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Les dispositions de l'article L. 5121-8 ne font pas obstacle à l'utilisation, à titre exceptionnel, de certains médicaments destinés à traiter des maladies graves ou rares lorsqu'il n'existe pas de traitement approprié :
\n
a) Et que l'efficacité et la sécurité de ces médicaments sont fortement présumées, au vu des résultats d'essais thérapeutiques auxquels il a été procédé en vue d'une demande d'autorisation de mise sur le marché, et que cette demande a été déposée ou que le demandeur s'engage à la déposer dans un délai déterminé ;
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b) Ou que ces médicaments sont prescrits à des malades nommément désignés et, le cas échéant, importés dans ce but, sous la responsabilité de leur médecin traitant, dès lors que leur efficacité et leur sécurité sont présumées en l'état des connaissances scientifiques et qu'ils sont susceptibles de présenter un bénéfice réel.
\n
L'utilisation de ces médicaments est autorisée, pour une durée limitée, par l'Agence française de sécurité sanitaire des produits de santé, à la demande du titulaire des droits d'exploitation du médicament dans le cas prévu au a ou à la demande du médecin traitant dans le cas prévu au b du présent article.
\n
Pour les médicaments mentionnés au a), l'autorisation peut être subordonnée par l'Agence française de sécurité sanitaire des produits de santé à la condition qu'elle soit sollicitée dans le cadre d'un protocole d'utilisation thérapeutique et de recueil d'informations, établi avec le titulaire des droits d'exploitation.
\n
L'autorisation peut être suspendue ou retirée si les conditions prévues au présent article ne sont plus remplies, ou pour des motifs de santé publique.
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(V)", "@sens": "cible", "@cidtexte": "JORFTEXT000028220981", "@nortexte": "AFSS1328324A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-11-18" }, { "@id": "LEGIARTI000034460480", "@num": "3", "#text": "Décret n°2017-605 du 21 avril 2017 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000034455675", "@nortexte": "AFSS1706603D", "@numtexte": "2017-605", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-04-21" }, { "@id": "LEGIARTI000034460482", "@num": "4", "#text": "Décret n°2017-605 du 21 avril 2017 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034455675", "@nortexte": "AFSS1706603D", "@numtexte": "2017-605", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-04-21" }, { "@id": "LEGIARTI000038944863", "@num": "2", "#text": "Décret n°2019-855 du 20 août 2019 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000038940078", "@nortexte": "SSAS1916802D", "@numtexte": "2019-855", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-08-20" }, { "@id": "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": "LEGIARTI000043734168", "@num": "1", "#text": "Décret n°2021-869 du 30 juin 2021 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000043728288", "@nortexte": "SSAS2114883D", "@numtexte": "2021-869", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-06-30" }, { "@id": "LEGIARTI000043734172", "@num": "3", "#text": "Décret n°2021-869 du 30 juin 2021 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000043728288", "@nortexte": "SSAS2114883D", "@numtexte": "2021-869", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-06-30" }, { "@id": "LEGIARTI000043734174", "@num": "4", "#text": "Décret n°2021-869 du 30 juin 2021 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043728288", "@nortexte": "SSAS2114883D", "@numtexte": "2021-869", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-06-30" }, { "@id": "LEGITEXT000043733765", "#text": "Décret n°2021-870 du 30 juin 2021 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043728411", "@nortexte": "SSAS2114929D", "@numtexte": "2021-870", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-06-30" }, { "@id": "LEGIARTI000044941358", "@num": "6", "#text": "Décret n°2021-1905 du 30 décembre 2021 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000044638030", "@nortexte": "TREP2130559D", "@numtexte": "2021-1905", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-12-30" }, { "@id": "LEGIARTI000045162554", "@num": "6", "#text": "Décret n°2022-164 du 11 février 2022 - art. 6 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000045159528", "@nortexte": "SSAP2131030D", "@numtexte": "2022-164", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2022-02-11" }, { "@id": "LEGIARTI000047543494", "@num": "6", "#text": "Décret n°2023-367 du 13 mai 2023 - art. 6 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000047542080", "@nortexte": "SPRS2300922D", "@numtexte": "2023-367", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2023-05-13" }, { "@id": "LEGIARTI000049350861", "@num": "1", "#text": "Décret n°2024-290 du 29 mars 2024 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000049345711", "@nortexte": "TSSH2335206D", "@numtexte": "2024-290", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-03-29" }, { "@id": "LEGIARTI000044962600", "@num": "R533-49", "#text": "Code de l'environnement - art. 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Les dispositions de l'article L. 5121-8 ne font pas obstacle à l'utilisation, à titre exceptionnel, de certains médicaments destinés à traiter des maladies graves ou rares lorsqu'il n'existe pas de traitement approprié :
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a) Et que l'efficacité et la sécurité de ces médicaments sont fortement présumées, au vu des résultats d'essais thérapeutiques auxquels il a été procédé en vue d'une demande d'autorisation de mise sur le marché, et que cette demande a été déposée ou que le demandeur s'engage à la déposer dans un délai déterminé ;
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b) Ou que ces médicaments sont prescrits à des malades nommément désignés et, le cas échéant, importés dans ce but, sous la responsabilité de leur médecin traitant, dès lors que leur efficacité et leur sécurité sont présumées en l'état des connaissances scientifiques et qu'ils sont susceptibles de présenter un bénéfice réel.
\n
L'utilisation de ces médicaments est autorisée, pour une durée limitée, par l'Agence française de sécurité sanitaire des produits de santé, à la demande du titulaire des droits d'exploitation du médicament dans le cas prévu au a ou à la demande du médecin traitant dans le cas prévu au b du présent article.
\n
Pour les médicaments mentionnés au a, l'autorisation est subordonnée par l'Agence française de sécurité sanitaire des produits de santé à la condition qu'elle soit sollicitée dans le cadre d'un protocole d'utilisation thérapeutique et de recueil d'informations établi avec le titulaire des droits d'exploitation et concernant notamment les conditions réelles d'utilisation et les caractéristiques de la population bénéficiant du médicament ainsi autorisé.
\n
Le demandeur de l'autorisation pour les médicaments mentionnés au a adresse systématiquement à l'agence, après l'octroi de cette autorisation, toute information concernant notamment les conditions réelles d'utilisation et les caractéristiques de la population bénéficiant du médicament ainsi autorisé ; il adresse également périodiquement au ministre chargé de la santé des informations sur le coût pour l'assurance maladie du médicament bénéficiant de l'autorisation octroyée.
\n
Pour les médicaments mentionnés au b, l'autorisation peut être subordonnée par l'Agence française de sécurité sanitaire des produits de santé à la mise en place d'un protocole d'utilisation thérapeutique et de recueil d'informations.
\n
L'autorisation des médicaments mentionnés au a et au b peut être suspendue ou retirée si les conditions prévues au présent article ne sont plus remplies, ou pour des motifs de santé publique.
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(V)", "@sens": "cible", "@cidtexte": "JORFTEXT000028220981", "@nortexte": "AFSS1328324A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-11-18" }, { "@id": "LEGIARTI000034460480", "@num": "3", "#text": "Décret n°2017-605 du 21 avril 2017 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000034455675", "@nortexte": "AFSS1706603D", "@numtexte": "2017-605", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-04-21" }, { "@id": "LEGIARTI000034460482", "@num": "4", "#text": "Décret n°2017-605 du 21 avril 2017 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034455675", "@nortexte": "AFSS1706603D", "@numtexte": "2017-605", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-04-21" }, { "@id": "LEGIARTI000038944863", "@num": "2", "#text": "Décret n°2019-855 du 20 août 2019 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000038940078", "@nortexte": "SSAS1916802D", "@numtexte": "2019-855", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-08-20" }, { "@id": "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": "LEGIARTI000043734168", "@num": "1", "#text": "Décret n°2021-869 du 30 juin 2021 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000043728288", "@nortexte": "SSAS2114883D", "@numtexte": "2021-869", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-06-30" }, { "@id": "LEGIARTI000043734172", "@num": "3", "#text": "Décret n°2021-869 du 30 juin 2021 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000043728288", "@nortexte": "SSAS2114883D", "@numtexte": "2021-869", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-06-30" }, { "@id": "LEGIARTI000043734174", "@num": "4", "#text": "Décret n°2021-869 du 30 juin 2021 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043728288", "@nortexte": "SSAS2114883D", "@numtexte": "2021-869", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-06-30" }, { "@id": "LEGITEXT000043733765", "#text": "Décret n°2021-870 du 30 juin 2021 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043728411", "@nortexte": "SSAS2114929D", "@numtexte": "2021-870", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-06-30" }, { "@id": "LEGIARTI000044941358", "@num": "6", "#text": "Décret n°2021-1905 du 30 décembre 2021 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000044638030", "@nortexte": "TREP2130559D", "@numtexte": "2021-1905", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-12-30" }, { "@id": "LEGIARTI000045162554", "@num": "6", "#text": "Décret n°2022-164 du 11 février 2022 - art. 6 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000045159528", "@nortexte": "SSAP2131030D", "@numtexte": "2022-164", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2022-02-11" }, { "@id": "LEGIARTI000047543494", "@num": "6", "#text": "Décret n°2023-367 du 13 mai 2023 - art. 6 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000047542080", "@nortexte": "SPRS2300922D", "@numtexte": "2023-367", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2023-05-13" }, { "@id": "LEGIARTI000049350861", "@num": "1", "#text": "Décret n°2024-290 du 29 mars 2024 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000049345711", "@nortexte": "TSSH2335206D", "@numtexte": "2024-290", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-03-29" }, { "@id": "LEGIARTI000044962600", "@num": "R533-49", "#text": "Code de l'environnement - art. 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Les dispositions de l'article L. 5121-8 ne font pas obstacle à l'utilisation, à titre exceptionnel, de certains médicaments destinés à traiter des maladies graves ou rares lorsqu'il n'existe pas de traitement approprié :
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a) Et que l'efficacité et la sécurité de ces médicaments sont fortement présumées, au vu des résultats d'essais thérapeutiques auxquels il a été procédé en vue d'une demande d'autorisation de mise sur le marché, et que cette demande a été déposée ou que le demandeur s'engage à la déposer dans un délai déterminé ;
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b) Ou que ces médicaments sont prescrits à des malades nommément désignés et, le cas échéant, importés dans ce but, sous la responsabilité de leur médecin traitant, dès lors que leur efficacité et leur sécurité sont présumées en l'état des connaissances scientifiques et qu'ils sont susceptibles de présenter un bénéfice réel.
\n
L'utilisation de ces médicaments est autorisée, pour une durée limitée, par l'Agence française de sécurité sanitaire des produits de santé, à la demande du titulaire des droits d'exploitation du médicament dans le cas prévu au a ou à la demande du médecin traitant dans le cas prévu au b du présent article.
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Pour les médicaments mentionnés au a, l'autorisation est subordonnée par l'Agence française de sécurité sanitaire des produits de santé à la condition qu'elle soit sollicitée dans le cadre d'un protocole d'utilisation thérapeutique et de recueil d'informations établi avec le titulaire des droits d'exploitation et concernant notamment les conditions réelles d'utilisation et les caractéristiques de la population bénéficiant du médicament ainsi autorisé.
\n
Le demandeur de l'autorisation pour les médicaments mentionnés au a adresse systématiquement à l'agence, après l'octroi de cette autorisation, toute information concernant notamment les conditions réelles d'utilisation et les caractéristiques de la population bénéficiant du médicament ainsi autorisé.
\n
Pour les médicaments mentionnés au b, l'autorisation peut être subordonnée par l'Agence française de sécurité sanitaire des produits de santé à la mise en place d'un protocole d'utilisation thérapeutique et de recueil d'informations.
\n
L'autorisation des médicaments mentionnés au a et au b peut être suspendue ou retirée si les conditions prévues au présent article ne sont plus remplies, ou pour des motifs de santé publique.
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Les dispositions de l'article L. 5121-8 ne font pas obstacle à l'utilisation, à titre exceptionnel, de certains médicaments destinés à traiter des maladies graves ou rares lorsqu'il n'existe pas de traitement approprié :
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a) Et que l'efficacité et la sécurité de ces médicaments sont fortement présumées, au vu des résultats d'essais thérapeutiques auxquels il a été procédé en vue d'une demande d'autorisation de mise sur le marché, et que cette demande a été déposée ou que le demandeur s'engage à la déposer dans un délai déterminé ;
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b) Ou que ces médicaments, le cas échéant importés, sont prescrits, sous la responsabilité d'un médecin, à un patient nommément désigné et ne pouvant participer à une recherche biomédicale, dès lors qu'ils sont susceptibles de présenter un bénéfice pour lui et que soit leur efficacité et leur sécurité sont présumées en l'état des connaissances scientifiques, soit une issue fatale à court terme pour le patient est, en l'état des thérapeutiques disponibles, inéluctable. Le médecin demandeur doit justifier que le patient, son représentant légal ou la personne de confiance qu'il a désignée en application de l'article L. 1111-6 a reçu une information adaptée à sa situation sur l'absence d'alternative thérapeutique, les risques courus, les contraintes et le bénéfice susceptible d'être apporté par le médicament. La procédure suivie est inscrite dans le dossier médical.
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L'utilisation de ces médicaments est autorisée, pour une durée limitée, par l'Agence française de sécurité sanitaire des produits de santé, à la demande du titulaire des droits d'exploitation du médicament dans le cas prévu au a ou à la demande du médecin prescripteur dans le cas prévu au b du présent article.
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Pour les médicaments mentionnés au a, l'autorisation est subordonnée par l'Agence française de sécurité sanitaire des produits de santé à la condition qu'elle soit sollicitée dans le cadre d'un protocole d'utilisation thérapeutique et de recueil d'informations établi avec le titulaire des droits d'exploitation et concernant notamment les conditions réelles d'utilisation et les caractéristiques de la population bénéficiant du médicament ainsi autorisé.
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Le demandeur de l'autorisation pour les médicaments mentionnés au a adresse systématiquement à l'agence, après l'octroi de cette autorisation, toute information concernant notamment les conditions réelles d'utilisation et les caractéristiques de la population bénéficiant du médicament ainsi autorisé.
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Pour les médicaments mentionnés au b, l'autorisation peut être subordonnée par l'Agence française de sécurité sanitaire des produits de santé à la mise en place d'un protocole d'utilisation thérapeutique et de recueil d'informations.
\n
L'autorisation des médicaments mentionnés au a et au b peut être suspendue ou retirée si les conditions prévues au présent article ne sont plus remplies, ou pour des motifs de santé publique.
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Le prix de vente au public de chacun des médicaments mentionnés au premier alinéa de l'article L. 162-17 est fixé par convention entre l'entreprise exploitant le médicament et le comité économique du médicament conformément à l'article L. 162-17-4 ou, à défaut, par arrêté des ministres chargés de la sécurité sociale, de la santé et de l'économie, après avis du comité. La fixation de ce prix tient compte principalement de l'amélioration du service médical rendu apportée par le médicament, des prix des médicaments à même visée thérapeutique, des volumes de vente prévus ou constatés ainsi que des conditions prévisibles et réelles d'utilisation du médicament.

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Ce prix comprend les marges prévues par l'arrêté interministériel mentionné à l'article L. 162-38 ainsi que les taxes en vigueur.

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Un décret en Conseil d'Etat détermine les conditions d'application du présent article, et notamment les procédures et délais de fixation des prix.

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Sont constatées et poursuivies, dans les conditions fixées par le titre VI de l'ordonnance n° 86-1243 du 1er décembre 1986 relative à la liberté des prix et de la concurrence, les infractions aux conventions et arrêtés mentionnés ci-dessus.

\n
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Ce prix comprend les marges prévues par l'arrêté interministériel mentionné à l'article L. 162-38 ainsi que les taxes en vigueur.

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Un décret en Conseil d'Etat détermine les conditions d'application du présent article, et notamment les procédures et délais de fixation des prix.

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" } }, "LEGIARTI000006740848": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L162-16-4", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2011-12-23", "DATE_DEBUT": "2004-08-17" } }, "META_COMMUN": { "ID": "LEGIARTI000006740848", "URL": "article/LEGI/ARTI/00/00/06/74/08/LEGIARTI000006740848.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SSAXXXXXXXX1X162L16EXXAC" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000866621", "#text": "Décret 85-1353 1985-12-17", "@sens": "source", "@cidtexte": "JORFTEXT000000866621", "@numtexte": "85-1353", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1985-12-17" }, { "@id": "JORFTEXT000000333548", "#text": "Ordonnance 86-1243 1986-12-01", "@sens": "source", "@cidtexte": "JORFTEXT000000333548", "@numtexte": "86-1243", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "1986-12-01" }, { "@id": "LEGIARTI000006758855", "@num": "20", "#text": "Loi n°2003-1199 du 18 décembre 2003 - art. 20 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000249276", "@nortexte": "SANX0300139L", "@numtexte": "2003-1199", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2003-12-18" }, { "@id": "LEGIARTI000006758972", "@num": "43", "#text": "Loi n°2004-810 du 13 août 2004 - art. 43 () JORF 17 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000625158", "@nortexte": "SANX0400122L", "@numtexte": "2004-810", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-13" }, { "@id": "LEGIARTI000028375935", "@num": "46", "#text": "LOI n°2013-1203\n du 23 décembre 2013 - art. 46 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000028372809", "@nortexte": "EFIX1324269L", "@numtexte": "2013-1203", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2013-12-23" }, { "@id": "LEGITEXT000029393218", "#text": "DÉCRET n°2014-955 du 21 août 2014 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029392050", "@nortexte": "AFSS1411668D", "@numtexte": "2014-955", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-08-21" }, { "@id": "LEGIARTI000038879548", "@num": "1", "#text": "Décret n°2019-818 du 1er août 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000038873188", "@nortexte": "SSAS1911214D", "@numtexte": "2019-818", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-08-01" }, { "@id": "LEGIARTI000043734168", "@num": "1", "#text": "Décret n°2021-869 du 30 juin 2021 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000043728288", "@nortexte": "SSAS2114883D", "@numtexte": "2021-869", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-06-30" }, { "@id": "LEGITEXT000049922585", "#text": "Arrêté du 5 juillet 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049892254", "@nortexte": "TSSS2418508A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-07-05" }, { "@id": "LEGIARTI000034901129", "@num": "L5123-1", "#text": "Code de la santé publique - art. 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Ce prix comprend les marges prévues par la décision mentionnée à l'article L. 162-38 ainsi que les taxes en vigueur.

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Un décret en Conseil d'Etat détermine les conditions d'application du présent article, et notamment les procédures et délais de fixation des prix.

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" } }, "LEGIARTI000025014102": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L162-16-4", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2014-03-19", "DATE_DEBUT": "2011-12-23" } }, "META_COMMUN": { "ID": "LEGIARTI000025014102", "URL": "article/LEGI/ARTI/00/00/25/01/41/LEGIARTI000025014102.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000866621", "#text": "Décret n° 85-1353 du 17 décembre 1985", "@sens": "source", "@cidtexte": "JORFTEXT000000866621", "@numtexte": "85-1353", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1985-12-17" }, { "@id": "LEGISCTA000006095871", "#text": "Ordonnance n°86-1243 du 1 décembre 1986", "@sens": "source", "@cidtexte": "JORFTEXT000000333548", "@numtexte": "86-1243", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "1986-12-01" }, { "@id": "LEGIARTI000006758855", "@num": "20", "#text": "Loi n°2003-1199 du 18 décembre 2003 - art. 20 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000249276", "@nortexte": "SANX0300139L", "@numtexte": "2003-1199", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2003-12-18" }, { "@id": "LEGIARTI000025007816", "@num": "48", "#text": "LOI n°2011-1906\n du 21 décembre 2011 - art. 48", "@sens": "cible", "@cidtexte": "JORFTEXT000025005833", "@nortexte": "BCRX1125833L", "@numtexte": "2011-1906", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2011-12-21" }, { "@id": "LEGIARTI000025007674", "@num": "47", "#text": "LOI n°2011-1906 du 21 décembre 2011 - art. 47 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025005833", "@nortexte": "BCRX1125833L", "@numtexte": "2011-1906", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2011-12-21" }, { "@id": "LEGIARTI000028375935", "@num": "46", "#text": "LOI n°2013-1203\n du 23 décembre 2013 - art. 46 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000028372809", "@nortexte": "EFIX1324269L", "@numtexte": "2013-1203", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2013-12-23" }, { "@id": "LEGITEXT000029393218", "#text": "DÉCRET n°2014-955 du 21 août 2014 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029392050", "@nortexte": "AFSS1411668D", "@numtexte": "2014-955", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-08-21" }, { "@id": "LEGIARTI000038879548", "@num": "1", "#text": "Décret n°2019-818 du 1er août 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000038873188", "@nortexte": "SSAS1911214D", "@numtexte": "2019-818", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-08-01" }, { "@id": "LEGIARTI000043734168", "@num": "1", "#text": "Décret n°2021-869 du 30 juin 2021 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000043728288", "@nortexte": "SSAS2114883D", "@numtexte": "2021-869", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-06-30" }, { "@id": "LEGITEXT000049922585", "#text": "Arrêté du 5 juillet 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049892254", "@nortexte": "TSSS2418508A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-07-05" }, { "@id": "LEGIARTI000006689961", "@num": "L5123-3", "#text": "Code de la santé publique - art. 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Le prix de vente au public de chacun des médicaments mentionnés au premier alinéa de l'article L. 162-17 est fixé par convention entre l'entreprise exploitant le médicament et le Comité économique des produits de santé conformément à l'article L. 162-17-4 ou, à défaut, par décision du comité, sauf opposition conjointe des ministres concernés qui arrêtent dans ce cas le prix dans un délai de quinze jours après la décision du comité. La fixation de ce prix tient compte principalement de l'amélioration du service médical rendu apportée par le médicament, le cas échéant des résultats de l'évaluation médico-économique, des prix des médicaments à même visée thérapeutique, des volumes de vente prévus ou constatés ainsi que des conditions prévisibles et réelles d'utilisation du médicament. Lorsque la fixation du prix du médicament est fondée sur une appréciation de l'amélioration du service médical rendu différente de celle de la commission mentionnée à l'article L. 5123-3 du code de la santé publique, le Comité économique des produits de santé fait connaître à la commission les motifs de son appréciation.

Ce prix comprend les marges prévues par la décision mentionnée à l'article L. 162-38 ainsi que les taxes en vigueur.

Un décret en Conseil d'Etat détermine les conditions d'application du présent article, et notamment les procédures et délais de fixation des prix.

" } }, "LEGIARTI000025086312": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5121-12", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-03-07", "DATE_DEBUT": "2011-12-31" } }, "META_COMMUN": { "ID": "LEGIARTI000025086312", "URL": "article/LEGI/ARTI/00/00/25/08/63/LEGIARTI000025086312.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Conformément à l'article 26 de la loi n° 2011-2012 du 29 décembre 2011, article 41-VII, les autorisations accordées sur le fondement des dispositions de l'article L. 5121-12 du code de la santé publique dans leur rédaction antérieure à la promulgation de la présente loi demeurent régies par ces dispositions, y compris pour leur renouvellement, pendant les trois années suivant la promulgation de la présente loi. Ces dispositions continuent également de s'appliquer, pendant la même période, aux nouvelles demandes d'autorisation mentionnées au 2° du I du même article L. 5121-12 si des autorisations de même nature ont déjà été accordées dans la même indication pour le médicament concerné.

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R322-2 (T)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044983676", "@num": "281 octies", "#text": "Code général des impôts, CGI. - art. 281 octies (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069577", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171366", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155085", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140630", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006689900", "@fin": "2004-08-11", "@num": "L5121-12", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006689901", "@fin": "2006-12-22", "@num": "L5121-12", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006689902", "@fin": "2007-02-27", "@num": "L5121-12", "@etat": "MODIFIE", "@debut": "2006-12-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006689903", "@fin": "2011-12-31", "@num": "L5121-12", "@etat": "MODIFIE", "@debut": "2007-02-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025086312", "@fin": "2012-03-07", "@num": "L5121-12", "@etat": "MODIFIE", "@debut": "2011-12-31", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025453908", "@fin": "2016-12-25", "@num": "L5121-12", "@etat": "MODIFIE", "@debut": "2012-03-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000033715544", "@fin": "2019-03-01", "@num": "L5121-12", "@etat": "MODIFIE", "@debut": "2016-12-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000037950766", "@fin": "2020-03-01", "@num": "L5121-12", "@etat": "MODIFIE", "@debut": "2019-03-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000041397496", "@fin": "2020-10-01", "@num": "L5121-12", "@etat": "MODIFIE", "@debut": "2020-03-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000041721215", "@fin": "2021-07-01", "@num": "L5121-12", "@etat": "MODIFIE", "@debut": "2020-10-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000042685762", "@fin": "2022-12-25", "@num": "L5121-12", "@etat": "MODIFIE", "@debut": "2021-07-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000046812649", "@fin": "2023-12-28", "@num": "L5121-12", "@etat": "MODIFIE", "@debut": "2022-12-25", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000048703237", "@fin": "2999-01-01", "@num": "L5121-12", "@etat": "VIGUEUR", "@debut": "2023-12-28", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "I. ― Les articles L. 5121-8 et L. 5121-9-1 ne font pas obstacle à l'utilisation, à titre exceptionnel, de certains médicaments destinés à traiter des maladies graves ou rares, en l'absence de traitement approprié, lorsque la mise en œuvre du traitement ne peut pas être différée et que l'une des conditions suivantes est remplie :
\n
1° L'efficacité et la sécurité de ces médicaments sont fortement présumées au vu des résultats d'essais thérapeutiques auxquels il a été procédé en vue d'une demande d'autorisation de mise sur le marché qui a été déposée ou que l'entreprise intéressée s'engage à déposer dans un délai déterminé ;
\n
2° Ces médicaments, le cas échéant importés, sont prescrits, sous la responsabilité d'un médecin, à un patient nommément désigné et ne pouvant participer à une recherche biomédicale dès lors qu'ils sont susceptibles de présenter un bénéfice pour lui et que leur efficacité et leur sécurité sont présumées en l'état des connaissances scientifiques. Le médecin prescripteur doit justifier que le patient, son représentant légal ou la personne de confiance qu'il a désignée en application de l'article L. 1111-6 a reçu une information adaptée à sa situation sur l'absence d'alternative thérapeutique, les risques courus, les contraintes et le bénéfice susceptible d'être apporté par le médicament. La procédure suivie est inscrite dans le dossier médical.
\n
II. ― L'utilisation des médicaments mentionnés au I est autorisée, pour une durée limitée, éventuellement renouvelable par l'Agence nationale de sécurité du médicament et des produits de santé, à la demande du titulaire des droits d'exploitation du médicament dans le cas prévu au 1° du I ou à la demande du médecin prescripteur dans le cas prévu au 2° du même I.
\n
III. ― Une demande au titre du 2° du I n'est recevable que si l'une des conditions suivantes est remplie :
\n
1° Le médicament a fait l'objet d'une demande au titre du 1° du même I ;
\n
2° Le médicament a fait l'objet d'une demande d'autorisation de mise sur le marché mentionnée à l'article L. 5121-8 ou d'une demande d'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 ;
\n
3° Des essais cliniques sont conduits en France ou une demande d'essai clinique a été déposée ;
\n
4° Le titulaire des droits d'exploitation s'engage à déposer, dans un délai déterminé par l'agence, une des demandes mentionnées aux 1° et 2° du présent III.
\n
En cas de rejet de l'une de ces demandes, l'autorisation mentionnée au 2° du I accordée sur son fondement est retirée pour les indications thérapeutiques sollicitées dans la demande.
\n
IV. ― Par dérogation aux dispositions du III, une autorisation demandée au titre du 2° du I peut être accordée dans l'un des cas suivants :
\n
1° Lorsque, en l'état des thérapeutiques disponibles, des conséquences graves pour le patient sont très fortement probables ;
\n
2° Lorsque le médicament a fait l'objet d'un arrêt de commercialisation, si l'indication thérapeutique sollicitée est différente de celle de l'autorisation du médicament ayant fait l'objet de cet arrêt et qu'il existe de fortes présomptions d'efficacité et de sécurité du médicament dans l'indication thérapeutique sollicitée ;
\n
3° Si, dans l'indication thérapeutique sollicitée, le titulaire des droits d'exploitation du médicament s'est vu refuser une demande pour un médicament mentionné au 1° du I ou si une demande d'autorisation d'essai clinique mentionnée au III a été refusée, sous condition d'une information du patient et du praticien sur les motifs du refus de la demande et sous réserve d'un bénéfice individuel pour le patient.
\n
V. ― Sauf si elle est accordée conformément au IV, l'autorisation est subordonnée à la conclusion, entre l'agence et le titulaire des droits d'exploitation du médicament, d'un protocole d'utilisation thérapeutique et de recueil d'informations concernant l'efficacité, les effets indésirables, les conditions réelles d'utilisation ainsi que les caractéristiques de la population bénéficiant du médicament ainsi autorisé.
\n
Ce recueil d'informations concerne notamment les personnes appartenant à des populations non ou insuffisamment représentées, au regard des populations amenées à faire usage de ces médicaments, au sein des essais thérapeutiques auxquels il a été procédé en vue d'une demande d'autorisation de mise sur le marché.
\n
Pour les médicaments autorisés au titre du même IV, les prescripteurs transmettent à l'agence, à l'expiration de l'autorisation et, le cas échéant, à l'occasion de chaque renouvellement, des données de suivi des patients traités. La nature de ces données est précisée par l'autorisation.
\n
Ces autorisations peuvent également être subordonnées par l'Agence nationale de sécurité du médicament et des produits de santé à la mise en place d'un protocole d'utilisation thérapeutique et de recueil d'informations.
\n
VI. ― L'autorisation mentionnée au II peut être suspendue ou retirée si les conditions prévues au présent article ne sont plus remplies ou pour des motifs de santé publique.
" } }, "LEGIARTI000025453908": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5121-12", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2016-12-25", "DATE_DEBUT": "2012-03-07" } }, "META_COMMUN": { "ID": "LEGIARTI000025453908", "URL": "article/LEGI/ARTI/00/00/25/45/39/LEGIARTI000025453908.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "
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(V)", "@sens": "cible", "@cidtexte": "JORFTEXT000018149510", "@nortexte": "SJSS0801290A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-02-15" }, { "@id": "LEGIARTI000023735278", "@num": "1", "#text": "Arrêté du 13 mars 2009 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020398786", "@nortexte": "SASH0904823A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-03-13" }, { "@id": "LEGIARTI000020561757", "@num": "1", "#text": "Arrêté du 27 avril 2009 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020560773", "@nortexte": "SASS0903462A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-04-27" }, { "@id": "LEGIARTI000025071069", "@num": "41", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 41 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000025442828", "@num": "1", "#text": "LOI n°2012-300\r\n du 5 mars 2012 - art. 1 (V)", "@sens": "source", "@cidtexte": "JORFTEXT000025441587", "@nortexte": "SASX0901817L", "@numtexte": "2012-300", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2012-03-05" }, { "@id": "LEGITEXT000026957330", "#text": "Décret n°2013-66\n du 18 janvier 2013 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000026955060", "@nortexte": "AFSP1230835D", "@numtexte": "2013-66", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2013-01-18" }, { "@id": "LEGIARTI000027699119", "@num": "1", "#text": "Arrêté du 17 juin 2013 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027697076", "@nortexte": "AFSP1301854A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-17" }, { "@id": "LEGIARTI000028222613", "#text": "Arrêté du 18 novembre 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000028220981", "@nortexte": "AFSS1328324A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-11-18" }, { "@id": "LEGIARTI000034460480", "@num": "3", "#text": "Décret n°2017-605 du 21 avril 2017 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000034455675", "@nortexte": "AFSS1706603D", "@numtexte": "2017-605", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-04-21" }, { "@id": "LEGIARTI000034460482", "@num": "4", "#text": "Décret n°2017-605 du 21 avril 2017 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034455675", "@nortexte": "AFSS1706603D", "@numtexte": "2017-605", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-04-21" }, { "@id": "LEGIARTI000038944863", "@num": "2", "#text": "Décret n°2019-855 du 20 août 2019 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000038940078", "@nortexte": "SSAS1916802D", "@numtexte": "2019-855", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-08-20" }, { "@id": "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": "LEGIARTI000043734168", "@num": "1", "#text": "Décret n°2021-869 du 30 juin 2021 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000043728288", "@nortexte": "SSAS2114883D", "@numtexte": "2021-869", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-06-30" }, { "@id": "LEGIARTI000043734172", "@num": "3", "#text": "Décret n°2021-869 du 30 juin 2021 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000043728288", "@nortexte": "SSAS2114883D", "@numtexte": "2021-869", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-06-30" }, { "@id": "LEGIARTI000043734174", "@num": "4", "#text": "Décret n°2021-869 du 30 juin 2021 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043728288", "@nortexte": "SSAS2114883D", "@numtexte": "2021-869", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-06-30" }, { "@id": "LEGITEXT000043733765", "#text": "Décret n°2021-870 du 30 juin 2021 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043728411", "@nortexte": "SSAS2114929D", "@numtexte": "2021-870", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-06-30" }, { "@id": "LEGIARTI000044941358", "@num": "6", "#text": "Décret n°2021-1905 du 30 décembre 2021 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000044638030", "@nortexte": "TREP2130559D", "@numtexte": "2021-1905", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-12-30" }, { "@id": "LEGIARTI000045162554", "@num": "6", "#text": "Décret n°2022-164 du 11 février 2022 - art. 6 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000045159528", "@nortexte": "SSAP2131030D", "@numtexte": "2022-164", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2022-02-11" }, { "@id": "LEGIARTI000047543494", "@num": "6", "#text": "Décret n°2023-367 du 13 mai 2023 - art. 6 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000047542080", "@nortexte": "SPRS2300922D", "@numtexte": "2023-367", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2023-05-13" }, { "@id": "LEGIARTI000049350861", "@num": "1", "#text": "Décret n°2024-290 du 29 mars 2024 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000049345711", "@nortexte": "TSSH2335206D", "@numtexte": "2024-290", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-03-29" }, { "@id": "LEGIARTI000044962600", "@num": "R533-49", "#text": "Code de l'environnement - art. R533-49 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034573672", "@num": "D5121-32", "#text": "Code de la santé publique - art. D5121-32 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043761527", "@num": "D5121-69-3", "#text": "Code de la santé publique - art. D5121-69-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685772", "@num": "L1111-6", "#text": "Code de la santé publique - art. L1111-6 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025445605", "@num": "L1121-16-1", "#text": "Code de la santé publique - art. L1121-16-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026499758", "@num": "L1123-14", "#text": "Code de la santé publique - art. L1123-14 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048701765", "@num": "L5121-1", "#text": "Code de la santé publique - art. L5121-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048703410", "@num": "L5121-14-3", "#text": "Code de la santé publique - art. L5121-14-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000042685733", "@num": "L5121-18", "#text": "Code de la santé publique - art. L5121-18 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048703384", "@num": "L5121-20", "#text": "Code de la santé publique - art. 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L5123-2 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048703364", "@num": "L5124-13", "#text": "Code de la santé publique - art. L5124-13 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000042685785", "@num": "L5521-6", "#text": "Code de la santé publique - art. L5521-6 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693759", "@num": "L601-2", "#text": "Code de la santé publique - art. L601-2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693756", "@num": "L601-2", "#text": "Code de la santé publique - art. 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I. ― Les articles L. 5121-8 et L. 5121-9-1 ne font pas obstacle à l'utilisation, à titre exceptionnel, de certains médicaments destinés à traiter des maladies graves ou rares, en l'absence de traitement approprié, lorsque la mise en œuvre du traitement ne peut pas être différée et que l'une des conditions suivantes est remplie :

1° L'efficacité et la sécurité de ces médicaments sont fortement présumées au vu des résultats d'essais thérapeutiques auxquels il a été procédé en vue d'une demande d'autorisation de mise sur le marché qui a été déposée ou que l'entreprise intéressée s'engage à déposer dans un délai déterminé ;

II. ― L'utilisation des médicaments mentionnés au I est autorisée, pour une durée limitée, éventuellement renouvelable par l'Agence nationale de sécurité du médicament et des produits de santé, à la demande du titulaire des droits d'exploitation du médicament dans le cas prévu au 1° du I ou à la demande du médecin prescripteur dans le cas prévu au 2° du même I.

III. ― Une demande au titre du 2° du I n'est recevable que si l'une des conditions suivantes est remplie :

1° Le médicament a fait l'objet d'une demande au titre du 1° du même I ;

2° Le médicament a fait l'objet d'une demande d'autorisation de mise sur le marché mentionnée à l'article L. 5121-8 ou d'une demande d'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 ;

3° Des essais cliniques sont conduits en France ou une demande d'essai clinique a été déposée ;

4° Le titulaire des droits d'exploitation s'engage à déposer, dans un délai déterminé par l'agence, une des demandes mentionnées aux 1° et 2° du présent III.

En cas de rejet de l'une de ces demandes, l'autorisation mentionnée au 2° du I accordée sur son fondement est retirée pour les indications thérapeutiques sollicitées dans la demande.

IV. ― Par dérogation aux dispositions du III, une autorisation demandée au titre du 2° du I peut être accordée dans l'un des cas suivants :

1° Lorsque, en l'état des thérapeutiques disponibles, des conséquences graves pour le patient sont très fortement probables ;

2° Lorsque le médicament a fait l'objet d'un arrêt de commercialisation, si l'indication thérapeutique sollicitée est différente de celle de l'autorisation du médicament ayant fait l'objet de cet arrêt et qu'il existe de fortes présomptions d'efficacité et de sécurité du médicament dans l'indication thérapeutique sollicitée ;

3° Si, dans l'indication thérapeutique sollicitée, le titulaire des droits d'exploitation du médicament s'est vu refuser une demande pour un médicament mentionné au 1° du I ou si une demande d'autorisation d'essai clinique mentionnée au III a été refusée, sous condition d'une information du patient et du praticien sur les motifs du refus de la demande et sous réserve d'un bénéfice individuel pour le patient.

V. ― Sauf si elle est accordée conformément au IV, l'autorisation est subordonnée à la conclusion, entre l'agence et le titulaire des droits d'exploitation du médicament, d'un protocole d'utilisation thérapeutique et de recueil d'informations concernant l'efficacité, les effets indésirables, les conditions réelles d'utilisation ainsi que les caractéristiques de la population bénéficiant du médicament ainsi autorisé.

Ce recueil d'informations concerne notamment les personnes appartenant à des populations non ou insuffisamment représentées, au regard des populations amenées à faire usage de ces médicaments, au sein des essais thérapeutiques auxquels il a été procédé en vue d'une demande d'autorisation de mise sur le marché.

Pour les médicaments autorisés au titre du même IV, les prescripteurs transmettent à l'agence, à l'expiration de l'autorisation et, le cas échéant, à l'occasion de chaque renouvellement, des données de suivi des patients traités. La nature de ces données est précisée par l'autorisation.

Ces autorisations peuvent également être subordonnées par l'Agence nationale de sécurité du médicament et des produits de santé à la mise en place d'un protocole d'utilisation thérapeutique et de recueil d'informations.

VI. ― L'autorisation mentionnée au II peut être suspendue ou retirée si les conditions prévues au présent article ne sont plus remplies ou pour des motifs de santé publique.

\n
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I. ― Un médicament qui, préalablement à l'obtention de son autorisation de mise sur le marché, a bénéficié d'une autorisation temporaire d'utilisation prévue au 1° du I de l'article L. 5121-12 du code de la santé publique peut, à compter de la date à laquelle l'autorisation temporaire d'utilisation cesse de produire ses effets, être acheté, fourni, pris en charge et utilisé au profit des patients par les collectivités publiques pour une indication répondant à l'une des situations suivantes :
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1° L'indication a fait l'objet de l'autorisation temporaire d'utilisation et est mentionnée soit dans l'autorisation de mise sur le marché, soit dans une extension d'autorisation de mise sur le marché en cours d'évaluation par les autorités compétentes ;
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2° L'indication n'a pas fait l'objet de l'autorisation temporaire d'utilisation, est mentionnée dans l'autorisation de mise sur le marché et soit il n'existe pas d'alternative thérapeutique prise en charge par les régimes obligatoires de sécurité sociale identifiée par la Haute Autorité de santé, soit le patient est en échec de traitement ou présente une contre-indication aux alternatives thérapeutiques prises en charge identifiées.
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Par dérogation au premier alinéa du présent I, lorsque le traitement a été initié au titre d'une autorisation temporaire d'utilisation soit mentionnée au 1° du I du même article L. 5121-12 dans une indication non reprise dans l'autorisation de mise sur le marché, soit mentionnée au 2° du même I, la prise en charge du médicament est autorisée, sous réserve que l'indication n'ait pas fait l'objet d'une évaluation défavorable au titre de l'autorisation de mise sur le marché au sens du premier alinéa de l'article L. 5121-9 du code de la santé publique.
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II. ― La prise en charge des indications mentionnées au 2° du I du présent article est autorisée sur avis conforme de la Haute Autorité de santé, saisie par l'Agence nationale de sécurité du médicament et des produits de santé.
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La saisine est transmise dans un délai de deux semaines à compter de l'avis du comité des médicaments à usage humain.
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La Haute Autorité de santé mentionne, pour chaque indication concernée, les alternatives thérapeutiques prises en charge au titre des articles L. 162-17, L. 162-17-2-1 ou L. 162-17-2-2 du présent code ou de l'article L. 5123-2 du code de la santé publique. Elle transmet son avis aux ministres chargés de la santé et de la sécurité sociale ainsi qu'à l'agence et le rend public, au plus tard un mois après l'obtention de l'autorisation de mise sur le marché.
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III. ― La prise en charge mentionnée au I du présent article dure jusqu'à ce qu'une décision relative à l'inscription de ce médicament, au titre de son autorisation de mise sur le marché, sur une des listes mentionnées au premier alinéa de l'article L. 5123-2 du code de la santé publique ou aux deux premiers alinéas de l'article L. 162-17 du présent code ait été prise et, le cas échéant, jusqu'à ce que l'avis de fixation du tarif de responsabilité ou du prix ait été publié.
\n
Le présent article cesse de s'appliquer si aucune demande d'inscription sur une des listes mentionnées au premier alinéa de l'article L. 5123-2 du code de la santé publique ou à l'article L. 162-17 du présent code n'a été déposée, pour le médicament considéré, dans le mois suivant l'obtention de son autorisation de mise sur le marché.

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Le prix de vente au public de chacun des médicaments mentionnés au premier alinéa de l'article L. 162-17 est fixé par convention entre l'entreprise exploitant le médicament et le Comité économique des produits de santé conformément à l'article L. 162-17-4 ou, à défaut, par décision du comité, sauf opposition conjointe des ministres concernés qui arrêtent dans ce cas le prix dans un délai de quinze jours après la décision du comité. La fixation de ce prix tient compte principalement de l'amélioration du service médical rendu apportée par le médicament, le cas échéant des résultats de l'évaluation médico-économique, des prix des médicaments à même visée thérapeutique, des volumes de vente prévus ou constatés ainsi que des conditions prévisibles et réelles d'utilisation du médicament. Lorsque la fixation du prix du médicament est fondée sur une appréciation de l'amélioration du service médical rendu différente de celle de la commission mentionnée à l'article L. 5123-3 du code de la santé publique, le Comité économique des produits de santé fait connaître à la commission les motifs de son appréciation.

Ce prix comprend les marges prévues par la décision mentionnée à l'article L. 162-38 ainsi que les taxes en vigueur.

Un décret en Conseil d'Etat détermine les conditions d'application du présent article, et notamment les procédures et délais de fixation des prix.

Sont constatées et poursuivies, dans les conditions prévues au titre V du livre IV du code de commerce, les infractions aux conventions et arrêtés mentionnés ci-dessus.

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I. ― Un médicament qui, préalablement à l'obtention de son autorisation de mise sur le marché, a bénéficié d'une autorisation temporaire d'utilisation prévue au 1° du I de l'article L. 5121-12 du code de la santé publique peut, à compter de la date à laquelle l'autorisation temporaire d'utilisation cesse de produire ses effets, être acheté, fourni, pris en charge et utilisé au profit des patients par les collectivités publiques pour une indication répondant à l'une des situations suivantes :
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1° L'indication a fait l'objet de l'autorisation temporaire d'utilisation et est mentionnée soit dans l'autorisation de mise sur le marché, soit dans une extension d'autorisation de mise sur le marché en cours d'évaluation par les autorités compétentes ;
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2° L'indication n'a pas fait l'objet de l'autorisation temporaire d'utilisation, est mentionnée dans l'autorisation de mise sur le marché et soit il n'existe pas d'alternative thérapeutique prise en charge par les régimes obligatoires de sécurité sociale identifiée par la Haute Autorité de santé, soit le patient est en échec de traitement ou présente une contre-indication aux alternatives thérapeutiques prises en charge identifiées.
\n
Par dérogation au premier alinéa du présent I, lorsque le traitement a été initié au titre d'une autorisation temporaire d'utilisation soit mentionnée au 1° du I du même article L. 5121-12 dans une indication non reprise dans l'autorisation de mise sur le marché, soit mentionnée au 2° du même I, la prise en charge du médicament est autorisée, sous réserve que l'indication n'ait pas fait l'objet d'une évaluation défavorable au titre de l'autorisation de mise sur le marché au sens du premier alinéa de l'article L. 5121-9 du code de la santé publique.
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II. ― La prise en charge des indications mentionnées au 2° du I du présent article est autorisée sur avis conforme de la Haute Autorité de santé, saisie par l'Agence nationale de sécurité du médicament et des produits de santé.
\n
La saisine est transmise dans un délai de deux semaines à compter de l'avis du comité des médicaments à usage humain.
\n
La Haute Autorité de santé mentionne, pour chaque indication concernée, les alternatives thérapeutiques prises en charge au titre des articles L. 162-17 ou L. 162-17-2-1 du présent code ou de l'article L. 5123-2 du code de la santé publique. Elle transmet son avis aux ministres chargés de la santé et de la sécurité sociale ainsi qu'à l'agence et le rend public, au plus tard un mois après l'obtention de l'autorisation de mise sur le marché.
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III. ― La prise en charge mentionnée au I du présent article dure jusqu'à ce qu'une décision relative à l'inscription de ce médicament, au titre de son autorisation de mise sur le marché, sur une des listes mentionnées au premier alinéa de l'article L. 5123-2 du code de la santé publique ou aux deux premiers alinéas de l'article L. 162-17 du présent code ait été prise et, le cas échéant, jusqu'à ce que l'avis de fixation du tarif de responsabilité ou du prix ait été publié.
\n
Le présent article cesse de s'appliquer si aucune demande d'inscription sur une des listes mentionnées au premier alinéa de l'article L. 5123-2 du code de la santé publique ou à l'article L. 162-17 du présent code n'a été déposée, pour le médicament considéré, dans le mois suivant l'obtention de son autorisation de mise sur le marché.

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Lorsque le chiffre d'affaires hors taxes réalisé en France métropolitaine et dans les départements d'outre-mer, au cours de l'année civile, au titre des médicaments destinés au traitement de l'infection chronique par le virus de l'hépatite C, minoré des remises mentionnées aux articles L. 162-16-5-1 et L. 162-18, est supérieur à un montant W déterminé par la loi et s'est accru de plus de 10 % par rapport au même chiffre d'affaires réalisé l'année précédente, minoré des remises mentionnées aux articles L. 138-19-4, L. 162-16-5-1 et L. 162-18 et de la contribution prévue au présent article, les entreprises titulaires des droits d'exploitation de ces médicaments sont assujetties à une contribution.

La liste des médicaments mentionnés au premier alinéa du présent article est établie et publiée par la Haute Autorité de santé. Le cas échéant, cette liste est actualisée après chaque autorisation de mise sur le marché ou autorisation temporaire d'utilisation de médicaments qui en relèvent.

\n
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L138-19-1 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000029954776", "@num": "L138-19-3", "#text": "Code de la sécurité sociale. - art. L138-19-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033713175", "@num": "L138-19-7", "#text": "Code de la sécurité sociale. - art. L138-19-7 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006740846", "@num": "L162-16-4", "#text": "Code de la sécurité sociale. - art. 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L162-17-4 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006741637", "@num": "L213-1", "#text": "Code de la sécurité sociale. - art. L213-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000029954746", "@fin": "2999-01-01", "#text": "Section 3 : Contribution au titre de médicaments destinés au traitement de l'hépatite C", "@debut": "2014-12-25" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006156017", "@fin": "2015-01-01", "#text": "Chapitre 8 : Contributions à la charge des entreprises de vente en gros de spécialités pharmaceutiques et des entreprises assurant l'exploitation d'une ou plusieurs spécialités pharmaceutiques au sens de l'article L. 596 du code de la santé publique", "@debut": "1998-12-27" }, { "@id": "LEGISCTA000029961756", "@fin": "2999-01-01", "#text": "Chapitre 8 : Contributions à la charge des entreprises de vente en gros de spécialités pharmaceutiques et des entreprises assurant l'exploitation d'une ou plusieurs spécialités pharmaceutiques", "@debut": "2015-01-01" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006141602", "@fin": "2999-01-01", "#text": "Titre III : Dispositions communes relatives au financement", "@debut": "1985-12-21" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006126885", "@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": "LEGISCTA000006106050", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "1985-12-21" } ] }, "@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": "LEGIARTI000029954786", "@fin": "2015-12-23", "@num": "L138-19-4", "@etat": "MODIFIE", "@debut": "2014-12-25", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000031684635", "@fin": "2016-12-25", "@num": "L138-19-4", "@etat": "ABROGE", "@debut": "2015-12-23", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Les entreprises redevables de la contribution qui, en application des articles L. 162-16-4 à L. 162-16-5 et L. 162-16-6, ont conclu avec le Comité économique des produits de santé, pour l'ensemble des médicaments de la liste mentionnée au second alinéa de l'article L. 138-19-1 qu'elles exploitent, une convention en cours de validité au 31 décembre de l'année civile au titre de laquelle la contribution est due et conforme aux modalités définies par un accord conclu, le cas échéant, en application du premier alinéa de l'article L. 162-17-4 peuvent signer avec le comité, avant le 31 janvier de l'année suivant l'année civile au titre de laquelle la contribution est due, un accord prévoyant le versement sous forme de remise, à un des organismes mentionnés à l'article L. 213-1 désigné par le directeur de l'Agence centrale des organismes de sécurité sociale, de tout ou partie du montant dû au titre de la contribution. Les entreprises exploitant les médicaments de la liste précitée bénéficiant d'une autorisation prévue à l'article L. 5121-12 du code de la santé publique ou pris en charge en application de l'article L. 162-16-5-2 du présent code, dont le syndicat représentatif est signataire de l'accord mentionné au premier alinéa de l'article L. 162-17-4, peuvent également signer avec le comité un accord prévoyant le versement de remises.

Une entreprise signataire d'un accord mentionné au premier alinéa du présent article est exonérée de la contribution si les remises qu'elle verse sont supérieures ou égales à 90 % du montant dont elle est redevable au titre de la contribution.

\n
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Conformément à l'article 4 de la loi n° 2015-1702 du 21 décembre 2015, ces dispositions s'appliquent à compter des contributions et remises dues au titre de 2015.

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L213-1", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000029954746", "@fin": "2999-01-01", "#text": "Section 3 : Contribution au titre de médicaments destinés au traitement de l'hépatite C", "@debut": "2014-12-25" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006156017", "@fin": "2015-01-01", "#text": "Chapitre 8 : Contributions à la charge des entreprises de vente en gros de spécialités pharmaceutiques et des entreprises assurant l'exploitation d'une ou plusieurs spécialités pharmaceutiques au sens de l'article L. 596 du code de la santé publique", "@debut": "1998-12-27" }, { "@id": "LEGISCTA000029961756", "@fin": "2999-01-01", "#text": "Chapitre 8 : Contributions à la charge des entreprises de vente en gros de spécialités pharmaceutiques et des entreprises assurant l'exploitation d'une ou plusieurs spécialités pharmaceutiques", "@debut": "2015-01-01" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006141602", "@fin": "2999-01-01", "#text": "Titre III : Dispositions communes relatives au financement", "@debut": "1985-12-21" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006126885", "@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": "LEGISCTA000006106050", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "1985-12-21" } ] }, "@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": "LEGIARTI000029954786", "@fin": "2015-12-23", "@num": "L138-19-4", "@etat": "MODIFIE", "@debut": "2014-12-25", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000031684635", "@fin": "2016-12-25", "@num": "L138-19-4", "@etat": "ABROGE", "@debut": "2015-12-23", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Une entreprise signataire d'un accord mentionné au premier alinéa du présent article est exonérée de la contribution si la remise qu'elle verse en application de cet accord est supérieure ou égale à 90 % du montant dont elle est redevable au titre de la contribution.

" } }, "LEGIARTI000031684669": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L138-19-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2016-12-25", "DATE_DEBUT": "2015-12-23" } }, "META_COMMUN": { "ID": "LEGIARTI000031684669", "URL": "article/LEGI/ARTI/00/00/31/68/46/LEGIARTI000031684669.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Conformément à l'article 4 de la loi n° 2015-1702 du 21 décembre 2015, ces dispositions s'appliquent à compter des contributions et remises dues au titre de 2015.

" }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000029954703", "@num": "3", "#text": "LOI n° 2014-1554 du 22 décembre 2014 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029953502", "@nortexte": "FCPX1422901L", "@numtexte": "2014-1554", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2014-12-22" }, { "@id": "LEGIARTI000031666216", "@num": "37", "#text": "LOI n°2015-1702 du 21 décembre 2015 - art. 37 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000031663208", "@nortexte": "FCPX1523191L", "@numtexte": "2015-1702", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2015-12-21" }, { "@id": "LEGIARTI000031666082", "@num": "4", "#text": "LOI n°2015-1702 du 21 décembre 2015 - art. 4", "@sens": "cible", "@cidtexte": "JORFTEXT000031663208", "@nortexte": "FCPX1523191L", "@numtexte": "2015-1702", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2015-12-21" }, { "@id": "LEGIARTI000034076540", "@num": "L138-10", "#text": "Code de la sécurité sociale. - art. L138-10 (MMN)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033713255", "@num": "L138-11", "#text": "Code de la sécurité sociale. - art. L138-11 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033713159", "@num": "L138-19-2", "#text": "Code de la sécurité sociale. - art. L138-19-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000029954776", "@num": "L138-19-3", "#text": "Code de la sécurité sociale. - art. L138-19-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000031684635", "@num": "L138-19-4", "#text": "Code de la sécurité sociale. - art. L138-19-4 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000029954793", "@num": "L138-19-5", "#text": "Code de la sécurité sociale. - art. L138-19-5 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048688899", "@num": "L138-20", "#text": "Code de la sécurité sociale. - art. L138-20 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006741362", "@num": "L162-16-5-1", "#text": "Code de la sécurité sociale. - art. L162-16-5-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006741370", "@num": "L162-17-5", "#text": "Code de la sécurité sociale. - art. L162-17-5 (VT)", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006740616", "@num": "L162-18", "#text": "Code de la sécurité sociale. - art. L162-18 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000037064698", "@num": "L221-1-1", "#text": "Code de la sécurité sociale. - art. L221-1-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000029954746", "@fin": "2999-01-01", "#text": "Section 3 : Contribution au titre de médicaments destinés au traitement de l'hépatite C", "@debut": "2014-12-25" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006156017", "@fin": "2015-01-01", "#text": "Chapitre 8 : Contributions à la charge des entreprises de vente en gros de spécialités pharmaceutiques et des entreprises assurant l'exploitation d'une ou plusieurs spécialités pharmaceutiques au sens de l'article L. 596 du code de la santé publique", "@debut": "1998-12-27" }, { "@id": "LEGISCTA000029961756", "@fin": "2999-01-01", "#text": "Chapitre 8 : Contributions à la charge des entreprises de vente en gros de spécialités pharmaceutiques et des entreprises assurant l'exploitation d'une ou plusieurs spécialités pharmaceutiques", "@debut": "2015-01-01" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006141602", "@fin": "2999-01-01", "#text": "Titre III : Dispositions communes relatives au financement", "@debut": "1985-12-21" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006126885", "@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": "LEGISCTA000006106050", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "1985-12-21" } ] }, "@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": "LEGIARTI000029954753", "@fin": "2015-12-23", "@num": "L138-19-1", "@etat": "MODIFIE", "@debut": "2014-12-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000031684669", "@fin": "2016-12-25", "@num": "L138-19-1", "@etat": "MODIFIE", "@debut": "2015-12-23", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000033713187", "@fin": "2999-01-01", "@num": "L138-19-1", "@etat": "VIGUEUR", "@debut": "2017-01-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Lorsque le chiffre d'affaires hors taxes réalisé en France métropolitaine et dans les départements d'outre-mer, au cours de l'année civile, au titre des médicaments destinés au traitement de l'infection chronique par le virus de l'hépatite C, minoré des remises mentionnées aux articles L. 162-16-5-1, L. 162-17-5 et L. 162-18, est supérieur à un montant W déterminé par la loi et s'est accru de plus de 10 % par rapport au même chiffre d'affaires réalisé l'année précédente, minoré des remises mentionnées aux articles L. 138-19-4, L. 162-16-5-1, L. 162-17-5 et L. 162-18 et de la contribution prévue au présent article, les entreprises titulaires des droits d'exploitation de ces médicaments sont assujetties à une contribution.

\n
" } }, "LEGIARTI000033685386": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "30", "ETAT": "VIGUEUR", "TYPE": "PARTIELLEMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2016-12-25" } }, "META_COMMUN": { "ID": "LEGIARTI000033685386", "URL": "article/LEGI/ARTI/00/00/33/68/53/LEGIARTI000033685386.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000033713289", "@num": "L138-10", "#text": "Code de la sécurité sociale. - art. L138-10 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033713255", "@num": "L138-11", "#text": "Code de la sécurité sociale. - art. L138-11 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033713245", "@num": "L138-12", "#text": "Code de la sécurité sociale. - art. L138-12 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033713227", "@num": "L138-13", "#text": "Code de la sécurité sociale. - art. L138-13 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033713224", "@num": "L138-14", "#text": "Code de la sécurité sociale. - art. L138-14 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033713216", "@num": "L138-15", "#text": "Code de la sécurité sociale. - art. L138-15 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033713211", "@num": "L138-16", "#text": "Code de la sécurité sociale. - art. L138-16 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033713187", "@num": "L138-19-1", "#text": "Code de la sécurité sociale. - art. L138-19-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000029954755", "@num": "L138-19-2", "#text": "Code de la sécurité sociale. - art. L138-19-2 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033713179", "@num": "L138-19-3", "#text": "Code de la sécurité sociale. - art. L138-19-3 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000031684635", "@num": "L138-19-4", "#text": "Code de la sécurité sociale. - art. L138-19-4 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000029954788", "@num": "L138-19-5", "#text": "Code de la sécurité sociale. - art. L138-19-5 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000029954795", "@num": "L138-19-6", "#text": "Code de la sécurité sociale. - art. L138-19-6 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033713175", "@num": "L138-19-7", "#text": "Code de la sécurité sociale. - art. L138-19-7 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000033685175", "@fin": "2999-01-01", "#text": "Chapitre III : Dispositions contribuant au financement de l'assurance maladie", "@debut": "2016-12-25" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000033685181", "@fin": "2999-01-01", "#text": "Titre Ier : DISPOSITIONS RELATIVES AUX RECETTES, AU RECOUVREMENT ET À LA TRÉSORERIE", "@debut": "2016-12-25" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000034981741", "@fin": "2999-01-01", "#text": "TROISIÈME PARTIE : DISPOSITIONS RELATIVES AUX RECETTES ET À L'ÉQUILIBRE FINANCIER DE LA SÉCURITÉ SOCIALE POUR L'EXERCICE 2017", "@debut": "2016-12-25" } ] }, "@cid": "JORFTEXT000033680665", "@nor": "ECFX1623944L", "@num": "2016-1827", "@nature": "LOI", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "LOI n° 2016-1827 du 23 décembre 2016 de financement de la sécurité sociale pour 2017 (1)", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000033680665", "@c_titre_court": "LOI n° 2016-1827 du 23 décembre 2016" }, { "@fin": "2999-01-01", "#text": "LOI n° 2016-1827 du 23 décembre 2016 de financement de la sécurité sociale pour 2017 (1)", "@debut": "2016-12-25", "@id_txt": "LEGITEXT000033685172", "@c_titre_court": "LOI n°2016-1827 du 23 décembre 2016" } ], "@date_publi": "2016-12-24", "@date_signature": "2016-12-23", "@num_parution_jo": "0299" } }, "VERSIONS": { "VERSION": [ { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000033685386", "@fin": "2999-01-01", "@num": "30", "@etat": "VIGUEUR", "@debut": "2016-12-25", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000033680748", "@fin": "2999-01-01", "@num": "30", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

\n
A modifié les dispositions suivantes :

-Code de la sécurité sociale.
\nArt. L138-10, Art. L138-11, Art. L138-12, Art. L138-13, Art. L138-14, Art. L138-15, Art. L138-16, Art. L138-19-1, Art. L138-19-3, Art. L138-19-4, Art. L138-19-7, Art. L138-19-2, Art. L138-19-5, Art. L138-19-6
\n

\n
\n

I.-B.-Pour l'année 2017, les taux (Lv) et (Lh) mentionnés à l'article L. 138-10 du code de la sécurité sociale sont fixés, respectivement, à 0 % et à 2 %

\n
\n

II.-B.-Les articles L. 138-19-1, L. 138-19-3, L. 138-19-7 du même code, dans leur rédaction résultant du présent article, et L. 138-19-2, L. 138-19-5 et L. 138-19-6 du même code s'appliquent pour l'année 2017.

\n
Pour l'année 2017, le montant W mentionné aux articles L. 138-19-1 et L. 138-19-3 du même code est fixé à 600 millions d'euros.

\n
" } }, "LEGIARTI000033713187": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L138-19-1", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2017-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000033713187", "URL": "article/LEGI/ARTI/00/00/33/71/31/LEGIARTI000033713187.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Conformément au B du II de l'article 30 de la loi n° 2016-1827 du 23 décembre 2016, le présent article, dans sa rédaction issue du A du II du même article, s'applique pour l'année 2017. Le montant w mentionné à l'article L. 138-19-1 est fixé à 600 millions d'euros.

\n
" }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000029954703", "@num": "3", "#text": "LOI n° 2014-1554 du 22 décembre 2014 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029953502", "@nortexte": "FCPX1422901L", "@numtexte": "2014-1554", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2014-12-22" }, { "@id": "LEGIARTI000031666216", "@num": "37", "#text": "LOI n°2015-1702 du 21 décembre 2015 - art. 37 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000031663208", "@nortexte": "FCPX1523191L", "@numtexte": "2015-1702", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2015-12-21" }, { "@id": "LEGIARTI000033685386", "@num": "30", "#text": "LOI n°2016-1827 du 23 décembre 2016 - art. 30 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033680665", "@nortexte": "ECFX1623944L", "@numtexte": "2016-1827", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2016-12-23" }, { "@id": "LEGIARTI000034076540", "@num": "L138-10", "#text": "Code de la sécurité sociale. - art. L138-10 (MMN)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033713255", "@num": "L138-11", "#text": "Code de la sécurité sociale. - art. L138-11 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033713159", "@num": "L138-19-2", "#text": "Code de la sécurité sociale. - art. L138-19-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033713179", "@num": "L138-19-3", "#text": "Code de la sécurité sociale. - art. L138-19-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000031684635", "@num": "L138-19-4", "#text": "Code de la sécurité sociale. - art. L138-19-4 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000029954793", "@num": "L138-19-5", "#text": "Code de la sécurité sociale. - art. L138-19-5 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048688899", "@num": "L138-20", "#text": "Code de la sécurité sociale. - art. L138-20 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006741362", "@num": "L162-16-5-1", "#text": "Code de la sécurité sociale. - art. L162-16-5-1", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006741370", "@num": "L162-17-5", "#text": "Code de la sécurité sociale. - art. L162-17-5", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033715552", "@num": "L162-18", "#text": "Code de la sécurité sociale. - art. L162-18 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000037064698", "@num": "L221-1-1", "#text": "Code de la sécurité sociale. - art. L221-1-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000029954746", "@fin": "2999-01-01", "#text": "Section 3 : Contribution au titre de médicaments destinés au traitement de l'hépatite C", "@debut": "2014-12-25" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006156017", "@fin": "2015-01-01", "#text": "Chapitre 8 : Contributions à la charge des entreprises de vente en gros de spécialités pharmaceutiques et des entreprises assurant l'exploitation d'une ou plusieurs spécialités pharmaceutiques au sens de l'article L. 596 du code de la santé publique", "@debut": "1998-12-27" }, { "@id": "LEGISCTA000029961756", "@fin": "2999-01-01", "#text": "Chapitre 8 : Contributions à la charge des entreprises de vente en gros de spécialités pharmaceutiques et des entreprises assurant l'exploitation d'une ou plusieurs spécialités pharmaceutiques", "@debut": "2015-01-01" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006141602", "@fin": "2999-01-01", "#text": "Titre III : Dispositions communes relatives au financement", "@debut": "1985-12-21" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006126885", "@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": "LEGISCTA000006106050", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "1985-12-21" } ] }, "@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": "LEGIARTI000029954753", "@fin": "2015-12-23", "@num": "L138-19-1", "@etat": "MODIFIE", "@debut": "2014-12-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000031684669", "@fin": "2016-12-25", "@num": "L138-19-1", "@etat": "MODIFIE", "@debut": "2015-12-23", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000033713187", "@fin": "2999-01-01", "@num": "L138-19-1", "@etat": "VIGUEUR", "@debut": "2017-01-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Lorsque le chiffre d'affaires hors taxes réalisé en France métropolitaine, en Guadeloupe, en Guyane, en Martinique, à La Réunion, à Saint-Barthélemy et à Saint-Martin, au cours de l'année civile, au titre des médicaments destinés au traitement de l'infection chronique par le virus de l'hépatite C, minoré des remises mentionnées aux articles L. 162-16-5-1, L. 162-17-5 et L. 162-18, est supérieur à un montant W déterminé par la loi et s'est accru de plus de 10 % par rapport au même chiffre d'affaires réalisé l'année précédente, minoré des remises mentionnées aux articles L. 162-16-5-1, L. 162-17-5 et L. 162-18 et de la contribution prévue au présent article, les entreprises titulaires des droits d'exploitation de ces médicaments sont assujetties à une contribution.

\n
" } }, "LEGIARTI000033713245": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L138-12", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2019-01-01", "DATE_DEBUT": "2016-12-25" } }, "META_COMMUN": { "ID": "LEGIARTI000033713245", "URL": "article/LEGI/ARTI/00/00/33/71/32/LEGIARTI000033713245.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000031666216", "@num": "37", "#text": "LOI n° 2015-1702 du 21 décembre 2015 - art. 37 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000031663208", "@nortexte": "FCPX1523191L", "@numtexte": "2015-1702", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2015-12-21" }, { "@id": "LEGIARTI000033685386", "@num": "30", "#text": "LOI n°2016-1827 du 23 décembre 2016 - art. 30 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033680665", "@nortexte": "ECFX1623944L", "@numtexte": "2016-1827", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2016-12-23" }, { "@id": "LEGIARTI000006689866", "@num": "L5111-1", "#text": "Code de la santé publique - art. L5111-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006740405", "@num": "L138-10", "#text": "Code de la sécurité sociale. - art. L138-10", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033713255", "@num": "L138-11", "#text": "Code de la sécurité sociale. - art. L138-11 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006741133", "@num": "L138-13", "#text": "Code de la sécurité sociale. - art. L138-13", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006172902", "@fin": "2015-01-01", "#text": "Section 2 : Contributions à la charge des entreprises assurant l'exploitation d'une ou plusieurs spécialités pharmaceutiques au sens de l'article L. 596 du code de la santé publique", "@debut": "2005-12-20" }, { "@id": "LEGISCTA000029961752", "@fin": "2019-12-28", "#text": "Section 2 : Contribution à la charge des entreprises assurant l'exploitation d'une ou de plusieurs spécialités pharmaceutiques", "@debut": "2015-01-01" }, { "@id": "LEGISCTA000041397409", "@fin": "2999-01-01", "#text": "Section 2 : Contribution à la charge des entreprises assurant l'exploitation, l'importation parallèle ou la distribution parallèle d'une ou de plusieurs spécialités pharmaceutiques", "@debut": "2019-12-28" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006156017", "@fin": "2015-01-01", "#text": "Chapitre 8 : Contributions à la charge des entreprises de vente en gros de spécialités pharmaceutiques et des entreprises assurant l'exploitation d'une ou plusieurs spécialités pharmaceutiques au sens de l'article L. 596 du code de la santé publique", "@debut": "1998-12-27" }, { "@id": "LEGISCTA000029961756", "@fin": "2999-01-01", "#text": "Chapitre 8 : Contributions à la charge des entreprises de vente en gros de spécialités pharmaceutiques et des entreprises assurant l'exploitation d'une ou plusieurs spécialités pharmaceutiques", "@debut": "2015-01-01" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006141602", "@fin": "2999-01-01", "#text": "Titre III : Dispositions communes relatives au financement", "@debut": "1985-12-21" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006126885", "@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": "LEGISCTA000006106050", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "1985-12-21" } ] }, "@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": "LEGIARTI000006741131", "@fin": "2005-12-20", "@num": "L138-12", "@etat": "MODIFIE", "@debut": "1998-12-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006741132", "@fin": "2012-12-19", "@num": "L138-12", "@etat": "MODIFIE", "@debut": "2005-12-20", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026798814", "@fin": "2015-01-01", "@num": "L138-12", "@etat": "MODIFIE", "@debut": "2012-12-19", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000029961713", "@fin": "2016-12-25", "@num": "L138-12", "@etat": "MODIFIE", "@debut": "2015-01-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000033713245", "@fin": "2019-01-01", "@num": "L138-12", "@etat": "MODIFIE", "@debut": "2016-12-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000037947989", "@fin": "2022-12-25", "@num": "L138-12", "@etat": "MODIFIE", "@debut": "2019-01-01", "@origine": "LEGI" } }, { "@etat": "ABROGE_DIFF", "LIEN_ART": { "@id": "LEGIARTI000046805505", "@fin": "2026-01-01", "@num": "L138-12", "@etat": "ABROGE_DIFF", "@debut": "2022-12-25", "@origine": "LEGI" } }, { "@etat": "VIGUEUR_DIFF", "LIEN_ART": { "@id": "LEGIARTI000048688945", "@fin": "2999-01-01", "@num": "L138-12", "@etat": "VIGUEUR_DIFF", "@debut": "2026-01-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
\n

Le montant total de chaque contribution est calculé comme suit, en prenant comme taux (L) mentionné dans le tableau ci-dessous soit le taux (Lv) s'agissant du chiffre d'affaires des médicaments mentionnés au 1° du II de l'article L. 138-10, soit le taux (Lh) s'agissant du chiffre d'affaires des médicaments mentionnés au 2° du même II :

\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n

\n TAUX D'ACCROISSEMENT DU CHIFFRE D'AFFAIRES \n de l'ensemble des entreprises redevables (T) \n \n	\n TAUX DE LA CONTRIBUTION \n (exprimé en % de la part du chiffre d'affaires concernée) \n \n
\n T supérieur à L et inférieur ou égal à L + 0,5 point \n	\n 50 % \n
\n T supérieur à L + 0,5 point et inférieur ou égal à L + 1 point \n	\n 60 % \n
\n T supérieur à L + 1 point \n	\n 70 % \n

\n\n
\n
\n

Chaque contribution due par chaque entreprise redevable est déterminée, à concurrence de 50 %, au prorata de son chiffre d'affaires respectif calculé selon les modalités définies à l'article L. 138-11 et, à concurrence de 50 %, en fonction de la progression de son chiffre d'affaires défini à l'article L. 138-10. Elle est minorée, le cas échéant, des remises versées au titre de l'article L. 138-13. Les entreprises créées depuis moins d'un an ne sont pas redevables de la part de la contribution répartie en fonction de la progression du chiffre d'affaires, sauf si la création résulte d'une scission ou d'une fusion d'une entreprise ou d'un groupe.

Le montant des contributions dues par chaque entreprise redevable ne peut excéder 10 % de son chiffre d'affaires hors taxes réalisé en France métropolitaine, en Guadeloupe, en Guyane, en Martinique, à La Réunion, à Saint-Barthélemy et à Saint-Martin, au cours de l'année civile considérée, au titre des médicaments mentionnés à l'article L. 5111-1 du code de la santé publique.

\n
" } }, "LEGIARTI000033715544": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5121-12", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2019-03-01", "DATE_DEBUT": "2016-12-25" } }, "META_COMMUN": { "ID": "LEGIARTI000033715544", "URL": "article/LEGI/ARTI/00/00/33/71/55/LEGIARTI000033715544.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "
" }, "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": "JORFTEXT000000217229", "#text": "Rapport relatif à l'ordonnance n° 2000-548 du 15 juin 2000", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi n°2002-303 du 4 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000006240491", "@num": "1", "#text": "Arrêté du 12 avril 2005 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000256880", "@nortexte": "SANH0521417A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2005-04-12" }, { "@id": "LEGIARTI000006781743", "@num": "ANNEXE", "#text": "Décret n°2005-1023 du 24 août 2005 - art. ANNEXE (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000631121", "@nortexte": "SANS0522239D", "@numtexte": "2005-1023", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2005-08-24" }, { "@id": "LEGIARTI000020140270", "@num": "4", "#text": "Arrêté du 24 mai 2006 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000457818", "@nortexte": "SANP0622223A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-05-24" }, { "@id": "LEGIARTI000020140271", "@num": "6", "#text": "Arrêté du 24 mai 2006 - art. 6 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000457818", "@nortexte": "SANP0622223A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-05-24" }, { "@id": "LEGIARTI000020040438", "@num": "1", "#text": "Arrêté du 18 septembre 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000607229", "@nortexte": "SANS0623839A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-09-18" }, { "@id": "LEGIARTI000043762395", "@num": "21", "#text": "Décret n° 2007-359 du 19 mars 2007 - art. 21 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000645145", "@nortexte": "AGRG0700643D", "@numtexte": "2007-359", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-19" }, { "@id": "LEGIARTI000018653113", "@num": "1", "#text": "Arrêté du 23 mars 2007 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000273621", "@nortexte": "SANH0721412A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2007-03-23" }, { "@id": "LEGIARTI000006261855", "@num": "2", "#text": "Décret n°2007-455 du 25 mars 2007 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000273942", "@nortexte": "SANP0622069D", "@numtexte": "2007-455", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-25" }, { "@id": "LEGIARTI000018149987", "#text": "Arrêté du 15 février 2008 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000018149510", "@nortexte": "SJSS0801290A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-02-15" }, { "@id": "LEGIARTI000023735278", "@num": "1", "#text": "Arrêté du 13 mars 2009 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020398786", "@nortexte": "SASH0904823A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-03-13" }, { "@id": "LEGIARTI000020561757", "@num": "1", "#text": "Arrêté du 27 avril 2009 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020560773", "@nortexte": "SASS0903462A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-04-27" }, { "@id": "LEGIARTI000025071069", "@num": "41", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 41 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGITEXT000026957330", "#text": "Décret n°2013-66\n du 18 janvier 2013 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000026955060", "@nortexte": "AFSP1230835D", "@numtexte": "2013-66", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2013-01-18" }, { "@id": "LEGIARTI000027699119", "@num": "1", "#text": "Arrêté du 17 juin 2013 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027697076", "@nortexte": "AFSP1301854A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-17" }, { "@id": "LEGIARTI000028222613", "#text": "Arrêté du 18 novembre 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000028220981", "@nortexte": "AFSS1328324A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-11-18" }, { "@id": "LEGIARTI000033685292", "@num": "97", "#text": "LOI n°2016-1827 du 23 décembre 2016 - art. 97 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033680665", "@nortexte": "ECFX1623944L", "@numtexte": "2016-1827", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2016-12-23" }, { "@id": "LEGIARTI000034460480", "@num": "3", "#text": "Décret n°2017-605 du 21 avril 2017 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000034455675", "@nortexte": "AFSS1706603D", "@numtexte": "2017-605", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-04-21" }, { "@id": "LEGIARTI000034460482", "@num": "4", "#text": "Décret n°2017-605 du 21 avril 2017 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034455675", "@nortexte": "AFSS1706603D", "@numtexte": "2017-605", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-04-21" }, { "@id": "LEGIARTI000038944863", "@num": "2", "#text": "Décret n°2019-855 du 20 août 2019 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000038940078", "@nortexte": "SSAS1916802D", "@numtexte": "2019-855", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-08-20" }, { "@id": "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": "LEGIARTI000043734168", "@num": "1", "#text": "Décret n°2021-869 du 30 juin 2021 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000043728288", "@nortexte": "SSAS2114883D", "@numtexte": "2021-869", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-06-30" }, { "@id": "LEGIARTI000043734172", "@num": "3", "#text": "Décret n°2021-869 du 30 juin 2021 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000043728288", "@nortexte": "SSAS2114883D", "@numtexte": "2021-869", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-06-30" }, { "@id": "LEGIARTI000043734174", "@num": "4", "#text": "Décret n°2021-869 du 30 juin 2021 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043728288", "@nortexte": "SSAS2114883D", "@numtexte": "2021-869", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-06-30" }, { "@id": "LEGITEXT000043733765", "#text": "Décret n°2021-870 du 30 juin 2021 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043728411", "@nortexte": "SSAS2114929D", "@numtexte": "2021-870", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-06-30" }, { "@id": "LEGIARTI000044941358", "@num": "6", "#text": "Décret n°2021-1905 du 30 décembre 2021 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000044638030", "@nortexte": "TREP2130559D", "@numtexte": "2021-1905", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-12-30" }, { "@id": "LEGIARTI000045162554", "@num": "6", "#text": "Décret n°2022-164 du 11 février 2022 - art. 6 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000045159528", "@nortexte": "SSAP2131030D", "@numtexte": "2022-164", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2022-02-11" }, { "@id": "LEGIARTI000047543494", "@num": "6", "#text": "Décret n°2023-367 du 13 mai 2023 - art. 6 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000047542080", "@nortexte": "SPRS2300922D", "@numtexte": "2023-367", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2023-05-13" }, { "@id": "LEGIARTI000049350861", "@num": "1", "#text": "Décret n°2024-290 du 29 mars 2024 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000049345711", "@nortexte": "TSSH2335206D", "@numtexte": "2024-290", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-03-29" }, { "@id": "LEGIARTI000044962600", "@num": "R533-49", "#text": "Code de l'environnement - art. 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Article L138-11 AUTONOME MODIFIE, en vigueur du 25/12/2016 au 01/01/2018 (Code de la sécurité sociale)