{ "article": { "LEGIARTI000046118738": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "11", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000046118738", "URL": "article/LEGI/ARTI/00/00/46/11/87/LEGIARTI000046118738.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000046126182", "@num": "L5311-1", "#text": "Code de la santé publique - art. L5311-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000046126169", "@num": "L5312-3", "#text": "Code de la santé publique - art. L5312-3 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000046113837", "@nor": "SPRP2217455R", "@num": "2022-1086", "@nature": "ORDONNANCE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Ordonnance n° 2022-1086 du 29 juillet 2022 portant adaptation du droit français au règlement (UE) 2017/746 du Parlement européen et du Conseil du 5 avril 2017 relatif aux dispositifs médicaux de diagnostic in vitro", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000046113837", "@c_titre_court": "Ordonnance n°2022-1086 du 29 juillet 2022" }, { "@fin": "2999-01-01", "#text": "Ordonnance n° 2022-1086 du 29 juillet 2022 portant adaptation du droit français au règlement (UE) 2017/746 du Parlement européen et du Conseil du 5 avril 2017 relatif aux dispositifs médicaux de diagnostic in vitro", "@debut": "2022-07-31", "@id_txt": "LEGITEXT000046118709", "@c_titre_court": "Ordonnance n°2022-1086 du 29 juillet 2022" } ], "@ministere": "Ministère de la santé et de la prévention", "@date_publi": "2022-07-30", "@date_signature": "2022-07-29", "@num_parution_jo": "0175" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000046118738", "@fin": "2999-01-01", "@num": "11", "@debut": "2999-01-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000046113848", "@fin": "2999-01-01", "@num": "11", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
A modifié les dispositions suivantes :

- Code de la santé publique
\n Art. L5311-1, Art. L5312-3\n
\n

\n
" } }, "LEGIARTI000046126169": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5312-3", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2022-07-31" } }, "META_COMMUN": { "ID": "LEGIARTI000046126169", "URL": "article/LEGI/ARTI/00/00/46/12/61/LEGIARTI000046126169.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "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": "LEGIARTI000046118738", "@num": "11", "#text": "Ordonnance n°2022-1086 du 29 juillet 2022 - art. 11", "@sens": "cible", "@cidtexte": "JORFTEXT000046113837", "@nortexte": "SPRP2217455R", "@numtexte": "2022-1086", "@typelien": "MODIFIE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2022-07-29" }, { "@id": "LEGIARTI000046126182", "@num": "L5311-1", "#text": "Code de la santé publique - art. L5311-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690357", "@num": "L5312-1", "#text": "Code de la santé publique - art. L5312-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690360", "@num": "L5312-2", "#text": "Code de la santé publique - art. L5312-2", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690364", "@num": "L5312-4", "#text": "Code de la santé publique - art. L5312-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000031932590", "@num": "L5451-1", "#text": "Code de la santé publique - art. L5451-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000047291570", "@num": "L5461-9", "#text": "Code de la santé publique - art. L5461-9 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006695243", "@num": "L793-5", "#text": "Code de la santé publique - art. L793-5 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique L793-5 III", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171402", "@fin": "2999-01-01", "#text": "Chapitre II : Prérogatives.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155093", "@fin": "2999-01-01", "#text": "Titre Ier : Missions et prérogatives", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140633", "@fin": "2012-05-01", "#text": "Livre III : Agence française de sécurité sanitaire des produits de santé", "@debut": "2000-06-22" }, { "@id": "LEGISCTA000025104258", "@fin": "2999-01-01", "#text": "Livre III : Agence nationale de sécurité du médicament et des produits de santé", "@debut": "2012-05-01" } ] }, "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": "LEGIARTI000006690362", "@fin": "2001-03-03", "@num": "L5312-3", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690363", "@fin": "2022-07-31", "@num": "L5312-3", "@etat": "MODIFIE", "@debut": "2001-03-03", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000046126169", "@fin": "2999-01-01", "@num": "L5312-3", "@etat": "VIGUEUR", "@debut": "2022-07-31", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Dans les cas mentionnés aux articles L. 5312-1 et L. 5312-2, ainsi que dans le cas d'une suspension ou d'un retrait d'autorisation ou d'enregistrement d'un produit ou groupe de produits mentionné à l'article L. 5311-1, l'agence peut enjoindre la personne physique ou morale responsable de la mise sur le marché, de la mise en service, de la mise à disposition sur le marché ou de l'utilisation de procéder au retrait du produit ou groupe de produits en tout lieu où il se trouve, à sa destruction lorsque celle-ci constitue le seul moyen de faire cesser le danger, et ordonner la diffusion de mises en garde ou de précautions d'emploi. Ces mesures sont à la charge de cette personne.

Le cas échéant, les mesures de suspension, d'interdiction, de retrait ou de destruction d'un produit peuvent être limitées à certains lots de fabrication.

Chaque fabricant, importateur, transporteur, distributeur en gros ou au détail ayant acquis ou cédé des lots concernés et ayant connaissance de la décision est tenu d'en informer ceux qui lui ont fourni la marchandise et ceux à qui il l'a cédée.

" } }, "LEGIARTI000046126182": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5311-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2024-01-01", "DATE_DEBUT": "2022-07-31" } }, "META_COMMUN": { "ID": "LEGIARTI000046126182", "URL": "article/LEGI/ARTI/00/00/46/12/61/LEGIARTI000046126182.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006630983", "@num": "1", "#text": "Décret n°81-278 du 25 mars 1981 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000503017", "@numtexte": "81-278", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1981-03-25" }, { "@id": "LEGIARTI000006631025", "@num": "Annexe I", "#text": "Décret n°81-278 du 25 mars 1981 - art. Annexe I (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000503017", "@numtexte": "81-278", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1981-03-25" }, { "@id": "LEGIARTI000035606736", "@num": "2-1", "#text": "Décret n°90-975 du 30 octobre 1990 - art. 2-1 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000000160314", "@nortexte": "SPSG9001546D", "@numtexte": "90-975", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1990-10-30" }, { "@id": "LEGIARTI000006712582", "@num": "2", "#text": "Décret n°92-1432 du 30 décembre 1992 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000726011", "@nortexte": "SPSG9202710D", "@numtexte": "92-1432", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1992-12-30" }, { "@id": "LEGIARTI000006355280", "@num": "87", "#text": "Loi n°93-122 du 29 janvier 1993 - art. 87 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000711604", "@nortexte": "PRMX9200148L", "@numtexte": "93-122", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "1993-01-29" }, { "@id": "LEGIARTI000006865783", "@num": "Annexe", "#text": "Décret n°96-850 du 20 septembre 1996 - art. Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000195660", "@nortexte": "ENVP9640024D", "@numtexte": "96-850", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1996-09-20" }, { "@id": "LEGIARTI000006506987", "@num": "3", "#text": "Décret n°98-385 du 18 mai 1998 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000571865", "@nortexte": "MESG9820693D", "@numtexte": "98-385", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1998-05-18" }, { "@id": "LEGIARTI000006724441", "@num": "5", "#text": "Décret n°2001-35 du 11 janvier 2001 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000388987", "@nortexte": "MJSK0070147D", "@numtexte": "2001-35", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2001-01-11" }, { "@id": "LEGIARTI000006254318", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254325", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639980", "@nortexte": "SANP0623382A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254307", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254319", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326653", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020320295", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326611", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254321", "@num": "4", "#text": "Arrêté du 16 août 2006 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254313", "@num": "7", "#text": "Arrêté du 16 août 2006 - art. 7 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006734099", "@num": "ANNEXE", "#text": "Arrêté du 16 août 2006 - art. ANNEXE (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639975", "@nortexte": "SANP0623370A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006255223", "@num": "1", "#text": "Arrêté du 11 septembre 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000271992", "@nortexte": "SANP0623792A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-09-11" }, { "@id": "LEGIARTI000020322856", "@num": "3", "#text": "Arrêté du 11 septembre 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000271992", "@nortexte": "SANP0623792A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-09-11" }, { "@id": "LEGIARTI000006697048", "@num": "39", "#text": "Loi n°2007-248 du 26 février 2007 - art. 39 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000613381", "@nortexte": "SANX0600004L", "@numtexte": "2007-248", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2007-02-26" }, { "@id": "LEGIARTI000006868630", "@num": "29", "#text": "Décret n° 2007-358 du 19 mars 2007 - art. 29 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000821090", "@nortexte": "AGRG0700644D", "@numtexte": "2007-358", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-19" }, { "@id": "LEGIARTI000006726837", "@num": "5", "#text": "Décret n°2007-462 du 25 mars 2007 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000466314", "@nortexte": "MJSK0770075D", "@numtexte": "2007-462", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-25" }, { "@id": "LEGIARTI000018361459", "@num": "Annexe", "#text": "Arrêté du 5 mars 2008 - art. Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000018360158", "@nortexte": "SJSP0805973A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-03-05" }, { "@id": "LEGIARTI000019382668", "@num": "2", "#text": "Arrêté du 11 août 2008 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019381783", "@nortexte": "SJSP0820319A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-08-11" }, { "@id": "LEGIARTI000034448482", "@num": "7", "#text": "Arrêté du 6 février 2009 - art. 7 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000020234297", "@nortexte": "SJSG0824493A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-06" }, { "@id": "LEGITEXT000020319418", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318429", "@nortexte": "SASP0904387A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319427", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318439", "@nortexte": "SASP0904427A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319436", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318449", "@nortexte": "SASP0904394A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGIARTI000021782780", "@num": "Annexe au règlement intérieur", "#text": "Arrêté du 13 janvier 2010 - art. Annexe au règlement intérieur (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000021782073", "@nortexte": "SASP1001133A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-01-13" }, { "@id": "LEGITEXT000022416787", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415149", "@nortexte": "SASP1017123A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416463", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415125", "@nortexte": "SASP1017105A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416472", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415141", "@nortexte": "SASP1017114A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGIARTI000023430029", "@num": "6", "#text": "Décret n°2011-57\n du 13 janvier 2011 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000023428330", "@nortexte": "SPOV1017553D", "@numtexte": "2011-57", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-01-13" }, { "@id": "LEGITEXT000023778069", "#text": "Arrêté du 17 mars 2011 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000023776935", "@nortexte": "ETSP1108041A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-03-17" }, { "@id": "LEGIARTI000025071143", "@num": "38", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 38 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000025071141", "@num": "39", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 39 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000026480621", "@num": "4", "#text": "Arrêté du 10 octobre 2012 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000026479723", "@nortexte": "AFSP1221372A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-10-10" }, { "@id": "LEGIARTI000027648252", "#text": "Arrêté du 23 janvier 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027047902", "@nortexte": "AFSP1228322A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-01-23" }, { "@id": "LEGITEXT000027434552", "#text": "Décret n°2013-414\n du 21 mai 2013 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027434029", "@nortexte": "AFSP1304115D", "@numtexte": "2013-414", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2013-05-21" }, { "@id": "LEGIARTI000027594512", "#text": "Arrêté du 20 juin 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027592947", "@nortexte": "AFSP1313848A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-20" }, { "@id": "LEGIARTI000027699119", "@num": "1", "#text": "Arrêté du 17 juin 2013 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027697076", "@nortexte": "AFSP1301854A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-17" }, { "@id": "LEGIARTI000033202304", "#text": "Arrêté du 29 août 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027910341", "@nortexte": "PROI1311061A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-08-29" }, { "@id": "LEGIARTI000035971526", "#text": "DÉCRET n°2014-1286 du 23 octobre 2014 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029675991", "@nortexte": "AFSX1419046D", "@numtexte": "2014-1286", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000036393921", "@num": "166", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 166 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000031916570", "@num": "169", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 169 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000043508038", "#text": "Arrêté du 28 novembre 2016 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033507693", "@nortexte": "AFSP1633477A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-11-28" }, { "@id": "LEGIARTI000033554483", "@num": "3", "#text": "Arrêté du 2 décembre 2016 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033553349", "@nortexte": "AFSP1635656A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000038887172", "@num": "2", "#text": "LOI n°2017-220 du 23 février 2017 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034078423", "@nortexte": "AFSP1622342L", "@numtexte": "2017-220", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2017-02-23" }, { "@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": "LEGIARTI000035988048", "@num": "3", "#text": "Arrêté du 27 février 2017 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150842", "@nortexte": "AFSP1706241A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000035269375", "@num": "1", "#text": "Arrêté du 17 juillet 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000035268202", "@nortexte": "SSAE1720859A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-07-17" }, { "@id": "LEGITEXT000036406189", "#text": "Décret n°2017-1781 du 27 décembre 2017 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036299141", "@nortexte": "SSAP1728401D", "@numtexte": "2017-1781", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-12-27" }, { "@id": "LEGIARTI000038432466", "@num": "1", "#text": "Décret n°2019-389 du 30 avril 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000038431240", "@nortexte": "SSAS1906324D", "@numtexte": "2019-389", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-04-30" }, { "@id": "LEGITEXT000039664011", "#text": "Arrêté du 20 décembre 2019 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000039663324", "@nortexte": "SSAP1936730A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-12-20" }, { "@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": "LEGIARTI000042645749", "@num": "17", "#text": "Ordonnance n°2020-460 du 22 avril 2020 - art. 17 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041814597", "@nortexte": "ECOX2009794R", "@numtexte": "2020-460", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2020-04-22" }, { "@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": "LEGIARTI000043103458", "#text": "Arrêté du 5 février 2021 - art. (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000043100729", "@nortexte": "SSAP2104251A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-02-05" }, { "@id": "LEGIARTI000043298491", "@num": "3", "#text": "Décret n°2021-331 du 26 mars 2021 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000043297285", "@nortexte": "SSAS2034156D", "@numtexte": "2021-331", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-03-26" }, { "@id": "LEGITEXT000043543262", "#text": "Décret n°2021-662 du 26 mai 2021 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043541690", "@nortexte": "ECOI2106880D", "@numtexte": "2021-662", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-05-26" }, { "@id": "LEGIARTI000043543283", "#text": "Décret n°2021-662 du 26 mai 2021 - art.", "@sens": "cible", "@cidtexte": "JORFTEXT000043541690", "@nortexte": "ECOI2106880D", "@numtexte": "2021-662", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-05-26" }, { "@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 1er juin 2021 - art. 27 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000046118738", "@num": "11", "#text": "Ordonnance n°2022-1086 du 29 juillet 2022 - art. 11", "@sens": "cible", "@cidtexte": "JORFTEXT000046113837", "@nortexte": "SPRP2217455R", "@numtexte": "2022-1086", "@typelien": "MODIFIE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2022-07-29" }, { "@id": "LEGIARTI000046567251", "@num": "Annexe 2", "#text": "Arrêté du 14 novembre 2022 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000046566303", "@nortexte": "SPRP2231874A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-11-14" }, { "@id": "LEGIARTI000049976728", "@num": "Annexe 1", "#text": "Arrêté du 14 novembre 2022 - art. Annexe 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000046566303", "@nortexte": "SPRP2231874A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-11-14" }, { "@id": "LEGIARTI000050409030", "#text": "Arrêté du 24 octobre 2024 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000050407232", "@nortexte": "MSAP2428789A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-10-24" }, { "@id": "LEGIARTI000050409032", "#text": "Arrêté du 24 octobre 2024 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000050407232", "@nortexte": "MSAP2428789A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-10-24" }, { "@id": "LEGIARTI000043545974", "@num": "Annexe I à l'article D523-8", "#text": "Code de l'environnement - art. Annexe I à l'article D523-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000027912149", "@num": "D523-8", "#text": "Code de l'environnement - art. D523-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000042654871", "@num": "L521-2", "#text": "Code de l'environnement - art. L521-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021666283", "@num": "L531-3", "#text": "Code de l'environnement - art. L531-3 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028749087", "@num": "L221-10", "#text": "Code de la consommation - art. L221-10 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069565", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000041985451", "@num": "L511-22", "#text": "Code de la consommation - art. L511-22 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069565", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000046012786", "@num": "R422-1", "#text": "Code de la consommation - art. R422-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069565", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006574178", "@num": "R*1142-25", "#text": "Code de la défense. - art. R*1142-25 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006071307", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006574182", "@num": "R*1142-29", "#text": "Code de la défense. - art. R*1142-29 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006071307", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049599041", "@num": "D1413-58", "#text": "Code de la santé publique - art. D1413-58 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033642702", "@num": "D6141-42", "#text": "Code de la santé publique - art. D6141-42 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025104470", "@num": "L1121-1", "#text": "Code de la santé publique - art. L1121-1 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000024325597", "@num": "L1121-11", "#text": "Code de la santé publique - art. L1121-11 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025457563", "@num": "L1121-16", "#text": "Code de la santé publique - art. L1121-16 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025104351", "@num": "L1121-3", "#text": "Code de la santé publique - art. L1121-3 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000032722946", "@num": "L1123-12", "#text": "Code de la santé publique - art. L1123-12 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685881", "@num": "L1123-7", "#text": "Code de la santé publique - art. L1123-7 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685885", "@num": "L1123-8", "#text": "Code de la santé publique - art. L1123-8 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685887", "@num": "L1123-9", "#text": "Code de la santé publique - art. 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I.-L'Agence nationale de sécurité du médicament et des produits de santé est un établissement public de l'Etat, placé sous la tutelle du ministre chargé de la santé.

II.-L'agence procède à l'évaluation des bénéfices et des risques liés à l'utilisation des produits à finalité sanitaire destinés à l'homme, des produits listés à l'annexe XVI du règlement (UE) 2017/745 relevant de sa compétence et des produits à finalité cosmétique. Elle surveille le risque lié à ces produits et effectue des réévaluations des bénéfices et des risques.

L'agence peut demander que les essais cliniques portant sur des médicaments soient effectués sous forme d'essais contre comparateurs actifs et contre placebo. Si la personne produisant ou exploitant un médicament s'oppose aux essais contre comparateurs actifs, elle doit le justifier.

L'agence participe à l'application des lois et règlements et prend, dans les cas prévus par des dispositions particulières, des décisions relatives à l'évaluation, aux essais, à la fabrication, à la préparation, à l'importation, à l'exportation, à la distribution en gros, au courtage, au conditionnement, à la conservation, à l'exploitation, à la mise sur le marché, à la publicité, à la mise en service ou à l'utilisation des produits mentionnés au premier alinéa du présent II, et notamment :

1° Les médicaments, y compris les insecticides, acaricides et antiparasitaires à usage humain, les préparations magistrales, hospitalières et officinales, les substances stupéfiantes, psychotropes ou autres substances vénéneuses, les huiles essentielles et plantes médicinales, les matières premières à usage pharmaceutique ;

2° Les produits contraceptifs et contragestifs ;

3° Les dispositifs médicaux et leurs accessoires ;

3° bis Les produits n'ayant pas de destination médicale dont la liste figure à l'annexe XVI du règlement (UE) 2017/745 ;

4° Les dispositifs médicaux de diagnostic in vitro et leurs accessoires ;

5° Les produits sanguins labiles ;

6° Les organes, tissus, cellules et produits d'origine humaine ou animale, y compris lorsqu'ils sont prélevés à l'occasion d'une intervention chirurgicale ;

7° Les produits cellulaires à finalité thérapeutique ;

8° Le lait maternel collecté, qualifié, préparé et conservé par les lactariums ;

9° (Abrogé) ;

10° (Abrogé) ;

11° Les procédés et appareils destinés à la désinfection des locaux et des véhicules dans les cas prévus à l'article L. 3114-1 ;

12° (Abrogé) ;

13° (Abrogé) ;

14° (Abrogé) ;

15° Les produits cosmétiques ;

16° Les micro-organismes et toxines mentionnés à l'article L. 5139-1 ;

17° Les produits de tatouage ;

18° Les logiciels qui ne sont pas des dispositifs médicaux et qui sont utilisés par les laboratoires de biologie médicale, pour la gestion des examens de biologie médicale et lors de la validation, de l'interprétation, de la communication appropriée en application du 3° de l'article L. 6211-2 et de l'archivage des résultats ;

19° Les dispositifs à finalité non strictement médicale utilisés dans les laboratoires de biologie médicale pour la réalisation des examens de biologie médicale ;

20° (Abrogé) ;

21° Les selles collectées par les établissements ou organismes mentionnés à l'article L. 513-11-1 et destinées à la fabrication d'un médicament.

III.- L'agence participe à l'application des dispositions législatives et règlementaires mentionnées au titre II du livre Ier de la première partie et prend, dans les cas prévus par des dispositions particulières, des décisions relatives à ces recherches.

Elle assure la mise en œuvre des systèmes de vigilance, portant sur les produits mentionnés au II, à l'exception de la biovigilance et du dispositif de vigilance relatif à l'assistance médicale à la procréation, et élabore la pharmacopée.

Elle rend publics un rapport de synthèse de l'évaluation effectuée pour tout nouveau médicament dans des conditions déterminées par voie réglementaire, ainsi que les décisions d'octroi, de suspension et de retrait de l'autorisation de mise sur le marché mentionnées aux articles L. 5121-8 et L. 5121-9. Elle organise des réunions régulières d'information avec des associations agréées de personnes malades et d'usagers du système de santé mentionnées à l'article L. 1114-1 sur les problèmes de sécurité sanitaire des produits de santé, notamment sur les actions entreprises dans le domaine de la prévention et de la répression de la falsification des médicaments.

Elle contrôle la publicité en faveur de tous les produits, objets, appareils et méthodes revendiquant une finalité sanitaire ainsi que celle en faveur des produits listés à l'annexe XVI du règlement (UE) 2017/745 relevant de sa compétence.

Elle prend ou demande aux autorités compétentes de prendre les mesures de police sanitaire nécessaires lorsque la santé de la population est menacée, dans les conditions prévues au présent code ou par toute autre disposition législative ou réglementaire visant à préserver la santé humaine.

Elle établit un rapport annuel d'activité adressé au Gouvernement et au Parlement. Ce rapport est rendu public. Le rapport comporte le bilan annuel de la réévaluation du rapport entre les bénéfices et les risques des médicaments à usage humain mentionnés à l'article L. 5121-8.

Elle organise des auditions publiques sur des thèmes de santé publique.

L'agence est également chargée du contrôle du respect des dispositions des autorisations délivrées en application de l'article L. 1161-5.

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Article 11 ENTIEREMENT_MODIF (Ordonnance n° 2022-1086 du 29 juillet 2022 portant adaptation du droit français au règlement (UE) 2017/746 du Parlement européen et du Conseil du 5 avril 2017 relatif aux dispositifs médicaux de diagnostic in vitro)