{"id":13865,"date":"2026-08-11T12:51:53","date_gmt":"2026-08-11T12:51:53","guid":{"rendered":"https:\/\/veilles-affaires-sociales.fr\/?p=13865"},"modified":"2026-08-13T15:25:36","modified_gmt":"2026-08-13T15:25:36","slug":"decision-du-22-07-2026-abrogation-de-lautorisation-douverture-de-letablissement-pharmaceutique-de-la-societe-pharmatrextitre-traduit-en-francais-par-lia","status":"publish","type":"post","link":"https:\/\/veilles-affaires-sociales.fr\/?p=13865","title":{"rendered":"D\u00e9cision du 22\/07\/2026 &#8211; Abrogation de l\u2019autorisation d\u2019ouverture de l\u2019\u00e9tablissement pharmaceutique de la soci\u00e9t\u00e9 Pharmatrex"},"content":{"rendered":"<p>La directrice g\u00e9n\u00e9rale de l\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM) se fonde sur plusieurs dispositions du Code de la sant\u00e9 publique (articles L. 5124-1 \u00e0 L. 5124-4 et R. 5124-2, R. 5124-10-1, R. 5124-15, R. 5124-19, R. 5124-22, R. 5124-23 et R. 5124-36) pour examiner la situation de la soci\u00e9t\u00e9 Pharmatrex, titulaire d\u2019une autorisation d\u2019\u00e9tablissement pharmaceutique de distribution en gros \u00e0 l\u2019exportation \u00e0 Chambly (Oise). Cette autorisation avait \u00e9t\u00e9 accord\u00e9e par d\u00e9cision n\u00b0 2024_016_7 du 17 janvier 2024, l\u2019ouverture effective de l\u2019\u00e9tablissement ayant \u00e9t\u00e9 notifi\u00e9e \u00e0 l\u2019ANSM pour le 15 avril 2024.<\/p>\n<p>L\u2019ANSM constate, sur la base des certificats de radiation de l\u2019Ordre des pharmaciens (section C) et des informations issues de l\u2019annuaire public de l\u2019Ordre, que le pharmacien responsable et le pharmacien responsable int\u00e9rimaire de Pharmatrex ont \u00e9t\u00e9 radi\u00e9s du tableau respectivement au 26 septembre et au 3 octobre 2024, et qu\u2019aucun nouveau pharmacien responsable ni int\u00e9rimaire n\u2019est inscrit pour cette soci\u00e9t\u00e9, situation confirm\u00e9e par plusieurs courriels de la section C des 10 juin, 2 juillet et 15 juillet 2026.<\/p>\n<p>Cette situation est analys\u00e9e au regard des exigences l\u00e9gales : l\u2019article L. 5124-2 impose qu\u2019une entreprise comportant un \u00e9tablissement pharmaceutique soit la propri\u00e9t\u00e9 d\u2019un pharmacien ou d\u2019une soci\u00e9t\u00e9 dont la g\u00e9rance ou la direction g\u00e9n\u00e9rale inclut un pharmacien, d\u00e9sign\u00e9 comme pharmacien responsable. L\u2019article R. 5124-19 pr\u00e9voit que tout acte pharmaceutique doit \u00eatre r\u00e9alis\u00e9 sous le contr\u00f4le effectif d\u2019un pharmacien remplissant les conditions d\u2019exercice en France. Les articles L. 5124-4 et R. 5124-36 pr\u00e9cisent que le pharmacien responsable organise et surveille l\u2019ensemble des op\u00e9rations pharmaceutiques de l\u2019\u00e9tablissement, qu\u2019il doit exercer personnellement sa profession, se faire assister et se faire remplacer en cas d\u2019absence temporaire.<\/p>\n<p>Face au d\u00e9faut persistant de pharmacien responsable et de pharmacien responsable int\u00e9rimaire, l\u2019ANSM a adress\u00e9, le 16 juin 2026, une mise en demeure \u00e0 Pharmatrex par lettre recommand\u00e9e avec avis de r\u00e9ception, comportant un projet de d\u00e9cision d\u2019abrogation de l\u2019autorisation d\u2019ouverture de l\u2019\u00e9tablissement. Cette lettre est rest\u00e9e sans r\u00e9ponse. Elle a \u00e9t\u00e9 transmise le m\u00eame jour par courriel au directeur g\u00e9n\u00e9ral de Pharmatrex, qui a r\u00e9pondu le 13 juillet 2026. L\u2019ensemble de ces \u00e9l\u00e9ments s\u2019inscrit dans le contr\u00f4le par l\u2019ANSM de la conformit\u00e9 des \u00e9tablissements pharmaceutiques de distribution en gros aux obligations l\u00e9gales relatives \u00e0 la pr\u00e9sence et au r\u00f4le du pharmacien responsable, enjeu central pour la s\u00e9curit\u00e9 sanitaire et la r\u00e9gulation des activit\u00e9s pharmaceutiques.\u00a0(contenu r\u00e9sum\u00e9 en fran\u00e7ais par l&rsquo;IA)<a href=\"https:\/\/ansm.sante.fr\/actualites\/decision-du-22-07-2026-abrogation-de-lautorisation-douverture-de-letablissement-pharmaceutique-de-la-societe-pharmatrex\" target=\"_blank\" class=\"feedzy-rss-link-icon\">Lire la Suite<\/a>\u200b<\/p>","protected":false},"excerpt":{"rendered":"<p>La directrice g\u00e9n\u00e9rale de l\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM) se fonde sur plusieurs dispositions du Code de la sant\u00e9 publique (articles L. 5124-1 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":3852,"comment_status":"closed","ping_status":"closed","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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