{ "article": { "LEGIARTI000043761852": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5121-172", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2021-07-01" } }, "META_COMMUN": { "ID": "LEGIARTI000043761852", "URL": "article/LEGI/ARTI/00/00/43/76/18/LEGIARTI000043761852.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

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

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Pour les médicaments mentionnés au 1° du II de l'article L. 5121-12 et au II de l'article L. 5121-12-1, les obligations prévues à l'article R. 5121-161 et aux articles R. 5121-166 à R. 5121-170 s'exercent selon les modalités fixées par le protocole d'utilisation thérapeutique.

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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. 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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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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. L5121-20 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689889", "@num": "L5121-8", "#text": "Code de la santé publique - art. L5121-8 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025013605", "@num": "L5123-2", "#text": "Code de la santé publique - art. 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. 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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 ;
\n
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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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 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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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 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 :
\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 ;
\n
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.
\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 prescripteur 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.
\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.
" } }, "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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\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.
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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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Article R5121-172 AUTONOME VIGUEUR, en vigueur depuis le 01/07/2021 (Code de la santé publique)