{ "article": { "LEGIARTI000029270949": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "1", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2014-07-23" } }, "META_COMMUN": { "ID": "LEGIARTI000029270949", "URL": "article/LEGI/ARTI/00/00/29/27/09/LEGIARTI000029270949.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@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" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000029270263", "@nor": "AFSP1416909A", "@nature": "ARRETE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Arrêté du 11 juillet 2014 portant classement sur la liste des substances vénéneuses", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000029270263", "@c_titre_court": "ARRÊTÉ du 11 juillet 2014" }, { "@fin": "2999-01-01", "#text": "Arrêté du 11 juillet 2014 portant classement sur la liste des substances vénéneuses", "@debut": "2014-07-23", "@id_txt": "LEGITEXT000029270946", "@c_titre_court": "ARRÊTÉ du 11 juillet 2014" } ], "@ministere": "Ministère des affaires sociales et de la santé", "@date_publi": "2014-07-22", "@date_signature": "2014-07-11" } }, "VERSIONS": { "VERSION": [ { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000029270949", "@fin": "2999-01-01", "@num": "1", "@etat": "VIGUEUR", "@debut": "2014-07-23", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000029270266", "@fin": "2999-01-01", "@num": "1", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

\n
Est classée sur la liste I des substances vénéneuses la spécialité pharmaceutique suivante, disposant de l'autorisation de mise sur le marché prévue à l'article L. 5121-8 du code de la santé publique et dont la substance active est l'extrait de Camellia sinensis (L.) O. Kuntze folium (feuille de thé vert) : VEREGEN 10 %, pommade.

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art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000768314", "@nortexte": "MESG0022611D", "@numtexte": "2000-1194", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2000-12-05" }, { "@id": "LEGIARTI000006724332", "@num": "3", "#text": "Décret n°2000-1194 du 5 décembre 2000 - art. 3 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000000768314", "@nortexte": "MESG0022611D", "@numtexte": "2000-1194", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2000-12-05" }, { "@id": "LEGITEXT000005631695", "#text": "Arrêté du 13 novembre 2001", "@sens": "cible", "@cidtexte": "JORFTEXT000000221792", "@nortexte": "MESG0123551A", "@typelien": "TXT_ASSOCIE", "@naturetexte": "ARRETE", "@datesignatexte": "2001-11-13" }, { "@id": "LEGIARTI000006334800", "@num": "1", "#text": "Arrêté du 13 novembre 2001 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000221792", "@nortexte": "MESG0123551A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2001-11-13" }, { "@id": "LEGIARTI000006334800", "@num": "1", "#text": "Arrêté du 13 novembre 2001 - 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art. 5 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000032093358", "@nortexte": "AFSP1604649A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-02-15" }, { "@id": "LEGIARTI000032096341", "@num": "6", "#text": "Arrêté du 15 février 2016 - art. 6 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000032093358", "@nortexte": "AFSP1604649A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-02-15" }, { "@id": "LEGIARTI000032096343", "@num": "7", "#text": "Arrêté du 15 février 2016 - art. 7 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000032093358", "@nortexte": "AFSP1604649A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-02-15" }, { "@id": "LEGIARTI000033122072", "@num": "4", "#text": "Arrêté du 8 septembre 2016 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033120953", "@nortexte": "AFSP1625292A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-09-08" }, { "@id": "LEGIARTI000036925433", "@num": "3", "#text": "Arrêté du 14 mai 2018 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036920946", "@nortexte": "SSAP1813104A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-05-14" }, { "@id": "LEGIARTI000036925435", "@num": "4", "#text": "Arrêté du 14 mai 2018 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036920946", "@nortexte": "SSAP1813104A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-05-14" }, { "@id": "LEGIARTI000037502021", "@num": "1", "#text": "Arrêté du 15 octobre 2018 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000037501422", "@nortexte": "SSAP1828085A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-10-15" }, { "@id": "LEGIARTI000037557939", "@num": "3", "#text": "Arrêté du 26 octobre 2018 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000037552934", "@nortexte": "SSAP1829446A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-10-26" }, { "@id": "LEGIARTI000038122113", "@num": "2", "#text": "Arrêté du 11 février 2019 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000038121150", "@nortexte": "SSAP1904422A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-02-11" }, { "@id": "LEGIARTI000038432466", "@num": "1", "#text": "Décret n°2019-389 du 30 avril 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000038431240", "@nortexte": "SSAS1906324D", "@numtexte": "2019-389", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-04-30" }, { "@id": "LEGIARTI000039157836", "@num": "2", "#text": "Arrêté du 26 septembre 2019 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000039146677", "@nortexte": "SSAP1927722A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-09-26" }, { "@id": "LEGIARTI000039373779", "@num": "1", "#text": "Arrêté du 5 novembre 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000039373247", "@nortexte": "SSAP1931830A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-11-05" }, { "@id": "LEGIARTI000041493923", "@num": "1", "#text": "Arrêté du 21 janvier 2020 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041459990", "@nortexte": "SSAP2001803A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-01-21" }, { "@id": "LEGIARTI000041521988", "@num": "2", "#text": "Arrêté du 30 janvier 2020 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041514887", "@nortexte": "SSAP2000708A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-01-30" }, { "@id": "LEGIARTI000041807940", "@num": "10-4", "#text": "Arrêté du 23 mars 2020 - art. 10-4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041807774", "@num": "10-5", "#text": "Arrêté du 23 mars 2020 - art. 10-5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041920905", "@num": "6-1", "#text": "Arrêté du 23 mars 2020 - art. 6-1 (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": "LEGIARTI000041756280", "@num": "1", "#text": "Décret n°2020-314 du 25 mars 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041755775", "@nortexte": "SSAZ2008362D", "@numtexte": "2020-314", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-25" }, { "@id": "LEGIARTI000041798665", "@num": "1", "#text": "Arrêté du 14 avril 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041798289", "@nortexte": "SSAZ2009592A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-04-14" }, { "@id": "LEGIARTI000041859122", "@num": "17", "#text": "Décret n°2020-545 du 11 mai 2020 - 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Toute spécialité pharmaceutique ou tout autre médicament fabriqué industriellement, ainsi que tout générateur, trousse ou précurseur qui ne fait pas l'objet d'une autorisation de mise sur le marché délivrée par la Communauté européenne en application du règlement (CEE) n° 2309/93 du Conseil du 22 juillet 1993 doit faire l'objet avant sa commercialisation ou sa distribution à titre gratuit, en gros ou en détail, d'une autorisation de mise sur le marché délivrée par l'Agence française de sécurité sanitaire des produits de santé. Cette autorisation peut être assortie de conditions adéquates.
\n
L'autorisation est délivrée pour une durée de cinq ans ; elle est ensuite renouvelable par période quinquennale. Toute modification des éléments d'une autorisation de mise sur le marché délivrée par l'Agence française de sécurité sanitaire des produits de santé, quelle que soit son importance, doit être préalablement autorisée.
\n
L'autorisation peut être modifiée, suspendue ou retirée par l'Agence française de sécurité sanitaire des produits de santé.
\n
L'accomplissement des formalités prévues au présent article n'a pas pour effet d'exonérer le fabricant ou, s'il est distinct, le titulaire de l'autorisation de mise sur le marché, de la responsabilité que l'un ou l'autre peut encourir dans les conditions du droit commun en raison de la fabrication ou de la mise sur le marché du médicament ou produit.
" } }, "LEGIARTI000006689890": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5121-8", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2010-02-26", "DATE_DEBUT": "2007-02-27" } }, "META_COMMUN": { "ID": "LEGIARTI000006689890", "URL": "article/LEGI/ARTI/00/00/06/68/98/LEGIARTI000006689890.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5121L08XXAB" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006700043", "@num": "15", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 15 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000039374401", "@num": "1", "#text": "Arrêté du 20 septembre 1999 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000761570", "@nortexte": "MESP9922897A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1999-09-20" }, { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006724328", "@num": "1", "#text": "Décret n°2000-1194 du 5 décembre 2000 - 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art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036920946", "@nortexte": "SSAP1813104A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-05-14" }, { "@id": "LEGIARTI000036925435", "@num": "4", "#text": "Arrêté du 14 mai 2018 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036920946", "@nortexte": "SSAP1813104A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-05-14" }, { "@id": "LEGIARTI000037502021", "@num": "1", "#text": "Arrêté du 15 octobre 2018 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000037501422", "@nortexte": "SSAP1828085A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-10-15" }, { "@id": "LEGIARTI000037557939", "@num": "3", "#text": "Arrêté du 26 octobre 2018 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000037552934", "@nortexte": "SSAP1829446A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-10-26" }, { "@id": "LEGIARTI000038122113", "@num": "2", "#text": "Arrêté du 11 février 2019 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000038121150", "@nortexte": "SSAP1904422A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-02-11" }, { "@id": "LEGIARTI000038432466", "@num": "1", "#text": "Décret n°2019-389 du 30 avril 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000038431240", "@nortexte": "SSAS1906324D", "@numtexte": "2019-389", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-04-30" }, { "@id": "LEGIARTI000039157836", "@num": "2", "#text": "Arrêté du 26 septembre 2019 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000039146677", "@nortexte": "SSAP1927722A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-09-26" }, { "@id": "LEGIARTI000039373779", "@num": "1", "#text": "Arrêté du 5 novembre 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000039373247", "@nortexte": "SSAP1931830A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-11-05" }, { "@id": "LEGIARTI000041493923", "@num": "1", "#text": "Arrêté du 21 janvier 2020 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041459990", "@nortexte": "SSAP2001803A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-01-21" }, { "@id": "LEGIARTI000041521988", "@num": "2", "#text": "Arrêté du 30 janvier 2020 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041514887", "@nortexte": "SSAP2000708A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-01-30" }, { "@id": "LEGIARTI000041807940", "@num": "10-4", "#text": "Arrêté du 23 mars 2020 - art. 10-4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041807774", "@num": "10-5", "#text": "Arrêté du 23 mars 2020 - art. 10-5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041920905", "@num": "6-1", "#text": "Arrêté du 23 mars 2020 - art. 6-1 (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": "LEGIARTI000041756280", "@num": "1", "#text": "Décret n°2020-314 du 25 mars 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041755775", "@nortexte": "SSAZ2008362D", "@numtexte": "2020-314", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-25" }, { "@id": "LEGIARTI000041798665", "@num": "1", "#text": "Arrêté du 14 avril 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041798289", "@nortexte": "SSAZ2009592A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-04-14" }, { "@id": "LEGIARTI000041859122", "@num": "17", "#text": "Décret n°2020-545 du 11 mai 2020 - art. 17 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041858681", "@nortexte": "SSAZ2011567D", "@numtexte": "2020-545", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041866847", "@num": "19", "#text": "Décret n°2020-548 du 11 mai 2020 - art. 19 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041865329", "@nortexte": "SSAZ2011695D", "@numtexte": "2020-548", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041920889", "@num": "1", "#text": "Arrêté du 26 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041920446", "@nortexte": "SSAZ2012694A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-26" }, { "@id": "LEGIARTI000042107205", "@num": "12", "#text": "Arrêté du 10 juillet 2020 - art. 12 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042507722", "@num": "17-2", "#text": "Arrêté du 10 juillet 2020 - art. 17-2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042362301", "@num": "2", "#text": "Arrêté du 11 septembre 2020 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042360578", "@nortexte": "SSAP2023295A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-09-11" }, { "@id": "LEGIARTI000042362303", "@num": "3", "#text": "Arrêté du 11 septembre 2020 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042360578", "@nortexte": "SSAP2023295A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-09-11" }, { "@id": "LEGIARTI000042507028", "@num": "1", "#text": "Arrêté du 7 novembre 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000042506409", "@nortexte": "SSAZ2030422A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-11-07" }, { "@id": "LEGIARTI000043507358", "@num": "1", "#text": "Arrêté du 17 mai 2021 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043507013", "@nortexte": "SSAP2115206A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-05-17" }, { "@id": "LEGIARTI000043577258", "@num": "4", "#text": "Arrêté du 1 juin 2021 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000043577276", "@num": "13", "#text": "Arrêté du 1er juin 2021 - art. 13 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000044132476", "@num": "2", "#text": "Arrêté du 28 septembre 2021 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000044126672", "@nortexte": "SSAP2129267A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-09-28" }, { "@id": "LEGIARTI000049735069", "@num": "2", "#text": "Décret n°2024-550 du 17 juin 2024 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000049734265", "@nortexte": "TSSP2411185D", "@numtexte": "2024-550", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-06-17" }, { "@id": "LEGIARTI000020529716", "@num": "D5121-64", "#text": "Code de la santé publique - art. 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Toute spécialité pharmaceutique ou tout autre médicament fabriqué industriellement ou selon une méthode dans laquelle intervient un processus industriel ainsi que tout générateur, trousse ou précurseur qui ne fait pas l'objet d'une autorisation de mise sur le marché délivrée par la Communauté européenne en application du règlement (CE) n° 726/2004 du Parlement européen et du Conseil, du 31 mars 2004, établissant des procédures communautaires pour l'autorisation et la surveillance en ce qui concerne les médicaments à usage humain et à usage vétérinaire, et instituant une Agence européenne des médicaments doit faire l'objet, avant sa mise sur le marché ou sa distribution à titre gratuit, d'une autorisation de mise sur le marché délivrée par l'Agence française de sécurité sanitaire des produits de santé. L'autorisation peut être assortie de conditions appropriées.
\n
Le demandeur de l'autorisation peut être dispensé de produire certaines données et études dans des conditions fixées par voie réglementaire.
\n
Une autorisation de mise sur le marché ne peut être délivrée qu'à un demandeur établi dans un Etat membre de la Communauté européenne ou partie à l'accord sur l'Espace économique européen.
\n
L'autorisation est délivrée pour une durée de cinq ans et peut ensuite être renouvelée, le cas échéant, sans limitation de durée, dans des conditions fixées par un décret en Conseil d'Etat, sauf si l'Agence française de sécurité sanitaire des produits de santé décide, pour des raisons justifiées ayant trait à la pharmacovigilance, de procéder à un renouvellement supplémentaire, sur la base d'une réévaluation des effets thérapeutiques positifs du médicament ou produit au regard des risques tels que définis au premier alinéa de l'article L. 5121-9. Ce décret détermine également les conditions dans lesquelles elle peut devenir caduque.
\n
L'autorisation peut être modifiée par l'Agence française de sécurité sanitaire des produits de santé.
\n
L'accomplissement des formalités prévues au présent article n'a pas pour effet d'exonérer le fabricant et, s'il est distinct, le titulaire de l'autorisation de mise sur le marché, de la responsabilité que l'un ou l'autre peut encourir dans les conditions du droit commun en raison de la fabrication ou de la mise sur le marché du médicament ou produit.
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art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000038121150", "@nortexte": "SSAP1904422A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-02-11" }, { "@id": "LEGIARTI000038432466", "@num": "1", "#text": "Décret n°2019-389 du 30 avril 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000038431240", "@nortexte": "SSAS1906324D", "@numtexte": "2019-389", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-04-30" }, { "@id": "LEGIARTI000039157836", "@num": "2", "#text": "Arrêté du 26 septembre 2019 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000039146677", "@nortexte": "SSAP1927722A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-09-26" }, { "@id": "LEGIARTI000039373779", "@num": "1", "#text": "Arrêté du 5 novembre 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000039373247", "@nortexte": "SSAP1931830A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-11-05" }, { "@id": "LEGIARTI000041493923", "@num": "1", "#text": "Arrêté du 21 janvier 2020 - 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Toute spécialité pharmaceutique ou tout autre médicament fabriqué industriellement ou selon une méthode dans laquelle intervient un processus industriel ainsi que tout générateur, trousse ou précurseur qui ne fait pas l'objet d'une autorisation de mise sur le marché délivrée par l'Union européenne en application du règlement (CE) n° 726 / 2004 du Parlement européen et du Conseil, du 31 mars 2004, établissant des procédures communautaires pour l'autorisation et la surveillance en ce qui concerne les médicaments à usage humain et à usage vétérinaire, et instituant une Agence européenne des médicaments doit faire l'objet, avant sa mise sur le marché ou sa distribution à titre gratuit, d'une autorisation de mise sur le marché délivrée par l'Agence française de sécurité sanitaire des produits de santé.L'autorisation peut être assortie de conditions appropriées.
\n
Le demandeur de l'autorisation peut être dispensé de produire certaines données et études dans des conditions fixées par voie réglementaire.
\n
Une autorisation de mise sur le marché ne peut être délivrée qu'à un demandeur établi dans un Etat membre de l'Union européenne ou partie à l'accord sur l'Espace économique européen.
\n
L'autorisation est délivrée pour une durée de cinq ans et peut ensuite être renouvelée, le cas échéant, sans limitation de durée, dans des conditions fixées par un décret en Conseil d'Etat, sauf si l'Agence française de sécurité sanitaire des produits de santé décide, pour des raisons justifiées ayant trait à la pharmacovigilance, de procéder à un renouvellement supplémentaire, sur la base d'une réévaluation des effets thérapeutiques positifs du médicament ou produit au regard des risques tels que définis au premier alinéa de l'article L. 5121-9. Ce décret détermine également les conditions dans lesquelles elle peut devenir caduque.
\n
L'autorisation peut être modifiée par l'Agence française de sécurité sanitaire des produits de santé.
\n
L'accomplissement des formalités prévues au présent article n'a pas pour effet d'exonérer le fabricant et, s'il est distinct, le titulaire de l'autorisation de mise sur le marché, de la responsabilité que l'un ou l'autre peut encourir dans les conditions du droit commun en raison de la fabrication ou de la mise sur le marché du médicament ou produit.
" } }, "LEGIARTI000025104474": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5121-8", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2012-05-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025104474", "URL": "article/LEGI/ARTI/00/00/25/10/44/LEGIARTI000025104474.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

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

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

" }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006700043", "@num": "15", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 15 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000039374401", "@num": "1", "#text": "Arrêté du 20 septembre 1999 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000761570", "@nortexte": "MESP9922897A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1999-09-20" }, { "@id": "LEGIARTI000006724328", "@num": "1", "#text": "Décret n°2000-1194 du 5 décembre 2000 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000768314", "@nortexte": "MESG0022611D", "@numtexte": "2000-1194", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2000-12-05" }, { "@id": "LEGIARTI000006724332", "@num": "3", "#text": "Décret n°2000-1194 du 5 décembre 2000 - art. 3 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000000768314", "@nortexte": "MESG0022611D", "@numtexte": "2000-1194", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2000-12-05" }, { "@id": "LEGITEXT000005631695", "#text": "Arrêté du 13 novembre 2001", "@sens": "cible", "@cidtexte": "JORFTEXT000000221792", "@nortexte": "MESG0123551A", "@typelien": "TXT_ASSOCIE", "@naturetexte": "ARRETE", "@datesignatexte": "2001-11-13" }, { "@id": "LEGIARTI000006334800", "@num": "1", "#text": "Arrêté du 13 novembre 2001 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000221792", "@nortexte": "MESG0123551A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2001-11-13" }, { "@id": "LEGIARTI000006334800", "@num": "1", "#text": "Arrêté du 13 novembre 2001 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000221792", "@nortexte": "MESG0123551A", "@typelien": "TXT_ASSOCIE", "@naturetexte": "ARRETE", "@datesignatexte": "2001-11-13" }, { "@id": "LEGIARTI000006334802", "@num": "3", "#text": "Arrêté du 13 novembre 2001 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000221792", "@nortexte": "MESG0123551A", "@typelien": "TXT_ASSOCIE", "@naturetexte": "ARRETE", "@datesignatexte": "2001-11-13" }, { "@id": "LEGIARTI000022158895", "@num": "1", "#text": "Arrêté du 23 avril 2004 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000436679", "@nortexte": "SANP0421445A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2004-04-23" }, { "@id": "LEGIARTI000006231372", "@num": "1", "#text": "Arrêté du 26 mai 2004 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000235408", "@nortexte": "SANG0420602A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2004-05-26" }, { "@id": "LEGIARTI000006231373", "@num": "2", "#text": "Arrêté du 26 mai 2004 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000235408", "@nortexte": "SANG0420602A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2004-05-26" }, { "@id": "LEGIARTI000006232079", "@num": "1", "#text": "Décret n°2004-651 du 2 juillet 2004 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000436350", "@nortexte": "SANG0421846D", "@numtexte": "2004-651", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-02" }, { "@id": "LEGIARTI000006256800", "@num": "1", "#text": "Arrêté du 8 novembre 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000641558", "@nortexte": "SANP0624618A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-11-08" }, { "@id": "LEGIARTI000006697010", "@num": "6", "#text": "Loi n°2007-248 du 26 février 2007 - art. 6 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000613381", "@nortexte": "SANX0600004L", "@numtexte": "2007-248", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2007-02-26" }, { "@id": "LEGITEXT000017833546", "#text": "Décret n°2007-1860\n du 26 décembre 2007 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000017762708", "@nortexte": "SJSP0771467D", "@numtexte": "2007-1860", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-12-26" }, { "@id": "LEGIARTI000026604165", "@num": "2", "#text": "Arrêté du 6 mai 2008 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000018768299", "@nortexte": "SJSP0810423A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-05-06" }, { "@id": "LEGIARTI000025882819", "#text": "Arrêté du 1er septembre 2009 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000021021310", "@nortexte": "SASP0920309A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-09-01" }, { "@id": "LEGIARTI000048060675", "@num": "4", "#text": "Arrêté du 5 mars 2010 - art. 4 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000021954715", "@nortexte": "BCFR1004493A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-03-05" }, { "@id": "LEGIARTI000050315041", "@num": "6", "#text": "Arrêté du 5 mars 2010 - art. 6 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000021954715", "@nortexte": "BCFR1004493A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-03-05" }, { "@id": "LEGITEXT000022158905", "#text": "Arrêté du 26 avril 2010 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000022149910", "@nortexte": "SASP1011405A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-04-26" }, { "@id": "LEGIARTI000024630541", "@num": "1", "#text": "Arrêté du 22 septembre 2011 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000024629129", "@nortexte": "ETSP1125976A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-09-22" }, { "@id": "LEGIARTI000025071134", "@num": "5", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 5", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000025832877", "@num": "1", "#text": "Arrêté du 7 mai 2012 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000025824505", "@nortexte": "ETSS1209429A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-05-07" }, { "@id": "LEGITEXT000026054718", "#text": "Arrêté du 12 juin 2012 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000026052302", "@nortexte": "AFSP1226069A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-06-12" }, { "@id": "LEGITEXT000028414510", "#text": "Arrêté du 20 décembre 2013 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000028398405", "@nortexte": "AFSS1331706A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-12-20" }, { "@id": "LEGIARTI000028414521", "@num": "1", "#text": "Arrêté du 20 décembre 2013 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000028398405", "@nortexte": "AFSS1331706A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-12-20" }, { "@id": "LEGIARTI000029270949", "@num": "1", "#text": "ARRÊTÉ du 11 juillet 2014 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029270263", "@nortexte": "AFSP1416909A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2014-07-11" }, { "@id": "LEGIARTI000029449716", "@num": "1", "#text": "ARRÊTÉ du 25 juillet 2014 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000029449036", "@nortexte": "FCPE1418309A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2014-07-25" }, { "@id": "LEGIARTI000042293117", "#text": "DÉCRET n°2014-1288 du 23 octobre 2014 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029676038", "@nortexte": "AFSX1419044D", "@numtexte": "2014-1288", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000030457713", "@num": "3", "#text": "ARRÊTÉ du 30 mars 2015 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000030456816", "@nortexte": "AFSP1508194A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2015-03-30" }, { "@id": "LEGIARTI000032096337", "@num": "3", "#text": "Arrêté du 15 février 2016 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000032093358", "@nortexte": "AFSP1604649A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-02-15" }, { "@id": "LEGIARTI000032096334", "@num": "4", "#text": "Arrêté du 15 février 2016 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000032093358", "@nortexte": "AFSP1604649A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-02-15" }, { "@id": "LEGIARTI000032096339", "@num": "5", "#text": "Arrêté du 15 février 2016 - art. 5 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000032093358", "@nortexte": "AFSP1604649A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-02-15" }, { "@id": "LEGIARTI000032096341", "@num": "6", "#text": "Arrêté du 15 février 2016 - art. 6 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000032093358", "@nortexte": "AFSP1604649A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-02-15" }, { "@id": "LEGIARTI000032096343", "@num": "7", "#text": "Arrêté du 15 février 2016 - art. 7 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000032093358", "@nortexte": "AFSP1604649A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-02-15" }, { "@id": "LEGIARTI000033122072", "@num": "4", "#text": "Arrêté du 8 septembre 2016 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033120953", "@nortexte": "AFSP1625292A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-09-08" }, { "@id": "LEGIARTI000036925433", "@num": "3", "#text": "Arrêté du 14 mai 2018 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036920946", "@nortexte": "SSAP1813104A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-05-14" }, { "@id": "LEGIARTI000036925435", "@num": "4", "#text": "Arrêté du 14 mai 2018 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036920946", "@nortexte": "SSAP1813104A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-05-14" }, { "@id": "LEGIARTI000037502021", "@num": "1", "#text": "Arrêté du 15 octobre 2018 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000037501422", "@nortexte": "SSAP1828085A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-10-15" }, { "@id": "LEGIARTI000037557939", "@num": "3", "#text": "Arrêté du 26 octobre 2018 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000037552934", "@nortexte": "SSAP1829446A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-10-26" }, { "@id": "LEGIARTI000038122113", "@num": "2", "#text": "Arrêté du 11 février 2019 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000038121150", "@nortexte": "SSAP1904422A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-02-11" }, { "@id": "LEGIARTI000038432466", "@num": "1", "#text": "Décret n°2019-389 du 30 avril 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000038431240", "@nortexte": "SSAS1906324D", "@numtexte": "2019-389", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-04-30" }, { "@id": "LEGIARTI000039157836", "@num": "2", "#text": "Arrêté du 26 septembre 2019 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000039146677", "@nortexte": "SSAP1927722A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-09-26" }, { "@id": "LEGIARTI000039373779", "@num": "1", "#text": "Arrêté du 5 novembre 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000039373247", "@nortexte": "SSAP1931830A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-11-05" }, { "@id": "LEGIARTI000041493923", "@num": "1", "#text": "Arrêté du 21 janvier 2020 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041459990", "@nortexte": "SSAP2001803A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-01-21" }, { "@id": "LEGIARTI000041521988", "@num": "2", "#text": "Arrêté du 30 janvier 2020 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041514887", "@nortexte": "SSAP2000708A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-01-30" }, { "@id": "LEGIARTI000041807940", "@num": "10-4", "#text": "Arrêté du 23 mars 2020 - art. 10-4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041807774", "@num": "10-5", "#text": "Arrêté du 23 mars 2020 - art. 10-5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041920905", "@num": "6-1", "#text": "Arrêté du 23 mars 2020 - art. 6-1 (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": "LEGIARTI000041756280", "@num": "1", "#text": "Décret n°2020-314 du 25 mars 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041755775", "@nortexte": "SSAZ2008362D", "@numtexte": "2020-314", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-25" }, { "@id": "LEGIARTI000041798665", "@num": "1", "#text": "Arrêté du 14 avril 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041798289", "@nortexte": "SSAZ2009592A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-04-14" }, { "@id": "LEGIARTI000041859122", "@num": "17", "#text": "Décret n°2020-545 du 11 mai 2020 - art. 17 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041858681", "@nortexte": "SSAZ2011567D", "@numtexte": "2020-545", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041866847", "@num": "19", "#text": "Décret n°2020-548 du 11 mai 2020 - art. 19 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041865329", "@nortexte": "SSAZ2011695D", "@numtexte": "2020-548", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041920889", "@num": "1", "#text": "Arrêté du 26 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041920446", "@nortexte": "SSAZ2012694A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-26" }, { "@id": "LEGIARTI000042107205", "@num": "12", "#text": "Arrêté du 10 juillet 2020 - art. 12 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042507722", "@num": "17-2", "#text": "Arrêté du 10 juillet 2020 - art. 17-2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042362301", "@num": "2", "#text": "Arrêté du 11 septembre 2020 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042360578", "@nortexte": "SSAP2023295A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-09-11" }, { "@id": "LEGIARTI000042362303", "@num": "3", "#text": "Arrêté du 11 septembre 2020 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042360578", "@nortexte": "SSAP2023295A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-09-11" }, { "@id": "LEGIARTI000042507028", "@num": "1", "#text": "Arrêté du 7 novembre 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000042506409", "@nortexte": "SSAZ2030422A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-11-07" }, { "@id": "LEGIARTI000043507358", "@num": "1", "#text": "Arrêté du 17 mai 2021 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043507013", "@nortexte": "SSAP2115206A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-05-17" }, { "@id": "LEGIARTI000043577258", "@num": "4", "#text": "Arrêté du 1 juin 2021 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000043577276", "@num": "13", "#text": "Arrêté du 1er juin 2021 - art. 13 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000044132476", "@num": "2", "#text": "Arrêté du 28 septembre 2021 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000044126672", "@nortexte": "SSAP2129267A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-09-28" }, { "@id": "LEGIARTI000049735069", "@num": "2", "#text": "Décret n°2024-550 du 17 juin 2024 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000049734265", "@nortexte": "TSSP2411185D", "@numtexte": "2024-550", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-06-17" }, { "@id": "LEGIARTI000020529716", "@num": "D5121-64", "#text": "Code de la santé publique - art. 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Toute spécialité pharmaceutique ou tout autre médicament fabriqué industriellement ou selon une méthode dans laquelle intervient un processus industriel ainsi que tout générateur, trousse ou précurseur qui ne fait pas l'objet d'une autorisation de mise sur le marché délivrée par l'Union européenne en application du règlement (CE) n° 726/2004 du Parlement européen et du Conseil, du 31 mars 2004, établissant des procédures communautaires pour l'autorisation et la surveillance en ce qui concerne les médicaments à usage humain et à usage vétérinaire, et instituant une Agence européenne des médicaments doit faire l'objet, avant sa mise sur le marché ou sa distribution à titre gratuit, d'une autorisation de mise sur le marché délivrée par l'Agence nationale de sécurité du médicament et des produits de santé. L'autorisation peut être assortie de conditions appropriées, notamment l'obligation de réaliser des études de sécurité ou d'efficacité post-autorisation.

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

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

L'autorisation est délivrée pour une durée de cinq ans et peut ensuite être renouvelée, le cas échéant, sans limitation de durée, dans des conditions fixées par un décret en Conseil d'Etat, sauf si l'Agence nationale de sécurité du médicament et des produits de santé décide de procéder à un renouvellement quinquennal, sur la base d'une réévaluation des effets thérapeutiques positifs du médicament ou produit au regard des risques tels que définis au premier alinéa de l'article L. 5121-9. Ce décret détermine également les conditions dans lesquelles elle peut devenir caduque.

L'autorisation peut être modifiée par l'Agence nationale de sécurité du médicament et des produits de santé.

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

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art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000038121150", "@nortexte": "SSAP1904422A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-02-11" }, { "@id": "LEGIARTI000038432466", "@num": "1", "#text": "Décret n°2019-389 du 30 avril 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000038431240", "@nortexte": "SSAS1906324D", "@numtexte": "2019-389", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-04-30" }, { "@id": "LEGIARTI000039157836", "@num": "2", "#text": "Arrêté du 26 septembre 2019 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000039146677", "@nortexte": "SSAP1927722A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-09-26" }, { "@id": "LEGIARTI000039373779", "@num": "1", "#text": "Arrêté du 5 novembre 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000039373247", "@nortexte": "SSAP1931830A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-11-05" }, { "@id": "LEGIARTI000041493923", "@num": "1", "#text": "Arrêté du 21 janvier 2020 - 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Toute spécialité pharmaceutique ou tout autre médicament fabriqué industriellement ou selon une méthode dans laquelle intervient un processus industriel ainsi que tout générateur, trousse ou précurseur qui ne fait pas l'objet d'une autorisation de mise sur le marché délivrée par l'Union européenne en application du règlement (CE) n° 726 / 2004 du Parlement européen et du Conseil, du 31 mars 2004, établissant des procédures communautaires pour l'autorisation et la surveillance en ce qui concerne les médicaments à usage humain et à usage vétérinaire, et instituant une Agence européenne des médicaments doit faire l'objet, avant sa mise sur le marché ou sa distribution à titre gratuit, d'une autorisation de mise sur le marché délivrée par l'Agence française de sécurité sanitaire des produits de santé. L'autorisation peut être assortie de conditions appropriées, notamment l'obligation de réaliser des études de sécurité ou d'efficacité post-autorisation.

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

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

L'autorisation est délivrée pour une durée de cinq ans et peut ensuite être renouvelée, le cas échéant, sans limitation de durée, dans des conditions fixées par un décret en Conseil d'Etat, sauf si l'Agence française de sécurité sanitaire des produits de santé décide, pour des raisons justifiées ayant trait à la pharmacovigilance, de procéder à un renouvellement supplémentaire, sur la base d'une réévaluation des effets thérapeutiques positifs du médicament ou produit au regard des risques tels que définis au premier alinéa de l'article L. 5121-9. Ce décret détermine également les conditions dans lesquelles elle peut devenir caduque.

L'autorisation peut être modifiée par l'Agence française de sécurité sanitaire des produits de santé.

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Article 1 AUTONOME VIGUEUR, en vigueur depuis le 23/07/2014 (Arrêté du 11 juillet 2014 portant classement sur la liste des substances vénéneuses)