{ "article": { "LEGIARTI000041780811": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "1", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000041780811", "URL": "article/LEGI/ARTI/00/00/41/78/08/LEGIARTI000041780811.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000041780819", "@num": "12-4", "#text": "Décret n°2020-293 du 23 mars 2020 - art. 12-4 (Ab)", "@sens": "source", "@cidtexte": "JORFTEXT000041746694", "@nortexte": "SSAZ2008253D", "@numtexte": "2020-293", "@typelien": "CREE", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000006689956", "@num": "L5123-2", "#text": "Code de la santé publique - art. L5123-2", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690196", "@num": "L5141-5", "#text": "Code de la santé publique - art. L5141-5", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690231", "@num": "L5142-1", "#text": "Code de la santé publique - art. L5142-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000041780609", "@nor": "SSAZ2009058D", "@num": "2020-393", "@nature": "DECRET", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Décret n° 2020-393 du 2 avril 2020 complétant le décret n° 2020-293 du 23 mars 2020 prescrivant les mesures générales nécessaires pour faire face à l'épidémie de covid-19 dans le cadre de l'état d'urgence sanitaire", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000041780609", "@c_titre_court": "Décret n°2020-393 du 2 avril 2020" }, { "@fin": "2999-01-01", "#text": "Décret n° 2020-393 du 2 avril 2020 complétant le décret n° 2020-293 du 23 mars 2020 prescrivant les mesures générales nécessaires pour faire face à l'épidémie de covid-19 dans le cadre de l'état d'urgence sanitaire", "@debut": "2020-04-03", "@id_txt": "LEGITEXT000041780806", "@c_titre_court": "Décret n°2020-393 du 2 avril 2020" } ], "@ministere": "Ministère des solidarités et de la santé", "@date_publi": "2020-04-03", "@date_signature": "2020-04-02", "@num_parution_jo": "0081" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000041780811", "@fin": "2999-01-01", "@num": "1", "@debut": "2999-01-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000041780614", "@fin": "2999-01-01", "@num": "1", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
A créé les dispositions suivantes :

- Décret n°2020-293 du 23 mars 2020
\n Art. 12-4\n
\n

\n
" } }, "LEGIARTI000006689956": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5123-2", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-11", "DATE_DEBUT": "2000-06-22" } }, "META_COMMUN": { "ID": "LEGIARTI000006689956", "URL": "article/LEGI/ARTI/00/00/06/68/99/LEGIARTI000006689956.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5123L02XXAA" } }, "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": "LEGIARTI000006334800", "@num": "1", "#text": "Arrêté du 13 novembre 2001 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000221792", "@nortexte": "MESG0123551A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2001-11-13" }, { "@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": "LEGIARTI000006758846", "@num": "12", "#text": "Loi n°2003-1199 du 18 décembre 2003 - art. 12 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000249276", "@nortexte": "SANX0300139L", "@numtexte": "2003-1199", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2003-12-18" }, { "@id": "LEGIARTI000006231372", "@num": "1", "#text": "Arrêté du 26 mai 2004 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000235408", "@nortexte": "SANG0420602A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2004-05-26" }, { "@id": "LEGIARTI000019351959", "@num": "1", "#text": "Arrêté du 25 juin 2008 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019350195", "@nortexte": "SJSS0803525A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-06-25" }, { "@id": "LEGIARTI000019351951", "@num": "1", "#text": "Arrêté du 25 juin 2008 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019350188", "@nortexte": "SJSS0803668A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-06-25" }, { "@id": "LEGIARTI000030131452", "@num": "4", "#text": "Arrêté du 5 mars 2010 - art. 4 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000021954715", "@nortexte": "BCFR1004493A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-03-05" }, { "@id": "LEGIARTI000025832877", "@num": "1", "#text": "Arrêté du 7 mai 2012 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000025824505", "@nortexte": "ETSS1209429A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-05-07" }, { "@id": "LEGIARTI000028414521", "@num": "1", "#text": "Arrêté du 20 décembre 2013 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000028398405", "@nortexte": "AFSS1331706A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-12-20" }, { "@id": "LEGIARTI000029449716", "@num": "1", "#text": "ARRÊTÉ du 25 juillet 2014 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000029449036", "@nortexte": "FCPE1418309A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2014-07-25" }, { "@id": "LEGIARTI000038879548", "@num": "1", "#text": "Décret n°2019-818 du 1er août 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000038873188", "@nortexte": "SSAS1911214D", "@numtexte": "2019-818", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-08-01" }, { "@id": "LEGIARTI000038944863", "@num": "2", "#text": "Décret n°2019-855 du 20 août 2019 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000038940078", "@nortexte": "SSAS1916802D", "@numtexte": "2019-855", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-08-20" }, { "@id": "LEGIARTI000048702348", "#text": "Arrêté du 28 août 2019 - art. (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000039003584", "@nortexte": "SSAS1924947A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-08-28" }, { "@id": "LEGIARTI000041577004", "@num": "6", "#text": "Décret n°2020-120 du 13 février 2020 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000041573390", "@nortexte": "SSAS1932960D", "@numtexte": "2020-120", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-02-13" }, { "@id": "LEGIARTI000041619114", "#text": "Arrêté du 19 février 2020 - art.", "@sens": "cible", "@cidtexte": "JORFTEXT000041617382", "@nortexte": "SSAS2005311A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-02-19" }, { "@id": "LEGIARTI000041760851", "@num": "12-2", "#text": "Décret n°2020-293 du 23 mars 2020 - art. 12-2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746694", "@nortexte": "SSAZ2008253D", "@numtexte": "2020-293", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041780819", "@num": "12-4", "#text": "Décret n°2020-293 du 23 mars 2020 - art. 12-4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746694", "@nortexte": "SSAZ2008253D", "@numtexte": "2020-293", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041756280", "@num": "1", "#text": "Décret n°2020-314 du 25 mars 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041755775", "@nortexte": "SSAZ2008362D", "@numtexte": "2020-314", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-25" }, { "@id": "LEGIARTI000041780811", "@num": "1", "#text": "Décret n°2020-393 du 2 avril 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041780609", "@nortexte": "SSAZ2009058D", "@numtexte": "2020-393", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-04-02" }, { "@id": "LEGIARTI000041859122", "@num": "17", "#text": "Décret n°2020-545 du 11 mai 2020 - art. 17 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041858681", "@nortexte": "SSAZ2011567D", "@numtexte": "2020-545", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041859126", "@num": "19", "#text": "Décret n°2020-545 du 11 mai 2020 - art. 19 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041858681", "@nortexte": "SSAZ2011567D", "@numtexte": "2020-545", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041866847", "@num": "19", "#text": "Décret n°2020-548 du 11 mai 2020 - art. 19 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041865329", "@nortexte": "SSAZ2011695D", "@numtexte": "2020-548", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041866851", "@num": "21", "#text": "Décret n°2020-548 du 11 mai 2020 - art. 21 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041865329", "@nortexte": "SSAZ2011695D", "@numtexte": "2020-548", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041943336", "@num": "52", "#text": "Décret n°2020-663 du 31 mai 2020 - art. 52 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041939818", "@nortexte": "SSAZ2013547D", "@numtexte": "2020-663", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-31" }, { "@id": "LEGIARTI000042267406", "@num": "1", "#text": "Décret n°2020-1090 du 25 août 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000042266405", "@nortexte": "SSAS2006857D", "@numtexte": "2020-1090", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-08-25" }, { "@id": "LEGIARTI000043510080", "@num": "55-1", "#text": "Décret n°2020-1262 du 16 octobre 2020 - art. 55-1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042430554", "@nortexte": "SSAZ2028015D", "@numtexte": "2020-1262", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-10-16" }, { "@id": "LEGIARTI000043510117", "@num": "53-1", "#text": "Décret n°2020-1310 du 29 octobre 2020 - art. 53-1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042475143", "@nortexte": "SSAZ2029612D", "@numtexte": "2020-1310", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-10-29" }, { "@id": "LEGITEXT000042559681", "#text": "Décret n°2020-1437 du 24 novembre 2020 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042558802", "@nortexte": "SSAS2022717D", "@numtexte": "2020-1437", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-11-24" }, { "@id": "LEGIARTI000042667306", "@num": "78", "#text": "LOI n°2020-1576 du 14 décembre 2020 - art. 78 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000042665307", "@nortexte": "ECOX2023815L", "@numtexte": "2020-1576", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2020-12-14" }, { "@id": "LEGIARTI000043329386", "@num": "1", "#text": "Décret n°2021-384 du 2 avril 2021 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000043327303", "@nortexte": "SSAZ2110799D", "@numtexte": "2021-384", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-04-02" }, { "@id": "LEGIARTI000043329388", "@num": "2", "#text": "Décret n°2021-384 du 2 avril 2021 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000043327303", "@nortexte": "SSAZ2110799D", "@numtexte": "2021-384", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-04-02" }, { "@id": "LEGIARTI000047009237", "@num": "5", "#text": "Arrêté du 1 juin 2021 - art. 5 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000043734170", "@num": "2", "#text": "Décret n°2021-869 du 30 juin 2021 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000043728288", "@nortexte": "SSAS2114883D", "@numtexte": "2021-869", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-06-30" }, { "@id": "LEGIARTI000044215949", "@num": "1", "#text": "Décret n°2021-1356 du 15 octobre 2021 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000044214351", "@nortexte": "SSAS2125312D", "@numtexte": "2021-1356", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-10-15" }, { "@id": "LEGIARTI000047543476", "@num": "2", "#text": "Décret n°2023-367 du 13 mai 2023 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000047542080", "@nortexte": "SPRS2300922D", "@numtexte": "2023-367", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2023-05-13" }, { "@id": "LEGIARTI000047750741", "@num": "1", "#text": "Décret n°2023-518 du 27 juin 2023 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000047749196", "@nortexte": "SPRS2234375D", "@numtexte": "2023-518", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2023-06-27" }, { "@id": "LEGIARTI000006915035", "@num": "D5123-4", "#text": "Code de la santé publique - 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L'achat, la fourniture, la prise en charge et l'utilisation par les collectivités publiques des médicaments définis aux articles L. 5121-8, L. 5121-12 et L. 5121-13 sont limités, dans les conditions propres à ces médicaments fixées par le décret mentionné à l'article L. 162-17 du code de la sécurité sociale, aux produits agréés dont la liste est établie par arrêté des ministres chargés de la santé et de la sécurité sociale.
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L'achat, la fourniture, la prise en charge et l'utilisation par les collectivités publiques des médicaments définis aux articles L. 5121-8, L. 5121-12 et L. 5121-13 sont limités, dans les conditions propres à ces médicaments fixées par le décret mentionné à l'article L. 162-17 du code de la sécurité sociale, aux produits agréés dont la liste est établie par arrêté des ministres chargés de la santé et de la sécurité sociale.
\n
L'inscription d'un médicament sur la liste mentionnée au premier alinéa peut, au vu des exigences de qualité et de sécurité des soins mettant en oeuvre ce médicament, énoncées le cas échéant par la commission prévue à l'article L. 5123-3, être assortie de conditions concernant la qualification ou la compétence des prescripteurs, l'environnement technique ou l'organisation de ces soins et d'un dispositif de suivi des patients traités.
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L'achat, la fourniture, la prise en charge et l'utilisation par les collectivités publiques des médicaments définis aux articles L. 5121-8, L. 5121-12 et L. 5121-13 ou importés selon la procédure prévue à l'article L. 5124-17-1 sont limités, dans les conditions propres à ces médicaments fixées par le décret mentionné à l'article L. 162-17 du code de la sécurité sociale, aux produits agréés dont la liste est établie par arrêté des ministres chargés de la santé et de la sécurité sociale.
\n
L'inscription d'un médicament sur la liste mentionnée au premier alinéa peut, au vu des exigences de qualité et de sécurité des soins mettant en oeuvre ce médicament, énoncées le cas échéant par la commission prévue à l'article L. 5123-3, être assortie de conditions concernant la qualification ou la compétence des prescripteurs, l'environnement technique ou l'organisation de ces soins et d'un dispositif de suivi des patients traités.
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L'achat, la fourniture, la prise en charge et l'utilisation par les collectivités publiques des médicaments définis aux articles L. 5121-8, L. 5121-9-1, L. 5121-12 et L. 5121-13 ou importés selon la procédure prévue à l'article L. 5124-17-1 sont limités, dans les conditions propres à ces médicaments fixées par le décret mentionné à l'article L. 162-17 du code de la sécurité sociale, aux produits agréés dont la liste est établie par arrêté des ministres chargés de la santé et de la sécurité sociale.
\n
L'inscription d'un médicament sur la liste mentionnée au premier alinéa peut, au vu des exigences de qualité et de sécurité des soins mettant en oeuvre ce médicament, énoncées le cas échéant par la commission prévue à l'article L. 5123-3, être assortie de conditions concernant la qualification ou la compétence des prescripteurs, l'environnement technique ou l'organisation de ces soins et d'un dispositif de suivi des patients traités.
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L'achat, la fourniture, la prise en charge et l'utilisation par les collectivités publiques des médicaments définis aux articles L. 5121-8, L. 5121-9-1, L. 5121-12, L. 5121-13 et L. 5121-14-1 ou importés selon la procédure prévue à l'article L. 5124-17-1 sont limités, dans les conditions propres à ces médicaments fixées par le décret mentionné à l'article L. 162-17 du code de la sécurité sociale, aux produits agréés dont la liste est établie par arrêté des ministres chargés de la santé et de la sécurité sociale.
\n
L'inscription d'un médicament sur la liste mentionnée au premier alinéa peut, au vu des exigences de qualité et de sécurité des soins mettant en oeuvre ce médicament, énoncées le cas échéant par la commission prévue à l'article L. 5123-3, être assortie de conditions concernant la qualification ou la compétence des prescripteurs, l'environnement technique ou l'organisation de ces soins et d'un dispositif de suivi des patients traités.
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R5141-47-8 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033240296", "@num": "R5141-48", "#text": "Code de la santé publique - art. R5141-48 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000030714471", "@num": "R5141-82-1", "#text": "Code de la santé publique - art. R5141-82-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000027859967", "@num": "R5142-1", "#text": "Code de la santé publique - art. R5142-1 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916131", "@num": "R5142-45", "#text": "Code de la santé publique - art. R5142-45 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000027859998", "@num": "R5142-46", "#text": "Code de la santé publique - art. R5142-46 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800649", "@num": "R5145-2", "#text": "Code de la santé publique - art. R5145-2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800687", "@num": "R5145-37", "#text": "Code de la santé publique - art. R5145-37 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800688", "@num": "R5145-38", "#text": "Code de la santé publique - art. R5145-38 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800978", "@num": "R5146-41-20", "#text": "Code de la santé publique - art. R5146-41-20 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique L617-1 alinéas 1, 4, 5", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006586374", "@num": "L934-2", "#text": "Code rural - art. L934-2 (T)", "@sens": "cible", "@cidtexte": "LEGITEXT000006071367", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045405624", "@num": "L234-2", "#text": "Code rural et de la pêche maritime - art. L234-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006071367", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171385", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155087", "@fin": "2999-01-01", "#text": "Titre IV : Médicaments vétérinaires", "@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": "LEGIARTI000006690196", "@fin": "2001-04-14", "@num": "L5141-5", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690197", "@fin": "2007-04-27", "@num": "L5141-5", "@etat": "MODIFIE", "@debut": "2001-04-14", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690198", "@fin": "2009-05-14", "@num": "L5141-5", "@etat": "MODIFIE", "@debut": "2007-04-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000020627757", "@fin": "2010-02-26", "@num": "L5141-5", "@etat": "MODIFIE", "@debut": "2009-05-14", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000021941921", "@fin": "2010-07-01", "@num": "L5141-5", "@etat": "MODIFIE", "@debut": "2010-02-26", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000021666237", "@fin": "2022-03-25", "@num": "L5141-5", "@etat": "ABROGE", "@debut": "2010-07-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Exception faite des aliments médicamenteux, et sous réserve des dispositions de l'article L. 5141-10, aucun médicament vétérinaire ne peut être délivré au public s'il n'a reçu, au préalable, une autorisation de mise sur le marché délivrée par l'Agence française de sécurité sanitaire des aliments.
\n
Aucun prémélange médicamenteux ne peut être délivré au public. Il ne peut être utilisé pour la fabrication d'aliments médicamenteux s'il n'a reçu au préalable l'autorisation prévue à l'alinéa ci-dessus. L'autorisation de mise sur le marché comporte les conditions techniques que doit respecter le fabricant d'aliments médicamenteux, ainsi que les modalités d'emploi de ces aliments.
\n
Elle peut être assortie de conditions adéquates, notamment lorsqu'elle porte sur des produits susceptibles de faire apparaître des résidus dans les denrées alimentaires provenant des animaux traités.
" } }, "LEGIARTI000006690197": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5141-5", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2007-04-27", "DATE_DEBUT": "2001-04-14" } }, "META_COMMUN": { "ID": "LEGIARTI000006690197", "URL": "article/LEGI/ARTI/00/00/06/69/01/LEGIARTI000006690197.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5141L05XXAB" } }, "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": "LEGIARTI000006698287", "@num": "2", "#text": "Rapport - art. 2 () JORF 14 avril 2001", "@sens": "source", "@cidtexte": "JORFTEXT000000588385", "@nortexte": "MESX0100033R", "@numtexte": "2001-313", "@typelien": "MODIFICATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2001-04-11" }, { "@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": "LEGIARTI000006733878", "@num": "ANNEXE", "#text": "Arrêté du 9 juin 2004 - art. ANNEXE (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000255672", "@nortexte": "SANP0422019A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2004-06-09" }, { "@id": "LEGIARTI000006734074", "@num": "ANNEXE", "#text": "Arrêté du 21 avril 2005 - art. ANNEXE (VT)", "@sens": "cible", "@cidtexte": "JORFTEXT000000627974", "@nortexte": "SANP0521551A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2005-04-21" }, { "@id": "LEGIARTI000006698469", "@num": "48", "#text": "Ordonnance n°2007-613 du 26 avril 2007 - art. 48 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000646989", "@nortexte": "SANX0700046R", "@numtexte": "2007-613", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2007-04-26" }, { "@id": "LEGIARTI000019679758", "@num": "2", "#text": "Arrêté du 24 juillet 2007 - art. 2 (VT)", "@sens": "cible", "@cidtexte": "JORFTEXT000000652683", "@nortexte": "AGRG0761515A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2007-07-24" }, { "@id": "LEGITEXT000017789296", "#text": "Arrêté du 26 décembre 2007 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000017755444", "@nortexte": "AGRG0772584A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2007-12-26" }, { "@id": "LEGIARTI000019675678", "@num": "2", "#text": "Arrêté du 10 octobre 2008 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019675107", "@nortexte": "AGRG0824222A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-10-10" }, { "@id": "LEGIARTI000025882819", "#text": "Arrêté du 1er septembre 2009 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000021021310", "@nortexte": "SASP0920309A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-09-01" }, { "@id": "LEGITEXT000026925495", "#text": "Décret n°2013-32\n du 9 janvier 2013 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000026924578", "@nortexte": "AGRG1200321D", "@numtexte": "2013-32", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2013-01-09" }, { "@id": "LEGIARTI000031143608", "#text": "ARRÊTÉ du 22 juillet 2015 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000031142007", "@nortexte": "AFSP1517963A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2015-07-22" }, { "@id": "LEGIARTI000041780819", "@num": "12-4", "#text": "Décret n°2020-293 du 23 mars 2020 - art. 12-4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746694", "@nortexte": "SSAZ2008253D", "@numtexte": "2020-293", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041780811", "@num": "1", "#text": "Décret n°2020-393 du 2 avril 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041780609", "@nortexte": "SSAZ2009058D", "@numtexte": "2020-393", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-04-02" }, { "@id": "LEGIARTI000041859126", "@num": "19", "#text": "Décret n°2020-545 du 11 mai 2020 - art. 19 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041858681", "@nortexte": "SSAZ2011567D", "@numtexte": "2020-545", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041866851", "@num": "21", "#text": "Décret n°2020-548 du 11 mai 2020 - art. 21 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041865329", "@nortexte": "SSAZ2011695D", "@numtexte": "2020-548", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041943336", "@num": "52", "#text": "Décret n°2020-663 du 31 mai 2020 - art. 52 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041939818", "@nortexte": "SSAZ2013547D", "@numtexte": "2020-663", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-31" }, { "@id": "LEGIARTI000006915792", "@num": "D5141-55", "#text": "Code de la santé publique - art. D5141-55 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915795", "@num": "D5141-56", "#text": "Code de la santé publique - art. D5141-56 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915798", "@num": "D5141-57", "#text": "Code de la santé publique - art. D5141-57 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915801", "@num": "D5141-58", "#text": "Code de la santé publique - art. D5141-58 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915804", "@num": "D5141-59", "#text": "Code de la santé publique - art. D5141-59 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045405046", "@num": "L5141-10", "#text": "Code de la santé publique - art. L5141-10 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021941898", "@num": "L5141-10-1", "#text": "Code de la santé publique - art. L5141-10-1 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690218", "@num": "L5141-11", "#text": "Code de la santé publique - art. L5141-11 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690225", "@num": "L5141-15", "#text": "Code de la santé publique - art. L5141-15 (T)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000047291490", "@num": "L5141-16", "#text": "Code de la santé publique - art. L5141-16 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690198", "@num": "L5141-5", "#text": "Code de la santé publique - art. L5141-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045405066", "@num": "L5141-5-1", "#text": "Code de la santé publique - art. L5141-5-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018652195", "@num": "L5141-5-2", "#text": "Code de la santé publique - art. L5141-5-2 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690203", "@num": "L5141-6", "#text": "Code de la santé publique - art. L5141-6 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000022288351", "@num": "L5141-7", "#text": "Code de la santé publique - art. L5141-7 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021941908", "@num": "L5141-8", "#text": "Code de la santé publique - art. L5141-8 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045405053", "@num": "L5141-9", "#text": "Code de la santé publique - art. L5141-9 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045405145", "@num": "L5142-7", "#text": "Code de la santé publique - art. L5142-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045405249", "@num": "L5143-2", "#text": "Code de la santé publique - art. L5143-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690255", "@num": "L5143-4", "#text": "Code de la santé publique - art. 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Exception faite des aliments médicamenteux, des autovaccins et des préparations extemporanées vétérinaires, tout médicament vétérinaire qui ne fait pas l'objet d'une autorisation de mise sur le marché délivrée par l'autorité compétente de la Communauté européenne en application du règlement (CEE) n° 2309/93 du Conseil du 22 juillet 1993 établissant des procédures communautaires pour l'autorisation et la surveillance des médicaments à usage humain et à usage vétérinaire et instituant une agence européenne pour l'évaluation des médicaments doit faire l'objet, avant sa mise sur le marché à titre gratuit ou onéreux, d'une autorisation de mise sur le marché délivrée par l'Agence française de sécurité sanitaire des aliments. Le titulaire de l'autorisation de mise sur le marché doit être établi dans la Communauté européenne.
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L'autorisation de mise sur le marché est délivrée pour une durée de cinq ans ; elle est ensuite renouvelable par période quinquennale.
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Toutefois, les médicaments contenant des substances actives figurant à l'annexe III du règlement (CEE) n° 2377/90 du Conseil du 26 juin 1990 établissant une procédure communautaire pour la fixation de limites maximales de résidus de médicaments vétérinaires dans les aliments pour animaux d'origine animale ne sont autorisés que pour la période pour laquelle une limite a été fixée par le règlement ; au cas où cette période est prolongée, l'autorisation peut être reconduite pour une durée égale.
\n
A titre exceptionnel, lorsque le médicament, compte tenu de l'état des connaissances, justifie l'octroi d'une autorisation de mise sur le marché, mais qu'il nécessite une surveillance particulière après sa mise sur le marché, l'autorisation peut être soumise à un réexamen annuel et à certaines obligations spécifiques visant, après son obtention, à la réalisation d'études complémentaires ou à la notification d'effets indésirables.
\n
Cette autorisation peut être assortie :
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1° De l'obligation de porter sur l'étiquetage et la notice des mentions utiles pour la protection de la santé publique ou de la santé animale, telles que des précautions particulières d'emploi ;
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2° De l'obligation d'introduire une substance de marquage dans le médicament ;
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3° De conditions restrictives de délivrance nécessaires à la protection de la santé humaine ou de la santé animale.
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Lorsqu'elle porte sur un prémélange médicamenteux, elle comporte les conditions techniques que doit respecter le fabricant des aliments médicamenteux correspondants, ainsi que les modalités d'emploi de ces aliments.
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Lorsque, du fait de la rareté des indications prévues ou du fait de l'état d'avancement de la science, la demande n'est pas assortie de l'ensemble des justifications prévues, une autorisation peut être accordée, dans des conditions fixées par le décret prévu au 5° de l'article L. 5141-16, sous réserve que le médicament soit délivré sur prescription d'un vétérinaire et administré sous la responsabilité de ce dernier.
\n
Toute modification des éléments d'une autorisation de mise sur le marché délivrée par l'Agence française de sécurité sanitaire des aliments, doit être préalablement autorisée.
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Tout médicament vétérinaire fabriqué industriellement ou selon une méthode dans laquelle intervient un processus industriel qui ne fait pas l'objet d'une autorisation de mise sur le marché délivrée par la Communauté européenne en application du règlement (CE) n° 726/2004 du Parlement européen et du Conseil du 31 mars 2004 doit faire l'objet, avant sa mise sur le marché ou sa distribution à titre gratuit, d'une autorisation préalable de mise sur le marché délivrée par l'Agence française de sécurité sanitaire des aliments. L'autorisation peut être assortie de conditions appropriées.
\n
Par exception au premier alinéa, ne sont pas soumis à autorisation de mise sur le marché les aliments médicamenteux, les autovaccins à usage vétérinaire, les allergènes pour un seul animal, les médicaments vétérinaires à base d'isotopes radioactifs, les préparations magistrales et officinales vétérinaires, les médicaments vétérinaires soumis aux essais de recherche et de développement, y compris les essais cliniques.
\n
Une autorisation de mise sur le marché ne peut être délivrée qu'à un demandeur établi dans un Etat membre de la Communauté européenne.
\n
Le demandeur de l'autorisation peut être dispensé de produire certaines données et études dans des conditions fixées par voie réglementaire.
\n
L'autorisation de mise sur le marché est initialement délivrée pour une durée de cinq ans. Elle peut être renouvelée, le cas échéant sans limitation de durée, dans des conditions fixées par décret en Conseil d'Etat, sauf si l'agence décide, pour des raisons justifiées ayant trait à la pharmacovigilance, de procéder à un renouvellement supplémentaire, sur la base d'une réévaluation des effets thérapeutiques du médicament vétérinaire au regard des risques tels que définis au 1° de l'article L. 5141-6. Ce décret détermine également les conditions dans lesquelles elle peut devenir caduque.
\n
Toute modification des éléments d'une autorisation de mise sur le marché délivrée par l'Agence française de sécurité sanitaire des aliments doit être préalablement autorisée.
\n
L'accomplissement des formalités prévues au présent article n'a pas pour effet d'exonérer le fabricant et, s'il est distinct, le titulaire de l'autorisation de mise sur le marché, de la responsabilité que l'un ou l'autre peut encourir dans les conditions du droit commun en raison de la fabrication ou de la mise sur le marché du médicament vétérinaire.
\n
L'agence rend publics sans délai un rapport de synthèse de l'évaluation effectuée pour tout nouveau médicament vétérinaire 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. 5141-5 et L. 5141-6. Elle rend également publics sans délai l'ordre du jour et les comptes rendus, assortis des détails et explications des votes, y compris les opinions minoritaires, à l'exclusion de toute information présentant un caractère de confidentialité commerciale, des réunions des commissions siégeant auprès d'elle et consultées en matière de mise sur le marché des médicaments vétérinaires et de pharmacovigilance vétérinaire, son règlement intérieur et celui de ces commissions.
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La fabrication, l'importation, l'exportation et la distribution en gros de médicaments vétérinaires, la fabrication, l'importation et la distribution de médicaments soumis à des essais cliniques, ainsi que l'exploitation de médicaments vétérinaires, ne peuvent être effectuées que dans des établissements régis par le présent chapitre.
\n
Toute entreprise qui comporte au moins un établissement visé au premier alinéa doit être la propriété d'un pharmacien, d'un vétérinaire ou d'une société à la gérance ou à la direction générale de laquelle participe un pharmacien ou un vétérinaire. Elle peut être, en tout ou partie, concédée en location-gérance à une société. Cette société doit être la propriété d'un pharmacien ou d'un vétérinaire ou comporter la participation d'un pharmacien ou d'un vétérinaire à sa direction générale ou sa gérance.
\n
Les pharmaciens ou vétérinaires mentionnés à l'alinéa précédent sont dénommés : \" pharmaciens ou vétérinaires responsables \". Ils sont personnellement responsables du respect des dispositions du livre II de la partie IV et du présent livre, ayant trait à leur activité, sans préjudice, le cas échéant, de la responsabilité solidaire de la société.
\n
Dans chaque établissement pharmaceutique de l'entreprise, un pharmacien ou un vétérinaire délégué veille au respect des dispositions du présent livre sous l'autorité du pharmacien ou du vétérinaire responsable de l'entreprise. Lorsque le pharmacien ou le vétérinaire responsable exerce ses fonctions dans l'un des établissements pharmaceutiques d'une entreprise, la désignation d'un pharmacien délégué ou d'un vétérinaire délégué n'est pas obligatoire dans cet établissement.
\n
Les pharmaciens ou vétérinaires responsables et les pharmaciens ou vétérinaires délégués doivent justifier d'une expérience pratique appropriée.
\n
Toutefois, les établissements assurant la fabrication ou la distribution d'aliments médicamenteux ne sont pas tenus aux obligations prévues aux deuxième à cinquième alinéas ci-dessus ; dans le cas où ils n'y souscrivent pas, le contrôle de la fabrication et de la délivrance est cependant assuré, dans des conditions fixées par décret, par un pharmacien ou un vétérinaire ; ce pharmacien ou ce vétérinaire est personnellement responsable de l'application des dispositions législatives et réglementaires concernant les aliments médicamenteux, sans préjudice, le cas échéant, de la responsabilité solidaire de la société.
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L'achat, la fourniture, la prise en charge et l'utilisation par les collectivités publiques des médicaments définis aux articles L. 5121-8, L. 5121-9-1, L. 5121-12, L. 5121-13 et L. 5121-14-1 ou importés selon la procédure prévue à l'article L. 5121-17 sont limités, dans les conditions propres à ces médicaments fixées par le décret mentionné à l'article L. 162-17 du code de la sécurité sociale, aux produits agréés dont la liste est établie par arrêté des ministres chargés de la santé et de la sécurité sociale.

L'inscription d'un médicament sur la liste mentionnée au premier alinéa peut, au vu des exigences de qualité et de sécurité des soins mettant en oeuvre ce médicament, énoncées le cas échéant par la commission prévue à l'article L. 5123-3, être assortie de conditions concernant la qualification ou la compétence des prescripteurs, l'environnement technique ou l'organisation de ces soins et d'un dispositif de suivi des patients traités.

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Tout médicament vétérinaire fabriqué industriellement ou selon une méthode dans laquelle intervient un processus industriel qui ne fait pas l'objet d'une autorisation de mise sur le marché délivrée par la Communauté européenne en application du règlement (CE) n° 726 / 2004 du Parlement européen et du Conseil du 31 mars 2004 doit faire l'objet, avant sa mise sur le marché ou sa distribution à titre gratuit, d'une autorisation préalable de mise sur le marché délivrée par l'Agence française de sécurité sanitaire des aliments.L'autorisation peut être assortie de conditions appropriées.

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Par exception au premier alinéa, ne sont pas soumis à autorisation de mise sur le marché les aliments médicamenteux, les autovaccins à usage vétérinaire, les allergènes pour un seul animal, les médicaments vétérinaires à base d'isotopes radioactifs, les préparations magistrales et officinales vétérinaires, les médicaments vétérinaires soumis aux essais de recherche et de développement, y compris les essais cliniques.

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Une autorisation de mise sur le marché ne peut être délivrée qu'à un demandeur établi dans un Etat membre de la Communauté européenne.

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Le demandeur de l'autorisation peut être dispensé de produire certaines données et études dans des conditions fixées par voie réglementaire.

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L'autorisation de mise sur le marché est initialement délivrée pour une durée de cinq ans. Elle peut être renouvelée, le cas échéant sans limitation de durée, dans des conditions fixées par décret en Conseil d'Etat, sauf si l'agence décide, pour des raisons justifiées ayant trait à la pharmacovigilance, de procéder à un renouvellement supplémentaire, sur la base d'une réévaluation des effets thérapeutiques du médicament vétérinaire au regard des risques tels que définis au 1° de l'article L. 5141-6. Ce décret détermine également les conditions dans lesquelles elle peut devenir caduque.

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Toute modification substantielle des éléments d'une autorisation de mise sur le marché délivrée par l'Agence française de sécurité sanitaire des aliments doit faire l'objet d'une autorisation préalable. Les autres modifications font l'objet d'une déclaration.

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L'accomplissement des formalités prévues au présent article n'a pas pour effet d'exonérer le fabricant et, s'il est distinct, le titulaire de l'autorisation de mise sur le marché, de la responsabilité que l'un ou l'autre peut encourir dans les conditions du droit commun en raison de la fabrication ou de la mise sur le marché du médicament vétérinaire.

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L'agence rend publics sans délai un rapport de synthèse de l'évaluation effectuée pour tout nouveau médicament vétérinaire 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. 5141-5 et L. 5141-6. Elle rend également publics sans délai l'ordre du jour et les comptes rendus, assortis des détails et explications des votes, y compris les opinions minoritaires, à l'exclusion de toute information présentant un caractère de confidentialité commerciale, des réunions des commissions siégeant auprès d'elle et consultées en matière de mise sur le marché des médicaments vétérinaires et de pharmacovigilance vétérinaire, son règlement intérieur et celui de ces commissions.

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Tout médicament vétérinaire fabriqué industriellement ou selon une méthode dans laquelle intervient un processus industriel qui ne fait pas l'objet d'une autorisation de mise sur le marché délivrée par l'Union européenne en application du règlement (CE) n° 726 / 2004 du Parlement européen et du Conseil du 31 mars 2004 doit faire l'objet, avant sa mise sur le marché ou sa distribution à titre gratuit, d'une autorisation préalable de mise sur le marché délivrée par l'Agence nationale chargée de la sécurité sanitaire de l'alimentation, de l'environnement et du travail. L'autorisation peut être assortie de conditions appropriées.

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Le demandeur de l'autorisation peut être dispensé de produire certaines données et études dans des conditions fixées par voie réglementaire.

Toute modification substantielle des éléments d'une autorisation de mise sur le marché délivrée par l'Agence nationale chargée de la sécurité sanitaire de l'alimentation, de l'environnement et du travail doit faire l'objet d'une autorisation préalable. Les autres modifications font l'objet d'une déclaration.

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Tout médicament vétérinaire fabriqué industriellement ou selon une méthode dans laquelle intervient un processus industriel qui ne fait pas l'objet d'une autorisation de mise sur le marché délivrée par l'Union européenne en application du règlement (CE) n° 726 / 2004 du Parlement européen et du Conseil du 31 mars 2004 doit faire l'objet, avant sa mise sur le marché ou sa distribution à titre gratuit, d'une autorisation préalable de mise sur le marché délivrée par l'Agence française de sécurité sanitaire des aliments.L'autorisation peut être assortie de conditions appropriées.

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Une autorisation de mise sur le marché ne peut être délivrée qu'à un demandeur établi dans un Etat membre de l'Union européenne.

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Le demandeur de l'autorisation peut être dispensé de produire certaines données et études dans des conditions fixées par voie réglementaire.

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L'achat, la fourniture, la prise en charge et l'utilisation par les collectivités publiques des médicaments définis aux articles L. 5121-8, L. 5121-9-1, L. 5121-12, L. 5121-13 et L. 5121-14-1 ou bénéficiant d'une autorisation d'importation parallèle en application de l'article L. 5124-13 sont limités, dans les conditions propres à ces médicaments fixées par le décret mentionné à l'article L. 162-17 du code de la sécurité sociale, aux produits agréés dont la liste est établie par arrêté des ministres chargés de la santé et de la sécurité sociale.

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L'achat, la fourniture, la prise en charge et l'utilisation par les collectivités publiques des médicaments définis aux articles L. 5121-8, L. 5121-9-1, L. 5121-13 et L. 5121-14-1 ou bénéficiant d'une autorisation d'importation parallèle en application de l'article L. 5124-13 sont limités, dans les conditions propres à ces médicaments fixées par le décret mentionné à l'article L. 162-17 du code de la sécurité sociale, aux produits agréés dont la liste est établie par arrêté des ministres chargés de la santé et de la sécurité sociale.

Les médicaments faisant l'objet des autorisations mentionnées à l'article L. 5121-12 peuvent être achetés, fournis, pris en charge et utilisés par les collectivités publiques sans figurer sur la liste mentionnée au premier alinéa du présent article.

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L162-17", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171368", "@fin": "2999-01-01", "#text": "Chapitre III : Prix et agrément.", "@debut": "2000-06-22" } ] }, "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": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006689956", "@fin": "2004-08-11", "@num": "L5123-2", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006689957", "@fin": "2004-08-17", "@num": "L5123-2", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006689958", "@fin": "2006-12-22", "@num": "L5123-2", "@etat": "MODIFIE", "@debut": "2004-08-17", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006689959", "@fin": "2007-04-27", "@num": "L5123-2", "@etat": "MODIFIE", "@debut": "2006-12-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006689960", "@fin": "2009-01-01", "@num": "L5123-2", "@etat": "MODIFIE", "@debut": "2007-04-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000020039256", "@fin": "2012-01-01", "@num": "L5123-2", "@etat": "MODIFIE", "@debut": "2009-01-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE_MORT_NE", "LIEN_ART": { "@id": "LEGIARTI000025013605", "@fin": "2011-12-31", "@num": "L5123-2", "@etat": "MODIFIE_MORT_NE", "@debut": "2012-01-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025124259", "@fin": "2013-12-25", "@num": "L5123-2", "@etat": "MODIFIE", "@debut": "2011-12-31", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000028394245", "@fin": "2019-12-28", "@num": "L5123-2", "@etat": "MODIFIE", "@debut": "2013-12-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000041397449", "@fin": "2021-06-01", "@num": "L5123-2", "@etat": "MODIFIE", "@debut": "2019-12-28", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000042654772", "@fin": "2021-07-01", "@num": "L5123-2", "@etat": "MODIFIE", "@debut": "2021-06-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000042685698", "@fin": "2021-12-25", "@num": "L5123-2", "@etat": "MODIFIE", "@debut": "2021-07-01", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000044628302", "@fin": "2999-01-01", "@num": "L5123-2", "@etat": "VIGUEUR", "@debut": "2021-12-25", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

L'achat, la fourniture, la prise en charge et l'utilisation par les collectivités publiques des médicaments définis aux articles L. 5121-8, L. 5121-9-1, L. 5121-13 et L. 5121-14-1 ou bénéficiant d'une autorisation d'importation parallèle en application de l'article L. 5124-13 ou faisant l'objet d'une distribution parallèle au sens de l'article L. 5124-13-2 sont limités, dans les conditions propres à ces médicaments fixées par le décret mentionné à l'article L. 162-17 du code de la sécurité sociale, aux produits agréés dont la liste est établie par arrêté des ministres chargés de la santé et de la sécurité sociale. Cette liste précise les seules indications thérapeutiques ouvrant droit à la prise en charge des médicaments.

" } }, "LEGIARTI000041780819": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "12-4", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2020-05-11", "DATE_DEBUT": "2020-04-03" } }, "META_COMMUN": { "ID": "LEGIARTI000041780819", "URL": "article/LEGI/ARTI/00/00/41/78/08/LEGIARTI000041780819.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000041780811", "@num": "1", "#text": "Décret n°2020-393 du 2 avril 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041780609", "@nortexte": "SSAZ2009058D", "@numtexte": "2020-393", "@typelien": "CREE", "@naturetexte": "DECRET", "@datesignatexte": "2020-04-02" }, { "@id": "LEGIARTI000041859140", "@num": "26", "#text": "Décret n°2020-545 du 11 mai 2020 - art. 26", "@sens": "cible", "@cidtexte": "JORFTEXT000041858681", "@nortexte": "SSAZ2011567D", "@numtexte": "2020-545", "@typelien": "ABROGE", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000025086171", "@num": "L5121-1-2", "#text": "Code de la santé publique - art. L5121-1-2", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689956", "@num": "L5123-2", "#text": "Code de la santé publique - art. L5123-2", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690196", "@num": "L5141-5", "#text": "Code de la santé publique - art. L5141-5", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690231", "@num": "L5142-1", "#text": "Code de la santé publique - art. L5142-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908160", "@num": "R1112-2", "#text": "Code de la santé publique - art. R1112-2", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000041756413", "@fin": "2020-05-11", "#text": "Chapitre 7 : Dispositions relatives à la mise à disposition de médicaments", "@debut": "2020-03-27" } ] }, "@cid": "JORFTEXT000041746694", "@nor": "SSAZ2008253D", "@num": "2020-293", "@nature": "DECRET", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Décret n° 2020-293 du 23 mars 2020 prescrivant les mesures générales nécessaires pour faire face à l'épidémie de covid-19 dans le cadre de l'état d'urgence sanitaire", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000041746694", "@c_titre_court": "Décret n°2020-293 du 23 mars 2020" }, { "@fin": "2020-05-23", "#text": "Décret n° 2020-293 du 23 mars 2020 prescrivant les mesures générales nécessaires pour faire face à l'épidémie de covid-19 dans le cadre de l'état d'urgence sanitaire", "@debut": "2020-03-24", "@id_txt": "LEGITEXT000041747861", "@c_titre_court": "Décret n°2020-293 du 23 mars 2020" } ], "@ministere": "Ministère des solidarités et de la santé", "@date_publi": "2020-03-24", "@date_signature": "2020-03-23", "@num_parution_jo": "0072" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000041780819", "@fin": "2020-05-11", "@num": "12-4", "@etat": "ABROGE", "@debut": "2020-04-03", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

En cas d'impossibilité d'approvisionnement en spécialités pharmaceutiques à usage humain, des médicaments à usage vétérinaire à même visée thérapeutique, bénéficiant d'une autorisation de mise sur le marché mentionnée à l'article L. 5141-5 du code de la santé publique de même substance active, de même dosage et de même voie d'administration, peuvent être prescrits, préparés, dispensés et administrés en milieu hospitalier. La liste de ces médicaments et leurs principes actifs désignés par leur dénomination commune internationale mentionnée à l'article L. 5121-1-2, et leurs conditions de préparation et d'emploi sont fixées par l'Agence nationale de sécurité du médicament et des produits de santé et publiées sur son site internet.
\n
Ces médicaments sont utilisés suivant ces conditions particulières d'emploi pour un patient, au vu de son état clinique. Leur utilisation doit être inscrite dans le dossier médical du patient mentionné à l'article R. 1112-2 du même code.
\n
Les médicaments figurant sur cette liste peuvent être fournis et achetés par les collectivités publiques auprès des fabricants et distributeurs mentionnés à l'article L. 5142-1 du code de la santé publique. Ils peuvent être utilisés et pris en charge dans les établissements de santé, dans les mêmes conditions que les médicaments inscrits sur la liste mentionnée au premier alinéa de l'article L. 5123-2 du code de la santé publique, sans qu'ils figurent sur cette dernière liste, sous réserve du respect par les professionnels de santé des conditions d'emploi mentionnées au premier alinéa du présent article.
\n
Le recueil d'informations concernant les effets indésirables et leur transmission à l'Agence nationale de sécurité du médicament et des produits de santé et au centre régional de pharmacovigilance territorialement compétent sont assurés par le professionnel de santé prenant en charge le patient dans le cadre des dispositions réglementaires en vigueur pour les médicaments à usage humain bénéficiant d'une autorisation de mise sur le marché.
\n
Pour l'application du présent article, les hôpitaux des armées, l'institution nationale des Invalides et les structures médicales opérationnelles relevant du ministre de la défense déployées dans le cadre de l'état d'urgence sanitaire sont également considérés comme des établissements de santé.

" } }, "LEGIARTI000042654772": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5123-2", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2021-07-01", "DATE_DEBUT": "2021-06-01" } }, "META_COMMUN": { "ID": "LEGIARTI000042654772", "URL": "article/LEGI/ARTI/00/00/42/65/47/LEGIARTI000042654772.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Conformément au III de l’article 148 de la loi n° 2020-1525 du 7 décembre 2020, les présentes dispositions entrent en vigueur le premier jour du sixième mois qui suit celui de la publication de la présente loi.

" }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006334800", "@num": "1", "#text": "Arrêté du 13 novembre 2001 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000221792", "@nortexte": "MESG0123551A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2001-11-13" }, { "@id": "LEGIARTI000006758846", "@num": "12", "#text": "Loi n°2003-1199 du 18 décembre 2003 - art. 12 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000249276", "@nortexte": "SANX0300139L", "@numtexte": "2003-1199", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2003-12-18" }, { "@id": "LEGIARTI000006231372", "@num": "1", "#text": "Arrêté du 26 mai 2004 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000235408", "@nortexte": "SANG0420602A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2004-05-26" }, { "@id": "LEGIARTI000019351959", "@num": "1", "#text": "Arrêté du 25 juin 2008 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019350195", "@nortexte": "SJSS0803525A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-06-25" }, { "@id": "LEGIARTI000019351951", "@num": "1", "#text": "Arrêté du 25 juin 2008 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019350188", "@nortexte": "SJSS0803668A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-06-25" }, { "@id": "LEGIARTI000030131452", "@num": "4", "#text": "Arrêté du 5 mars 2010 - art. 4 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000021954715", "@nortexte": "BCFR1004493A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-03-05" }, { "@id": "LEGIARTI000025832877", "@num": "1", "#text": "Arrêté du 7 mai 2012 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000025824505", "@nortexte": "ETSS1209429A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-05-07" }, { "@id": "LEGIARTI000028414521", "@num": "1", "#text": "Arrêté du 20 décembre 2013 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000028398405", "@nortexte": "AFSS1331706A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-12-20" }, { "@id": "LEGIARTI000029449716", "@num": "1", "#text": "ARRÊTÉ du 25 juillet 2014 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000029449036", "@nortexte": "FCPE1418309A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2014-07-25" }, { "@id": "LEGIARTI000038879548", "@num": "1", "#text": "Décret n°2019-818 du 1er août 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000038873188", "@nortexte": "SSAS1911214D", "@numtexte": "2019-818", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-08-01" }, { "@id": "LEGIARTI000038944863", "@num": "2", "#text": "Décret n°2019-855 du 20 août 2019 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000038940078", "@nortexte": "SSAS1916802D", "@numtexte": "2019-855", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-08-20" }, { "@id": "LEGIARTI000048702348", "#text": "Arrêté du 28 août 2019 - art. (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000039003584", "@nortexte": "SSAS1924947A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-08-28" }, { "@id": "LEGIARTI000041577004", "@num": "6", "#text": "Décret n°2020-120 du 13 février 2020 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000041573390", "@nortexte": "SSAS1932960D", "@numtexte": "2020-120", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-02-13" }, { "@id": "LEGIARTI000041619114", "#text": "Arrêté du 19 février 2020 - art.", "@sens": "cible", "@cidtexte": "JORFTEXT000041617382", "@nortexte": "SSAS2005311A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-02-19" }, { "@id": "LEGIARTI000041760851", "@num": "12-2", "#text": "Décret n°2020-293 du 23 mars 2020 - art. 12-2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746694", "@nortexte": "SSAZ2008253D", "@numtexte": "2020-293", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041780819", "@num": "12-4", "#text": "Décret n°2020-293 du 23 mars 2020 - art. 12-4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746694", "@nortexte": "SSAZ2008253D", "@numtexte": "2020-293", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041756280", "@num": "1", "#text": "Décret n°2020-314 du 25 mars 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041755775", "@nortexte": "SSAZ2008362D", "@numtexte": "2020-314", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-25" }, { "@id": "LEGIARTI000041780811", "@num": "1", "#text": "Décret n°2020-393 du 2 avril 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041780609", "@nortexte": "SSAZ2009058D", "@numtexte": "2020-393", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-04-02" }, { "@id": "LEGIARTI000041859122", "@num": "17", "#text": "Décret n°2020-545 du 11 mai 2020 - art. 17 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041858681", "@nortexte": "SSAZ2011567D", "@numtexte": "2020-545", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041859126", "@num": "19", "#text": "Décret n°2020-545 du 11 mai 2020 - 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L162-17", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171368", "@fin": "2999-01-01", "#text": "Chapitre III : Prix et agrément.", "@debut": "2000-06-22" } ] }, "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": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006689956", "@fin": "2004-08-11", "@num": "L5123-2", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006689957", "@fin": "2004-08-17", "@num": "L5123-2", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006689958", "@fin": "2006-12-22", "@num": "L5123-2", "@etat": "MODIFIE", "@debut": "2004-08-17", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006689959", "@fin": "2007-04-27", "@num": "L5123-2", "@etat": "MODIFIE", "@debut": "2006-12-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006689960", "@fin": "2009-01-01", "@num": "L5123-2", "@etat": "MODIFIE", "@debut": "2007-04-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000020039256", "@fin": "2012-01-01", "@num": "L5123-2", "@etat": "MODIFIE", "@debut": "2009-01-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE_MORT_NE", "LIEN_ART": { "@id": "LEGIARTI000025013605", "@fin": "2011-12-31", "@num": "L5123-2", "@etat": "MODIFIE_MORT_NE", "@debut": "2012-01-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025124259", "@fin": "2013-12-25", "@num": "L5123-2", "@etat": "MODIFIE", "@debut": "2011-12-31", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000028394245", "@fin": "2019-12-28", "@num": "L5123-2", "@etat": "MODIFIE", "@debut": "2013-12-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000041397449", "@fin": "2021-06-01", "@num": "L5123-2", "@etat": "MODIFIE", "@debut": "2019-12-28", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000042654772", "@fin": "2021-07-01", "@num": "L5123-2", "@etat": "MODIFIE", "@debut": "2021-06-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000042685698", "@fin": "2021-12-25", "@num": "L5123-2", "@etat": "MODIFIE", "@debut": "2021-07-01", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000044628302", "@fin": "2999-01-01", "@num": "L5123-2", "@etat": "VIGUEUR", "@debut": "2021-12-25", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
\n

L'achat, la fourniture, la prise en charge et l'utilisation par les collectivités publiques des médicaments définis aux articles L. 5121-8, L. 5121-9-1, L. 5121-13 et L. 5121-14-1 ou bénéficiant d'une autorisation d'importation parallèle en application de l'article L. 5124-13 ou faisant l'objet d'une distribution parallèle au sens de l'article L. 5124-13-2 sont limités, dans les conditions propres à ces médicaments fixées par le décret mentionné à l'article L. 162-17 du code de la sécurité sociale, aux produits agréés dont la liste est établie par arrêté des ministres chargés de la santé et de la sécurité sociale. Cette liste précise les seules indications thérapeutiques ouvrant droit à la prise en charge des médicaments.

Toute demande d'inscription sur la liste mentionnée au même premier alinéa d'un médicament défini aux articles L. 5121-8 et L. 5121-9-1 ou bénéficiant d'une autorisation d'importation parallèle en application de l'article L. 5124-13 qui n'a pas fait l'objet d'un classement dans la catégorie des médicaments réservés à l'usage hospitalier n'est recevable que si elle est accompagnée d'une demande d'inscription dudit médicament sur la liste mentionnée au premier alinéa de l'article L. 162-17 du code de la sécurité sociale. Le présent alinéa n'est pas applicable aux vaccins à usage réservé, imposés ou conseillés pour certains voyages.

L'inscription d'un médicament sur la liste mentionnée au premier alinéa du présent article peut, au vu des exigences de qualité et de sécurité des soins mettant en oeuvre ce médicament, énoncées le cas échéant par la commission prévue à l'article L. 5123-3, être assortie de conditions concernant la qualification ou la compétence des prescripteurs, l'environnement technique ou l'organisation de ces soins et d'un dispositif de suivi des patients traités.

\n
" } }, "LEGIARTI000042685698": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5123-2", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2021-12-25", "DATE_DEBUT": "2021-07-01" } }, "META_COMMUN": { "ID": "LEGIARTI000042685698", "URL": "article/LEGI/ARTI/00/00/42/68/56/LEGIARTI000042685698.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Conformément au A du IV de l'article 78 de la loi n° 2020-1576 du 14 décembre 2020, ces dispositions entrent en vigueur à une date fixée par décret, et au plus tard le 1er juillet 2021.

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art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000042266405", "@nortexte": "SSAS2006857D", "@numtexte": "2020-1090", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-08-25" }, { "@id": "LEGIARTI000043510080", "@num": "55-1", "#text": "Décret n°2020-1262 du 16 octobre 2020 - art. 55-1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042430554", "@nortexte": "SSAZ2028015D", "@numtexte": "2020-1262", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-10-16" }, { "@id": "LEGIARTI000043510117", "@num": "53-1", "#text": "Décret n°2020-1310 du 29 octobre 2020 - art. 53-1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042475143", "@nortexte": "SSAZ2029612D", "@numtexte": "2020-1310", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-10-29" }, { "@id": "LEGITEXT000042559681", "#text": "Décret n°2020-1437 du 24 novembre 2020 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042558802", "@nortexte": "SSAS2022717D", "@numtexte": "2020-1437", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-11-24" }, { "@id": "LEGIARTI000042667306", "@num": "78", "#text": "LOI n°2020-1576 du 14 décembre 2020 - art. 78 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000042665307", "@nortexte": "ECOX2023815L", "@numtexte": "2020-1576", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2020-12-14" }, { "@id": "LEGIARTI000042667306", "@num": "78", "#text": "LOI n°2020-1576 du 14 décembre 2020 - art. 78 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000042665307", "@nortexte": "ECOX2023815L", "@numtexte": "2020-1576", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2020-12-14" }, { "@id": "LEGIARTI000043329386", "@num": "1", "#text": "Décret n°2021-384 du 2 avril 2021 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000043327303", "@nortexte": "SSAZ2110799D", "@numtexte": "2021-384", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-04-02" }, { "@id": "LEGIARTI000043329388", "@num": "2", "#text": "Décret n°2021-384 du 2 avril 2021 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000043327303", "@nortexte": "SSAZ2110799D", "@numtexte": "2021-384", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-04-02" }, { "@id": "LEGIARTI000047009237", "@num": "5", "#text": "Arrêté du 1 juin 2021 - 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art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000047749196", "@nortexte": "SPRS2234375D", "@numtexte": "2023-518", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2023-06-27" }, { "@id": "LEGIARTI000006915035", "@num": "D5123-4", "#text": "Code de la santé publique - art. 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L'achat, la fourniture, la prise en charge et l'utilisation par les collectivités publiques des médicaments définis aux articles L. 5121-8, L. 5121-9-1, L. 5121-13 et L. 5121-14-1 ou bénéficiant d'une autorisation d'importation parallèle en application de l'article L. 5124-13 ou faisant l'objet d'une distribution parallèle au sens de l'article L. 5124-13-2 sont limités, dans les conditions propres à ces médicaments fixées par le décret mentionné à l'article L. 162-17 du code de la sécurité sociale, aux produits agréés dont la liste est établie par arrêté des ministres chargés de la santé et de la sécurité sociale. Cette liste précise les seules indications thérapeutiques ouvrant droit à la prise en charge des médicaments.

Les médicaments faisant l'objet des autorisations ou cadres de prescription compassionnelle dans une indication considérée mentionnés aux articles L. 5121-12 et L. 5121-12-1 ainsi que ceux bénéficiant d'une autorisation d'importation délivrée en application de l'article L. 5124-13 dans le cadre d'une rupture de stock, d'un risque de rupture ou d'un arrêt de commercialisation peuvent être achetés, fournis, pris en charge et utilisés par les collectivités publiques sans figurer sur la liste mentionnée au premier alinéa du présent article.

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L'achat, la fourniture, la prise en charge et l'utilisation par les collectivités publiques des médicaments définis aux articles L. 5121-8, L. 5121-9-1, L. 5121-13 et L. 5121-14-1 ou bénéficiant d'une autorisation d'importation parallèle en application de l'article L. 5124-13 ou faisant l'objet d'une distribution parallèle au sens de l'article L. 5124-13-2 sont limités, dans les conditions propres à ces médicaments fixées par le décret mentionné à l'article L. 162-17 du code de la sécurité sociale, aux produits agréés dont la liste est établie par arrêté des ministres chargés de la santé et de la sécurité sociale. Cette liste précise les seules indications thérapeutiques ouvrant droit à la prise en charge des médicaments.

Les médicaments faisant l'objet, dans une indication considérée, des autorisations d'accès précoce mentionnées à l'article L. 5121-12 ou du dispositif relatif aux continuités des traitements initiés à ce titre en application de l'article L. 162-16-5-4 du code de la sécurité sociale, des autorisations ou cadres de prescription compassionnelle mentionnés à l'article L. 5121-12-1 du présent code ou du dispositif relatif aux continuités des traitements initiés à ce titre en application du VI de l'article L. 162-16-5-2 du code de la sécurité sociale, les médicaments faisant l'objet d'une autorisation comme médicaments de thérapie innovante préparés ponctuellement mentionnés au 17° de l'article L. 5121-1 du présent code ainsi que ceux faisant l'objet, en association, dans une indication considérée, d'une autorisation en application de l'article L. 162-18-1 du code de la sécurité sociale et ceux bénéficiant d'une autorisation d'importation délivrée en application de l'article L. 5124-13 du présent code dans le cadre d'une rupture de stock, d'un risque de rupture ou d'un arrêt de commercialisation peuvent être achetés, fournis, pris en charge et utilisés par les collectivités publiques sans figurer sur la liste mentionnée au premier alinéa du présent article.

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I.-La fabrication, l'importation, l'exportation et la distribution en gros de médicaments vétérinaires, la fabrication, l'importation et la distribution de médicaments soumis à des essais cliniques, sont effectuées par des établissements régis par le règlement (UE) 2019/6 du 11 décembre 2018 et par le présent chapitre.
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\n II.-Dans chaque établissement autorisé au titre de l'article 88 du règlement (UE) 2019/6 du 11 décembre 2018, une personne qualifiée est notamment responsable de l'exécution des missions spécifiées à l'article 97 du même règlement.
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\n III.-Dans chaque établissement de distribution en gros de médicaments vétérinaires autorisé au titre de l'article 99 du règlement (UE) 2019/6 du 11 décembre 2018, une personne est responsable de l'exécution des missions spécifiées à l'article 101 du même règlement.
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\n IV.-Les personnes mentionnées aux II et III sont personnellement responsables respectivement du respect des dispositions des points 6 à 8 de l'article 97 et des dispositions de l'article 101 du règlement (UE) 2019/6 du 11 décembre 2018 et du présent livre ayant trait à leur activité, sans préjudice, le cas échéant, de la responsabilité solidaire de l'entreprise.

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Article 1 ENTIEREMENT_MODIF (Décret n° 2020-393 du 2 avril 2020 complétant le décret n° 2020-293 du 23 mars 2020 prescrivant les mesures générales nécessaires pour faire face à l'épidémie de covid-19 dans le cadre de l'état d'urgence sanitaire)