{ "article": { "LEGIARTI000006915001": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5122-18", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2004-08-08" } }, "META_COMMUN": { "ID": "LEGIARTI000006915001", "URL": "article/LEGI/ARTI/00/00/06/91/50/LEGIARTI000006915001.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "YXXXXXXXXXX5122R0180XX0A" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006689870", "@num": "L5121-1", "#text": "Code de la santé publique - art. L5121-1 (VT)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799378", "@num": "R5049", "#text": "Code de la santé publique - art. R5049 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799374", "@num": "R5049", "#text": "Code de la santé publique - art. R5049 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915000", "@num": "R5122-17", "#text": "Code de la santé publique - art. R5122-17 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006196564", "@fin": "2999-01-01", "#text": "Sous-section 1 : Générateurs, trousses et précurseurs.", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190678", "@fin": "2999-01-01", "#text": "Section 4 : Publicité pour certains produits ou objets", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178650", "@fin": "2999-01-01", "#text": "Chapitre II : Publicité", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161012", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000006915001", "@fin": "2999-01-01", "@num": "R5122-18", "@etat": "VIGUEUR", "@debut": "2004-08-08", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les dispositions des sections 1 à 3 du présent chapitre, à l'exception de l'article R. 5122-17, sont applicables à la publicité pour les générateurs, trousses et précurseurs définis aux 8°, 9° et 10° de l'article L. 5121-1.
\n
" } }, "LEGIARTI000006689870": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5121-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2002-12-24", "DATE_DEBUT": "2000-06-22" } }, "META_COMMUN": { "ID": "LEGIARTI000006689870", "URL": "article/LEGI/ARTI/00/00/06/68/98/LEGIARTI000006689870.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5121L01XXAA" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000049923273", "@num": "2", "#text": "Arrêté du 4 août 1987 - art. 2 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000000843609", "@nortexte": "ECOX8798330A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1987-08-04" }, { "@id": "LEGIARTI000023731730", "@num": "3", "#text": "Arrêté du 4 août 1987 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000843609", "@nortexte": "ECOX8798330A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1987-08-04" }, { "@id": "LEGIARTI000034405848", "@num": "69", "#text": "Décret n°90-1215 du 20 décembre 1990 - art. 69 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000717193", "@nortexte": "SPSS9001980D", "@numtexte": "90-1215", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1990-12-20" }, { "@id": "LEGIARTI000006699999", "@num": "1", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700029", "@num": "10", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 10 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700040", "@num": "14", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 14 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700043", "@num": "15", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 15 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700045", "@num": "16", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 16 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700047", "@num": "17", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 17 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700002", "@num": "2", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700054", "@num": "20", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 20 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700005", "@num": "3", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700008", "@num": "4", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@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": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006725129", "@num": "71", "#text": "Décret n°2001-1065 du 15 novembre 2001 - art. 71 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000403855", "@nortexte": "INTM0100035D", "@numtexte": "2001-1065", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2001-11-15" }, { "@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": "LEGIARTI000006697606", "@num": "35", "#text": "Loi n°2004-800 du 6 août 2004 - art. 35 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000441469", "@nortexte": "SANX0100053L", "@numtexte": "2004-800", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-06" }, { "@id": "LEGIARTI000047109474", "@num": "14", "#text": "Décret n°2004-942 du 3 septembre 2004 - art. 14 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000000253592", "@nortexte": "SANS0422327D", "@numtexte": "2004-942", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-09-03" }, { "@id": "LEGIARTI000032182077", "@num": "41", "#text": "Loi n°2005-1579 du 19 décembre 2005 - art. 41 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000815414", "@nortexte": "SANX0500246L", "@numtexte": "2005-1579", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2005-12-19" }, { "@id": "LEGIARTI000020140266", "@num": "8", "#text": "Arrêté du 24 mai 2006 - art. 8 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000457818", "@nortexte": "SANP0622223A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-05-24" }, { "@id": "LEGIARTI000043762395", "@num": "21", "#text": "Décret n° 2007-359 du 19 mars 2007 - art. 21 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000645145", "@nortexte": "AGRG0700643D", "@numtexte": "2007-359", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-19" }, { "@id": "LEGIARTI000022933811", "@num": "3", "#text": "Arrêté du 29 septembre 2010 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000022932466", "@nortexte": "SASP1025728A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-09-29" }, { "@id": "LEGIARTI000023501118", "@num": "4", "#text": "Arrêté du 21 janvier 2011 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023491451", "@nortexte": "ETSP1101997A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-01-21" }, { "@id": "LEGIARTI000023824330", "@num": "1", "#text": "Arrêté du 29 mars 2011 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023823216", "@nortexte": "ETSP1108796A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-03-29" }, { "@id": "LEGIARTI000046423270", "@num": "13", "#text": "Arrêté du 6 avril 2011 - art. 13 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023865866", "@nortexte": "ETSH1109848A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-04-06" }, { "@id": "LEGITEXT000024154142", "#text": "Décret n°2011-655\n du 10 juin 2011 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000024153599", "@nortexte": "ETSP1024824D", "@numtexte": "2011-655", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-06-10" }, { "@id": "LEGIARTI000026041157", "@num": "2", "#text": "Arrêté du 8 juin 2012 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000026040448", "@nortexte": "AFSP1225501A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-06-08" }, { "@id": "LEGITEXT000026558683", "#text": "Décret n°2012-1201\n du 29 octobre 2012 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000026557838", "@nortexte": "AFSP1232892D", "@numtexte": "2012-1201", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2012-10-29" }, { "@id": "LEGIARTI000026589554", "@num": "2", "#text": "Décret n°2012-1236\n du 6 novembre 2012 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000026588856", "@nortexte": "AFSP1226229D", "@numtexte": "2012-1236", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2012-11-06" }, { "@id": "LEGIARTI000035971424", "#text": "DÉCRET n°2014-1287 du 23 octobre 2014 - art. (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000029676018", "@nortexte": "AFSX1419039D", "@numtexte": "2014-1287", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000042293117", "#text": "DÉCRET n°2014-1288 du 23 octobre 2014 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029676038", "@nortexte": "AFSX1419044D", "@numtexte": "2014-1288", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000030189762", "@num": "8", "#text": "ARRÊTÉ du 28 novembre 2014 - art. 8 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000030189026", "@nortexte": "EINC1415451A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2014-11-28" }, { "@id": "LEGIARTI000030189876", "@num": "1", "#text": "ARRÊTÉ du 3 février 2015 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000030188934", "@nortexte": "AFSP1503244A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2015-02-03" }, { "@id": "LEGIARTI000032291698", "@num": "1", "#text": "Décret n°2016-349 du 24 mars 2016 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000032291186", "@nortexte": "AFSH1532721D", "@numtexte": "2016-349", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2016-03-24" }, { "@id": "LEGIARTI000032730970", "@num": "3", "#text": "Décret n°2016-817 du 20 juin 2016 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000032729458", "@nortexte": "AFSS1610671D", "@numtexte": "2016-817", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2016-06-20" }, { "@id": "LEGIARTI000034392999", "@num": "1", "#text": "Décret n°2017-500 du 6 avril 2017 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000034390458", "@nortexte": "AFSH1702718D", "@numtexte": "2017-500", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-04-06" }, { "@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": "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": "LEGIARTI000044941358", "@num": "6", "#text": "Décret n°2021-1905 du 30 décembre 2021 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000044638030", "@nortexte": "TREP2130559D", "@numtexte": "2021-1905", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-12-30" }, { "@id": "LEGIARTI000045632789", "@num": "1", "#text": "Décret n°2022-597 du 21 avril 2022 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000045632039", "@nortexte": "SSAH2205181D", "@numtexte": "2022-597", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2022-04-21" }, { "@id": "LEGITEXT000049536357", "#text": "Décret n°2024-435 du 14 mai 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049535648", "@nortexte": "TSSS2408227D", "@numtexte": "2024-435", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-05-14" }, { "@id": "LEGITEXT000049850758", "#text": "Décret n°2024-626 du 27 juin 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049832038", "@nortexte": "TSSP2408968D", "@numtexte": "2024-626", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-06-27" }, { "@id": "LEGITEXT000049922585", "#text": "Arrêté du 5 juillet 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049892254", "@nortexte": "TSSS2418508A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-07-05" }, { "@id": "LEGITEXT000050737433", "#text": "Décret n°2024-1135 du 4 décembre 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000050731183", "@nortexte": "MSAH2429400D", "@numtexte": "2024-1135", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-12-04" }, { "@id": "LEGIARTI000006279394", "@num": "L611-2", "#text": "Code de la propriété intellectuelle - art. 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R163-19 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043912140", "@num": "R163-3", "#text": "Code de la sécurité sociale. - art. R163-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043912129", "@num": "R163-4", "#text": "Code de la sécurité sociale. - art. R163-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043762068", "@num": "R163-5", "#text": "Code de la sécurité sociale. - art. R163-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000038897696", "@num": "R163-6", "#text": "Code de la sécurité sociale. - art. R163-6 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000030919417", "@num": "R322-1", "#text": "Code de la sécurité sociale. - art. 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"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": "LEGIARTI000006689870", "@fin": "2002-12-24", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006689871", "@fin": "2004-08-07", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2002-12-24", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006689872", "@fin": "2004-08-11", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2004-08-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006689873", "@fin": "2004-08-17", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": 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On entend par :
\n
1° Préparation magistrale, tout médicament préparé extemporanément en pharmacie selon une prescription destinée à un malade déterminé ;
\n
2° Préparation hospitalière, tout médicament, à l'exception des produits de thérapies génique ou cellulaire, préparé selon les indications de la pharmacopée et en conformité avec les bonnes pratiques mentionnées à l'article L. 5121-5, en raison de l'absence de spécialité pharmaceutique disponible ou adaptée dans une pharmacie à usage intérieur d'un établissement de santé, ou dans l'établissement pharmaceutique de cet établissement de santé autorisé en application de l'article L. 5124-9. Les préparations hospitalières sont dispensées sur prescription médicale à un ou plusieurs patients par une pharmacie à usage intérieur dudit établissement. Elles font l'objet d'une déclaration auprès de l'Agence française de sécurité sanitaire des produits de santé, dans des conditions définies par arrêté du ministre chargé de la santé ;
\n
3° Préparation officinale, tout médicament préparé en pharmacie selon les indications de la pharmacopée et destiné à être dispensé directement aux patients approvisionnés par cette pharmacie ;
\n
4° Produit officinal divisé, toute drogue simple, tout produit chimique ou toute préparation stable décrite par la pharmacopée, préparés à l'avance par un établissement pharmaceutique et divisés soit par lui, soit par la pharmacie d'officine qui le met en vente, soit par une pharmacie à usage intérieur, telle que définie au chapitre VI du présent titre ;
\n
5° Sans préjudice des dispositions des articles L. 611-2 et suivants du code de la propriété intellectuelle, spécialité générique d'une spécialité de référence, celle qui a la même composition qualitative et quantitative en principe actif, la même forme pharmaceutique et dont la bioéquivalence avec la spécialité de référence est démontrée par des études de biodisponibilité appropriées. La spécialité de référence et les spécialités qui en sont génériques constituent un groupe générique. Pour l'application du présent 5°, les différentes formes pharmaceutiques orales à libération immédiate sont considérées comme une même forme pharmaceutique ;
\n
6° Médicament immunologique, tout médicament consistant en :
\n
a) Allergène, défini comme tout produit destiné à identifier ou provoquer une modification spécifique et acquise de la réponse immunologique à un agent allergisant ;
\n
b) Vaccin, toxine ou sérum, définis comme tous agents utilisés en vue de provoquer une immunité active ou passive ou en vue de diagnostiquer l'état d'immunité ;
\n
7° Médicament radiopharmaceutique, tout médicament qui, lorsqu'il est prêt à l'emploi, contient un ou plusieurs isotopes radioactifs, dénommés radionucléides, incorporés à des fins médicales ;
\n
8° Générateur, tout système contenant un radionucléide parent déterminé servant à la production d'un radionucléide de filiation obtenu par élution ou par toute autre méthode et utilisé dans un médicament radiopharmaceutique ;
\n
9° Trousse, toute préparation qui doit être reconstituée ou combinée avec des radionucléides dans le produit radiopharmaceutique final ;
\n
10° Précurseur, tout autre radionucléide produit pour le marquage radioactif d'une autre substance avant administration ;
\n
11° Médicament homéopathique, tout médicament obtenu à partir de produits, substances ou compositions appelés souches homéopathiques, selon un procédé de fabrication homéopathique décrit par la pharmacopée européenne, la pharmacopée française ou, à défaut, par les pharmacopées utilisées de façon officielle dans un autre Etat membre de la Communauté européenne. Un médicament homéopathique peut aussi contenir plusieurs principes.
" } }, "LEGIARTI000006689871": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5121-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-07", "DATE_DEBUT": "2002-12-24" } }, "META_COMMUN": { "ID": "LEGIARTI000006689871", "URL": "article/LEGI/ARTI/00/00/06/68/98/LEGIARTI000006689871.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5121L01XXAB" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000049923273", "@num": "2", "#text": "Arrêté du 4 août 1987 - art. 2 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000000843609", "@nortexte": "ECOX8798330A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1987-08-04" }, { "@id": "LEGIARTI000023731730", "@num": "3", "#text": "Arrêté du 4 août 1987 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000843609", "@nortexte": "ECOX8798330A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1987-08-04" }, { "@id": "LEGIARTI000034405848", "@num": "69", "#text": "Décret n°90-1215 du 20 décembre 1990 - art. 69 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000717193", "@nortexte": "SPSS9001980D", "@numtexte": "90-1215", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1990-12-20" }, { "@id": "LEGIARTI000006699999", "@num": "1", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700029", "@num": "10", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 10 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700040", "@num": "14", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 14 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700043", "@num": "15", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 15 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700045", "@num": "16", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 16 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700047", "@num": "17", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 17 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700002", "@num": "2", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700054", "@num": "20", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 20 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700005", "@num": "3", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700008", "@num": "4", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@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": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006725129", "@num": "71", "#text": "Décret n°2001-1065 du 15 novembre 2001 - art. 71 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000403855", "@nortexte": "INTM0100035D", "@numtexte": "2001-1065", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2001-11-15" }, { "@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": "LEGIARTI000006758508", "@num": "43", "#text": "Loi n°2002-1487 du 20 décembre 2002 - art. 43 () JORF 24 décembre 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000235196", "@nortexte": "SANX0200141L", "@numtexte": "2002-1487", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-12-20" }, { "@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": "LEGIARTI000006697606", "@num": "35", "#text": "Loi n°2004-800 du 6 août 2004 - art. 35 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000441469", "@nortexte": "SANX0100053L", "@numtexte": "2004-800", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-06" }, { "@id": "LEGIARTI000047109474", "@num": "14", "#text": "Décret n°2004-942 du 3 septembre 2004 - art. 14 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000000253592", "@nortexte": "SANS0422327D", "@numtexte": "2004-942", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-09-03" }, { "@id": "LEGIARTI000032182077", "@num": "41", "#text": "Loi n°2005-1579 du 19 décembre 2005 - art. 41 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000815414", "@nortexte": "SANX0500246L", "@numtexte": "2005-1579", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2005-12-19" }, { "@id": "LEGIARTI000020140266", "@num": "8", "#text": "Arrêté du 24 mai 2006 - art. 8 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000457818", "@nortexte": "SANP0622223A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-05-24" }, { "@id": "LEGIARTI000043762395", "@num": "21", "#text": "Décret n° 2007-359 du 19 mars 2007 - art. 21 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000645145", "@nortexte": "AGRG0700643D", "@numtexte": "2007-359", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-19" }, { "@id": "LEGIARTI000022933811", "@num": "3", "#text": "Arrêté du 29 septembre 2010 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000022932466", "@nortexte": "SASP1025728A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-09-29" }, { "@id": "LEGIARTI000023501118", "@num": "4", "#text": "Arrêté du 21 janvier 2011 - 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R5126-14 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000038598131", "@num": "R5126-5", "#text": "Code de la santé publique - art. R5126-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000038597568", "@num": "R5126-54", "#text": "Code de la santé publique - art. R5126-54 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044381806", "@num": "R5126-57", "#text": "Code de la santé publique - art. R5126-57 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026560035", "@num": "R5132-15", "#text": "Code de la santé publique - art. R5132-15 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028390416", "@num": "R5132-3-1", "#text": "Code de la santé publique - art. R5132-3-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800424", "@num": "R5143-8", "#text": "Code de la santé publique - art. R5143-8 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800534", "@num": "R5143-8-1", "#text": "Code de la santé publique - art. R5143-8-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800551", "@num": "R5144-3", "#text": "Code de la santé publique - art. R5144-3 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000027998282", "@num": "D161-20", "#text": "Code de la sécurité sociale. - art. D161-20 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000031813563", "@num": "D325-7", "#text": "Code de la sécurité sociale. - art. D325-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000036392620", "@num": "L138-10", "#text": "Code de la sécurité sociale. - art. L138-10 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000038725858", "@num": "L138-9", "#text": "Code de la sécurité sociale. - art. L138-9 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000038725840", "@num": "L138-9-1", "#text": "Code de la sécurité sociale. - art. 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L162-16-4-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048677591", "@num": "L162-16-4-6", "#text": "Code de la sécurité sociale. - art. L162-16-4-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000046812181", "@num": "L162-16-7", "#text": "Code de la sécurité sociale. - art. L162-16-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000031688222", "@num": "L162-30-2", "#text": "Code de la sécurité sociale. - art. L162-30-2 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000038886222", "@num": "L162-5", "#text": "Code de la sécurité sociale. - art. L162-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000041397190", "@num": "L245-2", "#text": "Code de la sécurité sociale. - art. L245-2 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044627577", "@num": "L245-6", "#text": "Code de la sécurité sociale. - art. 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On entend par :
\n
1° Préparation magistrale, tout médicament préparé extemporanément en pharmacie selon une prescription destinée à un malade déterminé ;
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2° Préparation hospitalière, tout médicament, à l'exception des produits de thérapies génique ou cellulaire, préparé selon les indications de la pharmacopée et en conformité avec les bonnes pratiques mentionnées à l'article L. 5121-5, en raison de l'absence de spécialité pharmaceutique disponible ou adaptée dans une pharmacie à usage intérieur d'un établissement de santé, ou dans l'établissement pharmaceutique de cet établissement de santé autorisé en application de l'article L. 5124-9. Les préparations hospitalières sont dispensées sur prescription médicale à un ou plusieurs patients par une pharmacie à usage intérieur dudit établissement. Elles font l'objet d'une déclaration auprès de l'Agence française de sécurité sanitaire des produits de santé, dans des conditions définies par arrêté du ministre chargé de la santé ;
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3° Préparation officinale, tout médicament préparé en pharmacie selon les indications de la pharmacopée et destiné à être dispensé directement aux patients approvisionnés par cette pharmacie ;
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4° Produit officinal divisé, toute drogue simple, tout produit chimique ou toute préparation stable décrite par la pharmacopée, préparés à l'avance par un établissement pharmaceutique et divisés soit par lui, soit par la pharmacie d'officine qui le met en vente, soit par une pharmacie à usage intérieur, telle que définie au chapitre VI du présent titre ;
\n
5° Sans préjudice des dispositions des articles L. 611-2 et suivants du code de la propriété intellectuelle, spécialité générique d'une spécialité de référence, celle qui a la même composition qualitative et quantitative en principe actif, la même forme pharmaceutique et dont la bioéquivalence avec la spécialité de référence est démontrée par des études de biodisponibilité appropriées. La spécialité de référence et les spécialités qui en sont génériques constituent un groupe générique. En l'absence de spécialité de référence, un groupe générique peut être constitué de spécialités ayant la même composition qualitative et quantitative en principe actif, la même forme pharmaceutique et dont le profil de sécurité et d'efficacité est équivalent. Pour l'application du présent 5°, les différentes formes pharmaceutiques orales à libération immédiate sont considérées comme une même forme pharmaceutique ;
\n
6° Médicament immunologique, tout médicament consistant en :
\n
a) Allergène, défini comme tout produit destiné à identifier ou provoquer une modification spécifique et acquise de la réponse immunologique à un agent allergisant ;
\n
b) Vaccin, toxine ou sérum, définis comme tous agents utilisés en vue de provoquer une immunité active ou passive ou en vue de diagnostiquer l'état d'immunité ;
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7° Médicament radiopharmaceutique, tout médicament qui, lorsqu'il est prêt à l'emploi, contient un ou plusieurs isotopes radioactifs, dénommés radionucléides, incorporés à des fins médicales ;
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8° Générateur, tout système contenant un radionucléide parent déterminé servant à la production d'un radionucléide de filiation obtenu par élution ou par toute autre méthode et utilisé dans un médicament radiopharmaceutique ;
\n
9° Trousse, toute préparation qui doit être reconstituée ou combinée avec des radionucléides dans le produit radiopharmaceutique final ;
\n
10° Précurseur, tout autre radionucléide produit pour le marquage radioactif d'une autre substance avant administration ;
\n
11° Médicament homéopathique, tout médicament obtenu à partir de produits, substances ou compositions appelés souches homéopathiques, selon un procédé de fabrication homéopathique décrit par la pharmacopée européenne, la pharmacopée française ou, à défaut, par les pharmacopées utilisées de façon officielle dans un autre Etat membre de la Communauté européenne. Un médicament homéopathique peut aussi contenir plusieurs principes.
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On entend par :
\n
1° Préparation magistrale, tout médicament préparé extemporanément en pharmacie selon une prescription destinée à un malade déterminé ;
\n
2° Préparation hospitalière, tout médicament, à l'exception des produits de thérapies génique ou cellulaire, préparé selon les indications de la pharmacopée et en conformité avec les bonnes pratiques mentionnées à l'article L. 5121-5, en raison de l'absence de spécialité pharmaceutique disponible ou adaptée dans une pharmacie à usage intérieur d'un établissement de santé, ou dans l'établissement pharmaceutique de cet établissement de santé autorisé en application de l'article L. 5124-9. Les préparations hospitalières sont dispensées sur prescription médicale à un ou plusieurs patients par une pharmacie à usage intérieur dudit établissement. Elles font l'objet d'une déclaration auprès de l'Agence française de sécurité sanitaire des produits de santé, dans des conditions définies par arrêté du ministre chargé de la santé ;
\n
3° Préparation officinale, tout médicament préparé en pharmacie selon les indications de la pharmacopée et destiné à être dispensé directement aux patients approvisionnés par cette pharmacie ;
\n
4° Produit officinal divisé, toute drogue simple, tout produit chimique ou toute préparation stable décrite par la pharmacopée, préparés à l'avance par un établissement pharmaceutique et divisés soit par lui, soit par la pharmacie d'officine qui le met en vente, soit par une pharmacie à usage intérieur, telle que définie au chapitre VI du présent titre ;
\n
5° Sans préjudice des dispositions des articles L. 611-2 et suivants du code de la propriété intellectuelle, spécialité générique d'une spécialité de référence, celle qui a la même composition qualitative et quantitative en principe actif, la même forme pharmaceutique et dont la bioéquivalence avec la spécialité de référence est démontrée par des études de biodisponibilité appropriées. La spécialité de référence et les spécialités qui en sont génériques constituent un groupe générique. En l'absence de spécialité de référence, un groupe générique peut être constitué de spécialités ayant la même composition qualitative et quantitative en principe actif, la même forme pharmaceutique et dont le profil de sécurité et d'efficacité est équivalent. Pour l'application du présent 5°, les différentes formes pharmaceutiques orales à libération immédiate sont considérées comme une même forme pharmaceutique ;
\n
6° Médicament immunologique, tout médicament consistant en :
\n
a) Allergène, défini comme tout produit destiné à identifier ou provoquer une modification spécifique et acquise de la réponse immunologique à un agent allergisant ;
\n
b) Vaccin, toxine ou sérum, définis comme tous agents utilisés en vue de provoquer une immunité active ou passive ou en vue de diagnostiquer l'état d'immunité ;
\n
7° Médicament radiopharmaceutique, tout médicament qui, lorsqu'il est prêt à l'emploi, contient un ou plusieurs isotopes radioactifs, dénommés radionucléides, incorporés à des fins médicales ;
\n
8° Générateur, tout système contenant un radionucléide parent déterminé servant à la production d'un radionucléide de filiation obtenu par élution ou par toute autre méthode et utilisé dans un médicament radiopharmaceutique ;
\n
9° Trousse, toute préparation qui doit être reconstituée ou combinée avec des radionucléides dans le produit radiopharmaceutique final ;
\n
10° Précurseur, tout autre radionucléide produit pour le marquage radioactif d'une autre substance avant administration ;
\n
11° Médicament homéopathique, tout médicament obtenu à partir de produits, substances ou compositions appelés souches homéopathiques, selon un procédé de fabrication homéopathique décrit par la pharmacopée européenne, la pharmacopée française ou, à défaut, par les pharmacopées utilisées de façon officielle dans un autre Etat membre de la Communauté européenne. Un médicament homéopathique peut aussi contenir plusieurs principes ;
\n
12° Préparation de thérapie génique, tout médicament autre que les spécialités pharmaceutiques et les médicaments fabriqués industriellement mentionnés à l'article L. 5121-8, servant à transférer du matériel génétique et ne consistant pas en des cellules d'origine humaine ou animale. Ces préparations sont préparées à l'avance et dispensées sur prescription médicale à un ou plusieurs patients. Elles font l'objet d'une autorisation de l'Agence française de sécurité sanitaire des produits de santé pour une indication thérapeutique donnée. Cette autorisation peut être assortie de conditions particulières ou de restrictions d'utilisation. Elle peut être modifiée, suspendue ou retirée ;
\n
13° Préparation de thérapie cellulaire xénogénique, tout médicament autre que les spécialités pharmaceutiques et les médicaments fabriqués industriellement mentionnés à l'article L. 5121-8, consistant en des cellules d'origine animale et leurs dérivés utilisés à des fins thérapeutiques, y compris les cellules servant à transférer du matériel génétique, quel que soit leur niveau de transformation. Ces préparations sont préparées à l'avance et dispensées sur prescription médicale à un ou plusieurs patients. Elles font l'objet d'une autorisation de l'Agence française de sécurité sanitaire des produits de santé pour une indication thérapeutique donnée. Cette autorisation peut être assortie de conditions particulières ou de restrictions d'utilisation. Elle peut être modifiée, suspendue ou retirée. L'Agence de la biomédecine est informée des décisions relatives à ces préparations prises en application du présent alinéa.
" } }, "LEGIARTI000006689873": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5121-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-17", "DATE_DEBUT": "2004-08-11" } }, "META_COMMUN": { "ID": "LEGIARTI000006689873", "URL": "article/LEGI/ARTI/00/00/06/68/98/LEGIARTI000006689873.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5121L01XXAD" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000049923273", "@num": "2", "#text": "Arrêté du 4 août 1987 - art. 2 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000000843609", "@nortexte": "ECOX8798330A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1987-08-04" }, { "@id": "LEGIARTI000023731730", "@num": "3", "#text": "Arrêté du 4 août 1987 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000843609", "@nortexte": "ECOX8798330A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1987-08-04" }, { "@id": "LEGIARTI000034405848", "@num": "69", "#text": "Décret n°90-1215 du 20 décembre 1990 - art. 69 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000717193", "@nortexte": "SPSS9001980D", "@numtexte": "90-1215", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1990-12-20" }, { "@id": "LEGIARTI000006699999", "@num": "1", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700029", "@num": "10", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 10 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700040", "@num": "14", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 14 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700043", "@num": "15", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 15 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700045", "@num": "16", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 16 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700047", "@num": "17", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 17 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700002", "@num": "2", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700054", "@num": "20", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 20 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700005", "@num": "3", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700008", "@num": "4", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@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": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006725129", "@num": "71", "#text": "Décret n°2001-1065 du 15 novembre 2001 - art. 71 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000403855", "@nortexte": "INTM0100035D", "@numtexte": "2001-1065", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2001-11-15" }, { "@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": "LEGIARTI000006697606", "@num": "35", "#text": "Loi n°2004-800 du 6 août 2004 - art. 35 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000441469", "@nortexte": "SANX0100053L", "@numtexte": "2004-800", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-06" }, { "@id": "LEGIARTI000006697666", "@num": "47", "#text": "Loi n°2004-806 du 9 août 2004 - art. 47 () JORF 11 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787078", "@nortexte": "SANX0300055L", "@numtexte": "2004-806", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-09" }, { "@id": "LEGIARTI000047109474", "@num": "14", "#text": "Décret n°2004-942 du 3 septembre 2004 - art. 14 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000000253592", "@nortexte": "SANS0422327D", "@numtexte": "2004-942", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-09-03" }, { "@id": "LEGIARTI000032182077", "@num": "41", "#text": "Loi n°2005-1579 du 19 décembre 2005 - art. 41 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000815414", "@nortexte": "SANX0500246L", "@numtexte": "2005-1579", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2005-12-19" }, { "@id": "LEGIARTI000020140266", "@num": "8", "#text": "Arrêté du 24 mai 2006 - art. 8 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000457818", "@nortexte": "SANP0622223A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-05-24" }, { "@id": "LEGIARTI000043762395", "@num": "21", "#text": "Décret n° 2007-359 du 19 mars 2007 - art. 21 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000645145", "@nortexte": "AGRG0700643D", "@numtexte": "2007-359", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-19" }, { "@id": "LEGIARTI000022933811", "@num": "3", "#text": "Arrêté du 29 septembre 2010 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000022932466", "@nortexte": "SASP1025728A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-09-29" }, { "@id": "LEGIARTI000023501118", "@num": "4", "#text": "Arrêté du 21 janvier 2011 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023491451", "@nortexte": "ETSP1101997A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-01-21" }, { "@id": "LEGIARTI000023824330", "@num": "1", "#text": "Arrêté du 29 mars 2011 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023823216", "@nortexte": "ETSP1108796A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-03-29" }, { "@id": "LEGIARTI000046423270", "@num": "13", "#text": "Arrêté du 6 avril 2011 - art. 13 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023865866", "@nortexte": "ETSH1109848A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-04-06" }, { "@id": "LEGITEXT000024154142", "#text": "Décret n°2011-655\n du 10 juin 2011 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000024153599", "@nortexte": "ETSP1024824D", "@numtexte": "2011-655", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-06-10" }, { "@id": "LEGIARTI000026041157", "@num": "2", "#text": "Arrêté du 8 juin 2012 - 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R5126-57 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026560035", "@num": "R5132-15", "#text": "Code de la santé publique - art. R5132-15 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028390416", "@num": "R5132-3-1", "#text": "Code de la santé publique - art. R5132-3-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800424", "@num": "R5143-8", "#text": "Code de la santé publique - art. R5143-8 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800534", "@num": "R5143-8-1", "#text": "Code de la santé publique - art. R5143-8-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800551", "@num": "R5144-3", "#text": "Code de la santé publique - art. R5144-3 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000027998282", "@num": "D161-20", "#text": "Code de la sécurité sociale. - art. D161-20 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000031813563", "@num": "D325-7", "#text": "Code de la sécurité sociale. - art. D325-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000036392620", "@num": "L138-10", "#text": "Code de la sécurité sociale. - art. L138-10 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000038725858", "@num": "L138-9", "#text": "Code de la sécurité sociale. - art. 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L162-16 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048677589", "@num": "L162-16-4-5", "#text": "Code de la sécurité sociale. - art. L162-16-4-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048677591", "@num": "L162-16-4-6", "#text": "Code de la sécurité sociale. - art. L162-16-4-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000046812181", "@num": "L162-16-7", "#text": "Code de la sécurité sociale. - art. L162-16-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000031688222", "@num": "L162-30-2", "#text": "Code de la sécurité sociale. - art. L162-30-2 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000038886222", "@num": "L162-5", "#text": "Code de la sécurité sociale. - art. L162-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000041397190", "@num": "L245-2", "#text": "Code de la sécurité sociale. - art. L245-2 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044627577", "@num": "L245-6", "#text": "Code de la sécurité sociale. - art. L245-6 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006742407", "@num": "L245-6-1", "#text": "Code de la sécurité sociale. - art. L245-6-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025013117", "@num": "L322-2", "#text": "Code de la sécurité sociale. - art. L322-2 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000047913149", "@num": "R160-5", "#text": "Code de la sécurité sociale. - art. R160-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000038956277", "@num": "R161-76-2", "#text": "Code de la sécurité sociale. - art. R161-76-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000050420846", "@num": "R162-34-13", "#text": "Code de la sécurité sociale. - art. R162-34-13 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045634176", "@num": "R162-34-14", "#text": "Code de la sécurité sociale. - art. R162-34-14 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000050420826", "@num": "R162-37-2", "#text": "Code de la sécurité sociale. - art. R162-37-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048630412", "@num": "R163-1", "#text": "Code de la sécurité sociale. - art. R163-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049737581", "@num": "R163-19", "#text": "Code de la sécurité sociale. - art. R163-19 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043912140", "@num": "R163-3", "#text": "Code de la sécurité sociale. - art. R163-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043912129", "@num": "R163-4", "#text": "Code de la sécurité sociale. - art. R163-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043762068", "@num": "R163-5", "#text": "Code de la sécurité sociale. - art. R163-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000038897696", "@num": "R163-6", "#text": "Code de la sécurité sociale. - art. R163-6 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000030919417", "@num": "R322-1", "#text": "Code de la sécurité sociale. - art. 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On entend par :
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1° Préparation magistrale, tout médicament préparé extemporanément en pharmacie selon une prescription destinée à un malade déterminé ;
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2° Préparation hospitalière, tout médicament, à l'exception des produits de thérapies génique ou cellulaire, préparé selon les indications de la pharmacopée et en conformité avec les bonnes pratiques mentionnées à l'article L. 5121-5, en raison de l'absence de spécialité pharmaceutique disponible ou adaptée dans une pharmacie à usage intérieur d'un établissement de santé, ou par l'établissement pharmaceutique de cet établissement de santé autorisé en application de l'article L. 5124-9. Les préparations hospitalières sont dispensées sur prescription médicale à un ou plusieurs patients par une pharmacie à usage intérieur dudit établissement. Elles font l'objet d'une déclaration auprès de l'Agence française de sécurité sanitaire des produits de santé, dans des conditions définies par arrêté du ministre chargé de la santé ;
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3° Préparation officinale, tout médicament préparé en pharmacie selon les indications de la pharmacopée et destiné à être dispensé directement aux patients approvisionnés par cette pharmacie ;
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4° Produit officinal divisé, toute drogue simple, tout produit chimique ou toute préparation stable décrite par la pharmacopée, préparés à l'avance par un établissement pharmaceutique et divisés soit par lui, soit par la pharmacie d'officine qui le met en vente, soit par une pharmacie à usage intérieur, telle que définie au chapitre VI du présent titre ;
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5° Sans préjudice des dispositions des articles L. 611-2 et suivants du code de la propriété intellectuelle, spécialité générique d'une spécialité de référence, celle qui a la même composition qualitative et quantitative en principe actif, la même forme pharmaceutique et dont la bioéquivalence avec la spécialité de référence est démontrée par des études de biodisponibilité appropriées. La spécialité de référence et les spécialités qui en sont génériques constituent un groupe générique. En l'absence de spécialité de référence, un groupe générique peut être constitué de spécialités ayant la même composition qualitative et quantitative en principe actif, la même forme pharmaceutique et dont le profil de sécurité et d'efficacité est équivalent. Pour l'application du présent 5°, les différentes formes pharmaceutiques orales à libération immédiate sont considérées comme une même forme pharmaceutique ;
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6° Médicament immunologique, tout médicament consistant en :
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a) Allergène, défini comme tout produit destiné à identifier ou provoquer une modification spécifique et acquise de la réponse immunologique à un agent allergisant ;
\n
b) Vaccin, toxine ou sérum, définis comme tous agents utilisés en vue de provoquer une immunité active ou passive ou en vue de diagnostiquer l'état d'immunité ;
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7° Médicament radiopharmaceutique, tout médicament qui, lorsqu'il est prêt à l'emploi, contient un ou plusieurs isotopes radioactifs, dénommés radionucléides, incorporés à des fins médicales ;
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8° Générateur, tout système contenant un radionucléide parent déterminé servant à la production d'un radionucléide de filiation obtenu par élution ou par toute autre méthode et utilisé dans un médicament radiopharmaceutique ;
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9° Trousse, toute préparation qui doit être reconstituée ou combinée avec des radionucléides dans le produit radiopharmaceutique final ;
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10° Précurseur, tout autre radionucléide produit pour le marquage radioactif d'une autre substance avant administration ;
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11° Médicament homéopathique, tout médicament obtenu à partir de produits, substances ou compositions appelés souches homéopathiques, selon un procédé de fabrication homéopathique décrit par la pharmacopée européenne, la pharmacopée française ou, à défaut, par les pharmacopées utilisées de façon officielle dans un autre Etat membre de la Communauté européenne. Un médicament homéopathique peut aussi contenir plusieurs principes ;
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12° Préparation de thérapie génique, tout médicament autre que les spécialités pharmaceutiques et les médicaments fabriqués industriellement mentionnés à l'article L. 5121-8, servant à transférer du matériel génétique et ne consistant pas en des cellules d'origine humaine ou animale. Ces préparations sont préparées à l'avance et dispensées sur prescription médicale à un ou plusieurs patients. Elles font l'objet d'une autorisation de l'Agence française de sécurité sanitaire des produits de santé pour une indication thérapeutique donnée. Cette autorisation peut être assortie de conditions particulières ou de restrictions d'utilisation. Elle peut être modifiée, suspendue ou retirée ;
\n
13° Préparation de thérapie cellulaire xénogénique, tout médicament autre que les spécialités pharmaceutiques et les médicaments fabriqués industriellement mentionnés à l'article L. 5121-8, consistant en des cellules d'origine animale et leurs dérivés utilisés à des fins thérapeutiques, y compris les cellules servant à transférer du matériel génétique, quel que soit leur niveau de transformation. Ces préparations sont préparées à l'avance et dispensées sur prescription médicale à un ou plusieurs patients. Elles font l'objet d'une autorisation de l'Agence française de sécurité sanitaire des produits de santé pour une indication thérapeutique donnée. Cette autorisation peut être assortie de conditions particulières ou de restrictions d'utilisation. Elle peut être modifiée, suspendue ou retirée. L'Agence de la biomédecine est informée des décisions relatives à ces préparations prises en application du présent alinéa.
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art. 12 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000249276", "@nortexte": "SANX0300139L", "@numtexte": "2003-1199", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2003-12-18" }, { "@id": "LEGIARTI000006697606", "@num": "35", "#text": "Loi n°2004-800 du 6 août 2004 - art. 35 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000441469", "@nortexte": "SANX0100053L", "@numtexte": "2004-800", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-06" }, { "@id": "LEGIARTI000006758958", "@num": "30", "#text": "Loi n°2004-810 du 13 août 2004 - art. 30 () JORF 17 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000625158", "@nortexte": "SANX0400122L", "@numtexte": "2004-810", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-13" }, { "@id": "LEGIARTI000047109474", "@num": "14", "#text": "Décret n°2004-942 du 3 septembre 2004 - art. 14 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000000253592", "@nortexte": "SANS0422327D", "@numtexte": "2004-942", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-09-03" }, { "@id": "LEGIARTI000032182077", "@num": "41", "#text": "Loi n°2005-1579 du 19 décembre 2005 - art. 41 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000815414", "@nortexte": "SANX0500246L", "@numtexte": "2005-1579", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2005-12-19" }, { "@id": "LEGIARTI000020140266", "@num": "8", "#text": "Arrêté du 24 mai 2006 - art. 8 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000457818", "@nortexte": "SANP0622223A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-05-24" }, { "@id": "LEGIARTI000043762395", "@num": "21", "#text": "Décret n° 2007-359 du 19 mars 2007 - art. 21 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000645145", "@nortexte": "AGRG0700643D", "@numtexte": "2007-359", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-19" }, { "@id": "LEGIARTI000022933811", "@num": "3", "#text": "Arrêté du 29 septembre 2010 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000022932466", "@nortexte": "SASP1025728A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-09-29" }, { "@id": "LEGIARTI000023501118", "@num": "4", "#text": "Arrêté du 21 janvier 2011 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023491451", "@nortexte": "ETSP1101997A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-01-21" }, { "@id": "LEGIARTI000023824330", "@num": "1", "#text": "Arrêté du 29 mars 2011 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023823216", "@nortexte": "ETSP1108796A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-03-29" }, { "@id": "LEGIARTI000046423270", "@num": "13", "#text": "Arrêté du 6 avril 2011 - art. 13 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023865866", "@nortexte": "ETSH1109848A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-04-06" }, { "@id": "LEGITEXT000024154142", "#text": "Décret n°2011-655\n du 10 juin 2011 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000024153599", "@nortexte": "ETSP1024824D", "@numtexte": "2011-655", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-06-10" }, { "@id": "LEGIARTI000026041157", "@num": "2", "#text": "Arrêté du 8 juin 2012 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000026040448", "@nortexte": "AFSP1225501A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-06-08" }, { "@id": "LEGITEXT000026558683", "#text": "Décret n°2012-1201\n du 29 octobre 2012 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000026557838", "@nortexte": "AFSP1232892D", "@numtexte": "2012-1201", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2012-10-29" }, { "@id": "LEGIARTI000026589554", "@num": "2", "#text": "Décret n°2012-1236\n du 6 novembre 2012 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000026588856", "@nortexte": "AFSP1226229D", "@numtexte": "2012-1236", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2012-11-06" }, { "@id": "LEGIARTI000035971424", "#text": "DÉCRET n°2014-1287 du 23 octobre 2014 - art. (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000029676018", "@nortexte": "AFSX1419039D", "@numtexte": "2014-1287", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000042293117", "#text": "DÉCRET n°2014-1288 du 23 octobre 2014 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029676038", "@nortexte": "AFSX1419044D", "@numtexte": "2014-1288", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000030189762", "@num": "8", "#text": "ARRÊTÉ du 28 novembre 2014 - art. 8 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000030189026", "@nortexte": "EINC1415451A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2014-11-28" }, { "@id": "LEGIARTI000030189876", "@num": "1", "#text": "ARRÊTÉ du 3 février 2015 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000030188934", "@nortexte": "AFSP1503244A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2015-02-03" }, { "@id": "LEGIARTI000032291698", "@num": "1", "#text": "Décret n°2016-349 du 24 mars 2016 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000032291186", "@nortexte": "AFSH1532721D", "@numtexte": "2016-349", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2016-03-24" }, { "@id": "LEGIARTI000032730970", "@num": "3", "#text": "Décret n°2016-817 du 20 juin 2016 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000032729458", "@nortexte": "AFSS1610671D", "@numtexte": "2016-817", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2016-06-20" }, { "@id": "LEGIARTI000034392999", "@num": "1", "#text": "Décret n°2017-500 du 6 avril 2017 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000034390458", "@nortexte": "AFSH1702718D", "@numtexte": "2017-500", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-04-06" }, { "@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": "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": "LEGIARTI000044941358", "@num": "6", "#text": "Décret n°2021-1905 du 30 décembre 2021 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000044638030", "@nortexte": "TREP2130559D", "@numtexte": "2021-1905", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-12-30" }, { "@id": "LEGIARTI000045632789", "@num": "1", "#text": "Décret n°2022-597 du 21 avril 2022 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000045632039", "@nortexte": "SSAH2205181D", "@numtexte": "2022-597", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2022-04-21" }, { "@id": "LEGITEXT000049536357", "#text": "Décret n°2024-435 du 14 mai 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049535648", "@nortexte": "TSSS2408227D", "@numtexte": "2024-435", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-05-14" }, { "@id": "LEGITEXT000049850758", "#text": "Décret n°2024-626 du 27 juin 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049832038", "@nortexte": "TSSP2408968D", "@numtexte": "2024-626", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-06-27" }, { "@id": "LEGITEXT000049922585", "#text": "Arrêté du 5 juillet 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049892254", "@nortexte": "TSSS2418508A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-07-05" }, { "@id": "LEGITEXT000050737433", "#text": "Décret n°2024-1135 du 4 décembre 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000050731183", "@nortexte": "MSAH2429400D", "@numtexte": "2024-1135", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-12-04" }, { "@id": "LEGIARTI000006279394", "@num": "L611-2", "#text": "Code de la propriété intellectuelle - art. 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On entend par :
\n
1° Préparation magistrale, tout médicament préparé extemporanément en pharmacie selon une prescription destinée à un malade déterminé ;
\n
2° Préparation hospitalière, tout médicament, à l'exception des produits de thérapies génique ou cellulaire, préparé selon les indications de la pharmacopée et en conformité avec les bonnes pratiques mentionnées à l'article L. 5121-5, en raison de l'absence de spécialité pharmaceutique disponible ou adaptée dans une pharmacie à usage intérieur d'un établissement de santé, ou par l'établissement pharmaceutique de cet établissement de santé autorisé en application de l'article L. 5124-9. Les préparations hospitalières sont dispensées sur prescription médicale à un ou plusieurs patients par une pharmacie à usage intérieur dudit établissement. Elles font l'objet d'une déclaration auprès de l'Agence française de sécurité sanitaire des produits de santé, dans des conditions définies par arrêté du ministre chargé de la santé ;
\n
3° Préparation officinale, tout médicament préparé en pharmacie selon les indications de la pharmacopée et destiné à être dispensé directement aux patients approvisionnés par cette pharmacie ;
\n
4° Produit officinal divisé, toute drogue simple, tout produit chimique ou toute préparation stable décrite par la pharmacopée, préparés à l'avance par un établissement pharmaceutique et divisés soit par lui, soit par la pharmacie d'officine qui le met en vente, soit par une pharmacie à usage intérieur, telle que définie au chapitre VI du présent titre ;
\n
5° Sans préjudice des dispositions des articles L. 611-2 et suivants du code de la propriété intellectuelle, spécialité générique d'une spécialité de référence, celle qui a la même composition qualitative et quantitative en principe actif, la même forme pharmaceutique et dont la bioéquivalence avec la spécialité de référence est démontrée par des études de biodisponibilité appropriées. La spécialité de référence et les spécialités qui en sont génériques constituent un groupe générique. En l'absence de spécialité de référence, un groupe générique peut être constitué de spécialités ayant la même composition qualitative et quantitative en principe actif, la même forme pharmaceutique et dont le profil de sécurité et d'efficacité est équivalent. Pour l'application du présent 5°, les différentes formes pharmaceutiques orales à libération immédiate sont considérées comme une même forme pharmaceutique et les différents sels, esters, éthers, isomères, mélanges d'isomères, complexes ou dérivés d'un principe actif sont considérés comme un même principe actif, sauf s'ils présentent des propriétés sensiblement différentes au regard de la sécurité ou de l'efficacité. Dans ce cas, des informations supplémentaires fournissant la preuve de la sécurité et de l'efficacité des différents sels, esters ou dérivés d'une substance active autorisée doivent être apportées ;
\n
6° Médicament immunologique, tout médicament consistant en :
\n
a) Allergène, défini comme tout produit destiné à identifier ou provoquer une modification spécifique et acquise de la réponse immunologique à un agent allergisant ;
\n
b) Vaccin, toxine ou sérum, définis comme tous agents utilisés en vue de provoquer une immunité active ou passive ou en vue de diagnostiquer l'état d'immunité ;
\n
7° Médicament radiopharmaceutique, tout médicament qui, lorsqu'il est prêt à l'emploi, contient un ou plusieurs isotopes radioactifs, dénommés radionucléides, incorporés à des fins médicales ;
\n
8° Générateur, tout système contenant un radionucléide parent déterminé servant à la production d'un radionucléide de filiation obtenu par élution ou par toute autre méthode et utilisé dans un médicament radiopharmaceutique ;
\n
9° Trousse, toute préparation qui doit être reconstituée ou combinée avec des radionucléides dans le produit radiopharmaceutique final ;
\n
10° Précurseur, tout autre radionucléide produit pour le marquage radioactif d'une autre substance avant administration ;
\n
11° Médicament homéopathique, tout médicament obtenu à partir de produits, substances ou compositions appelés souches homéopathiques, selon un procédé de fabrication homéopathique décrit par la pharmacopée européenne, la pharmacopée française ou, à défaut, par les pharmacopées utilisées de façon officielle dans un autre Etat membre de la Communauté européenne. Un médicament homéopathique peut aussi contenir plusieurs principes ;
\n
12° Préparation de thérapie génique, tout médicament autre que les spécialités pharmaceutiques et les médicaments fabriqués industriellement mentionnés à l'article L. 5121-8, servant à transférer du matériel génétique et ne consistant pas en des cellules d'origine humaine ou animale. Ces préparations sont préparées à l'avance et dispensées sur prescription médicale à un ou plusieurs patients. Elles font l'objet d'une autorisation de l'Agence française de sécurité sanitaire des produits de santé pour une indication thérapeutique donnée. Cette autorisation peut être assortie de conditions particulières ou de restrictions d'utilisation. Elle peut être modifiée, suspendue ou retirée ;
\n
13° Préparation de thérapie cellulaire xénogénique, tout médicament autre que les spécialités pharmaceutiques et les médicaments fabriqués industriellement mentionnés à l'article L. 5121-8, consistant en des cellules d'origine animale et leurs dérivés utilisés à des fins thérapeutiques, y compris les cellules servant à transférer du matériel génétique, quel que soit leur niveau de transformation. Ces préparations sont préparées à l'avance et dispensées sur prescription médicale à un ou plusieurs patients. Elles font l'objet d'une autorisation de l'Agence française de sécurité sanitaire des produits de santé pour une indication thérapeutique donnée. Cette autorisation peut être assortie de conditions particulières ou de restrictions d'utilisation. Elle peut être modifiée, suspendue ou retirée. L'Agence de la biomédecine est informée des décisions relatives à ces préparations prises en application du présent alinéa.
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Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000195660", "@nortexte": "ENVP9640024D", "@numtexte": "96-850", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1996-09-20" }, { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006725129", "@num": "71", "#text": "Décret n°2001-1065 du 15 novembre 2001 - art. 71 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000403855", "@nortexte": "INTM0100035D", "@numtexte": "2001-1065", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2001-11-15" }, { "@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": "LEGIARTI000006697606", "@num": "35", "#text": "Loi n°2004-800 du 6 août 2004 - art. 35 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000441469", "@nortexte": "SANX0100053L", "@numtexte": "2004-800", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-06" }, { "@id": "LEGIARTI000047109474", "@num": "14", "#text": "Décret n°2004-942 du 3 septembre 2004 - art. 14 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000000253592", "@nortexte": "SANS0422327D", "@numtexte": "2004-942", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-09-03" }, { "@id": "LEGIARTI000032182077", "@num": "41", "#text": "Loi n°2005-1579 du 19 décembre 2005 - art. 41 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000815414", "@nortexte": "SANX0500246L", "@numtexte": "2005-1579", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2005-12-19" }, { "@id": "LEGIARTI000020140266", "@num": "8", "#text": "Arrêté du 24 mai 2006 - art. 8 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000457818", "@nortexte": "SANP0622223A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-05-24" }, { "@id": "LEGIARTI000006697008", "@num": "4", "#text": "Loi n°2007-248 du 26 février 2007 - art. 4 () JORF 27 février 2007", "@sens": "source", "@cidtexte": "JORFTEXT000000613381", "@nortexte": "SANX0600004L", "@numtexte": "2007-248", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2007-02-26" }, { "@id": "LEGIARTI000043762395", "@num": "21", "#text": "Décret n° 2007-359 du 19 mars 2007 - art. 21 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000645145", "@nortexte": "AGRG0700643D", "@numtexte": "2007-359", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-19" }, { "@id": "LEGIARTI000022933811", "@num": "3", "#text": "Arrêté du 29 septembre 2010 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000022932466", "@nortexte": "SASP1025728A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-09-29" }, { "@id": "LEGIARTI000023501118", "@num": "4", "#text": "Arrêté du 21 janvier 2011 - 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On entend par :
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1° Préparation magistrale, tout médicament préparé extemporanément au vu de la prescription destinée à un malade déterminé soit dans la pharmacie dispensatrice, soit, dans des conditions définies par décret, dans une pharmacie à laquelle celle-ci confie l'exécution de la préparation par un contrat écrit et qui est soumise pour l'exercice de cette activité de sous-traitance à une autorisation préalable délivrée par le représentant de l'État dans le département après avis du directeur régional des affaires sanitaires et sociales ;
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2° Préparation hospitalière, tout médicament, à l'exception des produits de thérapies génique ou cellulaire, préparé selon les indications de la pharmacopée et en conformité avec les bonnes pratiques mentionnées à l'article L. 5121-5, en raison de l'absence de spécialité pharmaceutique disponible ou adaptée dans une pharmacie à usage intérieur d'un établissement de santé, ou par l'établissement pharmaceutique de cet établissement de santé autorisé en application de l'article L. 5124-9. Les préparations hospitalières sont dispensées sur prescription médicale à un ou plusieurs patients par une pharmacie à usage intérieur dudit établissement. Elles font l'objet d'une déclaration auprès de l'Agence française de sécurité sanitaire des produits de santé, dans des conditions définies par arrêté du ministre chargé de la santé ;
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3° Préparation officinale, tout médicament préparé en pharmacie, inscrit à la pharmacopée ou au formulaire national et destiné à être dispensé directement aux patients approvisionnés par cette pharmacie ;
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4° Produit officinal divisé, toute drogue simple, tout produit chimique ou toute préparation stable décrite par la pharmacopée, préparés à l'avance par un établissement pharmaceutique et divisés soit par lui, soit par la pharmacie d'officine qui le met en vente, soit par une pharmacie à usage intérieur, telle que définie au chapitre VI du présent titre ;
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5° a) Sans préjudice des articles L. 611-2 et suivants du code de la propriété intellectuelle, spécialité générique d'une spécialité de référence, celle qui a la même composition qualitative et quantitative en principes actifs, la même forme pharmaceutique et dont la bioéquivalence avec la spécialité de référence est démontrée par des études de biodisponibilité appropriées. Une spécialité ne peut être qualifiée de spécialité de référence que si son autorisation de mise sur le marché a été délivrée au vu d'un dossier comportant, dans des conditions fixées par voie réglementaire, l'ensemble des données nécessaires et suffisantes à elles seules pour son évaluation. Pour l'application du présent alinéa, les différentes formes pharmaceutiques orales à libération immédiate sont considérées comme une même forme pharmaceutique. De même, les différents sels, esters, éthers, isomères, mélanges d'isomères, complexes ou dérivés d'un principe actif sont regardés comme ayant la même composition qualitative en principe actif, sauf s'ils présentent des propriétés sensiblement différentes au regard de la sécurité ou de l'efficacité. Dans ce cas, des informations supplémentaires fournissant la preuve de la sécurité et de l'efficacité des différents sels, esters ou dérivés d'une substance active autorisée doivent être données par le demandeur de l'autorisation de mise sur le marché ;
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b) Groupe générique, le regroupement d'une spécialité de référence et des spécialités qui en sont génériques. Toutefois, une spécialité remplissant les conditions pour être une spécialité de référence, qui présente la même composition qualitative et quantitative en principes actifs et la même forme pharmaceutique qu'une spécialité de référence d'un groupe générique déjà existant, et dont la bioéquivalence avec cette spécialité est démontrée par des études de biodisponibilité appropriées, peut aussi figurer dans ce groupe générique, à condition que ces deux spécialités soient considérées comme relevant d'une même autorisation de mise sur le marché globale, définie par voie réglementaire. En l'absence de spécialité de référence, un groupe générique peut être constitué de spécialités ayant la même composition qualitative et quantitative en principes actifs, la même forme pharmaceutique et dont les caractéristiques en termes de sécurité et d'efficacité sont équivalentes ;
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6° Médicament immunologique, tout médicament consistant en :
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a) Allergène, défini comme tout produit destiné à identifier ou provoquer une modification spécifique et acquise de la réponse immunologique à un agent allergisant ;
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b) Vaccin, toxine ou sérum, définis comme tous agents utilisés en vue de provoquer une immunité active ou passive ou en vue de diagnostiquer l'état d'immunité ;
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7° Médicament radiopharmaceutique, tout médicament qui, lorsqu'il est prêt à l'emploi, contient un ou plusieurs isotopes radioactifs, dénommés radionucléides, incorporés à des fins médicales ;
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8° Générateur, tout système contenant un radionucléide parent déterminé servant à la production d'un radionucléide de filiation obtenu par élution ou par toute autre méthode et utilisé dans un médicament radiopharmaceutique ;
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9° Trousse, toute préparation qui doit être reconstituée ou combinée avec des radionucléides dans le produit radiopharmaceutique final ;
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10° Précurseur, tout autre radionucléide produit pour le marquage radioactif d'une autre substance avant administration ;
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11° Médicament homéopathique, tout médicament obtenu à partir de substances appelées souches homéopathiques, selon un procédé de fabrication homéopathique décrit par la pharmacopée européenne, la pharmacopée française ou, à défaut, par les pharmacopées utilisées de façon officielle dans un autre Etat membre de la Communauté européenne. Un médicament homéopathique peut aussi contenir plusieurs principes ;
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12° Préparation de thérapie génique, tout médicament autre que les spécialités pharmaceutiques et les médicaments fabriqués industriellement mentionnés à l'article L. 5121-8, servant à transférer du matériel génétique et ne consistant pas en des cellules d'origine humaine ou animale. Ces préparations sont préparées à l'avance et dispensées sur prescription médicale à un ou plusieurs patients. Elles font l'objet d'une autorisation de l'Agence française de sécurité sanitaire des produits de santé pour une indication thérapeutique donnée. Cette autorisation peut être assortie de conditions particulières ou de restrictions d'utilisation. Elle peut être modifiée, suspendue ou retirée ;
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13° Préparation de thérapie cellulaire xénogénique, tout médicament autre que les spécialités pharmaceutiques et les médicaments fabriqués industriellement mentionnés à l'article L. 5121-8, consistant en des cellules d'origine animale et leurs dérivés utilisés à des fins thérapeutiques, y compris les cellules servant à transférer du matériel génétique, quel que soit leur niveau de transformation. Ces préparations sont préparées à l'avance et dispensées sur prescription médicale à un ou plusieurs patients. Elles font l'objet d'une autorisation de l'Agence française de sécurité sanitaire des produits de santé pour une indication thérapeutique donnée. Cette autorisation peut être assortie de conditions particulières ou de restrictions d'utilisation. Elle peut être modifiée, suspendue ou retirée. L'Agence de la biomédecine est informée des décisions relatives à ces préparations prises en application du présent alinéa ;
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14° Médicament biologique, tout médicament dont la substance active est produite à partir d'une source biologique ou en est extraite et dont la caractérisation et la détermination de la qualité nécessitent une combinaison d'essais physiques, chimiques et biologiques ainsi que la connaissance de son procédé de fabrication et de son contrôle ;
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15° Sans préjudice des articles L. 611-2 et suivants du code de la propriété intellectuelle, médicament biologique similaire, tout médicament biologique de même composition qualitative et quantitative en substance active et de même forme pharmaceutique qu'un médicament biologique de référence mais qui ne remplit pas les conditions prévues au a du 5° du présent article pour être regardé comme une spécialité générique en raison de différences liées notamment à la variabilité de la matière première ou aux procédés de fabrication et nécessitant que soient produites des données précliniques et cliniques supplémentaires dans des conditions déterminées par voie réglementaire.
" } }, "LEGIARTI000006689876": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5121-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2008-04-17", "DATE_DEBUT": "2007-04-27" } }, "META_COMMUN": { "ID": "LEGIARTI000006689876", "URL": "article/LEGI/ARTI/00/00/06/68/98/LEGIARTI000006689876.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5121L01XXAG" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000049923273", "@num": "2", "#text": "Arrêté du 4 août 1987 - art. 2 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000000843609", "@nortexte": "ECOX8798330A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1987-08-04" }, { "@id": "LEGIARTI000023731730", "@num": "3", "#text": "Arrêté du 4 août 1987 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000843609", "@nortexte": "ECOX8798330A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1987-08-04" }, { "@id": "LEGIARTI000034405848", "@num": "69", "#text": "Décret n°90-1215 du 20 décembre 1990 - art. 69 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000717193", "@nortexte": "SPSS9001980D", "@numtexte": "90-1215", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1990-12-20" }, { "@id": "LEGIARTI000006699999", "@num": "1", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700029", "@num": "10", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 10 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700040", "@num": "14", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 14 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700043", "@num": "15", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 15 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700045", "@num": "16", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 16 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700047", "@num": "17", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 17 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700002", "@num": "2", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700054", "@num": "20", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 20 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700005", "@num": "3", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700008", "@num": "4", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006865783", "@num": "Annexe", "#text": "Décret n°96-850 du 20 septembre 1996 - art. 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art. 12 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000249276", "@nortexte": "SANX0300139L", "@numtexte": "2003-1199", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2003-12-18" }, { "@id": "LEGIARTI000006697606", "@num": "35", "#text": "Loi n°2004-800 du 6 août 2004 - art. 35 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000441469", "@nortexte": "SANX0100053L", "@numtexte": "2004-800", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-06" }, { "@id": "LEGIARTI000047109474", "@num": "14", "#text": "Décret n°2004-942 du 3 septembre 2004 - art. 14 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000000253592", "@nortexte": "SANS0422327D", "@numtexte": "2004-942", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-09-03" }, { "@id": "LEGIARTI000032182077", "@num": "41", "#text": "Loi n°2005-1579 du 19 décembre 2005 - art. 41 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000815414", "@nortexte": "SANX0500246L", "@numtexte": "2005-1579", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2005-12-19" }, { "@id": "LEGIARTI000020140266", "@num": "8", "#text": "Arrêté du 24 mai 2006 - art. 8 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000457818", "@nortexte": "SANP0622223A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-05-24" }, { "@id": "LEGIARTI000043762395", "@num": "21", "#text": "Décret n° 2007-359 du 19 mars 2007 - art. 21 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000645145", "@nortexte": "AGRG0700643D", "@numtexte": "2007-359", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-19" }, { "@id": "LEGIARTI000006698416", "@num": "1", "#text": "Ordonnance n°2007-613 du 26 avril 2007 - art. 1 () JORF 27 avril 2007", "@sens": "source", "@cidtexte": "JORFTEXT000000646989", "@nortexte": "SANX0700046R", "@numtexte": "2007-613", "@typelien": "MODIFICATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2007-04-26" }, { "@id": "LEGIARTI000022933811", "@num": "3", "#text": "Arrêté du 29 septembre 2010 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000022932466", "@nortexte": "SASP1025728A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-09-29" }, { "@id": "LEGIARTI000023501118", "@num": "4", "#text": "Arrêté du 21 janvier 2011 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023491451", "@nortexte": "ETSP1101997A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-01-21" }, { "@id": "LEGIARTI000023824330", "@num": "1", "#text": "Arrêté du 29 mars 2011 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023823216", "@nortexte": "ETSP1108796A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-03-29" }, { "@id": "LEGIARTI000046423270", "@num": "13", "#text": "Arrêté du 6 avril 2011 - art. 13 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023865866", "@nortexte": "ETSH1109848A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-04-06" }, { "@id": "LEGITEXT000024154142", "#text": "Décret n°2011-655\n du 10 juin 2011 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000024153599", "@nortexte": "ETSP1024824D", "@numtexte": "2011-655", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-06-10" }, { "@id": "LEGIARTI000026041157", "@num": "2", "#text": "Arrêté du 8 juin 2012 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000026040448", "@nortexte": "AFSP1225501A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-06-08" }, { "@id": "LEGITEXT000026558683", "#text": "Décret n°2012-1201\n du 29 octobre 2012 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000026557838", "@nortexte": "AFSP1232892D", "@numtexte": "2012-1201", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2012-10-29" }, { "@id": "LEGIARTI000026589554", "@num": "2", "#text": "Décret n°2012-1236\n du 6 novembre 2012 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000026588856", "@nortexte": "AFSP1226229D", "@numtexte": "2012-1236", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2012-11-06" }, { "@id": "LEGIARTI000035971424", "#text": "DÉCRET n°2014-1287 du 23 octobre 2014 - art. 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L162-30-2 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000038886222", "@num": "L162-5", "#text": "Code de la sécurité sociale. - art. L162-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000041397190", "@num": "L245-2", "#text": "Code de la sécurité sociale. - art. L245-2 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044627577", "@num": "L245-6", "#text": "Code de la sécurité sociale. - art. 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On entend par :
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1° Préparation magistrale, tout médicament préparé extemporanément au vu de la prescription destinée à un malade déterminé soit dans la pharmacie dispensatrice, soit, dans des conditions définies par décret, dans une pharmacie à laquelle celle-ci confie l'exécution de la préparation par un contrat écrit et qui est soumise pour l'exercice de cette activité de sous-traitance à une autorisation préalable délivrée par le représentant de l'État dans le département après avis du directeur régional des affaires sanitaires et sociales ;
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2° Préparation hospitalière, tout médicament, à l'exception des produits de thérapies génique ou cellulaire, préparé selon les indications de la pharmacopée et en conformité avec les bonnes pratiques mentionnées à l'article L. 5121-5, en raison de l'absence de spécialité pharmaceutique disponible ou adaptée dans une pharmacie à usage intérieur d'un établissement de santé, ou par l'établissement pharmaceutique de cet établissement de santé autorisé en application de l'article L. 5124-9. Les préparations hospitalières sont dispensées sur prescription médicale à un ou plusieurs patients par une pharmacie à usage intérieur dudit établissement. Elles font l'objet d'une déclaration auprès de l'Agence française de sécurité sanitaire des produits de santé, dans des conditions définies par arrêté du ministre chargé de la santé ;
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3° Préparation officinale, tout médicament préparé en pharmacie, inscrit à la pharmacopée ou au formulaire national et destiné à être dispensé directement aux patients approvisionnés par cette pharmacie ;
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4° Produit officinal divisé, toute drogue simple, tout produit chimique ou toute préparation stable décrite par la pharmacopée, préparés à l'avance par un établissement pharmaceutique et divisés soit par lui, soit par la pharmacie d'officine qui le met en vente, soit par une pharmacie à usage intérieur, telle que définie au chapitre VI du présent titre ;
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5° a) Sans préjudice des articles L. 611-2 et suivants du code de la propriété intellectuelle, spécialité générique d'une spécialité de référence, celle qui a la même composition qualitative et quantitative en principes actifs, la même forme pharmaceutique et dont la bioéquivalence avec la spécialité de référence est démontrée par des études de biodisponibilité appropriées. Une spécialité ne peut être qualifiée de spécialité de référence que si son autorisation de mise sur le marché a été délivrée au vu d'un dossier comportant, dans des conditions fixées par voie réglementaire, l'ensemble des données nécessaires et suffisantes à elles seules pour son évaluation. Pour l'application du présent alinéa, les différentes formes pharmaceutiques orales à libération immédiate sont considérées comme une même forme pharmaceutique. De même, les différents sels, esters, éthers, isomères, mélanges d'isomères, complexes ou dérivés d'un principe actif sont regardés comme ayant la même composition qualitative en principe actif, sauf s'ils présentent des propriétés sensiblement différentes au regard de la sécurité ou de l'efficacité. Dans ce cas, des informations supplémentaires fournissant la preuve de la sécurité et de l'efficacité des différents sels, esters ou dérivés d'une substance active autorisée doivent être données par le demandeur de l'autorisation de mise sur le marché ;
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b) Groupe générique, le regroupement d'une spécialité de référence et des spécialités qui en sont génériques. Toutefois, une spécialité remplissant les conditions pour être une spécialité de référence, qui présente la même composition qualitative et quantitative en principes actifs et la même forme pharmaceutique qu'une spécialité de référence d'un groupe générique déjà existant, et dont la bioéquivalence avec cette spécialité est démontrée par des études de biodisponibilité appropriées, peut aussi figurer dans ce groupe générique, à condition que ces deux spécialités soient considérées comme relevant d'une même autorisation de mise sur le marché globale, définie par voie réglementaire. En l'absence de spécialité de référence, un groupe générique peut être constitué de spécialités ayant la même composition qualitative et quantitative en principes actifs, la même forme pharmaceutique et dont les caractéristiques en termes de sécurité et d'efficacité sont équivalentes ;
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6° Médicament immunologique, tout médicament consistant en :
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a) Allergène, défini comme tout produit destiné à identifier ou provoquer une modification spécifique et acquise de la réponse immunologique à un agent allergisant ;
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b) Vaccin, toxine ou sérum, définis comme tous agents utilisés en vue de provoquer une immunité active ou passive ou en vue de diagnostiquer l'état d'immunité ;
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7° Médicament radiopharmaceutique, tout médicament qui, lorsqu'il est prêt à l'emploi, contient un ou plusieurs isotopes radioactifs, dénommés radionucléides, incorporés à des fins médicales ;
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8° Générateur, tout système contenant un radionucléide parent déterminé servant à la production d'un radionucléide de filiation obtenu par élution ou par toute autre méthode et utilisé dans un médicament radiopharmaceutique ;
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9° Trousse, toute préparation qui doit être reconstituée ou combinée avec des radionucléides dans le produit radiopharmaceutique final ;
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10° Précurseur, tout autre radionucléide produit pour le marquage radioactif d'une autre substance avant administration ;
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11° Médicament homéopathique, tout médicament obtenu à partir de substances appelées souches homéopathiques, selon un procédé de fabrication homéopathique décrit par la pharmacopée européenne, la pharmacopée française ou, à défaut, par les pharmacopées utilisées de façon officielle dans un autre Etat membre de la Communauté européenne. Un médicament homéopathique peut aussi contenir plusieurs principes ;
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12° Préparation de thérapie génique, tout médicament autre que les spécialités pharmaceutiques et les médicaments fabriqués industriellement mentionnés à l'article L. 5121-8, servant à transférer du matériel génétique et ne consistant pas en des cellules d'origine humaine ou animale. Ces préparations sont préparées à l'avance et dispensées sur prescription médicale à un ou plusieurs patients. Elles font l'objet d'une autorisation de l'Agence française de sécurité sanitaire des produits de santé pour une indication thérapeutique donnée. Cette autorisation peut être assortie de conditions particulières ou de restrictions d'utilisation. Elle peut être modifiée, suspendue ou retirée ;
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13° Préparation de thérapie cellulaire xénogénique, tout médicament autre que les spécialités pharmaceutiques et les médicaments fabriqués industriellement mentionnés à l'article L. 5121-8, consistant en des cellules d'origine animale et leurs dérivés utilisés à des fins thérapeutiques, y compris les cellules servant à transférer du matériel génétique, quel que soit leur niveau de transformation. Ces préparations sont préparées à l'avance et dispensées sur prescription médicale à un ou plusieurs patients. Elles font l'objet d'une autorisation de l'Agence française de sécurité sanitaire des produits de santé pour une indication thérapeutique donnée. Cette autorisation peut être assortie de conditions particulières ou de restrictions d'utilisation. Elle peut être modifiée, suspendue ou retirée. L'Agence de la biomédecine est informée des décisions relatives à ces préparations prises en application du présent alinéa ;
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14° Médicament biologique, tout médicament dont la substance active est produite à partir d'une source biologique ou en est extraite et dont la caractérisation et la détermination de la qualité nécessitent une combinaison d'essais physiques, chimiques et biologiques ainsi que la connaissance de son procédé de fabrication et de son contrôle ;
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15° Sans préjudice des articles L. 611-2 et suivants du code de la propriété intellectuelle, médicament biologique similaire, tout médicament biologique de même composition qualitative et quantitative en substance active et de même forme pharmaceutique qu'un médicament biologique de référence mais qui ne remplit pas les conditions prévues au a du 5° du présent article pour être regardé comme une spécialité générique en raison de différences liées notamment à la variabilité de la matière première ou aux procédés de fabrication et nécessitant que soient produites des données précliniques et cliniques supplémentaires dans des conditions déterminées par voie réglementaire ;
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16° Médicament à base de plantes, tout médicament dont les substances actives sont exclusivement une ou plusieurs substances végétales ou préparations à base de plantes ou une association de plusieurs substances végétales ou préparations à base de plantes.
" } }, "LEGIARTI000006799374": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5049", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1987-09-24", "DATE_DEBUT": "1956-11-28" } }, "META_COMMUN": { "ID": "LEGIARTI000006799374", "URL": "article/LEGI/ARTI/00/00/06/79/93/LEGIARTI000006799374.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5049R0000XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (Décret de codification)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "JORFTEXT000000861564", "#text": "Décret 76-807 1976-08-24 art. 1 JORF 26 août 1976", "@sens": "source", "@cidtexte": "JORFTEXT000000861564", "@numtexte": "76-807", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1976-08-24" }, { "@id": "LEGIARTI000006799364", "@num": "R5047", "#text": "Code de la santé publique - art. R5047 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915001", "@num": "R5122-18", "#text": "Code de la santé publique - art. R5122-18 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (Loi de validation)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174502", "@fin": "1987-09-24", "#text": "Section 2 : Dispositions concernant la publicité pour les médicaments.", "@debut": "1956-11-28" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157745", "@fin": "2004-08-08", "#text": "Chapitre 4 : Réglementation de la publicité", "@debut": "1956-11-28" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142895", "@fin": "2004-08-08", "#text": "Titre 1 : Dispositions générales", "@debut": "1956-11-28" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128471", "@fin": "2999-01-01", "#text": "Livre 5 : Pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@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": "LEGIARTI000006799374", "@fin": "1987-09-24", "@num": "R5049", "@etat": "MODIFIE", "@debut": "1956-11-28", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006799375", "@fin": "1993-08-07", "@num": "R5049", "@etat": "MODIFIE", "@debut": "1987-09-24", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006799376", "@fin": "1994-01-09", "@num": "R5049", "@etat": "MODIFIE", "@debut": "1993-08-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006799377", "@fin": "1996-06-16", "@num": "R5049", "@etat": "MODIFIE", "@debut": "1994-01-09", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006799378", "@fin": "2004-08-08", "@num": "R5049", "@etat": "ABROGE", "@debut": "1996-06-16", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le support publicitaire ne peut, en aucun cas, être constitué par un article de valeur commerciale destiné à être remis comme prime ou cadeau.
\n
" } }, "LEGIARTI000006799375": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5049", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1993-08-07", "DATE_DEBUT": "1987-09-24" } }, "META_COMMUN": { "ID": "LEGIARTI000006799375", "URL": "article/LEGI/ARTI/00/00/06/79/93/LEGIARTI000006799375.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5049R0000XXAB" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (Décret de codification)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006701540", "@num": "2", "#text": "Décret n°87-772 du 23 septembre 1987 - art. 2 () JORF 24 septembre 1987", "@sens": "source", "@cidtexte": "JORFTEXT000000867629", "@nortexte": "ASEN8700908D", "@numtexte": "87-772", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1987-09-23" }, { "@id": "LEGIARTI000006799364", "@num": "R5047", "#text": "Code de la santé publique - art. R5047 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915001", "@num": "R5122-18", "#text": "Code de la santé publique - art. R5122-18 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800123", "@num": "R5128-1", "#text": "Code de la santé publique - art. R5128-1 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800264", "@num": "R5143", "#text": "Code de la santé publique - art. R5143 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (Loi de validation)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174503", "@fin": "1996-06-16", "#text": "Section 2 : Dispositions concernant la publicité ou la propagande auprès du public relative aux médicaments, produits et objets mentionnés à l'article L. 551.", "@debut": "1987-09-24" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157745", "@fin": "2004-08-08", "#text": "Chapitre 4 : Réglementation de la publicité", "@debut": "1956-11-28" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142895", "@fin": "2004-08-08", "#text": "Titre 1 : Dispositions générales", "@debut": "1956-11-28" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128471", "@fin": "2999-01-01", "#text": "Livre 5 : Pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@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": "LEGIARTI000006799374", "@fin": "1987-09-24", "@num": "R5049", "@etat": "MODIFIE", "@debut": "1956-11-28", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006799375", "@fin": "1993-08-07", "@num": "R5049", "@etat": "MODIFIE", "@debut": "1987-09-24", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006799376", "@fin": "1994-01-09", "@num": "R5049", "@etat": "MODIFIE", "@debut": "1993-08-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006799377", "@fin": "1996-06-16", "@num": "R5049", "@etat": "MODIFIE", "@debut": "1994-01-09", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006799378", "@fin": "2004-08-08", "@num": "R5049", "@etat": "ABROGE", "@debut": "1996-06-16", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Sont dispensés du visa de publicité, lorsqu'ils figurent sur les conditionnements, récipients, prospectus ou notices des spécialités pharmaceutiques :
\n
a) Les renseignements et indications prévus aux articles R. 5128-1 et R. 5143 (1° et 2°) ;
\n
b) L'indication de la situation de la spécialité au regard des législations sociales ;
\n
c) L'indication du prix limite de vente au public lorsqu'un tel prix est fixé en application des lois et règlements en vigueur.
\n
Les mentions qui figurent sur les conditionnements, récipients, prospectus et notices et qui sont dispensées de visa de publicité doivent faire l'objet d'un dépôt auprès du ministre chargé de la santé. Toute modification apportée à ces mentions doit suivre la même procédure.
" } }, "LEGIARTI000006799376": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5049", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1994-01-09", "DATE_DEBUT": "1993-08-07" } }, "META_COMMUN": { "ID": "LEGIARTI000006799376", "URL": "article/LEGI/ARTI/00/00/06/79/93/LEGIARTI000006799376.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5049R0000XXAC" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (Décret de codification)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006713441", "@num": "3", "#text": "Décret n°93-982 du 5 août 1993 - art. 3 () JORF 7 août 1993", "@sens": "source", "@cidtexte": "JORFTEXT000000727412", "@nortexte": "SPSP9302069D", "@numtexte": "93-982", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1993-08-05" }, { "@id": "LEGIARTI000006799364", "@num": "R5047", "#text": "Code de la santé publique - art. R5047 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915001", "@num": "R5122-18", "#text": "Code de la santé publique - art. R5122-18 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800123", "@num": "R5128-1", "#text": "Code de la santé publique - art. R5128-1 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800264", "@num": "R5143", "#text": "Code de la santé publique - art. R5143 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (Loi de validation)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174503", "@fin": "1996-06-16", "#text": "Section 2 : Dispositions concernant la publicité ou la propagande auprès du public relative aux médicaments, produits et objets mentionnés à l'article L. 551.", "@debut": "1987-09-24" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157745", "@fin": "2004-08-08", "#text": "Chapitre 4 : Réglementation de la publicité", "@debut": "1956-11-28" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142895", "@fin": "2004-08-08", "#text": "Titre 1 : Dispositions générales", "@debut": "1956-11-28" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128471", "@fin": "2999-01-01", "#text": "Livre 5 : Pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@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": "LEGIARTI000006799374", "@fin": "1987-09-24", "@num": "R5049", "@etat": "MODIFIE", "@debut": "1956-11-28", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006799375", "@fin": "1993-08-07", "@num": "R5049", "@etat": "MODIFIE", "@debut": "1987-09-24", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006799376", "@fin": "1994-01-09", "@num": "R5049", "@etat": "MODIFIE", "@debut": "1993-08-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006799377", "@fin": "1996-06-16", "@num": "R5049", "@etat": "MODIFIE", "@debut": "1994-01-09", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006799378", "@fin": "2004-08-08", "@num": "R5049", "@etat": "ABROGE", "@debut": "1996-06-16", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Sont dispensés du visa de publicité, lorsqu'ils figurent sur les conditionnements, récipients, prospectus ou notices des spécialités pharmaceutiques :
\n
a) Les renseignements et indications prévus aux articles R. 5128-1 et R. 5143 (1° et 2°) ;
\n
b) L'indication de la situation de la spécialité au regard des législations sociales ;
\n
c) L'indication du prix limite de vente au public lorsqu'un tel prix est fixé en application des lois et règlements en vigueur.
\n
Les mentions qui figurent sur les conditionnements, récipients, prospectus et notices et qui sont dispensées de visa de publicité doivent faire l'objet d'un dépôt auprès de l'Agence du médicament. Toute modification apportée à ces mentions doit suivre la même procédure.
" } }, "LEGIARTI000006799377": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5049", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1996-06-16", "DATE_DEBUT": "1994-01-09" } }, "META_COMMUN": { "ID": "LEGIARTI000006799377", "URL": "article/LEGI/ARTI/00/00/06/79/93/LEGIARTI000006799377.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5049R0000XXAD" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (Décret de codification)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006698596", "@num": "2", "#text": "Décret n°94-19 du 5 janvier 1994 - art. 2 () JORF 9 janvier 1994", "@sens": "source", "@cidtexte": "JORFTEXT000000180444", "@nortexte": "SPSM9303267D", "@numtexte": "94-19", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1994-01-05" }, { "@id": "LEGIARTI000006799364", "@num": "R5047", "#text": "Code de la santé publique - art. R5047 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915001", "@num": "R5122-18", "#text": "Code de la santé publique - art. R5122-18 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800123", "@num": "R5128-1", "#text": "Code de la santé publique - art. R5128-1 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800264", "@num": "R5143", "#text": "Code de la santé publique - art. R5143 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (Loi de validation)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174503", "@fin": "1996-06-16", "#text": "Section 2 : Dispositions concernant la publicité ou la propagande auprès du public relative aux médicaments, produits et objets mentionnés à l'article L. 551.", "@debut": "1987-09-24" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157745", "@fin": "2004-08-08", "#text": "Chapitre 4 : Réglementation de la publicité", "@debut": "1956-11-28" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142895", "@fin": "2004-08-08", "#text": "Titre 1 : Dispositions générales", "@debut": "1956-11-28" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128471", "@fin": "2999-01-01", "#text": "Livre 5 : Pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@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": "LEGIARTI000006799374", "@fin": "1987-09-24", "@num": "R5049", "@etat": "MODIFIE", "@debut": "1956-11-28", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006799375", "@fin": "1993-08-07", "@num": "R5049", "@etat": "MODIFIE", "@debut": "1987-09-24", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006799376", "@fin": "1994-01-09", "@num": "R5049", "@etat": "MODIFIE", "@debut": "1993-08-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006799377", "@fin": "1996-06-16", "@num": "R5049", "@etat": "MODIFIE", "@debut": "1994-01-09", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006799378", "@fin": "2004-08-08", "@num": "R5049", "@etat": "ABROGE", "@debut": "1996-06-16", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Sont dispensés du visa de publicité, lorsqu'ils figurent sur les conditionnements, récipients, prospectus ou notices des spécialités pharmaceutiques :
\n
a) Les renseignements et indications prévus aux articles R. 5128-1 et R. 5143 (1° et 2°) ;
\n
b) L'indication de la situation de la spécialité au regard des législations sociales ;
\n
c) L'indication du prix limite de vente au public lorsqu'un tel prix est fixé en application des lois et règlements en vigueur.
" } }, "LEGIARTI000006799378": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5049", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "1996-06-16" } }, "META_COMMUN": { "ID": "LEGIARTI000006799378", "URL": "article/LEGI/ARTI/00/00/06/79/93/LEGIARTI000006799378.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5049R0000XXAE" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (Décret de codification)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006700460", "@num": "1", "#text": "Décret n°96-531 du 14 juin 1996 - art. 1 () JORF 16 juin 1996", "@sens": "source", "@cidtexte": "JORFTEXT000000376974", "@nortexte": "TASP9620968D", "@numtexte": "96-531", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1996-06-14" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006693413", "@num": "L511-1", "#text": "Code de la santé publique - art. L511-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799364", "@num": "R5047", "#text": "Code de la santé publique - art. R5047 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799369", "@num": "R5048", "#text": "Code de la santé publique - art. R5048 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915001", "@num": "R5122-18", "#text": "Code de la santé publique - art. R5122-18 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915001", "@num": "R5122-18", "#text": "Code de la santé publique - art. R5122-18 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (Loi de validation)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187451", "@fin": "2004-08-08", "#text": "Sous-section 1 : Générateurs, trousses et précurseurs.", "@debut": "1996-06-16" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174504", "@fin": "2004-08-08", "#text": "Section 2 : Publicité pour certains produits et objets", "@debut": "1996-06-16" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157745", "@fin": "2004-08-08", "#text": "Chapitre 4 : Réglementation de la publicité", "@debut": "1956-11-28" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142895", "@fin": "2004-08-08", "#text": "Titre 1 : Dispositions générales", "@debut": "1956-11-28" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128471", "@fin": "2999-01-01", "#text": "Livre 5 : Pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@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": "LEGIARTI000006799374", "@fin": "1987-09-24", "@num": "R5049", "@etat": "MODIFIE", "@debut": "1956-11-28", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006799375", "@fin": "1993-08-07", "@num": "R5049", "@etat": "MODIFIE", "@debut": "1987-09-24", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006799376", "@fin": "1994-01-09", "@num": "R5049", "@etat": "MODIFIE", "@debut": "1993-08-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006799377", "@fin": "1996-06-16", "@num": "R5049", "@etat": "MODIFIE", "@debut": "1994-01-09", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006799378", "@fin": "2004-08-08", "@num": "R5049", "@etat": "ABROGE", "@debut": "1996-06-16", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les dispositions de la section 1 du présent chapitre, à l'exception de l'article R. 5048, sont applicables à la publicité pour les générateurs, trousses et précurseurs définis aux 8°, 9° et 10° de l'article L. 511-1.
\n
" } }, "LEGIARTI000006915000": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5122-17", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-05-01", "DATE_DEBUT": "2004-08-08" } }, "META_COMMUN": { "ID": "LEGIARTI000006915000", "URL": "article/LEGI/ARTI/00/00/06/91/50/LEGIARTI000006915000.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "YXXXXXXXXXX5122R0170XX0A" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000042234982", "@num": "1", "#text": "Arrêté du 7 août 2020 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042234007", "@nortexte": "ECOC2019446A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-08-07" }, { "@id": "LEGIARTI000006689945", "@num": "L5122-10", "#text": "Code de la santé publique - art. L5122-10 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799373", "@num": "R5048", "#text": "Code de la santé publique - art. R5048 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799369", "@num": "R5048", "#text": "Code de la santé publique - art. R5048 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914744", "@num": "R5121-21", "#text": "Code de la santé publique - art. R5121-21 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915001", "@num": "R5122-18", "#text": "Code de la santé publique - art. R5122-18 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006190677", "@fin": "2999-01-01", "#text": "Section 3 : Publicité à destination des professions de santé", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178650", "@fin": "2999-01-01", "#text": "Chapitre II : Publicité", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161012", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006915000", "@fin": "2012-05-01", "@num": "R5122-17", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025787777", "@fin": "2012-05-11", "@num": "R5122-17", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000025853198", "@fin": "2999-01-01", "@num": "R5122-17", "@etat": "VIGUEUR", "@debut": "2012-05-11", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les échantillons gratuits de médicaments mentionnés à l'article L. 5122-10 ne peuvent être remis que dans les conditions suivantes :
\n
1° Chaque fourniture d'échantillons répond à une demande écrite, datée et signée, émanant du destinataire ;
\n
2° Pour chaque médicament, il ne peut être remis qu'un nombre restreint d'échantillons, dans la limite de dix par an et par destinataire, déterminé en fonction de la nature du médicament et de la nécessité pour le prescripteur de se familiariser avec celui-ci ; chaque échantillon est identique au plus petit conditionnement commercialisé ;
\n
3° Lorsqu'un médicament est soumis aux conditions de prescription restreinte prévues à la section 8 du chapitre Ier du présent titre, les échantillons ne peuvent être remis qu'aux pharmaciens gérants des pharmacies à usage intérieur des établissements de santé et aux prescripteurs habilités à établir la prescription ;
\n
4° Chaque établissement pharmaceutique remettant des échantillons organise en son sein le contrôle de cette remise et le suivi des échantillons ;
\n
5° Chaque échantillon est accompagné d'une copie du résumé des caractéristiques du produit, mentionné à l'article R. 5121-21.
\n
Le directeur général de l'Agence française de sécurité sanitaire des produits de santé peut restreindre, en raison d'un risque possible pour la santé publique, la distribution d'échantillons de certains médicaments.
" } }, "LEGIARTI000018652237": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5121-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2008-12-19", "DATE_DEBUT": "2008-04-17" } }, "META_COMMUN": { "ID": "LEGIARTI000018652237", "URL": "article/LEGI/ARTI/00/00/18/65/22/LEGIARTI000018652237.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000049923273", "@num": "2", "#text": "Arrêté du 4 août 1987 - art. 2 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000000843609", "@nortexte": "ECOX8798330A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1987-08-04" }, { "@id": "LEGIARTI000023731730", "@num": "3", "#text": "Arrêté du 4 août 1987 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000843609", "@nortexte": "ECOX8798330A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1987-08-04" }, { "@id": "LEGIARTI000034405848", "@num": "69", "#text": "Décret n°90-1215 du 20 décembre 1990 - art. 69 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000717193", "@nortexte": "SPSS9001980D", "@numtexte": "90-1215", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1990-12-20" }, { "@id": "LEGIARTI000006699999", "@num": "1", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700029", "@num": "10", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 10 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700040", "@num": "14", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 14 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700043", "@num": "15", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 15 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700045", "@num": "16", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 16 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700047", "@num": "17", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 17 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700002", "@num": "2", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700054", "@num": "20", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 20 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700005", "@num": "3", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700008", "@num": "4", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006865783", "@num": "Annexe", "#text": "Décret n°96-850 du 20 septembre 1996 - art. 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On entend par :

1° Préparation magistrale, tout médicament préparé selon une prescription médicale destinée à un malade déterminé, soit extemporanément en pharmacie, soit dans les conditions prévues à l'article L. 5125-1 ;

3° Préparation officinale, tout médicament préparé en pharmacie, inscrit à la pharmacopée ou au formulaire national et destiné à être dispensé directement aux patients approvisionnés par cette pharmacie ;

4° Produit officinal divisé, toute drogue simple, tout produit chimique ou toute préparation stable décrite par la pharmacopée, préparés à l'avance par un établissement pharmaceutique et divisés soit par lui, soit par la pharmacie d'officine qui le met en vente, soit par une pharmacie à usage intérieur, telle que définie au chapitre VI du présent titre ;

5° a) Sans préjudice des articles L. 611-2 et suivants du code de la propriété intellectuelle, spécialité générique d'une spécialité de référence, celle qui a la même composition qualitative et quantitative en principes actifs, la même forme pharmaceutique et dont la bioéquivalence avec la spécialité de référence est démontrée par des études de biodisponibilité appropriées. Une spécialité ne peut être qualifiée de spécialité de référence que si son autorisation de mise sur le marché a été délivrée au vu d'un dossier comportant, dans des conditions fixées par voie réglementaire, l'ensemble des données nécessaires et suffisantes à elles seules pour son évaluation. Pour l'application du présent alinéa, les différentes formes pharmaceutiques orales à libération immédiate sont considérées comme une même forme pharmaceutique. De même, les différents sels, esters, éthers, isomères, mélanges d'isomères, complexes ou dérivés d'un principe actif sont regardés comme ayant la même composition qualitative en principe actif, sauf s'ils présentent des propriétés sensiblement différentes au regard de la sécurité ou de l'efficacité. Dans ce cas, des informations supplémentaires fournissant la preuve de la sécurité et de l'efficacité des différents sels, esters ou dérivés d'une substance active autorisée doivent être données par le demandeur de l'autorisation de mise sur le marché ;

6° Médicament immunologique, tout médicament consistant en :

a) Allergène, défini comme tout produit destiné à identifier ou provoquer une modification spécifique et acquise de la réponse immunologique à un agent allergisant ;

b) Vaccin, toxine ou sérum, définis comme tous agents utilisés en vue de provoquer une immunité active ou passive ou en vue de diagnostiquer l'état d'immunité ;

7° Médicament radiopharmaceutique, tout médicament qui, lorsqu'il est prêt à l'emploi, contient un ou plusieurs isotopes radioactifs, dénommés radionucléides, incorporés à des fins médicales ;

8° Générateur, tout système contenant un radionucléide parent déterminé servant à la production d'un radionucléide de filiation obtenu par élution ou par toute autre méthode et utilisé dans un médicament radiopharmaceutique ;

9° Trousse, toute préparation qui doit être reconstituée ou combinée avec des radionucléides dans le produit radiopharmaceutique final ;

10° Précurseur, tout autre radionucléide produit pour le marquage radioactif d'une autre substance avant administration ;

11° Médicament homéopathique, tout médicament obtenu à partir de substances appelées souches homéopathiques, selon un procédé de fabrication homéopathique décrit par la pharmacopée européenne, la pharmacopée française ou, à défaut, par les pharmacopées utilisées de façon officielle dans un autre Etat membre de la Communauté européenne. Un médicament homéopathique peut aussi contenir plusieurs principes ;

12° Préparation de thérapie génique, tout médicament autre que les spécialités pharmaceutiques et les médicaments fabriqués industriellement mentionnés à l'article L. 5121-8, servant à transférer du matériel génétique et ne consistant pas en des cellules d'origine humaine ou animale. Ces préparations sont préparées à l'avance et dispensées sur prescription médicale à un ou plusieurs patients. Elles font l'objet d'une autorisation de l'Agence française de sécurité sanitaire des produits de santé pour une indication thérapeutique donnée. Cette autorisation peut être assortie de conditions particulières ou de restrictions d'utilisation. Elle peut être modifiée, suspendue ou retirée ;

13° Préparation de thérapie cellulaire xénogénique, tout médicament autre que les spécialités pharmaceutiques et les médicaments fabriqués industriellement mentionnés à l'article L. 5121-8, consistant en des cellules d'origine animale et leurs dérivés utilisés à des fins thérapeutiques, y compris les cellules servant à transférer du matériel génétique, quel que soit leur niveau de transformation. Ces préparations sont préparées à l'avance et dispensées sur prescription médicale à un ou plusieurs patients. Elles font l'objet d'une autorisation de l'Agence française de sécurité sanitaire des produits de santé pour une indication thérapeutique donnée. Cette autorisation peut être assortie de conditions particulières ou de restrictions d'utilisation. Elle peut être modifiée, suspendue ou retirée. L'Agence de la biomédecine est informée des décisions relatives à ces préparations prises en application du présent alinéa ;

14° Médicament biologique, tout médicament dont la substance active est produite à partir d'une source biologique ou en est extraite et dont la caractérisation et la détermination de la qualité nécessitent une combinaison d'essais physiques, chimiques et biologiques ainsi que la connaissance de son procédé de fabrication et de son contrôle ;

15° Sans préjudice des articles L. 611-2 et suivants du code de la propriété intellectuelle, médicament biologique similaire, tout médicament biologique de même composition qualitative et quantitative en substance active et de même forme pharmaceutique qu'un médicament biologique de référence mais qui ne remplit pas les conditions prévues au a du 5° du présent article pour être regardé comme une spécialité générique en raison de différences liées notamment à la variabilité de la matière première ou aux procédés de fabrication et nécessitant que soient produites des données précliniques et cliniques supplémentaires dans des conditions déterminées par voie réglementaire ;

16° Médicament à base de plantes, tout médicament dont les substances actives sont exclusivement une ou plusieurs substances végétales ou préparations à base de plantes ou une association de plusieurs substances végétales ou préparations à base de plantes.

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Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000195660", "@nortexte": "ENVP9640024D", "@numtexte": "96-850", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1996-09-20" }, { "@id": "LEGIARTI000006725129", "@num": "71", "#text": "Décret n°2001-1065 du 15 novembre 2001 - art. 71 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000403855", "@nortexte": "INTM0100035D", "@numtexte": "2001-1065", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2001-11-15" }, { "@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": "LEGIARTI000006697606", "@num": "35", "#text": "Loi n°2004-800 du 6 août 2004 - art. 35 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000441469", "@nortexte": "SANX0100053L", "@numtexte": "2004-800", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-06" }, { "@id": "LEGIARTI000047109474", "@num": "14", "#text": "Décret n°2004-942 du 3 septembre 2004 - art. 14 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000000253592", "@nortexte": "SANS0422327D", "@numtexte": "2004-942", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-09-03" }, { "@id": "LEGIARTI000032182077", "@num": "41", "#text": "Loi n°2005-1579 du 19 décembre 2005 - art. 41 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000815414", "@nortexte": "SANX0500246L", "@numtexte": "2005-1579", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2005-12-19" }, { "@id": "LEGIARTI000020140266", "@num": "8", "#text": "Arrêté du 24 mai 2006 - art. 8 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000457818", "@nortexte": "SANP0622223A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-05-24" }, { "@id": "LEGIARTI000043762395", "@num": "21", "#text": "Décret n° 2007-359 du 19 mars 2007 - art. 21 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000645145", "@nortexte": "AGRG0700643D", "@numtexte": "2007-359", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-19" }, { "@id": "LEGIARTI000019945438", "@num": "49", "#text": "LOI n°2008-1330\n du 17 décembre 2008 - art. 49", "@sens": "cible", "@cidtexte": "JORFTEXT000019942966", "@nortexte": "BCFX0823210L", "@numtexte": "2008-1330", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2008-12-17" }, { "@id": "LEGIARTI000022933811", "@num": "3", "#text": "Arrêté du 29 septembre 2010 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000022932466", "@nortexte": "SASP1025728A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-09-29" }, { "@id": "LEGIARTI000023501118", "@num": "4", "#text": "Arrêté du 21 janvier 2011 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023491451", "@nortexte": "ETSP1101997A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-01-21" }, { "@id": "LEGIARTI000023824330", "@num": "1", "#text": "Arrêté du 29 mars 2011 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023823216", "@nortexte": "ETSP1108796A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-03-29" }, { "@id": "LEGIARTI000046423270", "@num": "13", "#text": "Arrêté du 6 avril 2011 - art. 13 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023865866", "@nortexte": "ETSH1109848A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-04-06" }, { "@id": "LEGITEXT000024154142", "#text": "Décret n°2011-655\n du 10 juin 2011 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000024153599", "@nortexte": "ETSP1024824D", "@numtexte": "2011-655", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-06-10" }, { "@id": "LEGIARTI000026041157", "@num": "2", "#text": "Arrêté du 8 juin 2012 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000026040448", "@nortexte": "AFSP1225501A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-06-08" }, { "@id": "LEGITEXT000026558683", "#text": "Décret n°2012-1201\n du 29 octobre 2012 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000026557838", "@nortexte": "AFSP1232892D", "@numtexte": "2012-1201", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2012-10-29" }, { "@id": "LEGIARTI000026589554", "@num": "2", "#text": "Décret n°2012-1236\n du 6 novembre 2012 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000026588856", "@nortexte": "AFSP1226229D", "@numtexte": "2012-1236", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2012-11-06" }, { "@id": "LEGIARTI000035971424", "#text": "DÉCRET n°2014-1287 du 23 octobre 2014 - art. (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000029676018", "@nortexte": "AFSX1419039D", "@numtexte": "2014-1287", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000042293117", "#text": "DÉCRET n°2014-1288 du 23 octobre 2014 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029676038", "@nortexte": "AFSX1419044D", "@numtexte": "2014-1288", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000030189762", "@num": "8", "#text": "ARRÊTÉ du 28 novembre 2014 - art. 8 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000030189026", "@nortexte": "EINC1415451A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2014-11-28" }, { "@id": "LEGIARTI000030189876", "@num": "1", "#text": "ARRÊTÉ du 3 février 2015 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000030188934", "@nortexte": "AFSP1503244A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2015-02-03" }, { "@id": "LEGIARTI000032291698", "@num": "1", "#text": "Décret n°2016-349 du 24 mars 2016 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000032291186", "@nortexte": "AFSH1532721D", "@numtexte": "2016-349", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2016-03-24" }, { "@id": "LEGIARTI000032730970", "@num": "3", "#text": "Décret n°2016-817 du 20 juin 2016 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000032729458", "@nortexte": "AFSS1610671D", "@numtexte": "2016-817", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2016-06-20" }, { "@id": "LEGIARTI000034392999", "@num": "1", "#text": "Décret n°2017-500 du 6 avril 2017 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000034390458", "@nortexte": "AFSH1702718D", "@numtexte": "2017-500", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-04-06" }, { "@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": "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": "LEGIARTI000044941358", "@num": "6", "#text": "Décret n°2021-1905 du 30 décembre 2021 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000044638030", "@nortexte": "TREP2130559D", "@numtexte": "2021-1905", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-12-30" }, { "@id": "LEGIARTI000045632789", "@num": "1", "#text": "Décret n°2022-597 du 21 avril 2022 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000045632039", "@nortexte": "SSAH2205181D", "@numtexte": "2022-597", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2022-04-21" }, { "@id": "LEGITEXT000049536357", "#text": "Décret n°2024-435 du 14 mai 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049535648", "@nortexte": "TSSS2408227D", "@numtexte": "2024-435", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-05-14" }, { "@id": "LEGITEXT000049850758", "#text": "Décret n°2024-626 du 27 juin 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049832038", "@nortexte": "TSSP2408968D", "@numtexte": "2024-626", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-06-27" }, { "@id": "LEGITEXT000049922585", "#text": "Arrêté du 5 juillet 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049892254", "@nortexte": "TSSS2418508A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-07-05" }, { "@id": "LEGITEXT000050737433", "#text": "Décret n°2024-1135 du 4 décembre 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000050731183", "@nortexte": "MSAH2429400D", "@numtexte": "2024-1135", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-12-04" }, { "@id": "LEGIARTI000006279394", "@num": "L611-2", "#text": "Code de la propriété intellectuelle - art. 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On entend par :

b) Groupe générique, le regroupement d'une spécialité de référence et des spécialités qui en sont génériques. Toutefois, une spécialité remplissant les conditions pour être une spécialité de référence, qui présente la même composition qualitative en substance active, la même composition quantitative en substance active ou, à défaut, une fraction thérapeutique active identique dans les limites prévues à l'annexe I de la directive 2001/83/CE du Parlement européen et du Conseil du 6 novembre 2001 instituant un code communautaire relatif aux médicaments à usage humain, et la même forme pharmaceutique qu'une spécialité de référence d'un groupe générique déjà existant, et dont la bioéquivalence avec cette spécialité est démontrée par des études de biodisponibilité appropriées, peut aussi figurer dans ce groupe générique, à condition que ces deux spécialités soient considérées comme relevant d'une même autorisation de mise sur le marché globale, définie par voie réglementaire et qu'elles ne présentent pas de propriétés sensiblement différentes au regard de la sécurité ou de l'efficacité. En l'absence de spécialité de référence, un groupe générique peut être constitué de spécialités ayant la même composition qualitative et quantitative en principes actifs, la même forme pharmaceutique et dont les caractéristiques en termes de sécurité et d'efficacité sont équivalentes. Pour l'application du présent b, sont inscrites au répertoire des groupes génériques les spécialités qui se présentent sous une forme pharmaceutique orale à libération modifiée différente de celle de la spécialité de référence, à condition que ces spécialités et la spécialité de référence appartiennent à la même catégorie de forme pharmaceutique à libération modifiée et qu'elles ne présentent pas de propriétés sensiblement différentes au regard de la sécurité ou de l'efficacité ;

6° Médicament immunologique, tout médicament consistant en :

a) Allergène, défini comme tout produit destiné à identifier ou provoquer une modification spécifique et acquise de la réponse immunologique à un agent allergisant ;

b) Vaccin, toxine ou sérum, définis comme tous agents utilisés en vue de provoquer une immunité active ou passive ou en vue de diagnostiquer l'état d'immunité ;

9° Trousse, toute préparation qui doit être reconstituée ou combinée avec des radionucléides dans le produit radiopharmaceutique final ;

10° Précurseur, tout autre radionucléide produit pour le marquage radioactif d'une autre substance avant administration ;

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"@debut": "2009-07-23", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000021941991", "@fin": "2011-12-23", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2010-02-26", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025014196", "@fin": "2011-12-31", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2011-12-23", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025122674", "@fin": "2012-05-01", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2011-12-31", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026499732", "@fin": "2012-05-08", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000029719721", "@fin": "2013-12-25", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2012-05-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000028394169", "@fin": "2014-12-25", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2013-12-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000029962685", "@fin": "2016-01-28", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2014-12-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000031930491", "@fin": "2016-07-17", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2016-01-28", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000032906295", "@fin": "2017-07-01", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2016-07-17", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000033621108", "@fin": "2019-01-01", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2017-07-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000037950971", "@fin": "2021-07-01", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2019-01-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000042685768", "@fin": "2021-08-04", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2021-07-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000043896320", "@fin": "2021-12-25", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2021-08-04", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000044628485", "@fin": "2023-12-28", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2021-12-25", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000048701765", "@fin": "2999-01-01", "@num": "L5121-1", "@etat": "VIGUEUR", "@debut": "2023-12-28", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

On entend par :

2° Préparation hospitalière, tout médicament, à l'exception des produits de thérapies génique ou cellulaire, préparé selon les indications de la pharmacopée et en conformité avec les bonnes pratiques mentionnées à l'article L. 5121-5, en raison de l'absence de spécialité pharmaceutique disponible ou adaptée par une pharmacie à usage intérieur d'un établissement de santé, ou par l'établissement pharmaceutique de cet établissement de santé autorisé en application de l'article L. 5124-9 ou dans les conditions prévues à l'article L. 5126-2. Les préparations hospitalières sont dispensées sur prescription médicale à un ou plusieurs patients par une pharmacie à usage intérieur dudit établissement. Elles font l'objet d'une déclaration auprès de l'Agence française de sécurité sanitaire des produits de santé, dans des conditions définies par arrêté du ministre chargé de la santé ;

6° Médicament immunologique, tout médicament consistant en :

a) Allergène, défini comme tout produit destiné à identifier ou provoquer une modification spécifique et acquise de la réponse immunologique à un agent allergisant ;

b) Vaccin, toxine ou sérum, définis comme tous agents utilisés en vue de provoquer une immunité active ou passive ou en vue de diagnostiquer l'état d'immunité ;

9° Trousse, toute préparation qui doit être reconstituée ou combinée avec des radionucléides dans le produit radiopharmaceutique final ;

10° Précurseur, tout autre radionucléide produit pour le marquage radioactif d'une autre substance avant administration ;

" } }, "LEGIARTI000021941991": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5121-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2011-12-23", "DATE_DEBUT": "2010-02-26" } }, "META_COMMUN": { "ID": "LEGIARTI000021941991", "URL": "article/LEGI/ARTI/00/00/21/94/19/LEGIARTI000021941991.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000049923273", "@num": "2", "#text": "Arrêté du 4 août 1987 - art. 2 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000000843609", "@nortexte": "ECOX8798330A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1987-08-04" }, { "@id": "LEGIARTI000023731730", "@num": "3", "#text": "Arrêté du 4 août 1987 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000843609", "@nortexte": "ECOX8798330A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1987-08-04" }, { "@id": "LEGIARTI000034405848", "@num": "69", "#text": "Décret n°90-1215 du 20 décembre 1990 - art. 69 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000717193", "@nortexte": "SPSS9001980D", "@numtexte": "90-1215", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1990-12-20" }, { "@id": "LEGIARTI000006699999", "@num": "1", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700029", "@num": "10", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 10 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700040", "@num": "14", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 14 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700043", "@num": "15", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 15 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700045", "@num": "16", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 16 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700047", "@num": "17", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 17 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700002", "@num": "2", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700054", "@num": "20", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 20 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700005", "@num": "3", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700008", "@num": "4", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@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": "LEGIARTI000006725129", "@num": "71", "#text": "Décret n°2001-1065 du 15 novembre 2001 - art. 71 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000403855", "@nortexte": "INTM0100035D", "@numtexte": "2001-1065", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2001-11-15" }, { "@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": "LEGIARTI000006697606", "@num": "35", "#text": "Loi n°2004-800 du 6 août 2004 - art. 35 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000441469", "@nortexte": "SANX0100053L", "@numtexte": "2004-800", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-06" }, { "@id": "LEGIARTI000047109474", "@num": "14", "#text": "Décret n°2004-942 du 3 septembre 2004 - art. 14 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000000253592", "@nortexte": "SANS0422327D", "@numtexte": "2004-942", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-09-03" }, { "@id": "LEGIARTI000032182077", "@num": "41", "#text": "Loi n°2005-1579 du 19 décembre 2005 - art. 41 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000815414", "@nortexte": "SANX0500246L", "@numtexte": "2005-1579", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2005-12-19" }, { "@id": "LEGIARTI000020140266", "@num": "8", "#text": "Arrêté du 24 mai 2006 - art. 8 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000457818", "@nortexte": "SANP0622223A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-05-24" }, { "@id": "LEGIARTI000043762395", "@num": "21", "#text": "Décret n° 2007-359 du 19 mars 2007 - art. 21 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000645145", "@nortexte": "AGRG0700643D", "@numtexte": "2007-359", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-19" }, { "@id": "LEGIARTI000021869972", "@num": "26", "#text": "Ordonnance n°2010-177\n du 23 février 2010 - art. 26", "@sens": "cible", "@cidtexte": "JORFTEXT000021868310", "@nortexte": "SASX0930688R", "@numtexte": "2010-177", "@typelien": "MODIFIE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2010-02-23" }, { "@id": "LEGIARTI000022933811", "@num": "3", "#text": "Arrêté du 29 septembre 2010 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000022932466", "@nortexte": "SASP1025728A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-09-29" }, { "@id": "LEGIARTI000023501118", "@num": "4", "#text": "Arrêté du 21 janvier 2011 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023491451", "@nortexte": "ETSP1101997A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-01-21" }, { "@id": "LEGIARTI000023824330", "@num": "1", "#text": "Arrêté du 29 mars 2011 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023823216", "@nortexte": "ETSP1108796A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-03-29" }, { "@id": "LEGIARTI000046423270", "@num": "13", "#text": "Arrêté du 6 avril 2011 - art. 13 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023865866", "@nortexte": "ETSH1109848A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-04-06" }, { "@id": "LEGITEXT000024154142", "#text": "Décret n°2011-655\n du 10 juin 2011 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000024153599", "@nortexte": "ETSP1024824D", "@numtexte": "2011-655", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-06-10" }, { "@id": "LEGIARTI000026041157", "@num": "2", "#text": "Arrêté du 8 juin 2012 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000026040448", "@nortexte": "AFSP1225501A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-06-08" }, { "@id": "LEGITEXT000026558683", "#text": "Décret n°2012-1201\n du 29 octobre 2012 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000026557838", "@nortexte": "AFSP1232892D", "@numtexte": "2012-1201", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2012-10-29" }, { "@id": "LEGIARTI000026589554", "@num": "2", "#text": "Décret n°2012-1236\n du 6 novembre 2012 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000026588856", "@nortexte": "AFSP1226229D", "@numtexte": "2012-1236", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2012-11-06" }, { "@id": "LEGIARTI000035971424", "#text": "DÉCRET n°2014-1287 du 23 octobre 2014 - art. (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000029676018", "@nortexte": "AFSX1419039D", "@numtexte": "2014-1287", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000042293117", "#text": "DÉCRET n°2014-1288 du 23 octobre 2014 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029676038", "@nortexte": "AFSX1419044D", "@numtexte": "2014-1288", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000030189762", "@num": "8", "#text": "ARRÊTÉ du 28 novembre 2014 - art. 8 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000030189026", "@nortexte": "EINC1415451A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2014-11-28" }, { "@id": "LEGIARTI000030189876", "@num": "1", "#text": "ARRÊTÉ du 3 février 2015 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000030188934", "@nortexte": "AFSP1503244A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2015-02-03" }, { "@id": "LEGIARTI000032291698", "@num": "1", "#text": "Décret n°2016-349 du 24 mars 2016 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000032291186", "@nortexte": "AFSH1532721D", "@numtexte": "2016-349", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2016-03-24" }, { "@id": "LEGIARTI000032730970", "@num": "3", "#text": "Décret n°2016-817 du 20 juin 2016 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000032729458", "@nortexte": "AFSS1610671D", "@numtexte": "2016-817", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2016-06-20" }, { "@id": "LEGIARTI000034392999", "@num": "1", "#text": "Décret n°2017-500 du 6 avril 2017 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000034390458", "@nortexte": "AFSH1702718D", "@numtexte": "2017-500", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-04-06" }, { "@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": "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": "LEGIARTI000044941358", "@num": "6", "#text": "Décret n°2021-1905 du 30 décembre 2021 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000044638030", "@nortexte": "TREP2130559D", "@numtexte": "2021-1905", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-12-30" }, { "@id": "LEGIARTI000045632789", "@num": "1", "#text": "Décret n°2022-597 du 21 avril 2022 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000045632039", "@nortexte": "SSAH2205181D", "@numtexte": "2022-597", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2022-04-21" }, { "@id": "LEGITEXT000049536357", "#text": "Décret n°2024-435 du 14 mai 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049535648", "@nortexte": "TSSS2408227D", "@numtexte": "2024-435", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-05-14" }, { "@id": "LEGITEXT000049850758", "#text": "Décret n°2024-626 du 27 juin 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049832038", "@nortexte": "TSSP2408968D", "@numtexte": "2024-626", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-06-27" }, { "@id": "LEGITEXT000049922585", "#text": "Arrêté du 5 juillet 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049892254", "@nortexte": "TSSS2418508A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-07-05" }, { "@id": "LEGITEXT000050737433", "#text": "Décret n°2024-1135 du 4 décembre 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000050731183", "@nortexte": "MSAH2429400D", "@numtexte": "2024-1135", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-12-04" }, { "@id": "LEGIARTI000006279394", "@num": "L611-2", "#text": "Code de la propriété intellectuelle - art. 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On entend par :

b) Groupe générique, le regroupement d'une spécialité de référence et des spécialités qui en sont génériques. Toutefois, une spécialité remplissant les conditions pour être une spécialité de référence, qui présente la même composition qualitative en substance active, la même composition quantitative en substance active ou, à défaut, une fraction thérapeutique active identique dans les limites prévues à l'annexe I de la directive 2001 / 83 / CE du Parlement européen et du Conseil du 6 novembre 2001 instituant un code communautaire relatif aux médicaments à usage humain, et la même forme pharmaceutique qu'une spécialité de référence d'un groupe générique déjà existant, et dont la bioéquivalence avec cette spécialité est démontrée par des études de biodisponibilité appropriées, peut aussi figurer dans ce groupe générique, à condition que ces deux spécialités soient considérées comme relevant d'une même autorisation de mise sur le marché globale, définie par voie réglementaire et qu'elles ne présentent pas de propriétés sensiblement différentes au regard de la sécurité ou de l'efficacité. En l'absence de spécialité de référence, un groupe générique peut être constitué de spécialités ayant la même composition qualitative et quantitative en principes actifs, la même forme pharmaceutique et dont les caractéristiques en termes de sécurité et d'efficacité sont équivalentes. Pour l'application du présent b, sont inscrites au répertoire des groupes génériques les spécialités qui se présentent sous une forme pharmaceutique orale à libération modifiée différente de celle de la spécialité de référence, à condition que ces spécialités et la spécialité de référence appartiennent à la même catégorie de forme pharmaceutique à libération modifiée et qu'elles ne présentent pas de propriétés sensiblement différentes au regard de la sécurité ou de l'efficacité ;

6° Médicament immunologique, tout médicament consistant en :

a) Allergène, défini comme tout produit destiné à identifier ou provoquer une modification spécifique et acquise de la réponse immunologique à un agent allergisant ;

b) Vaccin, toxine ou sérum, définis comme tous agents utilisés en vue de provoquer une immunité active ou passive ou en vue de diagnostiquer l'état d'immunité ;

9° Trousse, toute préparation qui doit être reconstituée ou combinée avec des radionucléides dans le produit radiopharmaceutique final ;

10° Précurseur, tout autre radionucléide produit pour le marquage radioactif d'une autre substance avant administration ;

11° Médicament homéopathique, tout médicament obtenu à partir de substances appelées souches homéopathiques, selon un procédé de fabrication homéopathique décrit par la pharmacopée européenne, la pharmacopée française ou, à défaut, par les pharmacopées utilisées de façon officielle dans un autre Etat membre de l'Union européenne. Un médicament homéopathique peut aussi contenir plusieurs principes ;

13° Préparation de thérapie cellulaire xénogénique, tout médicament autre que les spécialités pharmaceutiques et les médicaments fabriqués industriellement mentionnés à l'article L. 5121-8, consistant en des cellules d'origine animale et leurs dérivés utilisés à des fins thérapeutiques, y compris les cellules servant à transférer du matériel génétique, quel que soit leur niveau de transformation. Ces préparations sont préparées à l'avance et dispensées sur prescription médicale à un ou plusieurs patients. Elles font l'objet d'une autorisation de l'Agence française de sécurité sanitaire des produits de santé pour une indication thérapeutique donnée. Cette autorisation peut être assortie de conditions particulières ou de restrictions d'utilisation. Elle peut être modifiée, suspendue ou retirée.L'Agence de la biomédecine est informée des décisions relatives à ces préparations prises en application du présent alinéa ;

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On entend par :

b) Groupe générique, le regroupement d'une spécialité de référence et des spécialités qui en sont génériques. Toutefois, une spécialité remplissant les conditions pour être une spécialité de référence, qui présente la même composition qualitative en substance active, la même composition quantitative en substance active ou, à défaut, une fraction thérapeutique active identique dans les limites prévues à l'annexe I de la directive 2001 / 83 / CE du Parlement européen et du Conseil du 6 novembre 2001 instituant un code communautaire relatif aux médicaments à usage humain, et la même forme pharmaceutique qu'une spécialité de référence d'un groupe générique déjà existant, et dont la bioéquivalence avec cette spécialité est démontrée par des études de biodisponibilité appropriées, peut aussi figurer dans ce groupe générique, à condition que ces deux spécialités soient considérées comme relevant d'une même autorisation de mise sur le marché globale, définie par voie réglementaire et qu'elles ne présentent pas de propriétés sensiblement différentes au regard de la sécurité ou de l'efficacité. En l'absence de spécialité de référence, un groupe générique peut être constitué de spécialités ayant la même composition qualitative et quantitative en principes actifs, la même forme pharmaceutique et dont les caractéristiques en termes de sécurité et d'efficacité sont équivalentes. Pour l'application du présent b, sont inscrites au répertoire des groupes génériques les spécialités qui se présentent sous une forme pharmaceutique orale à libération modifiée différente de celle de la spécialité de référence, à condition que ces spécialités et la spécialité de référence appartiennent à la même catégorie de forme pharmaceutique à libération modifiée et qu'elles ne présentent pas de propriétés sensiblement différentes au regard de la sécurité ou de l'efficacité ;

Pour l'application du présent b, sont inscrites, après avis du directeur général de l'Agence nationale de sécurité du médicament et des produits de santé, au répertoire des spécialités génériques les spécialités dont le principe actif est d'origine végétale ou minérale qui présentent la même composition quantitative que ce principe actif et qui ont une activité thérapeutique équivalente à celle de la spécialité de référence, à condition que ces spécialités et la spécialité de référence ne présentent pas de propriétés sensiblement différentes au regard de la sécurité ou de l'efficacité ;

6° Médicament immunologique, tout médicament consistant en :

a) Allergène, défini comme tout produit destiné à identifier ou provoquer une modification spécifique et acquise de la réponse immunologique à un agent allergisant ;

b) Vaccin, toxine ou sérum, définis comme tous agents utilisés en vue de provoquer une immunité active ou passive ou en vue de diagnostiquer l'état d'immunité ;

9° Trousse, toute préparation qui doit être reconstituée ou combinée avec des radionucléides dans le produit radiopharmaceutique final ;

10° Précurseur, tout autre radionucléide produit pour le marquage radioactif d'une autre substance avant administration ;

11° Médicament homéopathique, tout médicament obtenu à partir de substances appelées souches homéopathiques, selon un procédé de fabrication homéopathique décrit par la pharmacopée européenne, la pharmacopée française ou, à défaut, par les pharmacopées utilisées de façon officielle dans un autre Etat membre de l'Union européenne. Un médicament homéopathique peut aussi contenir plusieurs principes ;

13° Préparation de thérapie cellulaire xénogénique, tout médicament autre que les spécialités pharmaceutiques et les médicaments fabriqués industriellement mentionnés à l'article L. 5121-8, consistant en des cellules d'origine animale et leurs dérivés utilisés à des fins thérapeutiques, y compris les cellules servant à transférer du matériel génétique, quel que soit leur niveau de transformation. Ces préparations sont préparées à l'avance et dispensées sur prescription médicale à un ou plusieurs patients. Elles font l'objet d'une autorisation de l'Agence française de sécurité sanitaire des produits de santé pour une indication thérapeutique donnée. Cette autorisation peut être assortie de conditions particulières ou de restrictions d'utilisation. Elle peut être modifiée, suspendue ou retirée.L'Agence de la biomédecine est informée des décisions relatives à ces préparations prises en application du présent alinéa ;

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Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000195660", "@nortexte": "ENVP9640024D", "@numtexte": "96-850", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1996-09-20" }, { "@id": "LEGIARTI000006725129", "@num": "71", "#text": "Décret n°2001-1065 du 15 novembre 2001 - art. 71 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000403855", "@nortexte": "INTM0100035D", "@numtexte": "2001-1065", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2001-11-15" }, { "@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": "LEGIARTI000006697606", "@num": "35", "#text": "Loi n°2004-800 du 6 août 2004 - art. 35 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000441469", "@nortexte": "SANX0100053L", "@numtexte": "2004-800", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-06" }, { "@id": "LEGIARTI000047109474", "@num": "14", "#text": "Décret n°2004-942 du 3 septembre 2004 - art. 14 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000000253592", "@nortexte": "SANS0422327D", "@numtexte": "2004-942", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-09-03" }, { "@id": "LEGIARTI000032182077", "@num": "41", "#text": "Loi n°2005-1579 du 19 décembre 2005 - art. 41 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000815414", "@nortexte": "SANX0500246L", "@numtexte": "2005-1579", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2005-12-19" }, { "@id": "LEGIARTI000020140266", "@num": "8", "#text": "Arrêté du 24 mai 2006 - art. 8 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000457818", "@nortexte": "SANP0622223A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-05-24" }, { "@id": "LEGIARTI000043762395", "@num": "21", "#text": "Décret n° 2007-359 du 19 mars 2007 - art. 21 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000645145", "@nortexte": "AGRG0700643D", "@numtexte": "2007-359", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-19" }, { "@id": "LEGIARTI000022933811", "@num": "3", "#text": "Arrêté du 29 septembre 2010 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000022932466", "@nortexte": "SASP1025728A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-09-29" }, { "@id": "LEGIARTI000023501118", "@num": "4", "#text": "Arrêté du 21 janvier 2011 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023491451", "@nortexte": "ETSP1101997A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-01-21" }, { "@id": "LEGIARTI000023824330", "@num": "1", "#text": "Arrêté du 29 mars 2011 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023823216", "@nortexte": "ETSP1108796A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-03-29" }, { "@id": "LEGIARTI000046423270", "@num": "13", "#text": "Arrêté du 6 avril 2011 - art. 13 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023865866", "@nortexte": "ETSH1109848A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-04-06" }, { "@id": "LEGITEXT000024154142", "#text": "Décret n°2011-655\n du 10 juin 2011 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000024153599", "@nortexte": "ETSP1024824D", "@numtexte": "2011-655", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-06-10" }, { "@id": "LEGIARTI000025071099", "@num": "16", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 16", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000026041157", "@num": "2", "#text": "Arrêté du 8 juin 2012 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000026040448", "@nortexte": "AFSP1225501A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-06-08" }, { "@id": "LEGITEXT000026558683", "#text": "Décret n°2012-1201\n du 29 octobre 2012 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000026557838", "@nortexte": "AFSP1232892D", "@numtexte": "2012-1201", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2012-10-29" }, { "@id": "LEGIARTI000026589554", "@num": "2", "#text": "Décret n°2012-1236\n du 6 novembre 2012 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000026588856", "@nortexte": "AFSP1226229D", "@numtexte": "2012-1236", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2012-11-06" }, { "@id": "LEGIARTI000035971424", "#text": "DÉCRET n°2014-1287 du 23 octobre 2014 - art. 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(V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029676038", "@nortexte": "AFSX1419044D", "@numtexte": "2014-1288", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000030189762", "@num": "8", "#text": "ARRÊTÉ du 28 novembre 2014 - art. 8 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000030189026", "@nortexte": "EINC1415451A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2014-11-28" }, { "@id": "LEGIARTI000030189876", "@num": "1", "#text": "ARRÊTÉ du 3 février 2015 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000030188934", "@nortexte": "AFSP1503244A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2015-02-03" }, { "@id": "LEGIARTI000032291698", "@num": "1", "#text": "Décret n°2016-349 du 24 mars 2016 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000032291186", "@nortexte": "AFSH1532721D", "@numtexte": "2016-349", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2016-03-24" }, { "@id": "LEGIARTI000032730970", "@num": "3", "#text": "Décret n°2016-817 du 20 juin 2016 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000032729458", "@nortexte": "AFSS1610671D", "@numtexte": "2016-817", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2016-06-20" }, { "@id": "LEGIARTI000034392999", "@num": "1", "#text": "Décret n°2017-500 du 6 avril 2017 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000034390458", "@nortexte": "AFSH1702718D", "@numtexte": "2017-500", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-04-06" }, { "@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": "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": "LEGIARTI000044941358", "@num": "6", "#text": "Décret n°2021-1905 du 30 décembre 2021 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000044638030", "@nortexte": "TREP2130559D", "@numtexte": "2021-1905", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-12-30" }, { "@id": "LEGIARTI000045632789", "@num": "1", "#text": "Décret n°2022-597 du 21 avril 2022 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000045632039", "@nortexte": "SSAH2205181D", "@numtexte": "2022-597", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2022-04-21" }, { "@id": "LEGITEXT000049536357", "#text": "Décret n°2024-435 du 14 mai 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049535648", "@nortexte": "TSSS2408227D", "@numtexte": "2024-435", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-05-14" }, { "@id": "LEGITEXT000049850758", "#text": "Décret n°2024-626 du 27 juin 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049832038", "@nortexte": "TSSP2408968D", "@numtexte": "2024-626", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-06-27" }, { "@id": "LEGITEXT000049922585", "#text": "Arrêté du 5 juillet 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049892254", "@nortexte": "TSSS2418508A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-07-05" }, { "@id": "LEGITEXT000050737433", "#text": "Décret n°2024-1135 du 4 décembre 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000050731183", "@nortexte": "MSAH2429400D", "@numtexte": "2024-1135", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-12-04" }, { "@id": "LEGIARTI000006279394", "@num": "L611-2", "#text": "Code de la propriété intellectuelle - art. 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On entend par :

1° Préparation magistrale, tout médicament préparé selon une prescription médicale destinée à un malade déterminé en raison de l'absence de spécialité pharmaceutique disponible disposant d'une autorisation de mise sur le marché, de l'une des autorisations mentionnées aux articles L. 5121-9-1 et L. 5121-12, d'une autorisation d'importation parallèle ou d'une autorisation d'importation délivrée à un établissement pharmaceutique dans le cadre d'une rupture de stock d'un médicament,, soit extemporanément en pharmacie, soit dans les conditions prévues à l'article L. 5125-1 ou à l'article L. 5126-2 ;

2° Préparation hospitalière, tout médicament, à l'exception des produits de thérapies génique ou cellulaire, préparé selon les indications de la pharmacopée et en conformité avec les bonnes pratiques mentionnées à l'article L. 5121-5, en raison de l'absence de spécialité pharmaceutique disponible ou adaptée disposant d'une autorisation de mise sur le marché, de l'une des autorisations mentionnées aux articles L. 5121-9-1 et L. 5121-12, d'une autorisation d'importation parallèle ou d'une autorisation d'importation délivrée à un établissement pharmaceutique dans le cadre d'une rupture de stock d'un médicament, par une pharmacie à usage intérieur d'un établissement de santé, ou par l'établissement pharmaceutique de cet établissement de santé autorisé en application de l'article L. 5124-9 ou dans les conditions prévues à l'article L. 5126-2. Les préparations hospitalières sont dispensées sur prescription médicale à un ou plusieurs patients par une pharmacie à usage intérieur dudit établissement. Elles font l'objet d'une déclaration auprès de l'Agence française de sécurité sanitaire des produits de santé, dans des conditions définies par arrêté du ministre chargé de la santé ;

b) Groupe générique, le regroupement d'une spécialité de référence et des spécialités qui en sont génériques. Toutefois, une spécialité remplissant les conditions pour être une spécialité de référence, qui présente la même composition qualitative en substance active, la même composition quantitative en substance active ou, à défaut, une fraction thérapeutique active identique dans les limites prévues à l'annexe I de la directive 2001/83/ CE du Parlement européen et du Conseil du 6 novembre 2001 instituant un code communautaire relatif aux médicaments à usage humain, et la même forme pharmaceutique qu'une spécialité de référence d'un groupe générique déjà existant, et dont la bioéquivalence avec cette spécialité est démontrée par des études de biodisponibilité appropriées, peut aussi figurer dans ce groupe générique, à condition que ces deux spécialités soient considérées comme relevant d'une même autorisation de mise sur le marché globale, définie par voie réglementaire et qu'elles ne présentent pas de propriétés sensiblement différentes au regard de la sécurité ou de l'efficacité. En l'absence de spécialité de référence, un groupe générique peut être constitué de spécialités ayant la même composition qualitative et quantitative en principes actifs, la même forme pharmaceutique et dont les caractéristiques en termes de sécurité et d'efficacité sont équivalentes. Pour l'application du présent b, sont inscrites au répertoire des groupes génériques les spécialités qui se présentent sous une forme pharmaceutique orale à libération modifiée différente de celle de la spécialité de référence, à condition que ces spécialités et la spécialité de référence appartiennent à la même catégorie de forme pharmaceutique à libération modifiée et qu'elles ne présentent pas de propriétés sensiblement différentes au regard de la sécurité ou de l'efficacité ;

6° Médicament immunologique, tout médicament consistant en :

a) Allergène, défini comme tout produit destiné à identifier ou provoquer une modification spécifique et acquise de la réponse immunologique à un agent allergisant ;

b) Vaccin, toxine ou sérum, définis comme tous agents utilisés en vue de provoquer une immunité active ou passive ou en vue de diagnostiquer l'état d'immunité ;

8° Générateur, tout système contenant un radionucléide parent déterminé en raison de l'absence de spécialité pharmaceutique disponible disposant d'une autorisation de mise sur le marché, de l'une des autorisations mentionnées aux articles L. 5121-9-1 et L. 5121-12, d'une autorisation d'importation parallèle ou d'une autorisation d'importation délivrée à un établissement pharmaceutique dans le cadre d'une rupture de stock d'un médicament, servant à la production d'un radionucléide de filiation obtenu par élution ou par toute autre méthode et utilisé dans un médicament radiopharmaceutique ;

9° Trousse, toute préparation qui doit être reconstituée ou combinée avec des radionucléides dans le produit radiopharmaceutique final ;

10° Précurseur, tout autre radionucléide produit pour le marquage radioactif d'une autre substance avant administration ;

11° Médicament homéopathique, tout médicament obtenu à partir de substances appelées souches homéopathiques, selon un procédé de fabrication homéopathique décrit par la pharmacopée européenne, la pharmacopée française ou, à défaut, par les pharmacopées utilisées de façon officielle dans un autre Etat membre de l'Union européenne. Un médicament homéopathique peut aussi contenir plusieurs principes ;

12° Préparation de thérapie génique, tout médicament autre que les spécialités pharmaceutiques et les médicaments fabriqués industriellement mentionnés à l'article L. 5121-8, servant à transférer du matériel génétique et ne consistant pas en des cellules d'origine humaine ou animale. Ces préparations sont préparées à l'avance et dispensées sur prescription médicale à un ou plusieurs patients. Elles font l'objet d'une autorisation de l'Agence nationale de sécurité du médicament et des produits de santé pour une indication thérapeutique donnée. Cette autorisation peut être assortie de conditions particulières ou de restrictions d'utilisation. Elle peut être modifiée, suspendue ou retirée ;

13° Préparation de thérapie cellulaire xénogénique, tout médicament autre que les spécialités pharmaceutiques et les médicaments fabriqués industriellement mentionnés à l'article L. 5121-8, consistant en des cellules d'origine animale et leurs dérivés utilisés à des fins thérapeutiques, y compris les cellules servant à transférer du matériel génétique, quel que soit leur niveau de transformation. Ces préparations sont préparées à l'avance et dispensées sur prescription médicale à un ou plusieurs patients. Elles font l'objet d'une autorisation de l'Agence nationale de sécurité du médicament et des produits de santé pour une indication thérapeutique donnée. Cette autorisation peut être assortie de conditions particulières ou de restrictions d'utilisation. Elle peut être modifiée, suspendue ou retirée. L'Agence de la biomédecine est informée des décisions relatives à ces préparations prises en application du présent alinéa ;

" } }, "LEGIARTI000025787777": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5122-17", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-05-11", "DATE_DEBUT": "2012-05-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025787777", "URL": "article/LEGI/ARTI/00/00/25/78/77/LEGIARTI000025787777.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000787339", "#text": "Décret n°2004-802 du 29 juillet 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000025765496", "@num": "5", "#text": "Décret n°2012-597\n du 27 avril 2012 - art. 5", "@sens": "cible", "@cidtexte": "JORFTEXT000025757625", "@nortexte": "ETSP1206945D", "@numtexte": "2012-597", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2012-04-27" }, { "@id": "LEGIARTI000042234982", "@num": "1", "#text": "Arrêté du 7 août 2020 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042234007", "@nortexte": "ECOC2019446A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-08-07" }, { "@id": "LEGIARTI000006689945", "@num": "L5122-10", "#text": "Code de la santé publique - art. L5122-10", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799373", "@num": "R5048", "#text": "Code de la santé publique - art. R5048 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799369", "@num": "R5048", "#text": "Code de la santé publique - art. R5048 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914744", "@num": "R5121-21", "#text": "Code de la santé publique - art. R5121-21", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915001", "@num": "R5122-18", "#text": "Code de la santé publique - art. R5122-18 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006190677", "@fin": "2999-01-01", "#text": "Section 3 : Publicité à destination des professions de santé", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178650", "@fin": "2999-01-01", "#text": "Chapitre II : Publicité", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161012", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006915000", "@fin": "2012-05-01", "@num": "R5122-17", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025787777", "@fin": "2012-05-11", "@num": "R5122-17", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000025853198", "@fin": "2999-01-01", "@num": "R5122-17", "@etat": "VIGUEUR", "@debut": "2012-05-11", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les échantillons gratuits de médicaments mentionnés à l'article L. 5122-10 ne peuvent être remis que dans les conditions suivantes :
\n
1° Chaque fourniture d'échantillons répond à une demande écrite, datée et signée, émanant du destinataire ;
\n
2° Pour chaque médicament, il ne peut être remis qu'un nombre restreint d'échantillons, dans la limite de dix par an et par destinataire, déterminé en fonction de la nature du médicament et de la nécessité pour le prescripteur de se familiariser avec celui-ci ; chaque échantillon est identique au plus petit conditionnement commercialisé ;
\n
3° Lorsqu'un médicament est soumis aux conditions de prescription restreinte prévues à la section 8 du chapitre Ier du présent titre, les échantillons ne peuvent être remis qu'aux pharmaciens gérants des pharmacies à usage intérieur des établissements de santé et aux prescripteurs habilités à établir la prescription ;
\n
4° Chaque établissement pharmaceutique remettant des échantillons organise en son sein le contrôle de cette remise et le suivi des échantillons ;
\n
5° Chaque échantillon est accompagné d'une copie du résumé des caractéristiques du produit, mentionné à l'article R. 5121-21.
\n
Le directeur général de l' Agence nationale de sécurité du médicament et des produits de santé peut restreindre, en raison d'un risque possible pour la santé publique, la distribution d'échantillons de certains médicaments.
" } }, "LEGIARTI000025853198": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5122-17", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2012-05-11" } }, "META_COMMUN": { "ID": "LEGIARTI000025853198", "URL": "article/LEGI/ARTI/00/00/25/85/31/LEGIARTI000025853198.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000787339", "#text": "Décret n°2004-802 du 29 juillet 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000025849193", "@num": "10", "#text": "Décret n°2012-741\n du 9 mai 2012 - art. 10", "@sens": "cible", "@cidtexte": "JORFTEXT000025836786", "@nortexte": "ETSP1208477D", "@numtexte": "2012-741", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2012-05-09" }, { "@id": "LEGIARTI000042234982", "@num": "1", "#text": "Arrêté du 7 août 2020 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042234007", "@nortexte": "ECOC2019446A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-08-07" }, { "@id": "LEGIARTI000006689945", "@num": "L5122-10", "#text": "Code de la santé publique - art. L5122-10 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799373", "@num": "R5048", "#text": "Code de la santé publique - art. R5048 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799369", "@num": "R5048", "#text": "Code de la santé publique - art. R5048 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914744", "@num": "R5121-21", "#text": "Code de la santé publique - art. R5121-21 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914763", "@num": "R5121-36", "#text": "Code de la santé publique - art. R5121-36 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915001", "@num": "R5122-18", "#text": "Code de la santé publique - art. R5122-18 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006190677", "@fin": "2999-01-01", "#text": "Section 3 : Publicité à destination des professions de santé", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178650", "@fin": "2999-01-01", "#text": "Chapitre II : Publicité", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161012", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006915000", "@fin": "2012-05-01", "@num": "R5122-17", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025787777", "@fin": "2012-05-11", "@num": "R5122-17", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000025853198", "@fin": "2999-01-01", "@num": "R5122-17", "@etat": "VIGUEUR", "@debut": "2012-05-11", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

I.-La remise d'échantillons gratuits mentionnée à l'article L. 5122-10 n'est admise que pendant les deux années suivant la première commercialisation effective en France :

1° D'une spécialité bénéficiant d'un premier enregistrement ou d'une première autorisation de mise sur le marché ; ou

2° D'une spécialité déjà enregistrée ou autorisée ayant obtenu un enregistrement ou une autorisation de mise sur le marché pour un nouveau dosage ou une nouvelle forme pharmaceutique, si l'enregistrement ou l'autorisation est assorti d'une extension d'indication.

Elle est également admise pendant les deux années suivant une modification du classement du médicament mentionné au 1° de l'article R. 5121-36.

II.-La remise d'échantillons gratuits respecte en outre les conditions suivantes :

1° Chaque fourniture d'échantillons répond à une demande écrite, datée et signée, émanant du destinataire ;

2° Pour chaque médicament, il ne peut être remis qu'un nombre restreint d'échantillons, dans la limite de quatre par an et par destinataire, déterminé en fonction de la nature du médicament et de la nécessité pour le prescripteur de se familiariser avec celui-ci ; chaque échantillon est identique au plus petit conditionnement commercialisé ;

3° Lorsqu'un médicament est soumis aux conditions de prescription restreinte prévues à la section 8 du chapitre Ier du présent titre, les échantillons ne peuvent être remis qu'aux pharmaciens gérants des pharmacies à usage intérieur des établissements de santé et aux prescripteurs habilités à établir la prescription ;

4° Chaque établissement pharmaceutique remettant des échantillons organise en son sein le contrôle de cette remise et le suivi des échantillons ;

5° Chaque échantillon est accompagné d'une copie du résumé des caractéristiques du produit, mentionné à l'article R. 5121-21.

Le directeur général de l'Agence nationale de sécurité du médicament et des produits de santé peut restreindre, en raison d'un risque possible pour la santé publique, la distribution d'échantillons de certains médicaments.

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(V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029676038", "@nortexte": "AFSX1419044D", "@numtexte": "2014-1288", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000030189762", "@num": "8", "#text": "ARRÊTÉ du 28 novembre 2014 - art. 8 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000030189026", "@nortexte": "EINC1415451A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2014-11-28" }, { "@id": "LEGIARTI000030189876", "@num": "1", "#text": "ARRÊTÉ du 3 février 2015 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000030188934", "@nortexte": "AFSP1503244A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2015-02-03" }, { "@id": "LEGIARTI000032291698", "@num": "1", "#text": "Décret n°2016-349 du 24 mars 2016 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000032291186", "@nortexte": "AFSH1532721D", "@numtexte": "2016-349", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2016-03-24" }, { "@id": "LEGIARTI000032730970", "@num": "3", "#text": "Décret n°2016-817 du 20 juin 2016 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000032729458", "@nortexte": "AFSS1610671D", "@numtexte": "2016-817", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2016-06-20" }, { "@id": "LEGIARTI000034392999", "@num": "1", "#text": "Décret n°2017-500 du 6 avril 2017 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000034390458", "@nortexte": "AFSH1702718D", "@numtexte": "2017-500", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-04-06" }, { "@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": "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": "LEGIARTI000044941358", "@num": "6", "#text": "Décret n°2021-1905 du 30 décembre 2021 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000044638030", "@nortexte": "TREP2130559D", "@numtexte": "2021-1905", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-12-30" }, { "@id": "LEGIARTI000045632789", "@num": "1", "#text": "Décret n°2022-597 du 21 avril 2022 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000045632039", "@nortexte": "SSAH2205181D", "@numtexte": "2022-597", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2022-04-21" }, { "@id": "LEGITEXT000049536357", "#text": "Décret n°2024-435 du 14 mai 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049535648", "@nortexte": "TSSS2408227D", "@numtexte": "2024-435", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-05-14" }, { "@id": "LEGITEXT000049850758", "#text": "Décret n°2024-626 du 27 juin 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049832038", "@nortexte": "TSSP2408968D", "@numtexte": "2024-626", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-06-27" }, { "@id": "LEGITEXT000049922585", "#text": "Arrêté du 5 juillet 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049892254", "@nortexte": "TSSS2418508A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-07-05" }, { "@id": "LEGITEXT000050737433", "#text": "Décret n°2024-1135 du 4 décembre 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000050731183", "@nortexte": "MSAH2429400D", "@numtexte": "2024-1135", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-12-04" }, { "@id": "LEGIARTI000006279394", "@num": "L611-2", "#text": "Code de la propriété intellectuelle - art. 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On entend par :

2° Préparation hospitalière, tout médicament, à l'exception des produits de thérapies génique ou cellulaire, préparé selon les indications de la pharmacopée et en conformité avec les bonnes pratiques mentionnées à l'article L. 5121-5, en raison de l'absence de spécialité pharmaceutique disponible ou adaptée disposant d'une autorisation de mise sur le marché, de l'une des autorisations mentionnées aux articles L. 5121-9-1 et L. 5121-12, d'une autorisation d'importation parallèle ou d'une autorisation d'importation délivrée à un établissement pharmaceutique dans le cadre d'une rupture de stock d'un médicament, par une pharmacie à usage intérieur d'un établissement de santé, ou par l'établissement pharmaceutique de cet établissement de santé autorisé en application de l'article L. 5124-9 ou dans les conditions prévues à l'article L. 5126-2. Les préparations hospitalières sont dispensées sur prescription médicale à un ou plusieurs patients par une pharmacie à usage intérieur dudit établissement. Elles font l'objet d'une déclaration auprès de l'Agence nationale de sécurité du médicament et des produits de santé, dans des conditions définies par arrêté du ministre chargé de la santé ;

Article R5122-18 AUTONOME VIGUEUR, en vigueur depuis le 08/08/2004 (Code de la santé publique)