", "DATE_DEBUT": "2001-03-03" } }, "META_COMMUN": { "ID": "LEGIARTI000006690309", "URL": "article/LEGI/ARTI/00/00/06/69/03/LEGIARTI000006690309.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5212L02XXAB" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006698239", "@num": "1", "#text": "n°2001-198 du 1 mars 2001 - art. 1 () JORF 3 mars 2001", "@sens": "source", "@cidtexte": "JORFTEXT000000588097", "@nortexte": "MESX0100017R", "@numtexte": "2001-198", "@typelien": "MODIFICATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2001-03-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "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": "LEGIARTI000049270115", "@num": "1", "#text": "Arrêté du 8 mars 2024 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049268178", "@nortexte": "TSSP2407108A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-03-08" }, { "@id": "LEGIARTI000049594308", "@num": "D1151-7", "#text": "Code de la santé publique - art. 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L1333-30 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000031930394", "@num": "L5461-9", "#text": "Code de la santé publique - art. L5461-9 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000027480644", "@num": "L6221-9", "#text": "Code de la santé publique - art. L6221-9 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694045", "@num": "L665-6", "#text": "Code de la santé publique - art. L665-6 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694044", "@num": "L665-6", "#text": "Code de la santé publique - art. 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R5212-31 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039659205", "@num": "R5212-6", "#text": "Code de la santé publique - art. R5212-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026886401", "@num": "R5461-2", "#text": "Code de la santé publique - art. R5461-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006802537", "@num": "R711-1-11", "#text": "Code de la santé publique - art. R711-1-11 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171396", "@fin": "2999-01-01", "#text": "Chapitre II : Matériovigilance.", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155090", "@fin": "2999-01-01", "#text": "Titre Ier : Dispositifs médicaux", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140632", "@fin": "2999-01-01", "#text": "Livre II : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro et autres produits et objets réglementés dans l'intérêt de la santé publique", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits 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": "LEGIARTI000006690308", "@fin": "2001-03-03", "@num": "L5212-2", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690309", "@fin": "2012-05-01", "@num": "L5212-2", "@etat": "MODIFIE", "@debut": "2001-03-03", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025104720", "@fin": "2022-04-22", "@num": "L5212-2", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000045630301", "@fin": "2999-01-01", "@num": "L5212-2", "@etat": "VIGUEUR", "@debut": "2022-04-22", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le fabricant, les utilisateurs d'un dispositif et les tiers ayant connaissance d'un incident ou d'un risque d'incident mettant en cause un dispositif ayant entraîné ou susceptible d'entraîner la mort ou la dégradation grave de l'état de santé d'un patient, d'un utilisateur ou d'un tiers doivent le signaler sans délai à l'Agence française de sécurité sanitaire des produits de santé.
\n
Le fabricant d'un dispositif ou son mandataire est tenu d'informer l'Agence française de sécurité sanitaire des produits de santé de tout rappel de ce dispositif du marché, motivé par une raison technique ou médicale.
" } }, "LEGIARTI000006690330": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5222-3", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-05-01", "DATE_DEBUT": "2001-03-03" } }, "META_COMMUN": { "ID": "LEGIARTI000006690330", "URL": "article/LEGI/ARTI/00/00/06/69/03/LEGIARTI000006690330.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5222L03XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006698241", "@num": "3", "#text": "n°2001-198 du 1 mars 2001 - art. 3 () JORF 3 mars 2001", "@sens": "source", "@cidtexte": "JORFTEXT000000588097", "@nortexte": "MESX0100017R", "@numtexte": "2001-198", "@typelien": "CREATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2001-03-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000023097035", "@num": "Annexe II", "#text": "Arrêté du 9 novembre 2010 - art. Annexe II (VT)", "@sens": "cible", "@cidtexte": "JORFTEXT000023093746", "@nortexte": "SASP1026545A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-11-09" }, { "@id": "LEGIARTI000032972920", "@num": "Annexe IV", "#text": "Arrêté du 1er août 2016 - art. Annexe IV (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000032967651", "@nortexte": "AFSP1622318A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-08-01" }, { "@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": "LEGIARTI000041898595", "@num": "10-3-1", "#text": "Arrêté du 23 mars 2020 - art. 10-3-1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041890409", "@num": "1", "#text": "Arrêté du 18 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041889362", "@nortexte": "SSAZ2011564A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-18" }, { "@id": "LEGIARTI000041898504", "@num": "1", "#text": "Arrêté du 20 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041897919", "@nortexte": "SSAZ2012596A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-20" }, { "@id": "LEGIARTI000043298218", "@num": "25", "#text": "Arrêté du 10 juillet 2020 - art. 25 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042609739", "@num": "26", "#text": "Arrêté du 10 juillet 2020 - art. 26 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000043298194", "@num": "26-1", "#text": "Arrêté du 10 juillet 2020 - art. 26-1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000043351359", "@num": "26-2", "#text": "Arrêté du 10 juillet 2020 - art. 26-2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042608596", "@num": "1", "#text": "Arrêté du 3 décembre 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000042607794", "@nortexte": "SSAZ2033724A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-12-03" }, { "@id": "LEGIARTI000043298023", "@num": "1", "#text": "Arrêté du 26 mars 2021 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000043294845", "@nortexte": "SSAZ2109865A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-03-26" }, { "@id": "LEGIARTI000047779186", "@num": "25", "#text": "Arrêté du 1 juin 2021 - art. 25 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000043770220", "@num": "27", "#text": "Arrêté du 1 juin 2021 - art. 27 (VT)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000047779165", "@num": "28", "#text": "Arrêté du 1 juin 2021 - art. 28 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000044808700", "@num": "29", "#text": "Arrêté du 1er juin 2021 - art. 29 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000043685770", "@num": "ANNEXE VI", "#text": "Arrêté du 16 juin 2021 - art. ANNEXE VI (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000043684636", "@nortexte": "SSAP2116553A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-16" }, { "@id": "LEGIARTI000043779691", "@num": "1", "#text": "Arrêté du 9 juillet 2021 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000043776706", "@nortexte": "SSAZ2121615A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-07-09" }, { "@id": "LEGITEXT000049305911", "#text": "Arrêté du 19 mars 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049304036", "@nortexte": "TSSP2405697A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-03-19" }, { "@id": "LEGIARTI000031937850", "@num": "D6211-10", "#text": "Code de la santé publique - art. D6211-10 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000046126105", "@num": "L5222-4", "#text": "Code de la santé publique - art. L5222-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690591", "@num": "L5462-2", "#text": "Code de la santé publique - art. L5462-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708723", "@num": "L6221-7", "#text": "Code de la santé publique - art. L6221-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039459172", "@num": "R1413-61-1", "#text": "Code de la santé publique - art. R1413-61-1 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034687007", "@num": "R1413-68", "#text": "Code de la santé publique - art. R1413-68 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034686956", "@num": "R1413-79", "#text": "Code de la santé publique - art. R1413-79 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034687243", "@num": "R1524-6", "#text": "Code de la santé publique - art. R1524-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025786997", "@num": "R5462-2", "#text": "Code de la santé publique - art. R5462-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171398", "@fin": "2999-01-01", "#text": "Chapitre II : Mesures de vigilance.", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155091", "@fin": "2999-01-01", "#text": "Titre II : Dispositifs médicaux de diagnostic in vitro", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140632", "@fin": "2999-01-01", "#text": "Livre II : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro et autres produits et objets réglementés dans l'intérêt de la santé publique", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits 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": "LEGIARTI000006690330", "@fin": "2012-05-01", "@num": "L5222-3", "@etat": "MODIFIE", "@debut": "2001-03-03", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025104704", "@fin": "2022-07-31", "@num": "L5222-3", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000046126072", "@fin": "2999-01-01", "@num": "L5222-3", "@etat": "VIGUEUR", "@debut": "2022-07-31", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le fabricant ou son mandataire, l'importateur, le distributeur, les professionnels de santé utilisateurs sont tenus de signaler sans délai à l'Agence française de sécurité sanitaire des produits de santé toute défaillance ou altération d'un dispositif médical de diagnostic in vitro susceptible d'entraîner des effets néfastes pour la santé des personnes. Le fabricant ou son mandataire est tenu d'informer l'Agence française de sécurité sanitaire des produits de santé de tout rappel de dispositifs médicaux de diagnostic in vitro, et de lui communiquer, à sa demande, toute information utile à la mise en oeuvre de mesures de protection sanitaire à l'égard des patients.
\n
Le fabricant ou son mandataire, l'importateur et le distributeur sont tenus de conserver toutes les informations nécessaires au rappel éventuel de dispositifs médicaux de diagnostic in vitro mentionné à l'alinéa précédent.
" } }, "LEGIARTI000025086407": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5121-22", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2011-12-31" } }, "META_COMMUN": { "ID": "LEGIARTI000025086407", "URL": "article/LEGI/ARTI/00/00/25/08/64/LEGIARTI000025086407.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000025071122", "@num": "28", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 28", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CREE", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000047346328", "@num": "2", "#text": "Arrêté du 29 octobre 2020 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042491264", "@nortexte": "SSAP2028896A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-10-29" }, { "@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": "LEGIARTI000039459172", "@num": "R1413-61-1", "#text": "Code de la santé publique - art. R1413-61-1 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000025086405", "@fin": "2999-01-01", "#text": "Chapitre Ier bis : Pharmacovigilance", "@debut": "2011-12-31" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155085", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140630", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits 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": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000025086407", "@fin": "2999-01-01", "@num": "L5121-22", "@etat": "VIGUEUR", "@debut": "2011-12-31", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "La pharmacovigilance a pour objet la surveillance, l'évaluation, la prévention et la gestion du risque d'effet indésirable résultant de l'utilisation des médicaments et produits mentionnés à l'article L. 5121-1." } }, "LEGIARTI000025104704": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5222-3", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2022-07-31", "DATE_DEBUT": "2012-05-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025104704", "URL": "article/LEGI/ARTI/00/00/25/10/47/LEGIARTI000025104704.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Loi n° 2011-2012 du 29 décembre 2011 article 41 III : Les présentes dispositions entrent en vigueur à une date prévue par le décret pris pour leur application et au plus tard le 1er août 2012. Dès cette entrée en vigueur, l'Agence nationale de sécurité du médicament et des produits de santé exerce l'ensemble des droits et supporte l'ensemble des obligations de l'Agence française de sécurité sanitaire des produits de santé. Jusqu'à l'entrée en vigueur mentionnée au premier alinéa du présent III, les compétences et pouvoirs que la présente loi attribue à l'Agence nationale de sécurité du médicament et des produits de santé sont exercés par l'Agence française de sécurité sanitaire des produits de santé.

Le décret n° 2012-597 du 27 avril 2012 est entré en vigueur le 1er mai 2012.

" }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Rapport relatif à l'ordonnance n° 2000-548 du 15 juin 2000", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi n°2002-303 du 4 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000023097035", "@num": "Annexe II", "#text": "Arrêté du 9 novembre 2010 - art. 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Annexe IV (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000032967651", "@nortexte": "AFSP1622318A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-08-01" }, { "@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": "LEGIARTI000041898595", "@num": "10-3-1", "#text": "Arrêté du 23 mars 2020 - art. 10-3-1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041890409", "@num": "1", "#text": "Arrêté du 18 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041889362", "@nortexte": "SSAZ2011564A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-18" }, { "@id": "LEGIARTI000041898504", "@num": "1", "#text": "Arrêté du 20 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041897919", "@nortexte": "SSAZ2012596A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-20" }, { "@id": "LEGIARTI000043298218", "@num": "25", "#text": "Arrêté du 10 juillet 2020 - art. 25 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042609739", "@num": "26", "#text": "Arrêté du 10 juillet 2020 - art. 26 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000043298194", "@num": "26-1", "#text": "Arrêté du 10 juillet 2020 - art. 26-1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000043351359", "@num": "26-2", "#text": "Arrêté du 10 juillet 2020 - art. 26-2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042608596", "@num": "1", "#text": "Arrêté du 3 décembre 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000042607794", "@nortexte": "SSAZ2033724A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-12-03" }, { "@id": "LEGIARTI000043298023", "@num": "1", "#text": "Arrêté du 26 mars 2021 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000043294845", "@nortexte": "SSAZ2109865A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-03-26" }, { "@id": "LEGIARTI000047779186", "@num": "25", "#text": "Arrêté du 1 juin 2021 - art. 25 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000043770220", "@num": "27", "#text": "Arrêté du 1 juin 2021 - art. 27 (VT)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000047779165", "@num": "28", "#text": "Arrêté du 1 juin 2021 - art. 28 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000044808700", "@num": "29", "#text": "Arrêté du 1er juin 2021 - art. 29 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000043685770", "@num": "ANNEXE VI", "#text": "Arrêté du 16 juin 2021 - art. ANNEXE VI (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000043684636", "@nortexte": "SSAP2116553A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-16" }, { "@id": "LEGIARTI000043779691", "@num": "1", "#text": "Arrêté du 9 juillet 2021 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000043776706", "@nortexte": "SSAZ2121615A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-07-09" }, { "@id": "LEGITEXT000049305911", "#text": "Arrêté du 19 mars 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049304036", "@nortexte": "TSSP2405697A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-03-19" }, { "@id": "LEGIARTI000031937850", "@num": "D6211-10", "#text": "Code de la santé publique - art. 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R1413-61-1 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034687007", "@num": "R1413-68", "#text": "Code de la santé publique - art. R1413-68 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034686956", "@num": "R1413-79", "#text": "Code de la santé publique - art. R1413-79 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034687243", "@num": "R1524-6", "#text": "Code de la santé publique - art. R1524-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025786997", "@num": "R5462-2", "#text": "Code de la santé publique - art. R5462-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171398", "@fin": "2999-01-01", "#text": "Chapitre II : Mesures de vigilance.", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155091", "@fin": "2999-01-01", "#text": "Titre II : Dispositifs médicaux de diagnostic in vitro", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140632", "@fin": "2999-01-01", "#text": "Livre II : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro et autres produits et objets réglementés dans l'intérêt de la santé publique", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits 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": "LEGIARTI000006690330", "@fin": "2012-05-01", "@num": "L5222-3", "@etat": "MODIFIE", "@debut": "2001-03-03", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025104704", "@fin": "2022-07-31", "@num": "L5222-3", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000046126072", "@fin": "2999-01-01", "@num": "L5222-3", "@etat": "VIGUEUR", "@debut": "2022-07-31", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le fabricant ou son mandataire, l'importateur, le distributeur, les professionnels de santé utilisateurs sont tenus de signaler sans délai à l'Agence nationale de sécurité du médicament et des produits de santé toute défaillance ou altération d'un dispositif médical de diagnostic in vitro susceptible d'entraîner des effets néfastes pour la santé des personnes. Le fabricant ou son mandataire est tenu d'informer l'Agence nationale de sécurité du médicament et des produits de santé de tout rappel de dispositifs médicaux de diagnostic in vitro, et de lui communiquer, à sa demande, toute information utile à la mise en oeuvre de mesures de protection sanitaire à l'égard des patients.
\n
Le fabricant ou son mandataire, l'importateur et le distributeur sont tenus de conserver toutes les informations nécessaires au rappel éventuel de dispositifs médicaux de diagnostic in vitro mentionné à l'alinéa précédent.
" } }, "LEGIARTI000025104720": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5212-2", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2022-04-22", "DATE_DEBUT": "2012-05-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025104720", "URL": "article/LEGI/ARTI/00/00/25/10/47/LEGIARTI000025104720.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Le décret n° 2012-597 du 27 avril 2012 est entré en vigueur le 1er mai 2012.

" }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Rapport relatif à l'ordonnance n° 2000-548 du 15 juin 2000", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi n°2002-303 du 4 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000025071134", "@num": "5", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 5", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@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": "LEGIARTI000049270115", "@num": "1", "#text": "Arrêté du 8 mars 2024 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049268178", "@nortexte": "TSSP2407108A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-03-08" }, { "@id": "LEGIARTI000049594308", "@num": "D1151-7", "#text": "Code de la santé publique - art. 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R5212-14 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025787193", "@num": "R5212-19", "#text": "Code de la santé publique - art. R5212-19 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025787188", "@num": "R5212-20", "#text": "Code de la santé publique - art. R5212-20 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025787184", "@num": "R5212-21", "#text": "Code de la santé publique - art. R5212-21 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045171497", "@num": "R5212-31", "#text": "Code de la santé publique - art. 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R711-1-11 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171396", "@fin": "2999-01-01", "#text": "Chapitre II : Matériovigilance.", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155090", "@fin": "2999-01-01", "#text": "Titre Ier : Dispositifs médicaux", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140632", "@fin": "2999-01-01", "#text": "Livre II : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro et autres produits et objets réglementés dans l'intérêt de la santé publique", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits 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": "LEGIARTI000006690308", "@fin": "2001-03-03", "@num": "L5212-2", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690309", "@fin": "2012-05-01", "@num": "L5212-2", "@etat": "MODIFIE", "@debut": "2001-03-03", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025104720", "@fin": "2022-04-22", "@num": "L5212-2", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000045630301", "@fin": "2999-01-01", "@num": "L5212-2", "@etat": "VIGUEUR", "@debut": "2022-04-22", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Le fabricant, les utilisateurs d'un dispositif et les tiers ayant connaissance d'un incident ou d'un risque d'incident mettant en cause un dispositif ayant entraîné ou susceptible d'entraîner la mort ou la dégradation grave de l'état de santé d'un patient, d'un utilisateur ou d'un tiers doivent le signaler sans délai à l'Agence nationale de sécurité du médicament et des produits de santé.

Le fabricant d'un dispositif ou son mandataire est tenu d'informer l'Agence nationale de sécurité du médicament et des produits de santé de tout rappel de ce dispositif du marché, motivé par une raison technique ou médicale.

" } }, "LEGIARTI000025139304": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1221-13", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2014-12-25", "DATE_DEBUT": "2012-05-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025139304", "URL": "article/LEGI/ARTI/00/00/25/13/93/LEGIARTI000025139304.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Le décret n° 2012-597 du 27 avril 2012 est entré en vigueur le 1er mai 2012.

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" }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Rapport relatif à l'ordonnance n° 2000-548 du 15 juin 2000", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi n°2002-303 du 4 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000025071134", "@num": "5", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 5", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@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": "LEGIARTI000006417944", "@num": "226-13", "#text": "Code pénal - art. 226-13 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006070719", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708723", "@num": "L6221-7", "#text": "Code de la santé publique - art. 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L'hémovigilance a pour objet l'ensemble des procédures de surveillance et d'évaluation des incidents, ainsi que des effets indésirables survenant chez les donneurs ou les receveurs de produits sanguins labiles. Elle porte sur l'ensemble de la chaîne transfusionnelle allant de la collecte des produits sanguins labiles jusqu'au suivi des receveurs. L'hémovigilance comprend également le suivi épidémiologique des donneurs.
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Les personnes qui ont à connaître de ces informations sont tenues au secret professionnel dans les conditions et sous les peines prévues aux articles 226-13 et 226-14 du code pénal.
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Un décret en Conseil d'Etat, pris après avis de l'Agence nationale de sécurité du médicament et des produits de santé , fixe les règles d'hémovigilance, et notamment la nature des informations nécessaires à la surveillance des effets de l'utilisation des produits sanguins labiles que les praticiens sont tenus de fournir, ainsi que les conditions d'exercice de cette surveillance.
" } }, "LEGIARTI000029962861": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1221-13", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2016-01-28", "DATE_DEBUT": "2014-12-25" } }, "META_COMMUN": { "ID": "LEGIARTI000029962861", "URL": "article/LEGI/ARTI/00/00/29/96/28/LEGIARTI000029962861.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "
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R1413-79 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034682983", "@num": "R1524-5", "#text": "Code de la santé publique - art. R1524-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034687243", "@num": "R1524-6", "#text": "Code de la santé publique - art. R1524-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006802537", "@num": "R711-1-11", "#text": "Code de la santé publique - art. R711-1-11 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171018", "@fin": "2999-01-01", "#text": "Chapitre Ier : Collecte, préparation et conservation du sang, de ses composants et des produits sanguins labiles.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006154985", "@fin": "2999-01-01", "#text": "Titre II : Sang humain", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140604", "@fin": "2999-01-01", "#text": "Livre II : Don et utilisation des éléments et produits du corps humain", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125345", "@fin": "2999-01-01", "#text": "Première partie : Protection générale de la santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686103", "@fin": "2004-08-11", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686104", "@fin": "2005-09-02", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686105", "@fin": "2012-05-01", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2005-09-02", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025139304", "@fin": "2014-12-25", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000029962861", "@fin": "2016-01-28", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2014-12-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000031931400", "@fin": "2017-07-01", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2016-01-28", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000033897135", "@fin": "2999-01-01", "@num": "L1221-13", "@etat": "VIGUEUR", "@debut": "2017-07-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

L'hémovigilance a pour objet l'ensemble des procédures de surveillance et d'évaluation des incidents, ainsi que des effets indésirables survenant chez les donneurs ou les receveurs de produits sanguins labiles et de plasma mentionné au 2° bis de l'article L. 1221-8, ce dernier produit demeurant également soumis au chapitre Ier bis du titre II du livre Ier de la cinquième partie. Elle porte sur l'ensemble de la chaîne transfusionnelle allant de la collecte des produits sanguins labiles jusqu'au suivi des receveurs. L'hémovigilance comprend également le suivi épidémiologique des donneurs.

Les personnes qui ont à connaître de ces informations sont tenues au secret professionnel dans les conditions et sous les peines prévues aux articles 226-13 et 226-14 du code pénal.

Un décret en Conseil d'Etat, pris après avis de l'Agence nationale de sécurité du médicament et des produits de santé, fixe les règles d'hémovigilance, et notamment la nature des informations nécessaires à la surveillance des effets de l'utilisation des produits sanguins labiles et du plasma mentionné au 2° bis de l'article L. 1221-8 du présent code que les praticiens sont tenus de fournir, ainsi que les conditions d'exercice de cette surveillance.

" } }, "LEGIARTI000031931400": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1221-13", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2017-07-01", "DATE_DEBUT": "2016-01-28" } }, "META_COMMUN": { "ID": "LEGIARTI000031931400", "URL": "article/LEGI/ARTI/00/00/31/93/14/LEGIARTI000031931400.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "
\n
\n
" }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Rapport relatif à l'ordonnance n° 2000-548 du 15 juin 2000", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi n°2002-303 du 4 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000031916572", "@num": "170", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 170", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@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": "LEGIARTI000006417944", "@num": "226-13", "#text": "Code pénal - art. 226-13", "@sens": "source", "@cidtexte": "LEGITEXT000006070719", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006686087", "@num": "L1221-8", "#text": "Code de la santé publique - art. L1221-8", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708723", "@num": "L6221-7", "#text": "Code de la santé publique - art. L6221-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000027480644", "@num": "L6221-9", "#text": "Code de la santé publique - art. L6221-9 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694212", "@num": "L666-12", "#text": "Code de la santé publique - art. L666-12 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694210", "@num": "L666-12", "#text": "Code de la santé publique - art. L666-12 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039459172", "@num": "R1413-61-1", "#text": "Code de la santé publique - art. R1413-61-1 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034687007", "@num": "R1413-68", "#text": "Code de la santé publique - art. R1413-68 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034686956", "@num": "R1413-79", "#text": "Code de la santé publique - art. R1413-79 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034682983", "@num": "R1524-5", "#text": "Code de la santé publique - art. R1524-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034687243", "@num": "R1524-6", "#text": "Code de la santé publique - art. R1524-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006802537", "@num": "R711-1-11", "#text": "Code de la santé publique - art. R711-1-11 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171018", "@fin": "2999-01-01", "#text": "Chapitre Ier : Collecte, préparation et conservation du sang, de ses composants et des produits sanguins labiles.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006154985", "@fin": "2999-01-01", "#text": "Titre II : Sang humain", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140604", "@fin": "2999-01-01", "#text": "Livre II : Don et utilisation des éléments et produits du corps humain", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125345", "@fin": "2999-01-01", "#text": "Première partie : Protection générale de la santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686103", "@fin": "2004-08-11", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686104", "@fin": "2005-09-02", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686105", "@fin": "2012-05-01", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2005-09-02", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025139304", "@fin": "2014-12-25", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000029962861", "@fin": "2016-01-28", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2014-12-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000031931400", "@fin": "2017-07-01", "@num": "L1221-13", "@etat": "MODIFIE", "@debut": "2016-01-28", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000033897135", "@fin": "2999-01-01", "@num": "L1221-13", "@etat": "VIGUEUR", "@debut": "2017-07-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

L'hémovigilance a pour objet l'ensemble des procédures de surveillance et d'évaluation des incidents, ainsi que des effets indésirables survenant chez les donneurs ou les receveurs de produits sanguins labiles. Elle porte sur l'ensemble de la chaîne transfusionnelle allant de la collecte des produits sanguins labiles jusqu'au suivi des receveurs. L'hémovigilance comprend également le suivi épidémiologique des donneurs.

Les personnes qui ont à connaître de ces informations sont tenues au secret professionnel dans les conditions et sous les peines prévues aux articles 226-13 et 226-14 du code pénal.

Un décret en Conseil d'Etat, pris après avis de l'Agence nationale de sécurité du médicament et des produits de santé, fixe les règles d'hémovigilance, et notamment la nature des informations nécessaires à la surveillance des effets de l'utilisation des produits sanguins labiles que les praticiens sont tenus de fournir, ainsi que les conditions d'exercice de cette surveillance.

" } }, "LEGIARTI000033897135": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1221-13", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2017-07-01" } }, "META_COMMUN": { "ID": "LEGIARTI000033897135", "URL": "article/LEGI/ARTI/00/00/33/89/71/LEGIARTI000033897135.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Conformément à l'article 7 de l'ordonnance n° 2017-51 du 19 janvier 2017, les présentes dispositions entrent en application à la date d'entrée en vigueur du décret en Conseil d'Etat pris pour son application, et au plus tard le 1er juillet 2017.
\n

L'hémovigilance a pour objet l'ensemble des procédures de surveillance et d'évaluation des incidents, ainsi que des effets indésirables survenant chez les donneurs ou les receveurs de produits sanguins labiles. Elle porte sur l'ensemble de la chaîne transfusionnelle allant de la collecte des produits sanguins labiles jusqu'au suivi des receveurs. L'hémovigilance comprend également le suivi épidémiologique des donneurs.

\n
\n

\n
Les professionnels de santé, les établissements de transfusion sanguine et les établissements de santé signalent et déclarent les informations relevant de l'hémovigilance. Un décret en Conseil d'Etat détermine les conditions d'application du présent article, notamment les modalités d'organisation du système d'hémovigilance.
" } }, "LEGIARTI000033897144": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5133-1", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2017-07-01" } }, "META_COMMUN": { "ID": "LEGIARTI000033897144", "URL": "article/LEGI/ARTI/00/00/33/89/71/LEGIARTI000033897144.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

" }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006696640", "@num": "19", "#text": "Loi n°93-5 du 4 janvier 1993 - art. 19 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000178299", "@nortexte": "SPSX9200032L", "@numtexte": "93-5", "@typelien": "CONCORDE", "@naturetexte": "LOI", "@datesignatexte": "1993-01-04" }, { "@id": "JORFTEXT000000217229", "#text": "Rapport relatif à l'ordonnance n° 2000-548 du 15 juin 2000", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006698248", "@num": "9", "#text": "n°2001-198 du 1 mars 2001 - art. 9 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000000588097", "@nortexte": "MESX0100017R", "@numtexte": "2001-198", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2001-03-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi n°2002-303 du 4 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000006228008", "@num": "1", "#text": "Arrêté du 15 janvier 2004 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000415652", "@nortexte": "SANP0420224A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2004-01-15" }, { "@id": "LEGIARTI000025860019", "@num": "1", "#text": "Arrêté du 30 juillet 2004 - art. 1 (VT)", "@sens": "cible", "@cidtexte": "JORFTEXT000000806957", "@nortexte": "SANP0422322A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2004-07-30" }, { "@id": "LEGIARTI000033894823", "@num": "1", "#text": "Ordonnance n°2017-51 du 19 janvier 2017 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000033893453", "@nortexte": "AFSP1632580R", "@numtexte": "2017-51", "@typelien": "MODIFIE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2017-01-19" }, { "@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": "LEGIARTI000043103478", "@num": "1", "#text": "Arrêté du 5 février 2021 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000043100729", "@nortexte": "SSAP2104251A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-02-05" }, { "@id": "LEGIARTI000046567255", "@num": "1", "#text": "Arrêté du 14 novembre 2022 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000046566303", "@nortexte": "SPRP2231874A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-11-14" }, { "@id": "LEGIARTI000006689004", "@num": "L4211-1", "#text": "Code de la santé publique - art. L4211-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691221", "@num": "L6211-1", "#text": "Code de la santé publique - art. L6211-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908671", "@num": "R1211-12", "#text": "Code de la santé publique - art. R1211-12 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039459172", "@num": "R1413-61-1", "#text": "Code de la santé publique - art. R1413-61-1 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000046554047", "@num": "R5311-2", "#text": "Code de la santé publique - art. 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\n
Les professionnels de santé, les établissements, personnes ou organismes figurant sur une liste fixée par décret en Conseil d'Etat déclarent les cas mentionnés au premier alinéa qu'ils constatent ou dont ils ont connaissance. Ce décret détermine également les conditions d'application du présent article.

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R5121-159 (VT)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034687120", "@num": "R5121-160", "#text": "Code de la santé publique - art. R5121-160 (VT)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039659062", "@num": "R5121-179", "#text": "Code de la santé publique - art. R5121-179 (VD)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039659118", "@num": "R5132-100", "#text": "Code de la santé publique - art. R5132-100 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025787482", "@num": "R5132-101", "#text": "Code de la santé publique - art. R5132-101 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "TRANSFERE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039659110", "@num": "R5132-101", "#text": "Code de la santé publique - art. R5132-101 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025787480", "@num": "R5132-102", "#text": "Code de la santé publique - art. R5132-102 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "TRANSFERE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039659116", "@num": "R5132-102", "#text": "Code de la santé publique - art. R5132-102 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039659143", "@num": "R5132-103", "#text": "Code de la santé publique - art. R5132-103 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039659132", "@num": "R5132-104", "#text": "Code de la santé publique - art. 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
" } }, "LEGIARTI000045630301": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5212-2", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2022-04-22" } }, "META_COMMUN": { "ID": "LEGIARTI000045630301", "URL": "article/LEGI/ARTI/00/00/45/63/03/LEGIARTI000045630301.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

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

" }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Rapport relatif à l'ordonnance n° 2000-548 du 15 juin 2000", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi n°2002-303 du 4 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "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": "LEGIARTI000045615379", "@num": "10", "#text": "Ordonnance n°2022-582 du 20 avril 2022 - art. 10", "@sens": "cible", "@cidtexte": "JORFTEXT000045614779", "@nortexte": "SSAP2205263R", "@numtexte": "2022-582", "@typelien": "MODIFIE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2022-04-20" }, { "@id": "LEGIARTI000049270115", "@num": "1", "#text": "Arrêté du 8 mars 2024 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049268178", "@nortexte": "TSSP2407108A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-03-08" }, { "@id": "LEGIARTI000049594308", "@num": "D1151-7", "#text": "Code de la santé publique - art. 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Les obligations de notification à l'Agence nationale de sécurité du médicament et des produits de santé ou d'information incombant, au titre de la vigilance exercée sur les dispositifs mentionnés à l'article premier du règlement (UE) 2017/745 du Parlement européen et du Conseil du 5 avril 2017, au fabricant ou, le cas échéant, à son mandataire, à l'importateur et au distributeur, sont définies par ce règlement, notamment à ses articles 10,13,14,87,88 et 89.
\n
\n En outre, tout professionnel de santé ou tout utilisateur professionnel du dispositif ayant connaissance d'un incident grave le déclare à l'agence. Il peut déclarer, en outre, tous les autres incidents dont il a connaissance suspectés d'être dus à un dispositif auprès du fabricant, afin que celui-ci puisse exercer ses activités de surveillance après commercialisation, conformément à l'article 83 du règlement (UE) 2017/745, et élaborer les rapports prévus aux articles 85,86 et 88 et 89 du même règlement.
\n
\n Tout patient, toute association agréée de patients ou tout utilisateur non professionnel du dispositif peut procéder à la déclaration, auprès de l'agence, de tout incident suspecté d'être dû à un dispositif qu'il utilise.

" } }, "LEGIARTI000046126072": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5222-3", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2022-07-31" } }, "META_COMMUN": { "ID": "LEGIARTI000046126072", "URL": "article/LEGI/ARTI/00/00/46/12/60/LEGIARTI000046126072.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Se reporter aux modalités d'application prévues à l'article 15 de l'ordonnance n° 2022-1086 du 29 juillet 2022.

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Les obligations de notification à l'Agence nationale de sécurité du médicament et des produits de santé ou d'information incombant, au titre de la vigilance exercée sur les dispositifs mentionnés à l'article premier du règlement (UE) 2017/746, au fabricant ou, le cas échéant, à son mandataire, à l'importateur et au distributeur, sont définies par ce règlement, notamment à ses articles 10, 13, 14, 82, 83 et 84.
\n
\n En outre, tout professionnel de santé ou tout personnel ayant reçu une formation adaptée et relevant des structures de prévention et associatives ou du service de santé des armées ayant connaissance d'un incident grave le déclare à l'agence. Il peut déclarer, en outre, tous les autres incidents dont il a connaissance, suspectés d'être dus à un dispositif auprès du fabricant afin que celui-ci puisse exercer ses activités de surveillance après commercialisation conformément à l'article 78 du règlement (UE) 2017/746 et élaborer les rapports prévus aux articles 80,81,83 et 84 du même règlement.
\n
\n Tout patient, toute association agréée de patients ou tout utilisateur non professionnel du dispositif peut procéder à la déclaration, auprès de l'agence, de tout incident suspecté d'être dû à un dispositif qu'il utilise.

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Article R1413-61-1 AUTONOME VIGUEUR, en vigueur depuis le 01/01/2021 (Code de la santé publique)