{ "article": { "LEGIARTI000044379674": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "2", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000044379674", "URL": "article/LEGI/ARTI/00/00/44/37/96/LEGIARTI000044379674.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006914853", "@num": "R5121-108", "#text": "Code de la santé publique - art. R5121-108", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915366", "@num": "R5126-58", "#text": "Code de la santé publique - art. R5126-58", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915368", "@num": "R5126-60", "#text": "Code de la santé publique - art. R5126-60", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044381862", "@num": "R160-8", "#text": "Code de la sécurité sociale. - art. R160-8 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044381135", "@num": "R163-9-1", "#text": "Code de la sécurité sociale. - art. R163-9-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044381137", "@num": "R163-9-2", "#text": "Code de la sécurité sociale. - art. R163-9-2 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000044378143", "@nor": "SSAP2124720D", "@num": "2021-1531", "@nature": "DECRET", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Décret n° 2021-1531 du 26 novembre 2021 relatif au transfert à l'Agence nationale de sécurité du médicament et des produits de santé de la gestion de la liste mentionnée au 1° de l'article L. 5126-6 du code de la santé publique", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000044378143", "@c_titre_court": "Décret n°2021-1531 du 26 novembre 2021" }, { "@fin": "2999-01-01", "#text": "Décret n° 2021-1531 du 26 novembre 2021 relatif au transfert à l'Agence nationale de sécurité du médicament et des produits de santé de la gestion de la liste mentionnée au 1° de l'article L. 5126-6 du code de la santé publique", "@debut": "2021-11-29", "@id_txt": "LEGITEXT000044379664", "@c_titre_court": "Décret n°2021-1531 du 26 novembre 2021" } ], "@ministere": "Ministère des solidarités et de la santé", "@date_publi": "2021-11-28", "@date_signature": "2021-11-26", "@num_parution_jo": "0277" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000044379674", "@fin": "2999-01-01", "@num": "2", "@debut": "2999-01-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000044378154", "@fin": "2999-01-01", "@num": "2", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
A créé les dispositions suivantes :

- Code de la sécurité sociale.
\n Art. R163-9-1, Art. R163-9-2\n
\n

\n
\n
A modifié les dispositions suivantes :

- Code de la sécurité sociale.
\n Art. R160-8\n
\n

\n
" } }, "LEGIARTI000006914853": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5121-108", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2006-04-27", "DATE_DEBUT": "2004-08-08" } }, "META_COMMUN": { "ID": "LEGIARTI000006914853", "URL": "article/LEGI/ARTI/00/00/06/91/48/LEGIARTI000006914853.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "YXXXXXXXXXX5121R1080XX0A" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000041817882", "@num": "12-4-3", "#text": "Décret n°2020-293 du 23 mars 2020 - art. 12-4-3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746694", "@nortexte": "SSAZ2008253D", "@numtexte": "2020-293", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041808807", "@num": "12-5", "#text": "Décret n°2020-293 du 23 mars 2020 - art. 12-5 (T)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746694", "@nortexte": "SSAZ2008253D", "@numtexte": "2020-293", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041808796", "@num": "1", "#text": "Décret n°2020-447 du 18 avril 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041808417", "@nortexte": "SSAZ2009990D", "@numtexte": "2020-447", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-04-18" }, { "@id": "LEGIARTI000041859132", "@num": "22", "#text": "Décret n°2020-545 du 11 mai 2020 - art. 22 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041858681", "@nortexte": "SSAZ2011567D", "@numtexte": "2020-545", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041866857", "@num": "24", "#text": "Décret n°2020-548 du 11 mai 2020 - art. 24 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041865329", "@nortexte": "SSAZ2011695D", "@numtexte": "2020-548", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041943340", "@num": "55", "#text": "Décret n°2020-663 du 31 mai 2020 - art. 55 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041939818", "@nortexte": "SSAZ2013547D", "@numtexte": "2020-663", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-31" }, { "@id": "LEGIARTI000042107249", "@num": "34", "#text": "Arrêté du 10 juillet 2020 - art. 34 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042431415", "@num": "55", "#text": "Décret n°2020-1262 du 16 octobre 2020 - art. 55 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042430554", "@nortexte": "SSAZ2028015D", "@numtexte": "2020-1262", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-10-16" }, { "@id": "LEGIARTI000042477838", "@num": "53", "#text": "Décret n°2020-1310 du 29 octobre 2020 - art. 53 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042475143", "@nortexte": "SSAZ2029612D", "@numtexte": "2020-1310", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-10-29" }, { "@id": "LEGIARTI000043770208", "@num": "40", "#text": "Arrêté du 1er juin 2021 - art. 40 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000044379674", "@num": "2", "#text": "Décret n°2021-1531 du 26 novembre 2021 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000044378143", "@nortexte": "SSAP2124720D", "@numtexte": "2021-1531", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-11-26" }, { "@id": "LEGIARTI000006689900", "@num": "L5121-12", "#text": "Code de la santé publique - art. L5121-12 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689904", "@num": "L5121-13", "#text": "Code de la santé publique - art. L5121-13 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689889", "@num": "L5121-8", "#text": "Code de la santé publique - art. L5121-8 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914863", "@num": "R5121-115", "#text": "Code de la santé publique - art. R5121-115 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800301", "@num": "R5142-11", "#text": "Code de la santé publique - art. R5142-11 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique L5121-8, L5121-12, L5121-13, R5121-109 à R5121-114, R5121-115", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique R5142-11", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006190669", "@fin": "2999-01-01", "#text": "Section 10 : Importation et exportation", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178649", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161012", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006914853", "@fin": "2006-04-27", "@num": "R5121-108", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006914854", "@fin": "2008-09-05", "@num": "R5121-108", "@etat": "MODIFIE", "@debut": "2006-04-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000019425512", "@fin": "2012-05-01", "@num": "R5121-108", "@etat": "MODIFIE", "@debut": "2008-09-05", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025787983", "@fin": "2013-01-21", "@num": "R5121-108", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026968549", "@fin": "2016-02-26", "@num": "R5121-108", "@etat": "MODIFIE", "@debut": "2013-01-21", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000032106017", "@fin": "2016-11-18", "@num": "R5121-108", "@etat": "MODIFIE", "@debut": "2016-02-26", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000033418568", "@fin": "2021-07-01", "@num": "R5121-108", "@etat": "MODIFIE", "@debut": "2016-11-18", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000043761918", "@fin": "2022-01-01", "@num": "R5121-108", "@etat": "MODIFIE", "@debut": "2021-07-01", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000044944601", "@fin": "2999-01-01", "@num": "R5121-108", "@etat": "VIGUEUR", "@debut": "2022-01-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Tout médicament qui n'est pas pourvu de l'autorisation de mise sur le marché mentionnée à l'article L. 5121-8 ou de l'autorisation temporaire d'utilisation mentionnée au b de l'article L. 5121-12 accordée pour des médicaments importés ou de l'enregistrement mentionné à l'article L. 5121-13 fait l'objet, avant son importation dans le territoire douanier, d'une autorisation d'importation délivrée par le directeur général de l'Agence française de sécurité sanitaire des produits de santé, soit dans les conditions prévues aux articles R. 5121-109 à R. 5121-114, soit au titre de l'autorisation d'importation parallèle définie aux articles R. 5121-115 et suivants. Cette autorisation peut être refusée si le médicament présente ou est susceptible de présenter un risque pour la santé publique.
\n
" } }, "LEGIARTI000006914854": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5121-108", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2008-09-05", "DATE_DEBUT": "2006-04-27" } }, "META_COMMUN": { "ID": "LEGIARTI000006914854", "URL": "article/LEGI/ARTI/00/00/06/91/48/LEGIARTI000006914854.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "YXXXXXXXXXX5121R1080XX0B" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006250975", "@num": "6", "#text": "Décret n°2006-477 du 26 avril 2006 - art. 6 () JORF 27 avril 2006", "@sens": "source", "@cidtexte": "JORFTEXT000000458901", "@nortexte": "SANP0524369D", "@numtexte": "2006-477", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2006-04-26" }, { "@id": "LEGIARTI000041817882", "@num": "12-4-3", "#text": "Décret n°2020-293 du 23 mars 2020 - art. 12-4-3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746694", "@nortexte": "SSAZ2008253D", "@numtexte": "2020-293", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041808807", "@num": "12-5", "#text": "Décret n°2020-293 du 23 mars 2020 - art. 12-5 (T)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746694", "@nortexte": "SSAZ2008253D", "@numtexte": "2020-293", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041808796", "@num": "1", "#text": "Décret n°2020-447 du 18 avril 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041808417", "@nortexte": "SSAZ2009990D", "@numtexte": "2020-447", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-04-18" }, { "@id": "LEGIARTI000041859132", "@num": "22", "#text": "Décret n°2020-545 du 11 mai 2020 - art. 22 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041858681", "@nortexte": "SSAZ2011567D", "@numtexte": "2020-545", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041866857", "@num": "24", "#text": "Décret n°2020-548 du 11 mai 2020 - art. 24 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041865329", "@nortexte": "SSAZ2011695D", "@numtexte": "2020-548", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041943340", "@num": "55", "#text": "Décret n°2020-663 du 31 mai 2020 - art. 55 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041939818", "@nortexte": "SSAZ2013547D", "@numtexte": "2020-663", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-31" }, { "@id": "LEGIARTI000042107249", "@num": "34", "#text": "Arrêté du 10 juillet 2020 - art. 34 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042431415", "@num": "55", "#text": "Décret n°2020-1262 du 16 octobre 2020 - art. 55 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042430554", "@nortexte": "SSAZ2028015D", "@numtexte": "2020-1262", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-10-16" }, { "@id": "LEGIARTI000042477838", "@num": "53", "#text": "Décret n°2020-1310 du 29 octobre 2020 - art. 53 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042475143", "@nortexte": "SSAZ2029612D", "@numtexte": "2020-1310", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-10-29" }, { "@id": "LEGIARTI000043770208", "@num": "40", "#text": "Arrêté du 1er juin 2021 - art. 40 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000044379674", "@num": "2", "#text": "Décret n°2021-1531 du 26 novembre 2021 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000044378143", "@nortexte": "SSAP2124720D", "@numtexte": "2021-1531", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-11-26" }, { "@id": "LEGIARTI000006800301", "@num": "R5142-11", "#text": "Code de la santé publique - art. R5142-11 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique R5142-11", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006190669", "@fin": "2999-01-01", "#text": "Section 10 : Importation et exportation", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178649", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161012", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006914853", "@fin": "2006-04-27", "@num": "R5121-108", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006914854", "@fin": "2008-09-05", "@num": "R5121-108", "@etat": "MODIFIE", "@debut": "2006-04-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000019425512", "@fin": "2012-05-01", "@num": "R5121-108", "@etat": "MODIFIE", "@debut": "2008-09-05", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025787983", "@fin": "2013-01-21", "@num": "R5121-108", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026968549", "@fin": "2016-02-26", "@num": "R5121-108", "@etat": "MODIFIE", "@debut": "2013-01-21", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000032106017", "@fin": "2016-11-18", "@num": "R5121-108", "@etat": "MODIFIE", "@debut": "2016-02-26", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000033418568", "@fin": "2021-07-01", "@num": "R5121-108", "@etat": "MODIFIE", "@debut": "2016-11-18", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000043761918", "@fin": "2022-01-01", "@num": "R5121-108", "@etat": "MODIFIE", "@debut": "2021-07-01", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000044944601", "@fin": "2999-01-01", "@num": "R5121-108", "@etat": "VIGUEUR", "@debut": "2022-01-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Tout médicament qui n'est pas pourvu de l'autorisation de mise sur le marché mentionnée à l'article L. 5121-8 ou de l'autorisation temporaire d'utilisation mentionnée au b de l'article L. 5121-12 accordée pour des médicaments importés ou de l'enregistrement mentionné à l'article L. 5121-13 ou qui n'est pas un médicament nécessaire à la réalisation d'une recherche biomédicale qui a fait l'objet d'une autorisation au sens de l'article L. 1123-8 fait l'objet, avant son importation dans le territoire douanier, d'une autorisation d'importation délivrée par le directeur général de l'Agence française de sécurité sanitaire des produits de santé, soit dans les conditions prévues aux articles R. 5121-109 à R. 5121-114, soit au titre de l'autorisation d'importation parallèle définie aux articles R. 5121-115 et suivants. Cette autorisation peut être refusée si le médicament présente ou est susceptible de présenter un risque pour la santé publique et, pour le médicament nécessaire à la réalisation d'une recherche biomédicale, si la recherche biomédicale a fait l'objet d'un refus d'autorisation.
\n
" } }, "LEGIARTI000006915366": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5126-58", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2007-10-05", "DATE_DEBUT": "2004-08-08" } }, "META_COMMUN": { "ID": "LEGIARTI000006915366", "URL": "article/LEGI/ARTI/00/00/06/91/53/LEGIARTI000006915366.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "YXXXXXXXXXX5126R0580XX0A" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006268574", "@num": "2", "#text": "Décret n°2007-1428 du 3 octobre 2007 - art. 2 () JORF 5 octobre 2007", "@sens": "source", "@cidtexte": "JORFTEXT000000252151", "@nortexte": "SJSH0762293D", "@numtexte": "2007-1428", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-10-03" }, { "@id": "LEGIARTI000044379674", "@num": "2", "#text": "Décret n°2021-1531 du 26 novembre 2021 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000044378143", "@nortexte": "SSAP2124720D", "@numtexte": "2021-1531", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-11-26" }, { "@id": "LEGIARTI000006799866", "@num": "R5104-61", "#text": "Code de la santé publique - art. R5104-61 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799865", "@num": "R5104-61", "#text": "Code de la santé publique - art. R5104-61 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915280", "@num": "R5126-16", "#text": "Code de la santé publique - art. R5126-16 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915287", "@num": "R5126-19", "#text": "Code de la santé publique - art. R5126-19 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006196596", "@fin": "2007-10-05", "#text": "Sous-section 3 : Conditions de l'autorisation.", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190698", "@fin": "2007-10-05", "#text": "Section 2 : Structures d'hospitalisation à domicile", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178654", "@fin": "2019-05-24", "#text": "Chapitre VI : Pharmacies à usage intérieur", "@debut": "2004-08-08" }, { "@id": "LEGISCTA000038598203", "@fin": "2999-01-01", "#text": "Chapitre VI", "@debut": "2019-05-24" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161012", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006915366", "@fin": "2007-10-05", "@num": "R5126-58", "@etat": "ABROGE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000038597543", "@fin": "2021-11-29", "@num": "R5126-58", "@etat": "MODIFIE", "@debut": "2019-05-24", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000044381797", "@fin": "2999-01-01", "@num": "R5126-58", "@etat": "VIGUEUR", "@debut": "2021-11-29", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
L'autorisation est délivrée par le directeur de l'agence régionale de l'hospitalisation. Les articles R. 5126-16, à l'exception des troisième et cinquième alinéas, R. 5126-17 et R. 5126-18 sont applicables aux pharmacies à usage intérieur des structures d'hospitalisation à domicile.
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L'autorisation mentionne le lieu d'implantation de la pharmacie, la zone géographique desservie ainsi que le nombre de patients concernés.
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L'article R. 5126-19 est applicable aux demandes de modification des pharmacies à usage intérieur des structures d'hospitalisation à domicile.
" } }, "LEGIARTI000006915368": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5126-60", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2007-10-05", "DATE_DEBUT": "2004-08-08" } }, "META_COMMUN": { "ID": "LEGIARTI000006915368", "URL": "article/LEGI/ARTI/00/00/06/91/53/LEGIARTI000006915368.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "YXXXXXXXXXX5126R0600XX0A" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006268574", "@num": "2", "#text": "Décret n°2007-1428 du 3 octobre 2007 - art. 2 () JORF 5 octobre 2007", "@sens": "source", "@cidtexte": "JORFTEXT000000252151", "@nortexte": "SJSH0762293D", "@numtexte": "2007-1428", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-10-03" }, { "@id": "LEGIARTI000044379674", "@num": "2", "#text": "Décret n°2021-1531 du 26 novembre 2021 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000044378143", "@nortexte": "SSAP2124720D", "@numtexte": "2021-1531", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-11-26" }, { "@id": "LEGIARTI000006690090", "@num": "L5126-10", "#text": "Code de la santé publique - art. L5126-10 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799871", "@num": "R5104-63", "#text": "Code de la santé publique - art. R5104-63 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799871", "@num": "R5104-63", "#text": "Code de la santé publique - art. R5104-63 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915293", "@num": "R5126-22", "#text": "Code de la santé publique - art. R5126-22 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049902774", "@num": "R160-8", "#text": "Code de la sécurité sociale. - art. R160-8 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006196596", "@fin": "2007-10-05", "#text": "Sous-section 3 : Conditions de l'autorisation.", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190698", "@fin": "2007-10-05", "#text": "Section 2 : Structures d'hospitalisation à domicile", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178654", "@fin": "2019-05-24", "#text": "Chapitre VI : Pharmacies à usage intérieur", "@debut": "2004-08-08" }, { "@id": "LEGISCTA000038598203", "@fin": "2999-01-01", "#text": "Chapitre VI", "@debut": "2019-05-24" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161012", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006915368", "@fin": "2007-10-05", "@num": "R5126-60", "@etat": "ABROGE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000038597534", "@fin": "2021-07-01", "@num": "R5126-60", "@etat": "MODIFIE", "@debut": "2019-05-24", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000043761776", "@fin": "2021-11-29", "@num": "R5126-60", "@etat": "MODIFIE", "@debut": "2021-07-01", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000044381781", "@fin": "2999-01-01", "@num": "R5126-60", "@etat": "VIGUEUR", "@debut": "2021-11-29", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Pour l'application de l'article L. 5126-10, les dispositions de l'article R. 5126-22 sont applicables aux structures d'hospitalisation à domicile.
\n
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Tout médicament qui n'est pas pourvu de l'autorisation de mise sur le marché mentionnée à l'article L. 5121-8 ou de l'autorisation temporaire d'utilisation mentionnée au b de l'article L. 5121-12 accordée pour des médicaments importés ou de l'enregistrement mentionné à l'article L. 5121-13 ou de l'autorisation mentionnée au 12° ou au 13° de l'article L. 5121-1 ou qui n'est pas un médicament nécessaire à la réalisation d'une recherche biomédicale qui a fait l'objet d'une autorisation au sens de l'article L. 1123-8 fait l'objet, avant son importation dans le territoire douanier, d'une autorisation d'importation délivrée par le directeur général de l'Agence française de sécurité sanitaire des produits de santé, soit dans les conditions prévues aux articles R. 5121-109 à R. 5121-114, soit au titre de l'autorisation d'importation parallèle définie aux articles R. 5121-115 et suivants. Cette autorisation peut être refusée si le médicament présente ou est susceptible de présenter un risque pour la santé publique et, pour le médicament nécessaire à la réalisation d'une recherche biomédicale, si la recherche biomédicale a fait l'objet d'un refus d'autorisation.
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Tout médicament qui n'est pas pourvu de l'autorisation de mise sur le marché mentionnée à l'article L. 5121-8 ou de l'autorisation temporaire d'utilisation mentionnée au b de l'article L. 5121-12 accordée pour des médicaments importés ou de l'enregistrement mentionné à l'article L. 5121-13 ou de l'autorisation mentionnée au 12° ou au 13° de l'article L. 5121-1 ou qui n'est pas un médicament nécessaire à la réalisation d'une recherche biomédicale qui a fait l'objet d'une autorisation au sens de l'article L. 1123-8 fait l'objet, avant son importation dans le territoire douanier, d'une autorisation d'importation délivrée par le directeur général de l'Agence nationale de sécurité du médicament et des produits de santé, soit dans les conditions prévues aux articles R. 5121-109 à R. 5121-114, soit au titre de l'autorisation d'importation parallèle définie aux articles R. 5121-115 et suivants. Cette autorisation peut être refusée si le médicament présente ou est susceptible de présenter un risque pour la santé publique et, pour le médicament nécessaire à la réalisation d'une recherche biomédicale, si la recherche biomédicale a fait l'objet d'un refus d'autorisation.

" } }, "LEGIARTI000026968549": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5121-108", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2016-02-26", "DATE_DEBUT": "2013-01-21" } }, "META_COMMUN": { "ID": "LEGIARTI000026968549", "URL": "article/LEGI/ARTI/00/00/26/96/85/LEGIARTI000026968549.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000026957342", "@num": "2", "#text": "Décret n°2013-66\n du 18 janvier 2013 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000026955060", "@nortexte": "AFSP1230835D", "@numtexte": "2013-66", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2013-01-18" }, { "@id": "LEGIARTI000041817882", "@num": "12-4-3", "#text": "Décret n°2020-293 du 23 mars 2020 - art. 12-4-3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746694", "@nortexte": "SSAZ2008253D", "@numtexte": "2020-293", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041808807", "@num": "12-5", "#text": "Décret n°2020-293 du 23 mars 2020 - art. 12-5 (T)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746694", "@nortexte": "SSAZ2008253D", "@numtexte": "2020-293", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041808796", "@num": "1", "#text": "Décret n°2020-447 du 18 avril 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041808417", "@nortexte": "SSAZ2009990D", "@numtexte": "2020-447", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-04-18" }, { "@id": "LEGIARTI000041859132", "@num": "22", "#text": "Décret n°2020-545 du 11 mai 2020 - art. 22 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041858681", "@nortexte": "SSAZ2011567D", "@numtexte": "2020-545", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041866857", "@num": "24", "#text": "Décret n°2020-548 du 11 mai 2020 - art. 24 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041865329", "@nortexte": "SSAZ2011695D", "@numtexte": "2020-548", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041943340", "@num": "55", "#text": "Décret n°2020-663 du 31 mai 2020 - art. 55 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041939818", "@nortexte": "SSAZ2013547D", "@numtexte": "2020-663", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-31" }, { "@id": "LEGIARTI000042107249", "@num": "34", "#text": "Arrêté du 10 juillet 2020 - art. 34 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042431415", "@num": "55", "#text": "Décret n°2020-1262 du 16 octobre 2020 - art. 55 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042430554", "@nortexte": "SSAZ2028015D", "@numtexte": "2020-1262", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-10-16" }, { "@id": "LEGIARTI000042477838", "@num": "53", "#text": "Décret n°2020-1310 du 29 octobre 2020 - art. 53 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042475143", "@nortexte": "SSAZ2029612D", "@numtexte": "2020-1310", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-10-29" }, { "@id": "LEGIARTI000043770208", "@num": "40", "#text": "Arrêté du 1er juin 2021 - art. 40 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000044379674", "@num": "2", "#text": "Décret n°2021-1531 du 26 novembre 2021 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000044378143", "@nortexte": "SSAP2124720D", "@numtexte": "2021-1531", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-11-26" }, { "@id": "LEGIARTI000006685883", "@num": "L1123-8", "#text": "Code de la santé publique - art. L1123-8", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689870", "@num": "L5121-1", "#text": "Code de la santé publique - art. L5121-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689900", "@num": "L5121-12", "#text": "Code de la santé publique - art. L5121-12 (VT)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689904", "@num": "L5121-13", "#text": "Code de la santé publique - art. L5121-13 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689889", "@num": "L5121-8", "#text": "Code de la santé publique - art. L5121-8", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914855", "@num": "R5121-109", "#text": "Code de la santé publique - art. R5121-109", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914863", "@num": "R5121-115", "#text": "Code de la santé publique - art. R5121-115", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800301", "@num": "R5142-11", "#text": "Code de la santé publique - art. R5142-11 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique R5142-11", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006190669", "@fin": "2999-01-01", "#text": "Section 10 : Importation et exportation", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178649", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161012", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006914853", "@fin": "2006-04-27", "@num": "R5121-108", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006914854", "@fin": "2008-09-05", "@num": "R5121-108", "@etat": "MODIFIE", "@debut": "2006-04-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000019425512", "@fin": "2012-05-01", "@num": "R5121-108", "@etat": "MODIFIE", "@debut": "2008-09-05", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025787983", "@fin": "2013-01-21", "@num": "R5121-108", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026968549", "@fin": "2016-02-26", "@num": "R5121-108", "@etat": "MODIFIE", "@debut": "2013-01-21", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000032106017", "@fin": "2016-11-18", "@num": "R5121-108", "@etat": "MODIFIE", "@debut": "2016-02-26", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000033418568", "@fin": "2021-07-01", "@num": "R5121-108", "@etat": "MODIFIE", "@debut": "2016-11-18", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000043761918", "@fin": "2022-01-01", "@num": "R5121-108", "@etat": "MODIFIE", "@debut": "2021-07-01", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000044944601", "@fin": "2999-01-01", "@num": "R5121-108", "@etat": "VIGUEUR", "@debut": "2022-01-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Tout médicament qui n'est pas pourvu de l'autorisation de mise sur le marché mentionnée à l'article L. 5121-8 ou de l'autorisation temporaire d'utilisation mentionnée à l'article L. 5121-12 ou de l'enregistrement mentionné à l'article L. 5121-13 ou de l'autorisation mentionnée au 12° ou au 13° de l'article L. 5121-1 ou qui n'est pas un médicament nécessaire à la réalisation d'une recherche biomédicale qui a fait l'objet d'une autorisation au sens de l'article L. 1123-8 fait l'objet, avant son importation dans le territoire douanier, d'une autorisation d'importation délivrée par le directeur général de l'Agence nationale de sécurité du médicament et des produits de santé, soit dans les conditions prévues aux articles R. 5121-109 à R. 5121-114, soit au titre de l'autorisation d'importation parallèle définie aux articles R. 5121-115 et suivants. Cette autorisation peut être refusée si le médicament présente ou est susceptible de présenter un risque pour la santé publique et, pour le médicament nécessaire à la réalisation d'une recherche biomédicale, si la recherche biomédicale a fait l'objet d'un refus d'autorisation.

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\n
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Les dispositions de l'alinéa précédent ne sont pas applicables en cas de transit ou d'emprunt du territoire douanier.

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Tout médicament qui n'est pas pourvu de l'autorisation de mise sur le marché mentionnée à l'article L. 5121-8 ou de l'autorisation temporaire d'utilisation mentionnée à l'article L. 5121-12 ou de l'enregistrement mentionné à l'article L. 5121-13 ou de l'autorisation mentionnée au 12° ou au 13° de l'article L. 5121-1 ou qui n'est pas un médicament nécessaire à la réalisation d'une recherche impliquant la personne humaine qui a fait l'objet d'une autorisation au sens de l'article L. 1123-8 fait l'objet, avant son importation dans le territoire douanier, d'une autorisation d'importation délivrée par le directeur général de l'Agence nationale de sécurité du médicament et des produits de santé, soit dans les conditions prévues aux articles R. 5121-109 à R. 5121-114, soit au titre de l'autorisation d'importation parallèle définie aux articles R. 5121-115 et suivants. Cette autorisation peut être refusée si le médicament présente ou est susceptible de présenter un risque pour la santé publique et, pour le médicament nécessaire à la réalisation d'une recherche impliquant la personne humaine, si la recherche impliquant la personne humaine a fait l'objet d'un refus d'autorisation.

\n
\n

Les dispositions de l'alinéa précédent ne sont pas applicables en cas de transit ou d'emprunt du territoire douanier.

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Sont réputées inscrites sur la liste prévue au 1° de l'article L. 5126-6 les catégories suivantes de médicaments :
\n
\n 1° Les médicaments bénéficiant d'une autorisation temporaire d'utilisation et qui ne sont pas classés dans la catégorie de médicaments réservés à l'usage hospitalier ;
\n
\n 2° Les médicaments ayant fait l'objet d'une autorisation temporaire d'utilisation mentionnée à l'article L. 5121-12, qui bénéficient des dispositions de l'article L. 162-16-5-2 du code de la sécurité sociale et qui ne sont pas classés dans la catégorie de médicaments réservés à l'usage hospitalier ;
\n
\n 3° Les préparations hospitalières mentionnées au 2° de l'article L. 5121-1 du présent code faisant l'objet d'une prescription initiale effectuée par un médecin répondant aux conditions prévues par l'article R. 5121-88 ;
\n
\n 4° Les préparations magistrales mentionnées au 1° de l'article L. 5121-1 réalisées dans un établissement de santé et faisant l'objet d'une prescription initiale effectuée par un médecin répondant aux conditions prévues par l'article R. 5121-88 ;
\n
\n 5° Les médicaments bénéficiant d'une autorisation d'importation autre que celle mentionnée à l'article R. 5121-116 et qui ne sont pas classés dans la catégorie de médicaments réservés à l'usage hospitalier ;
\n
\n 6° Les médicaments mentionnés à l'article L. 5111-4 en rupture ou en risque de rupture d'approvisionnement autorisés à être vendus au public et au détail conformément à l'article L. 5121-30.

\n
\n
" } }, "LEGIARTI000038597543": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5126-58", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2021-11-29", "DATE_DEBUT": "2019-05-24" } }, "META_COMMUN": { "ID": "LEGIARTI000038597543", "URL": "article/LEGI/ARTI/00/00/38/59/75/LEGIARTI000038597543.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000787339", "#text": "Décret n°2004-802 du 29 juillet 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000038542763", "@num": "1", "#text": "Décret n°2019-489 du 21 mai 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000038496476", "@nortexte": "SSAH1815249D", "@numtexte": "2019-489", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2019-05-21" }, { "@id": "LEGIARTI000044379674", "@num": "2", "#text": "Décret n°2021-1531 du 26 novembre 2021 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000044378143", "@nortexte": "SSAP2124720D", "@numtexte": "2021-1531", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-11-26" }, { "@id": "LEGIARTI000006799866", "@num": "R5104-61", "#text": "Code de la santé publique - art. R5104-61 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799865", "@num": "R5104-61", "#text": "Code de la santé publique - art. R5104-61 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915280", "@num": "R5126-16", "#text": "Code de la santé publique - art. R5126-16", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915287", "@num": "R5126-19", "#text": "Code de la santé publique - art. R5126-19", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000030076895", "@fin": "2019-05-24", "#text": "Section 3 : Dispositions communes à l'ensemble des pharmacies à usage intérieur", "@debut": "2016-09-01" }, { "@id": "LEGISCTA000038597562", "@fin": "2021-11-29", "#text": "Section 3 : Vente au public", "@debut": "2019-05-24" }, { "@id": "LEGISCTA000044381832", "@fin": "2999-01-01", "#text": "Section 3 : Dispensation au public", "@debut": "2021-11-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178654", "@fin": "2019-05-24", "#text": "Chapitre VI : Pharmacies à usage intérieur", "@debut": "2004-08-08" }, { "@id": "LEGISCTA000038598203", "@fin": "2999-01-01", "#text": "Chapitre VI", "@debut": "2019-05-24" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161012", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006915366", "@fin": "2007-10-05", "@num": "R5126-58", "@etat": "ABROGE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000038597543", "@fin": "2021-11-29", "@num": "R5126-58", "@etat": "MODIFIE", "@debut": "2019-05-24", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000044381797", "@fin": "2999-01-01", "@num": "R5126-58", "@etat": "VIGUEUR", "@debut": "2021-11-29", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Peuvent être inscrits sur la liste prévue au 1° de l'article L. 5126-6, dans l'intérêt des malades non hospitalisés, les médicaments dont la vente au public par la pharmacie à usage intérieur d'un établissement de santé se justifie pour des raisons tenant notamment à des contraintes de dispensation, d'administration, à la sécurité de l'approvisionnement ou à la nécessité d'effectuer un suivi de leur prescription ou de leur délivrance.

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Sont réputées inscrites sur la liste prévue au 1° de l'article L. 5126-6 les catégories suivantes de médicaments :
\n
\n1° Les médicaments bénéficiant d'une autorisation d'accès précoce, d'une autorisation d'accès compassionnel ou d'un cadre de prescription compassionnelle au sens des articles L. 5121-12 et L. 5121-12-1 et qui ne sont pas classés dans la catégorie de médicaments réservés à l'usage hospitalier ;
\n
\n2° (Abrogé)
\n
\n3° Les préparations hospitalières mentionnées au 2° de l'article L. 5121-1 du présent code faisant l'objet d'une prescription initiale effectuée par un médecin répondant aux conditions prévues par l'article R. 5121-88 ;
\n
\n4° Les préparations magistrales mentionnées au 1° de l'article L. 5121-1 réalisées dans un établissement de santé et faisant l'objet d'une prescription initiale effectuée par un médecin répondant aux conditions prévues par l'article R. 5121-88 ;
\n
\n5° Les médicaments bénéficiant d'une autorisation d'importation autre que celle mentionnée à l'article R. 5121-116 et qui ne sont pas classés dans la catégorie de médicaments réservés à l'usage hospitalier ;
\n
\n6° Les médicaments mentionnés à l'article L. 5111-4 en rupture ou en risque de rupture d'approvisionnement autorisés à être vendus au public et au détail conformément à l'article L. 5121-30.

" } }, "LEGIARTI000043761918": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5121-108", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2022-01-01", "DATE_DEBUT": "2021-07-01" } }, "META_COMMUN": { "ID": "LEGIARTI000043761918", "URL": "article/LEGI/ARTI/00/00/43/76/19/LEGIARTI000043761918.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Conformément à l’article 4 du décret n° 2021-869 du 30 juin 2021, ces dispositions entrent en vigueur le 1er juillet 2021 sous réserve des dispositions mentionnées au présent article.

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L1123-8", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689870", "@num": "L5121-1", "#text": "Code de la santé publique - art. L5121-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689900", "@num": "L5121-12", "#text": "Code de la santé publique - art. L5121-12", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689904", "@num": "L5121-13", "#text": "Code de la santé publique - art. L5121-13", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689889", "@num": "L5121-8", "#text": "Code de la santé publique - art. L5121-8", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914855", "@num": "R5121-109", "#text": "Code de la santé publique - art. R5121-109", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914863", "@num": "R5121-115", "#text": "Code de la santé publique - art. R5121-115", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800301", "@num": "R5142-11", "#text": "Code de la santé publique - art. R5142-11 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique R5142-11", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006190669", "@fin": "2999-01-01", "#text": "Section 10 : Importation et exportation", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178649", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161012", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006914853", "@fin": "2006-04-27", "@num": "R5121-108", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006914854", "@fin": "2008-09-05", "@num": "R5121-108", "@etat": "MODIFIE", "@debut": "2006-04-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000019425512", "@fin": "2012-05-01", "@num": "R5121-108", "@etat": "MODIFIE", "@debut": "2008-09-05", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025787983", "@fin": "2013-01-21", "@num": "R5121-108", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026968549", "@fin": "2016-02-26", "@num": "R5121-108", "@etat": "MODIFIE", "@debut": "2013-01-21", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000032106017", "@fin": "2016-11-18", "@num": "R5121-108", "@etat": "MODIFIE", "@debut": "2016-02-26", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000033418568", "@fin": "2021-07-01", "@num": "R5121-108", "@etat": "MODIFIE", "@debut": "2016-11-18", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000043761918", "@fin": "2022-01-01", "@num": "R5121-108", "@etat": "MODIFIE", "@debut": "2021-07-01", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000044944601", "@fin": "2999-01-01", "@num": "R5121-108", "@etat": "VIGUEUR", "@debut": "2022-01-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Tout médicament qui n'est pas pourvu de l'autorisation de mise sur le marché mentionnée à l'article L. 5121-8 ou de l'autorisation d'accès précoce au titre de l'article L. 5121-12 ou de l'autorisation d'accès compassionnel au titre du II de l'article L. 5121-12-1 mentionnée à l'article L. 5121-12 ou de l'enregistrement mentionné à l'article L. 5121-13 ou de l'autorisation mentionnée au 12° ou au 13° de l'article L. 5121-1 ou qui n'est pas un médicament nécessaire à la réalisation d'une recherche impliquant la personne humaine qui a fait l'objet d'une autorisation au sens de l'article L. 1123-8 fait l'objet, avant son importation dans le territoire douanier, d'une autorisation d'importation délivrée par le directeur général de l'Agence nationale de sécurité du médicament et des produits de santé, soit dans les conditions prévues aux articles R. 5121-109 à R. 5121-114, soit au titre de l'autorisation d'importation parallèle définie aux articles R. 5121-115 et suivants. Cette autorisation peut être refusée si le médicament présente ou est susceptible de présenter un risque pour la santé publique et, pour le médicament nécessaire à la réalisation d'une recherche impliquant la personne humaine, si la recherche impliquant la personne humaine a fait l'objet d'un refus d'autorisation.

Les dispositions de l'alinéa précédent ne sont pas applicables en cas de transit ou d'emprunt du territoire douanier.

" } }, "LEGIARTI000044381135": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R163-9-1", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2021-11-29" } }, "META_COMMUN": { "ID": "LEGIARTI000044381135", "URL": "article/LEGI/ARTI/00/00/44/38/11/LEGIARTI000044381135.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000044379674", "@num": "2", "#text": "Décret n°2021-1531 du 26 novembre 2021 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000044378143", "@nortexte": "SSAP2124720D", "@numtexte": "2021-1531", "@typelien": "CREE", "@naturetexte": "DECRET", "@datesignatexte": "2021-11-26" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006173275", "@fin": "2999-01-01", "#text": "Section 1 : Prise en charge par les organismes de sécurité sociale - Liste des médicaments remboursables - Liste des médicaments agréés.", "@debut": "1985-12-21" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006156530", "@fin": "2999-01-01", "#text": "Chapitre 3 : Médicaments remboursables et médicaments agréés pour les collectivités", "@debut": "1985-12-21" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006141849", "@fin": "2999-01-01", "#text": "Titre VI : Dispositions relatives aux prestations et aux soins - Contrôle médical - Tutelle aux prestations sociales", "@debut": "1985-12-21" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006126950", "@fin": "2999-01-01", "#text": "Livre I : Généralités - Dispositions communes à tout ou partie des régimes de base", "@debut": "1985-12-21" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006106085", "@fin": "2999-01-01", "#text": "Partie réglementaire - Décrets en Conseil d'Etat", "@debut": "1961-01-12" } ] }, "@cid": "LEGITEXT000006073189", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la sécurité sociale", "@debut": "1958-10-16", "@id_txt": "LEGITEXT000006073189", "@c_titre_court": "Code de la sécurité sociale." } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000044381135", "@fin": "2999-01-01", "@num": "R163-9-1", "@etat": "VIGUEUR", "@debut": "2021-11-29", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

I.-Le remboursement ou la prise en charge des médicaments inscrits en application des 1° ou 2° de la liste mentionnée à l'article R. 5126-58 du code de la santé publique est effectué sur la base de leur prix de cession déterminé dans les conditions définies à l'article L. 162-16-5 et à l'article R. 160-5 du présent code.
\n
\nLes ministres chargés de la santé et de la sécurité sociale déterminent les conditions de prise en charge de ces médicaments en application des conditions énoncées au troisième alinéa de l'article L. 162-17.
\n
\nII.-Lorsqu'un médicament mentionné au I figure également sur la liste des médicaments remboursables aux assurés sociaux en application de l'article L. 162-17, le taux de participation de l'assuré est le même dans les deux cas.

" } }, "LEGIARTI000044381137": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R163-9-2", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2021-11-29" } }, "META_COMMUN": { "ID": "LEGIARTI000044381137", "URL": "article/LEGI/ARTI/00/00/44/38/11/LEGIARTI000044381137.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000044379674", "@num": "2", "#text": "Décret n°2021-1531 du 26 novembre 2021 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000044378143", "@nortexte": "SSAP2124720D", "@numtexte": "2021-1531", "@typelien": "CREE", "@naturetexte": "DECRET", "@datesignatexte": "2021-11-26" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006173275", "@fin": "2999-01-01", "#text": "Section 1 : Prise en charge par les organismes de sécurité sociale - Liste des médicaments remboursables - Liste des médicaments agréés.", "@debut": "1985-12-21" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006156530", "@fin": "2999-01-01", "#text": "Chapitre 3 : Médicaments remboursables et médicaments agréés pour les collectivités", "@debut": "1985-12-21" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006141849", "@fin": "2999-01-01", "#text": "Titre VI : Dispositions relatives aux prestations et aux soins - Contrôle médical - Tutelle aux prestations sociales", "@debut": "1985-12-21" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006126950", "@fin": "2999-01-01", "#text": "Livre I : Généralités - Dispositions communes à tout ou partie des régimes de base", "@debut": "1985-12-21" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006106085", "@fin": "2999-01-01", "#text": "Partie réglementaire - Décrets en Conseil d'Etat", "@debut": "1961-01-12" } ] }, "@cid": "LEGITEXT000006073189", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la sécurité sociale", "@debut": "1958-10-16", "@id_txt": "LEGITEXT000006073189", "@c_titre_court": "Code de la sécurité sociale." } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000044381137", "@fin": "2999-01-01", "@num": "R163-9-2", "@etat": "VIGUEUR", "@debut": "2021-11-29", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

I.-Les préparations mentionnées aux 1° et 2° de l'article R. 5126-60 du code de la santé publique, réalisées et délivrées par la pharmacie à usage intérieur mentionnée à l'article R. 5126-56 du même code, sont facturées à l'assurance maladie et prises en charge sur la base du montant égal à leur coût de fabrication majoré de la marge forfaitaire mentionnée au I de l'article L. 162-16-5 du présent code, auquel est appliqué, le cas échéant la taxe sur la valeur ajoutée.
\n
\n Les dispositions du présent I ne sont pas applicables aux préparations magistrales et aux préparations hospitalières pour la nutrition parentérale à domicile dont les conditions de prise en charge sont prévues à l'article L. 162-16-4-2.
\n
\n II.-Les médicaments faisant l'objet, dans le cadre d'une rupture de stock, d'un risque de rupture ou d'un arrêt de commercialisation, d'une autorisation d'importation mentionnée à l'article R. 5121-108 du code de la santé publique, inscrits sur la liste mentionnée à l'article R. 5126-59 du même code dans une indication considérée, sont facturés à l'assurance maladie et pris en charge s'ils ont vocation à remplacer un médicament qui figure sur l'une des listes de remboursement mentionnées à l'article L. 162-17 du présent code dans l'indication considérée et s'ils sont délivrés par une pharmacie à usage intérieur mentionnée au I.
\n
\n En ce cas, ils sont facturés sur la base du montant égal au prix d'achat du médicament par l'établissement de santé majoré de la marge forfaitaire mentionnée au I de l'article L. 162-16-5, auquel est appliqué, le cas échéant la taxe sur la valeur ajoutée.
\n
\n III.-Les médicaments réputés inscrits en application du 3° de l'article R. 5126-60 du code de la santé publique sont facturés à l'assurance maladie et pris en charge, lorsqu'ils sont délivrés par une pharmacie à usage intérieur mentionnée au I, sur la base de leur prix fabricant hors taxes, lorsqu'ils figurent sur la liste mentionnée au premier alinéa de l'article L. 162-17 précité ou, à défaut, de leur prix d'achat par l'établissement de santé, majoré de la marge forfaitaire mentionnée au I de l'article L. 162-16-5. A ce montant est appliqué, le cas échéant, la taxe sur la valeur ajoutée.

" } }, "LEGIARTI000044381781": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5126-60", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2021-11-29" } }, "META_COMMUN": { "ID": "LEGIARTI000044381781", "URL": "article/LEGI/ARTI/00/00/44/38/17/LEGIARTI000044381781.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000787339", "#text": "Décret n°2004-802 du 29 juillet 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000044379672", "@num": "1", "#text": "Décret n°2021-1531 du 26 novembre 2021 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000044378143", "@nortexte": "SSAP2124720D", "@numtexte": "2021-1531", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2021-11-26" }, { "@id": "LEGIARTI000044379674", "@num": "2", "#text": "Décret n°2021-1531 du 26 novembre 2021 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000044378143", "@nortexte": "SSAP2124720D", "@numtexte": "2021-1531", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-11-26" }, { "@id": "LEGIARTI000006690090", "@num": "L5126-10", "#text": "Code de la santé publique - art. L5126-10", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799871", "@num": "R5104-63", "#text": "Code de la santé publique - art. R5104-63 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799871", "@num": "R5104-63", "#text": "Code de la santé publique - art. R5104-63 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915293", "@num": "R5126-22", "#text": "Code de la santé publique - art. R5126-22", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049902774", "@num": "R160-8", "#text": "Code de la sécurité sociale. - art. R160-8 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000030076895", "@fin": "2019-05-24", "#text": "Section 3 : Dispositions communes à l'ensemble des pharmacies à usage intérieur", "@debut": "2016-09-01" }, { "@id": "LEGISCTA000038597562", "@fin": "2021-11-29", "#text": "Section 3 : Vente au public", "@debut": "2019-05-24" }, { "@id": "LEGISCTA000044381832", "@fin": "2999-01-01", "#text": "Section 3 : Dispensation au public", "@debut": "2021-11-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178654", "@fin": "2019-05-24", "#text": "Chapitre VI : Pharmacies à usage intérieur", "@debut": "2004-08-08" }, { "@id": "LEGISCTA000038598203", "@fin": "2999-01-01", "#text": "Chapitre VI", "@debut": "2019-05-24" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161012", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006915368", "@fin": "2007-10-05", "@num": "R5126-60", "@etat": "ABROGE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000038597534", "@fin": "2021-07-01", "@num": "R5126-60", "@etat": "MODIFIE", "@debut": "2019-05-24", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000043761776", "@fin": "2021-11-29", "@num": "R5126-60", "@etat": "MODIFIE", "@debut": "2021-07-01", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000044381781", "@fin": "2999-01-01", "@num": "R5126-60", "@etat": "VIGUEUR", "@debut": "2021-11-29", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Sont réputés inscrits au titre de la liste mentionnée à l'article R. 5126-58 :
\n
\n 1° Les préparations hospitalières mentionnées au 2° de l'article L. 5121-1 faisant l'objet d'une prescription initiale effectuée par un médecin répondant aux conditions prévues par l'article R. 5121-88 ;
\n
\n 2° Les préparations magistrales mentionnées au 1° de l'article L. 5121-1 réalisées dans un établissement de santé et faisant l'objet d'une prescription initiale effectuée par un médecin répondant aux conditions prévues par l'article R. 5121-88 ;
\n
\n 3° Les médicaments mentionnés à l'article L. 5111-4 en rupture ou en risque de rupture d'approvisionnement autorisés à être dispensés au public conformément à l'article L. 5121-30 ;
\n
\n 4° Les autres médicaments mentionnés au deuxième alinéa du 1° de l'article L. 5126-6.

" } }, "LEGIARTI000044381797": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5126-58", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2021-11-29" } }, "META_COMMUN": { "ID": "LEGIARTI000044381797", "URL": "article/LEGI/ARTI/00/00/44/38/17/LEGIARTI000044381797.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000787339", "#text": "Décret n°2004-802 du 29 juillet 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000044379672", "@num": "1", "#text": "Décret n°2021-1531 du 26 novembre 2021 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000044378143", "@nortexte": "SSAP2124720D", "@numtexte": "2021-1531", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2021-11-26" }, { "@id": "LEGIARTI000044379674", "@num": "2", "#text": "Décret n°2021-1531 du 26 novembre 2021 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000044378143", "@nortexte": "SSAP2124720D", "@numtexte": "2021-1531", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-11-26" }, { "@id": "LEGIARTI000006799866", "@num": "R5104-61", "#text": "Code de la santé publique - art. R5104-61 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799865", "@num": "R5104-61", "#text": "Code de la santé publique - art. R5104-61 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915280", "@num": "R5126-16", "#text": "Code de la santé publique - art. R5126-16", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915287", "@num": "R5126-19", "#text": "Code de la santé publique - art. R5126-19", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000030076895", "@fin": "2019-05-24", "#text": "Section 3 : Dispositions communes à l'ensemble des pharmacies à usage intérieur", "@debut": "2016-09-01" }, { "@id": "LEGISCTA000038597562", "@fin": "2021-11-29", "#text": "Section 3 : Vente au public", "@debut": "2019-05-24" }, { "@id": "LEGISCTA000044381832", "@fin": "2999-01-01", "#text": "Section 3 : Dispensation au public", "@debut": "2021-11-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178654", "@fin": "2019-05-24", "#text": "Chapitre VI : Pharmacies à usage intérieur", "@debut": "2004-08-08" }, { "@id": "LEGISCTA000038598203", "@fin": "2999-01-01", "#text": "Chapitre VI", "@debut": "2019-05-24" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161012", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006915366", "@fin": "2007-10-05", "@num": "R5126-58", "@etat": "ABROGE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000038597543", "@fin": "2021-11-29", "@num": "R5126-58", "@etat": "MODIFIE", "@debut": "2019-05-24", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000044381797", "@fin": "2999-01-01", "@num": "R5126-58", "@etat": "VIGUEUR", "@debut": "2021-11-29", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Relèvent de la liste mentionnée au 1° de l'article L. 5126-6, les médicaments :
\n
\n 1° Inscrits à l'initiative du directeur général de l'Agence nationale de sécurité du médicament et des produits de santé, pour des raisons de santé publique dans l'intérêt des patients non hospitalisés, lorsque leur dispensation au public par la pharmacie à usage intérieur d'un établissement de santé se justifie pour des raisons tenant à des contraintes de dispensation, d'administration, à la sécurité de l'approvisionnement ou à la nécessité d'effectuer un suivi de leur prescription ou de leur délivrance ;
\n
\n 2° Inscrits d'office, par le directeur général de l'Agence nationale de sécurité du médicament et des produits de santé sur demande des ministres chargés de la santé et de la sécurité sociale ;
\n
\n 3° Réputés inscrits, dans les conditions prévues à l'article R. 5126-60.

" } }, "LEGIARTI000044381862": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R160-8", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2024-09-01", "DATE_DEBUT": "2021-11-29" } }, "META_COMMUN": { "ID": "LEGIARTI000044381862", "URL": "article/LEGI/ARTI/00/00/44/38/18/LEGIARTI000044381862.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000869923", "#text": "Décret n°56-284 du 9 mars 1956", "@sens": "source", "@cidtexte": "JORFTEXT000000869923", "@numtexte": "56-284", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1956-03-09" }, { "@id": "LEGIARTI000048874948", "@num": "14", "#text": "Décret n°2004-942 du 3 septembre 2004 - art. 14 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000253592", "@nortexte": "SANS0422327D", "@numtexte": "2004-942", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-09-03" }, { "@id": "LEGIARTI000036884649", "@num": "1", "#text": "Arrêté du 29 septembre 2006 - art. 1 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000000460656", "@nortexte": "SANP0623877A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-09-29" }, { "@id": "LEGIARTI000042240130", "@num": "2", "#text": "Arrêté du 29 septembre 2006 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000460656", "@nortexte": "SANP0623877A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-09-29" }, { "@id": "LEGIARTI000041976638", "@num": "4", "#text": "Arrêté du 23 mars 2020 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041891834", "@num": "5-2", "#text": "Arrêté du 23 mars 2020 - art. 5-2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041760851", "@num": "12-2", "#text": "Décret n°2020-293 du 23 mars 2020 - art. 12-2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746694", "@nortexte": "SSAZ2008253D", "@numtexte": "2020-293", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041798075", "@num": "12-3", "#text": "Décret n°2020-293 du 23 mars 2020 - art. 12-3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746694", "@nortexte": "SSAZ2008253D", "@numtexte": "2020-293", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041764942", "@num": "1", "#text": "Décret n°2020-360 du 28 mars 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041763328", "@nortexte": "SSAZ2008744D", "@numtexte": "2020-360", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-28" }, { "@id": "LEGIARTI000041780846", "@num": "1", "#text": "Arrêté du 2 avril 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041780622", "@nortexte": "SSAZ2008988A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-04-02" }, { "@id": "LEGIARTI000041859124", "@num": "18", "#text": "Décret n°2020-545 du 11 mai 2020 - art. 18 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041858681", "@nortexte": "SSAZ2011567D", "@numtexte": "2020-545", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041866849", "@num": "20", "#text": "Décret n°2020-548 du 11 mai 2020 - art. 20 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041865329", "@nortexte": "SSAZ2011695D", "@numtexte": "2020-548", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041943334", "@num": "51", "#text": "Décret n°2020-663 du 31 mai 2020 - art. 51 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041939818", "@nortexte": "SSAZ2013547D", "@numtexte": "2020-663", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-31" }, { "@id": "LEGIARTI000042107245", "@num": "32", "#text": "Arrêté du 10 juillet 2020 - art. 32 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042107199", "@num": "9 EUS", "#text": "Arrêté du 10 juillet 2020 - art. 9 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042431413", "@num": "53", "#text": "Décret n°2020-1262 du 16 octobre 2020 - art. 53 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042430554", "@nortexte": "SSAZ2028015D", "@numtexte": "2020-1262", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-10-16" }, { "@id": "LEGIARTI000042477834", "@num": "51", "#text": "Décret n°2020-1310 du 29 octobre 2020 - art. 51 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042475143", "@nortexte": "SSAZ2029612D", "@numtexte": "2020-1310", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-10-29" }, { "@id": "LEGIARTI000043577326", "@num": "38", "#text": "Arrêté du 1er juin 2021 - art. 38 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000044379674", "@num": "2", "#text": "Décret n°2021-1531 du 26 novembre 2021 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000044378143", "@nortexte": "SSAP2124720D", "@numtexte": "2021-1531", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2021-11-26" }, { "@id": "LEGIARTI000049967627", "@num": "6", "#text": "Décret n°2024-795 du 8 juillet 2024 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000049962633", "@nortexte": "TSSP2329890D", "@numtexte": "2024-795", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-07-08" }, { "@id": "LEGITEXT000050071786", "#text": "Arrêté du 31 juillet 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000050069566", "@nortexte": "TSSP2420387A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-07-31" }, { "@id": "LEGIARTI000006686921", "@num": "L1411-6", "#text": "Code de la santé publique - art. L1411-6", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689900", "@num": "L5121-12", "#text": "Code de la santé publique - art. L5121-12", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690082", "@num": "L5126-6", "#text": "Code de la santé publique - art. L5126-6", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915368", "@num": "R5126-60", "#text": "Code de la santé publique - art. R5126-60", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049979574", "@num": "R1125-30", "#text": "Code de la santé publique - art. R1125-30 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049975924", "@num": "R1126-30", "#text": "Code de la santé publique - art. R1126-30 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000031813563", "@num": "D325-7", "#text": "Code de la sécurité sociale. - art. D325-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000031670012", "@num": "L160-13", "#text": "Code de la sécurité sociale. - art. L160-13", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000031670469", "@num": "L160-14", "#text": "Code de la sécurité sociale. - art. L160-14", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006740841", "@num": "L162-16-1", "#text": "Code de la sécurité sociale. - art. L162-16-1", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006747664", "@num": "R163-15", "#text": "Code de la sécurité sociale. - art. R163-15", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049737602", "@num": "R163-18", "#text": "Code de la sécurité sociale. - art. R163-18 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000029924718", "@num": "R322-2", "#text": "Code de la sécurité sociale. - art. R322-2 (T)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000031795495", "@fin": "2999-01-01", "#text": "Sous-section 1 : Montant de la participation de l'assuré", "@debut": "2016-01-01" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000031795488", "@fin": "2999-01-01", "#text": "Section 3 : Participation de l'assuré social", "@debut": "2016-01-01" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000031795455", "@fin": "2999-01-01", "#text": "Chapitre préliminaire : Dispositions relatives à la prise en charge des frais de santé", "@debut": "2016-01-01" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006141849", "@fin": "2999-01-01", "#text": "Titre VI : Dispositions relatives aux prestations et aux soins - Contrôle médical - Tutelle aux prestations sociales", "@debut": "1985-12-21" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006126950", "@fin": "2999-01-01", "#text": "Livre I : Généralités - Dispositions communes à tout ou partie des régimes de base", "@debut": "1985-12-21" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006106085", "@fin": "2999-01-01", "#text": "Partie réglementaire - Décrets en Conseil d'Etat", "@debut": "1961-01-12" } ] }, "@cid": "LEGITEXT000006073189", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la sécurité sociale", "@debut": "1958-10-16", "@id_txt": "LEGITEXT000006073189", "@c_titre_court": "Code de la sécurité sociale." } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000031796687", "@fin": "2019-01-01", "@num": "R160-8", "@etat": "MODIFIE", "@debut": "2016-01-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000037964511", "@fin": "2019-05-24", "@num": "R160-8", "@etat": "MODIFIE", "@debut": "2019-01-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000038598306", "@fin": "2021-07-01", "@num": "R160-8", "@etat": "MODIFIE", "@debut": "2019-05-24", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000043762105", "@fin": "2021-11-29", "@num": "R160-8", "@etat": "MODIFIE", "@debut": "2021-07-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000044381862", "@fin": "2024-09-01", "@num": "R160-8", "@etat": "MODIFIE", "@debut": "2021-11-29", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000049902774", "@fin": "2999-01-01", "@num": "R160-8", "@etat": "VIGUEUR", "@debut": "2024-09-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

La participation de l'assuré prévue au I de l'article L. 160-13 est supprimée pour certains médicaments reconnus comme irremplaçables et particulièrement coûteux, figurant sur une liste établie par arrêté conjoint du ministre chargé de la santé et du ministre chargé de la sécurité sociale, après avis de la commission instituée par l'article R. 163-15 ainsi que pour l'honoraire de dispensation prévu au 7° de l'article L. 162-16-1 afférent à ces médicaments ou à l'ordonnance comportant un ou plusieurs de ces médicaments. Elle est également supprimée pour les frais d'examens de biologie médicale relatifs au dépistage sérologique de l'infection par le virus de l'immunodéficience humaine et par le virus de l'hépatite C. Il n'y a pas non plus de participation de l'assuré :
\n
\n 1° Pour les médicaments réputés inscrits au titre des 1° et 2° de l'article R. 5126-60 du code de la santé publique ainsi qu'au titre du 4° de ce même article, à l'exception, dans ce dernier cas, des médicaments faisant l'objet d'un cadre de prescription compassionnelle au sens de l'article L. 5121-12-1 du même code ;
\n
\n 2° Pour les médicaments faisant l'objet, dans le cadre d'une rupture de stock, d'un risque de rupture ou d'un arrêt de commercialisation, d'une autorisation d'importation délivrée en application de l'article R. 5121-108 du code de la santé publique, inscrits sur la liste en application du 1° de l'article R. 5126-59 de ce code.

La participation de l'assuré prévue au I de l'article L. 160-13 est également supprimée pour les frais d'examens de dépistage sous réserve que ces examens soient effectués dans le cadre des programmes mentionnés à l'article L. 1411-6 du code de la santé publique.

La participation de l'assuré en ce qui concerne les frais de transport n'est pas due lorsque l'état du bénéficiaire hospitalisé dans un établissement de soins nécessite son transfert vers un autre établissement d'hospitalisation en vue d'un traitement mieux adapté à cet état. Toutefois, cette disposition dérogatoire n'est pas applicable aux transports vers une maison de repos ou de convalescence, présentant les caractéristiques techniques définies à l'article premier de l'annexe XIX du décret n° 56-284 du 9 mars 1956.

La participation de l'assuré est supprimée pour les frais de transport mentionnés au 19° de l'article L. 160-14.

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Les dispositions de l'alinéa précédent ne sont pas applicables en cas de transit ou d'emprunt du territoire douanier.

L'autorisation d'importation prévue au premier alinéa indique, pour les médicaments soumis à un régime d'autorisation ou d'enregistrement et destinés à être mis sur le marché en France, le numéro national identifiant chacune des présentations du médicament, mentionné à l'article R. 5121-4 selon les modalités fixées par l'arrêté mentionné à cet article.

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Article 2 ENTIEREMENT_MODIF (Décret n° 2021-1531 du 26 novembre 2021 relatif au transfert à l'Agence nationale de sécurité du médicament et des produits de santé de la gestion de la liste mentionnée au 1° de l'article L. 5126-6 du code de la santé publique)