{ "article": { "LEGIARTI000037017220": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R1333-78", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2018-07-01" } }, "META_COMMUN": { "ID": "LEGIARTI000037017220", "URL": "article/LEGI/ARTI/00/00/37/01/72/LEGIARTI000037017220.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000412528", "#text": "Décret n°2003-462 du 21 mai 2003", "@sens": "source", "@cidtexte": "JORFTEXT000000412528", "@nortexte": "SANP0321523D", "@numtexte": "2003-462", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2003-05-21" }, { "@id": "LEGIARTI000036987533", "@num": "1", "#text": "Décret n°2018-434 du 4 juin 2018 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000036984723", "@nortexte": "TREP1615598D", "@numtexte": "2018-434", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2018-06-04" }, { "@id": "LEGIARTI000006689870", "@num": "L5121-1", "#text": "Code de la santé publique - art. L5121-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690305", "@num": "L5212-1", "#text": "Code de la santé publique - art. L5212-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000037017225", "@num": "R1333-77", "#text": "Code de la santé publique - art. R1333-77 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798575", "@num": "R43-73", "#text": "Code de la santé publique - art. R43-73 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798575", "@num": "R43-73", "#text": "Code de la santé publique - art. R43-73 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000036997350", "@fin": "2999-01-01", "#text": "Sous-section 8 : Dispositifs médicaux et médicaments radiopharmaceutiques", "@debut": "2018-07-01" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006191034", "@fin": "2018-07-01", "#text": "Section 3 : Régime des autorisations et déclarations", "@debut": "2007-11-09" }, { "@id": "LEGISCTA000037017098", "@fin": "2999-01-01", "#text": "Section 3 : Protection des personnes exposées à des rayonnements ionisants dans un cadre médical", "@debut": "2018-07-01" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178514", "@fin": "2999-01-01", "#text": "Chapitre III : Rayonnements ionisants", "@debut": "2006-06-10" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006160960", "@fin": "2999-01-01", "#text": "Titre III : Prévention des risques sanitaires liés à l'environnement et au travail", "@debut": "2006-06-10" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145469", "@fin": "2999-01-01", "#text": "Livre III : Protection de la santé et environnement", "@debut": "2003-05-27" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132378", "@fin": "2999-01-01", "#text": "Première partie : Protection générale de la santé", "@debut": "2000-12-23" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006910208", "@fin": "2006-06-10", "@num": "R1333-78", "@etat": "MODIFIE", "@debut": "2003-05-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006910209", "@fin": "2007-11-09", "@num": "R1333-78", "@etat": "MODIFIE", "@debut": "2006-06-10", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006910210", "@fin": "2018-07-01", "@num": "R1333-78", "@etat": "MODIFIE", "@debut": "2007-11-09", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000037017220", "@fin": "2999-01-01", "@num": "R1333-78", "@etat": "VIGUEUR", "@debut": "2018-07-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Tout dispositif médical exposant aux rayonnements ionisants satisfait aux dispositions réglementaires prises en application de l'article L. 5212-1.

Les médicaments et produits radiopharmaceutiques sont utilisés conformément à l'article L. 5121-1 et suivants.

" } }, "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. 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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": "LEGIARTI000051140851", "@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. 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R161-76-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000050942061", "@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": "LEGIARTI000050942216", "@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 :
\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.
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"MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006689874", "@fin": "2007-02-27", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2004-08-17", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006689875", "@fin": "2007-04-27", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2007-02-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006689876", "@fin": "2008-04-17", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2007-04-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000018652237", "@fin": "2008-12-19", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2008-04-17", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000019954081", "@fin": "2009-07-23", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2008-12-19", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000020886469", "@fin": "2010-02-26", "@num": "L5121-1", "@etat": "MODIFIE", "@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 :
\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.
" } }, "LEGIARTI000006689872": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5121-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-11", "DATE_DEBUT": "2004-08-07" } }, "META_COMMUN": { "ID": "LEGIARTI000006689872", "URL": "article/LEGI/ARTI/00/00/06/68/98/LEGIARTI000006689872.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5121L01XXAC" } }, "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": "LEGIARTI000006697588", "@num": "19", "#text": "Loi n°2004-800 du 6 août 2004 - art. 19 () JORF 7 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000441469", "@nortexte": "SANX0100053L", "@numtexte": "2004-800", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-06" }, { "@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. 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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": "LEGIARTI000051287431", "@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": "LEGIARTI000051287416", "@num": "L138-9-1", "#text": "Code de la sécurité sociale. - art. L138-9-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000051284908", "@num": "L160-13", "#text": "Code de la sécurité sociale. - art. L160-13 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000047568729", "@num": "L162-16", "#text": "Code de la sécurité sociale. - art. 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": "LEGIARTI000051140851", "@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": "LEGIARTI000050942061", "@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. 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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. 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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 ;
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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. 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 ;
\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.
" } }, "LEGIARTI000006689874": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5121-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2007-02-27", "DATE_DEBUT": "2004-08-17" } }, "META_COMMUN": { "ID": "LEGIARTI000006689874", "URL": "article/LEGI/ARTI/00/00/06/68/98/LEGIARTI000006689874.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5121L01XXAE" } }, "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": "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 - 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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 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 ;
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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 ;
\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.
" } }, "LEGIARTI000006689875": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5121-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2007-04-27", "DATE_DEBUT": "2007-02-27" } }, "META_COMMUN": { "ID": "LEGIARTI000006689875", "URL": "article/LEGI/ARTI/00/00/06/68/98/LEGIARTI000006689875.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5121L01XXAF" } }, "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 :
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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 ;
\n
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 ;
\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 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 ;
\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 ;
\n
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 ;
\n
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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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": "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. (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": "LEGIARTI000044404516", "@num": "L251-2", "#text": "Code de l'action sociale et des familles - 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.
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Pour les dispositifs médicaux dont la liste est fixée par le ministre chargé de la santé après avis de l'Agence française de sécurité sanitaire des produits de santé, l'exploitant est tenu de s'assurer du maintien de ces performances et de la maintenance du dispositif médical.
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Cette obligation donne lieu, le cas échéant, à un contrôle de qualité dont les modalités sont définies par décret et dont le coût est pris en charge par les exploitants des dispositifs.
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Pour les dispositifs médicaux dont la liste est fixée par le ministre chargé de la santé après avis de l'Agence française de sécurité sanitaire des produits de santé, la personne morale ou physique responsable d'une nouvelle mise sur le marché fait établir préalablement une attestation technique, dont les modalités sont définies par décret, garantissant que le dispositif médical concerné est toujours conforme aux exigences essentielles prévues au premier alinéa de l'article L. 5211-3.
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Le non-respect des dispositions du présent article peut entraîner la mise hors service provisoire ou définitive du dispositif médical, prononcée par l'Agence française de sécurité sanitaire des produits de santé, ainsi que, le cas échéant, le retrait ou la suspension de l'autorisation de l'installation dans les conditions prévues aux articles L. 6122-11 et L. 6122-13.
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Pour les dispositifs médicaux dont la liste est fixée par le ministre chargé de la santé après avis de l'Agence française de sécurité sanitaire des produits de santé, l'exploitant est tenu de s'assurer du maintien de ces performances et de la maintenance du dispositif médical.
\n
Cette obligation donne lieu, le cas échéant, à un contrôle de qualité dont les modalités sont définies par décret et dont le coût est pris en charge par les exploitants des dispositifs.
\n
Pour les dispositifs médicaux dont la liste est fixée par le ministre chargé de la santé après avis de l'Agence française de sécurité sanitaire des produits de santé, la personne morale ou physique responsable d'une nouvelle mise sur le marché fait établir préalablement une attestation technique, dont les modalités sont définies par décret, garantissant que le dispositif médical concerné est toujours conforme aux exigences essentielles prévues au premier alinéa de l'article L. 5211-3.
\n
Le non-respect des dispositions du présent article peut entraîner la mise hors service provisoire ou définitive du dispositif médical, prononcée par l'Agence française de sécurité sanitaire des produits de santé, ainsi que, le cas échéant, le retrait ou la suspension de l'autorisation de l'installation dans les conditions prévues aux articles L. 6122-11 et L. 6122-13.
" } }, "LEGIARTI000006690307": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5212-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2011-03-24", "DATE_DEBUT": "2004-08-11" } }, "META_COMMUN": { "ID": "LEGIARTI000006690307", "URL": "article/LEGI/ARTI/00/00/06/69/03/LEGIARTI000006690307.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5212L01XXAC" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000006697765", "@num": "140", "#text": "Loi n°2004-806 du 9 août 2004 - art. 140 () JORF 11 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787078", "@nortexte": "SANX0300055L", "@numtexte": "2004-806", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-09" }, { "@id": "LEGITEXT000024478563", "#text": "Décret n°2011-968\n du 16 août 2011 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000024476540", "@nortexte": "ETSP1110434D", "@numtexte": "2011-968", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-08-16" }, { "@id": "LEGIARTI000038533524", "#text": "Arrêté du 23 mai 2019 - art. 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Pour les dispositifs médicaux dont la liste est fixée par le ministre chargé de la santé après avis de l'Agence française de sécurité sanitaire des produits de santé, l'exploitant est tenu de s'assurer du maintien de ces performances et de la maintenance du dispositif médical.
\n
Cette obligation donne lieu, le cas échéant, à un contrôle de qualité dont les modalités sont définies par décret et dont le coût est pris en charge par les exploitants des dispositifs.
\n
La personne physique ou morale responsable de la revente d'un dispositif médical d'occasion figurant sur une liste fixée par arrêté du ministre chargé de la santé, pris sur proposition du directeur général de l'Agence française de sécurité sanitaire des produits de santé, fait établir préalablement par un organisme agréé à cet effet par décision du directeur général de l'Agence française de sécurité sanitaire des produits de santé une attestation technique justifiant d'une maintenance régulière et du maintien des performances du dispositif médical concerné. Les modalités de l'agrément des organismes et de l'attestation technique sont définies par décret.
\n
Le non-respect des dispositions du présent article peut entraîner la mise hors service provisoire ou définitive du dispositif médical, prononcée par l'Agence française de sécurité sanitaire des produits de santé, ainsi que, le cas échéant, le retrait ou la suspension de l'autorisation de l'installation dans les conditions prévues aux articles L. 6122-11 et L. 6122-13.
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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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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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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 ;

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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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Pour les dispositifs médicaux dont la liste est fixée par le ministre chargé de la santé après avis de l'Agence française de sécurité sanitaire des produits de santé, l'exploitant est tenu de s'assurer du maintien de ces performances et de la maintenance du dispositif médical.

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Cette obligation donne lieu, le cas échéant, à un contrôle de qualité dont les modalités sont définies par décret et dont le coût est pris en charge par les exploitants des dispositifs.

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La personne physique ou morale responsable de la revente d'un dispositif médical d'occasion figurant sur une liste fixée par arrêté du ministre chargé de la santé, pris sur proposition du directeur général de l'Agence française de sécurité sanitaire des produits de santé, établit, selon des modalités fixées par décret en Conseil d'Etat, une attestation justifiant de la maintenance régulière et du maintien des performances du dispositif médical concerné.

\n
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Le non-respect des dispositions du présent article peut entraîner la mise hors service provisoire ou définitive du dispositif médical, prononcée par l'Agence française de sécurité sanitaire des produits de santé, ainsi que, le cas échéant, le retrait ou la suspension de l'autorisation de l'installation dans les conditions prévues aux articles L. 6122-11 et L. 6122-13.

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

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

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Pour les dispositifs médicaux dont la liste est fixée par le ministre chargé de la santé après avis de l'Agence nationale de sécurité du médicament et des produits de santé, l'exploitant est tenu de s'assurer du maintien de ces performances et de la maintenance du dispositif médical.

Cette obligation donne lieu, le cas échéant, à un contrôle de qualité dont les modalités sont définies par décret et dont le coût est pris en charge par les exploitants des dispositifs.

La personne physique ou morale responsable de la cession à titre onéreux ou à titre gratuit d'un dispositif médical d'occasion figurant sur une liste fixée par arrêté du ministre chargé de la santé, pris sur proposition du directeur général de l'Agence nationale de sécurité du médicament et des produits de santé, établit, selon des modalités fixées par décret en Conseil d'Etat, une attestation justifiant de la maintenance régulière et du maintien des performances du dispositif médical concerné.

Le non-respect des dispositions du présent article peut entraîner la mise hors service provisoire ou définitive du dispositif médical, prononcée par l'Agence nationale de sécurité du médicament et des produits de santé, ainsi que, le cas échéant, le retrait ou la suspension de l'autorisation de l'installation dans les conditions prévues aux articles L. 6122-11 et L. 6122-13.

" } }, "LEGIARTI000025122674": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5121-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-05-01", "DATE_DEBUT": "2011-12-31" } }, "META_COMMUN": { "ID": "LEGIARTI000025122674", "URL": "article/LEGI/ARTI/00/00/25/12/26/LEGIARTI000025122674.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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L138-9-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000051284908", "@num": "L160-13", "#text": "Code de la sécurité sociale. - art. L160-13 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000047568729", "@num": "L162-16", "#text": "Code de la sécurité sociale. - art. 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": "LEGIARTI000051140851", "@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": "LEGIARTI000050942061", "@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. 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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. 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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 ;

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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 R1333-78 AUTONOME VIGUEUR, en vigueur depuis le 01/07/2018 (Code de la santé publique)