{"id":9485,"date":"2026-02-16T16:20:31","date_gmt":"2026-02-16T08:20:31","guid":{"rendered":"https:\/\/regask.com\/?p=9485"},"modified":"2026-02-16T16:20:31","modified_gmt":"2026-02-16T08:20:31","slug":"lagence-britannique-mhra-publie-des-lignes-directrices-sur-les-exigences-en-matiere-de-pharmacovigilance-en-vertu-de-la-circulaire-modifiee-520-de-2012","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/uk-mhra-issues-guidance-on-pharmacovigilance-requirements-under-amended-cir-520-2012\/","title":{"rendered":"L\u2019agence britannique MHRA publie des lignes directrices sur les exigences en mati\u00e8re de pharmacovigilance\u2026"},"content":{"rendered":"<p>Sur <strong>9 f\u00e9vrier 2026,<\/strong> le <strong>Agence britannique de r\u00e9glementation des m\u00e9dicaments et des produits de sant\u00e9 (MHRA)<\/strong> de nouvelles lignes directrices ont \u00e9t\u00e9 publi\u00e9es \u00e0 l&#039;intention des titulaires d&#039;autorisation de mise sur le march\u00e9 au Royaume-Uni, pr\u00e9cisant comment les exigences en mati\u00e8re de pharmacovigilance s&#039;appliqueront suite aux modifications apport\u00e9es \u00e0 <strong>R\u00e8glement d\u2019ex\u00e9cution de la Commission (CIR) 520\/2012.<\/strong> Ces orientations refl\u00e8tent l&#039;adoption par la Commission europ\u00e9enne de <strong>R\u00e8glement (UE) 2025\/1466,<\/strong> qui modifie le d\u00e9cret CIR 520\/2012 et entre en vigueur \u00e0 compter de <strong>12 f\u00e9vrier 2026,<\/strong> avec des dispositions limit\u00e9es en vigueur \u00e0 compter de <strong>12 ao\u00fbt 2025.<\/strong> Cette mise \u00e0 jour est particuli\u00e8rement pertinente pour les organisations d\u00e9tenant des droits de propri\u00e9t\u00e9 intellectuelle. <strong>m\u00e9dicaments autoris\u00e9s au Royaume-Uni<\/strong> dans diff\u00e9rentes cat\u00e9gories sous le <strong>Cadre de Windsor. <\/strong><\/p>\n<div class=\"row\"  id=\"row-533723972\">\n\n\t<div id=\"col-1745947558\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"gap-453611756\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-453611756 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>D\u00e9tails de la mise \u00e0 jour<\/h2>\n\t<div id=\"gap-607731918\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-607731918 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les directives expliquent que <strong>CIR 520\/2012<\/strong> a \u00e9t\u00e9 officiellement modifi\u00e9 par <strong>R\u00e8glement (UE) 2025\/1466,<\/strong> introduction de modifications aux exigences en mati\u00e8re de pharmacovigilance. Suite \u00e0 la mise en \u0153uvre de<strong> Cadre de Windsor,<\/strong> Les m\u00e9dicaments autoris\u00e9s au Royaume-Uni sont d\u00e9sormais class\u00e9s comme <strong>Cat\u00e9gorie 1<\/strong> ou <strong>Cat\u00e9gorie 2,<\/strong> qui d\u00e9termine le cadre juridique applicable.<\/p>\n<p>Depuis <strong>12 f\u00e9vrier 2026, HMR 2012, annexe 12A<\/strong> et la version modifi\u00e9e <strong>CIR 520\/2012<\/strong> Les obligations en mati\u00e8re de pharmacovigilance ne seront plus juridiquement align\u00e9es. Cette divergence implique que des exigences diff\u00e9rentes peuvent s&#039;appliquer selon la cat\u00e9gorie de produit et la structure du portefeuille.<\/p>\n<p>Afin de r\u00e9duire les contraintes r\u00e9glementaires inutiles, la MHRA pr\u00e9sente les grandes lignes <strong>une approche pragmatique de la conformit\u00e9<\/strong>. Titulaires d&#039;autorisation de mise sur le march\u00e9 <strong>portefeuilles mixtes<\/strong> Les entreprises dont les produits appartiennent \u00e0 la fois \u00e0 la cat\u00e9gorie 1 et \u00e0 la cat\u00e9gorie 2 sont invit\u00e9es \u00e0 appliquer la r\u00e9glementation modifi\u00e9e. <strong>CIR 520\/2012<\/strong> pour tous les produits autoris\u00e9s au Royaume-Uni. En revanche, les d\u00e9tenteurs de <strong>Produits de cat\u00e9gorie 1<\/strong> <strong>seulement<\/strong> peut continuer \u00e0 suivre <strong>Annexe HMR 12A,<\/strong> \u00e0 moins qu&#039;ils ne d\u00e9tiennent \u00e9galement <strong>autorisations \u00e9quivalentes de l&#039;Union europ\u00e9enne<\/strong>, auquel cas des consid\u00e9rations suppl\u00e9mentaires s&#039;appliquent.<\/p>\n<p>La MHRA note \u00e9galement que les futures mises \u00e0 jour de <strong>HMR 2012 Annexe 12A<\/strong> peuvent \u00eatre consid\u00e9r\u00e9s comme refl\u00e9tant mieux les modifications apport\u00e9es \u00e0 <strong>CIR 520\/2012,<\/strong> bien qu&#039;aucun changement n&#039;ait \u00e9t\u00e9 confirm\u00e9 \u00e0 ce stade.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1745947558 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1278517806\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Date d&#039;entr\u00e9e en vigueur<\/h2>\n\t<div id=\"gap-603432129\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-603432129 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La version modifi\u00e9e <strong>R\u00e8glement d\u2019ex\u00e9cution (RE) 520\/2012 de la Commission,<\/strong> tel que r\u00e9vis\u00e9 par <strong>Le r\u00e8glement (UE) 2025\/1466 s&#039;applique \u00e0 compter du 12 f\u00e9vrier 2026.<\/strong> Cependant, <strong>Articles 1(7) et 1(9)<\/strong> du r\u00e8glement modificatif <strong>Elle est entr\u00e9e en vigueur plus t\u00f4t, le 12 ao\u00fbt 2025. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1278517806 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2127138467\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Pourquoi c&#039;est important<\/h2>\n\t<div id=\"gap-336931650\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-336931650 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Cette mise \u00e0 jour introduit <strong>non-alignement entre les cadres juridiques de pharmacovigilance du Royaume-Uni et de l&#039;UE,<\/strong> cr\u00e9ant des implications pratiques pour la planification de la conformit\u00e9. Alors que l&#039;approche pragmatique de la MHRA vise \u00e0 soutenir <strong>clart\u00e9 r\u00e9glementaire, efficacit\u00e9 op\u00e9rationnelle,<\/strong> et <strong>alignement num\u00e9rique,<\/strong> Cela exige \u00e9galement des organisations qu&#039;elles g\u00e8rent rigoureusement leurs processus afin d&#039;\u00e9viter toute mauvaise application des exigences. Ces changements peuvent n\u00e9cessiter des mises \u00e0 jour cibl\u00e9es des syst\u00e8mes de pharmacovigilance, des structures de gouvernance et des proc\u00e9dures internes, notamment pour les organisations disposant de portefeuilles de produits complexes ou diversifi\u00e9s.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2127138467 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1494396492\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u00c0 qui cela s&#039;adresse-t-il ?<\/h2>\n\t<div id=\"gap-18578025\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-18578025 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Ces recommandations concernent <strong>Pharmacovigilance, Affaires r\u00e9glementaires, Assurance qualit\u00e9, Conformit\u00e9,<\/strong> et moi<strong>T ou \u00e9quipes de gouvernance num\u00e9rique<\/strong> impliqu\u00e9 dans la gestion des m\u00e9dicaments autoris\u00e9s au Royaume-Uni et des obligations r\u00e9glementaires transfrontali\u00e8res.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1494396492 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2084159328\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Prochaines \u00e9tapes<\/h2>\n\t<div id=\"gap-959469056\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-959469056 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les organisations devraient revoir leur <strong>portefeuilles de produits britanniques<\/strong> pour confirmer si les produits rel\u00e8vent de la cat\u00e9gorie <strong>Cat\u00e9gorie 1 ou Cat\u00e9gorie 2<\/strong> et \u00e9valuer la pr\u00e9sence de tout <strong>licences \u00e9quivalentes \u00e0 celles de l&#039;UE<\/strong>. Les proc\u00e9dures internes de pharmacovigilance, les cadres d\u00e9cisionnels et les mod\u00e8les de gouvernance doivent \u00eatre v\u00e9rifi\u00e9s au regard des attentes clarifi\u00e9es, avec un alignement interfonctionnel pr\u00e9alable. <strong>12 f\u00e9vrier 2026<\/strong> date d&#039;entr\u00e9e en vigueur afin de minimiser les risques de non-conformit\u00e9.<\/p>\n<p>Face \u00e0 la complexit\u00e9 op\u00e9rationnelle croissante engendr\u00e9e par la divergence des r\u00e9glementations, il devient de plus en plus important de disposer d&#039;une m\u00e9thode structur\u00e9e pour suivre les changements et \u00e9valuer leur impact. <strong><a href=\"http:\/\/regask.com\/fr\/\">RegASK<\/a> est une plateforme de pointe d&#039;intelligence r\u00e9glementaire et d&#039;orchestration des flux de travail bas\u00e9e sur l&#039;IA agentielle<\/strong> qui permet aux organisations internationales op\u00e9rant dans des secteurs fortement r\u00e9glement\u00e9s, notamment les sciences de la vie, d&#039;anticiper l&#039;\u00e9volution des environnements r\u00e9glementaires. En combinant des technologies de pointe <strong>IA agentielle avec des experts impliqu\u00e9s, <a href=\"http:\/\/regask.com\/fr\/\">RegASK<\/a><\/strong> Elle fournit des informations opportunes, pr\u00e9dictives et exploitables, aidant les \u00e9quipes \u00e0 rationaliser les processus de conformit\u00e9 et \u00e0 maintenir une surveillance dans plus de 160 pays.<strong> <a href=\"http:\/\/regask.com\/fr\/\">En savoir plus<\/a><\/strong> ou <strong><a href=\"https:\/\/regask.com\/fr\/reserver-une-demo\/\">r\u00e9servez une d\u00e9mo maintenant.\u00a0<\/a><\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2084159328 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-1752719188\">\n\n\t<div id=\"col-207180269\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<h3>FAQ<\/h3>\n\t<div id=\"gap-1031010036\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1031010036 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW240545805 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW240545805 BCX0\">Qu\u2019est-ce que le r\u00e8glement d\u2019ex\u00e9cution (CE) n\u00b0 520\/2012 de la Commission\u00a0?<\/span><\/span><span class=\"EOP SCXW240545805 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-1774766150\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1774766150 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW37803039 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW37803039 BCX0\">Il s&#039;agit d&#039;un r\u00e8glement de l&#039;UE qui d\u00e9finit des modalit\u00e9s d\u00e9taill\u00e9es<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW37803039 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW37803039 BCX0\">exigences en mati\u00e8re de pharmacovigilance<\/span><\/span><\/strong><span class=\"TextRun SCXW37803039 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW37803039 BCX0\">\u00a0pour les m\u00e9dicaments, y compris les obligations en mati\u00e8re de marketing\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW37803039 BCX0\">Autorisation<\/span><span class=\"NormalTextRun SCXW37803039 BCX0\">\u00a0D\u00e9tenteurs.<\/span><\/span><span class=\"EOP SCXW37803039 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-207180269 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-91540833\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>Qu\u2019est-ce qui a chang\u00e9 avec le r\u00e8glement (UE) 2025\/1466\u00a0?<\/h4>\n\t<div id=\"gap-1793546029\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1793546029 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>R\u00e8glement (UE) 2025\/1466<strong> modifie le CIR 520\/2012,<\/strong> r\u00e9vision des exigences en mati\u00e8re de pharmacovigilance et application \u00e0 partir de <strong>12 f\u00e9vrier 2026,<\/strong> avec des dispositions limit\u00e9es en vigueur \u00e0 compter de<strong> 12 ao\u00fbt 2025. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-91540833 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-932691178\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>Quel est l\u2019impact du cadre de Windsor sur les obligations de pharmacovigilance au Royaume-Uni\u00a0?<\/h4>\n\t<div id=\"gap-2071180192\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2071180192 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Le cadre de Windsor introduit <strong>Classifications de cat\u00e9gorie 1 et de cat\u00e9gorie 2<\/strong> pour les m\u00e9dicaments autoris\u00e9s au Royaume-Uni, ce qui entra\u00eene<strong> diff\u00e9rents cadres juridiques applicables <\/strong>pour la pharmacovigilance.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-932691178 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-708308651\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>H<span class=\"NormalTextRun SCXW207083187 BCX0\">comment\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW207083187 BCX0\">RegASK<\/span><span class=\"NormalTextRun SCXW207083187 BCX0\">\u00a0aide\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW207083187 BCX0\">organisations<\/span><span class=\"NormalTextRun SCXW207083187 BCX0\">\u00a0g\u00e9rer ces changements ?<\/span><\/h4>\n\t<div id=\"gap-958822623\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-958822623 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"http:\/\/regask.com\/fr\/\"><strong>RegASK<\/strong><\/a> aide les \u00e9quipes \u00e0 suivre <strong>mises \u00e0 jour r\u00e9glementaires,<\/strong> \u00e9valuer <strong>impact sp\u00e9cifique au portefeuille,<\/strong> et coordonner <strong>flux de travail de conformit\u00e9,<\/strong> permettre une gestion plus efficace des exigences divergentes en mati\u00e8re de pharmacovigilance entre le Royaume-Uni et l&#039;UE.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-708308651 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>On 9 February 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance for UK Marketing Authorisation Holders outlining how pharmacovigilance requirements will apply following amendments to Commission Implementing Regulation (CIR) 520\/2012. The guidance reflects the European Commission\u2019s adoption of Regulation (EU) 2025\/1466, which revises CIR 520\/2012 and becomes applicable from 12&#8230;<\/p>","protected":false},"author":43,"featured_media":9486,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,526,35],"tags":[],"class_list":["post-9485","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-united-kingdom-regulations","category-pharma-biotech-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.8 (Yoast SEO v27.9) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>UK MHRA Issues Guidance on Pharmacovigilance Overview<\/title>\n<meta name=\"description\" content=\"Explore the UK MHRA&#039;s new guidance on pharmacovigilance requirements under amended CIR 520\/2012 for UK 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