La directrice g\u00e9n\u00e9rale de l\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM) adopte une d\u00e9cision modifiant les seuils de stocks de s\u00e9curit\u00e9 pour certains m\u00e9dicaments d\u2019int\u00e9r\u00eat th\u00e9rapeutique majeur (MITM) du laboratoire Sanofi Winthrop Industrie, en tenant compte de la saisonnalit\u00e9 des besoins. Cette d\u00e9cision intervient sur le fondement des articles L. 5111-4, L. 5121-29 \u00e0 L. 5121-32 et R. 5124-49-4 du code de la sant\u00e9 publique, et fait suite \u00e0 une d\u00e9cision pr\u00e9c\u00e9dente du 16 juin 2026, contest\u00e9e par le laboratoire par un recours gracieux du 12 ao\u00fbt 2026, puis \u00e0 des \u00e9changes entre l\u2019ANSM et Sanofi Winthrop Industrie le 1er octobre 2026.<\/p>\n
L\u2019ANSM confirme que les m\u00e9dicaments list\u00e9s en annexe sont des MITM et qu\u2019il est n\u00e9cessaire d\u2019en adapter le stock de s\u00e9curit\u00e9 de mani\u00e8re saisonni\u00e8re pour garantir une disponibilit\u00e9 continue et suffisante tout en \u00e9vitant la constitution de volumes exc\u00e9dentaires. Le laboratoire faisait valoir que le niveau de stock fix\u00e9 en juin 2026 conduisait \u00e0 des stocks sup\u00e9rieurs \u00e0 ce qui est n\u00e9cessaire pour s\u00e9curiser l\u2019approvisionnement du march\u00e9 fran\u00e7ais.<\/p>\n
La d\u00e9cision fixe, pour la p\u00e9riode du 1er ao\u00fbt au 30 novembre (saison \u00ab haute \u00bb), un seuil de stock de s\u00e9curit\u00e9 destin\u00e9 au march\u00e9 national \u00e9quivalant \u00e0 deux mois de couverture des besoins, calcul\u00e9s selon les modalit\u00e9s pr\u00e9vues par l\u2019article R. 5124-49-4. Par d\u00e9rogation, pour la p\u00e9riode du 1er d\u00e9cembre au 31 juillet (saison \u00ab basse \u00bb), ce seuil est ramen\u00e9 \u00e0 un mois de couverture des besoins. Pour la saison \u00ab haute \u00bb, la moiti\u00e9 des doses n\u00e9cessaires doit \u00eatre r\u00e9ceptionn\u00e9e au plus tard le 1er ao\u00fbt, avant le lancement de la campagne d\u2019immunisation, et l\u2019autre moiti\u00e9 au plus tard le 1er octobre.<\/p>\n
Les acteurs principaux sont l\u2019ANSM, en charge de la r\u00e9gulation et de la s\u00e9curit\u00e9 d\u2019approvisionnement des m\u00e9dicaments en France, et le laboratoire Sanofi Winthrop Industrie, concern\u00e9 par l\u2019obligation de constituer et g\u00e9rer ces stocks. La mesure vise \u00e0 concilier la s\u00e9curisation de l\u2019approvisionnement en MITM pour le march\u00e9 fran\u00e7ais avec la limitation de l\u2019immobilisation de stocks jug\u00e9s sup\u00e9rieurs aux besoins, dans un cadre juridique encadrant les obligations industrielles en mati\u00e8re de stocks de s\u00e9curit\u00e9.\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) adopte une d\u00e9cision modifiant les seuils de stocks de s\u00e9curit\u00e9 pour certains m\u00e9dicaments d\u2019int\u00e9r\u00eat […]<\/p>\n","protected":false},"author":1,"featured_media":3852,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center 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