L\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) a publi\u00e9 le 17 juillet 2026 un document d\u2019orientation \u00e0 destination de l\u2019industrie sur la mise en \u0153uvre de plans de pr\u00e9vention des p\u00e9nuries (Shortage Prevention Plans, SPP) pour les m\u00e9dicaments. Ce document s\u2019inscrit dans la strat\u00e9gie du R\u00e9seau europ\u00e9en des autorit\u00e9s de r\u00e9glementation des m\u00e9dicaments (EMRN), qui regroupe l\u2019EMA et les autorit\u00e9s nationales comp\u00e9tentes des \u00c9tats membres de l\u2019Union europ\u00e9enne, visant \u00e0 am\u00e9liorer la disponibilit\u00e9 des m\u00e9dicaments humains et v\u00e9t\u00e9rinaires et \u00e0 renforcer la continuit\u00e9 des approvisionnements en Europe.<\/p>\n
Depuis 2016, l\u2019EMRN surveille et g\u00e8re les probl\u00e8mes de disponibilit\u00e9 des m\u00e9dicaments, y compris les perturbations de la cha\u00eene d\u2019approvisionnement. Ces dispositifs ont \u00e9t\u00e9 consolid\u00e9s par le r\u00e8glement (UE) 2022\/123 qui a \u00e9tendu le mandat de l\u2019EMA, notamment par la cr\u00e9ation formelle du groupe directeur ex\u00e9cutif sur les p\u00e9nuries et la s\u00e9curit\u00e9 des m\u00e9dicaments (Executive Steering Group on Shortages and Safety of Medicinal Products, MSSG) et du groupe de travail des points de contact uniques pour les p\u00e9nuries (Medicines Shortages Single Point of Contact Working Party, SPOC Working Party).<\/p>\n
Le nouveau cadre l\u00e9gislatif pharmaceutique de l\u2019UE renforce encore la surveillance et la gestion des p\u00e9nuries de m\u00e9dicaments et vise \u00e0 accro\u00eetre la r\u00e9silience des cha\u00eenes d\u2019approvisionnement. Il pr\u00e9voit en particulier une obligation pour les titulaires d\u2019autorisation de mise sur le march\u00e9 (AMM) de mettre en place et de tenir \u00e0 jour un plan de pr\u00e9vention des p\u00e9nuries pour tout m\u00e9dicament soumis \u00e0 prescription dans l\u2019Union europ\u00e9enne, avec la possibilit\u00e9 pour la Commission europ\u00e9enne d\u2019\u00e9tendre ce champ d\u2019application. Cette obligation compl\u00e8te l\u2019obligation g\u00e9n\u00e9rale faite aux titulaires d\u2019AMM d\u2019assurer, dans les limites de leurs responsabilit\u00e9s, un approvisionnement ad\u00e9quat et continu du march\u00e9, telle que pr\u00e9vue par la nouvelle directive pharmaceutique (article 56(3)). La recommandation d\u2019\u00e9laborer des SPP figure \u00e9galement parmi les bonnes pratiques adress\u00e9es \u00e0 l\u2019industrie pour pr\u00e9venir les p\u00e9nuries de m\u00e9dicaments \u00e0 usage humain (recommandation 4).<\/p>\n
Le document d\u2019orientation pr\u00e9cise le type d\u2019informations et le niveau de d\u00e9tail attendus dans les plans de pr\u00e9vention des p\u00e9nuries, en fonction du niveau de risque associ\u00e9 \u00e0 chaque m\u00e9dicament, ainsi que les mesures pertinentes de gestion des p\u00e9nuries. Il souligne le caract\u00e8re proportionn\u00e9 des efforts, de la formalisation et de la documentation \u00e0 fournir pour chaque plan, et des mesures d\u2019att\u00e9nuation propos\u00e9es, par rapport au risque identifi\u00e9. Le texte rappelle par ailleurs que le r\u00e8glement (UE) 2022\/123 s\u2019applique en cas de crise de sant\u00e9 publique, mais l\u2019extrait disponible ne d\u00e9taille pas l\u2019ensemble des dispositions juridiques correspondantes. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" L\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) a publi\u00e9 le 17 juillet 2026 un document d\u2019orientation \u00e0 destination de l\u2019industrie sur la mise en \u0153uvre de plans de pr\u00e9vention des p\u00e9nuries (Shortage […]<\/p>\n","protected":false},"author":1,"featured_media":17698,"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 center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[36,31],"tags":[257,227,226],"class_list":["post-17738","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-droit-social-sante-travail-et-securite-sociale","category-politiques-europeennes-sante-social-travail","tag-ema","tag-ia","tag-sources-etrangeres"],"_links":{"self":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/17738","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=17738"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/17738\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/media\/17698"}],"wp:attachment":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=17738"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=17738"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=17738"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}