La directrice g\u00e9n\u00e9rale de l\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM) a pris, le 9 octobre 2026, une d\u00e9cision relative au r\u00e9gime d\u2019exon\u00e9ration de la r\u00e9glementation applicable aux substances v\u00e9n\u00e9neuses destin\u00e9es \u00e0 la m\u00e9decine humaine. Cette d\u00e9cision s\u2019inscrit dans le cadre du code de la sant\u00e9 publique (articles L. 5132-1, L. 5132-6, L. 5132-7, R. 5132-1 et R. 5132-2) et modifie l\u2019application de l\u2019arr\u00eat\u00e9 du 22 f\u00e9vrier 1990 portant inscription sur les listes I et II des substances v\u00e9n\u00e9neuses, ainsi que l\u2019arr\u00eat\u00e9 du 22 f\u00e9vrier 1990 relatif aux exon\u00e9rations \u00e0 cette r\u00e9glementation.<\/p>\n
La d\u00e9cision pr\u00e9cise que les exon\u00e9rations applicables aux m\u00e9dicaments contenant l\u2019etof\u00e9namate sont d\u00e9sormais fix\u00e9es conform\u00e9ment \u00e0 l\u2019arr\u00eat\u00e9 du 22 f\u00e9vrier 1990 modifi\u00e9, sous r\u00e9serve des adaptations introduites par le texte du 9 octobre 2026. Elle encadre, pour cette substance, les formes pharmaceutiques ou voies d\u2019administration concern\u00e9es, les concentrations maximales en pourcentage (masse\/masse), les doses limites par unit\u00e9 de prise pour les formes divis\u00e9es, ainsi que la quantit\u00e9 maximale de substance pouvant \u00eatre remise au public, en lien avec l\u2019indication th\u00e9rapeutique. Les valeurs chiffr\u00e9es d\u00e9taill\u00e9es ne sont pas reproduites dans l\u2019extrait disponible.<\/p>\n
Le principal acteur mentionn\u00e9 est l\u2019ANSM, autorit\u00e9 comp\u00e9tente en mati\u00e8re de s\u00e9curit\u00e9 du m\u00e9dicament, qui ajuste ici le r\u00e9gime de contr\u00f4le et d\u2019exon\u00e9ration pour une substance v\u00e9n\u00e9neuse donn\u00e9e, dans le cadre r\u00e9glementaire national. L\u2019enjeu de politique publique concerne la r\u00e9gulation des m\u00e9dicaments contenant des substances inscrites sur les listes de stup\u00e9fiants et psychotropes ou autres substances v\u00e9n\u00e9neuses, avec un impact potentiel sur les conditions de prescription, de dispensation et de mise \u00e0 disposition du public. Aucune information suppl\u00e9mentaire n\u2019est fournie sur d\u2019\u00e9ventuels effets en mati\u00e8re d\u2019acc\u00e8s aux soins, de sant\u00e9 publique ou d\u2019organisation des services.\u00a0(contenu r\u00e9sum\u00e9 par l’IA)Lire la Suite<\/a>\u200b<\/p>","protected":false},"excerpt":{"rendered":" La directrice g\u00e9n\u00e9rale de l\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM) a pris, le 9 octobre 2026, une d\u00e9cision relative au r\u00e9gime d\u2019exon\u00e9ration de la 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