{"id":9718,"date":"2026-03-25T17:20:33","date_gmt":"2026-03-25T09:20:33","guid":{"rendered":"https:\/\/regask.com\/?p=9718"},"modified":"2026-03-25T17:20:33","modified_gmt":"2026-03-25T09:20:33","slug":"lagence-neerlandaise-meb-introduit-une-exigence-de-declaration-pour-les-demandes-dautorisation-de-mise-sur-le-marche-en-double","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/netherlands-meb-introduces-declaration-requirement-for-duplex-marketing-authorisation-applications\/","title":{"rendered":"Le minist\u00e8re n\u00e9erlandais de l&#039;\u00c9conomie et des Affaires \u00e9conomiques (MEB) introduit une obligation de d\u00e9claration pour\u2026"},"content":{"rendered":"<p>Sur <strong>11 mars 2026<\/strong>, le <strong>Conseil d&#039;\u00e9valuation des m\u00e9dicaments (MEB) aux Pays-Bas<\/strong> nouveau publi\u00e9 <strong>guide de d\u00e9claration<\/strong> pour les candidats recherchant <strong>Autorisation de commercialisation duplex<\/strong> pour les m\u00e9dicaments \u00e0 usage humain. La mise \u00e0 jour introduit une proc\u00e9dure de d\u00e9claration formelle d\u00e9crivant <strong>conditions r\u00e9glementaires suppl\u00e9mentaires<\/strong> Ces conditions doivent \u00eatre remplies pour l&#039;approbation et le maintien de la conformit\u00e9. Elles s&#039;appliquent \u00e0 toutes les demandes concern\u00e9es \u00e0 compter de la date de publication.<\/p>\n<div class=\"row\"  id=\"row-1367269260\">\n\n\t<div id=\"col-1976466804\" 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-502808426\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-502808426 {\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-1114773225\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1114773225 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les nouvelles directives exigent que les candidats soumettent un <strong>formulaire de d\u00e9claration d\u00fbment rempli<\/strong> dans le cadre de toute <strong>Demande d&#039;autorisation de commercialisation duplex<\/strong>, ce qui permet la commercialisation parall\u00e8le de m\u00e9dicaments identiques ou tr\u00e8s similaires.<\/p>\n<p>La d\u00e9claration sp\u00e9cifie <strong>conditions suppl\u00e9mentaires<\/strong> que les candidats doivent satisfaire, y compris les exigences relatives \u00e0 <strong>qualit\u00e9 du produit<\/strong>, <strong>surveillance de la s\u00e9curit\u00e9<\/strong>, et <strong>obligations de conformit\u00e9 continues<\/strong>. Ces conditions visent \u00e0 garantir que les m\u00e9dicaments commercialis\u00e9s en parall\u00e8le restent conformes aux normes r\u00e9glementaires n\u00e9erlandaises tout au long de leur cycle de vie.<\/p>\n<p>Cette exigence s&#039;applique \u00e0 <strong>toutes les nouvelles demandes<\/strong> pour l&#039;autorisation de mise sur le march\u00e9 de Duplex <strong>m\u00e9dicaments \u00e0 usage humain<\/strong> aux Pays-Bas. Bien que les recommandations aient \u00e9t\u00e9 publi\u00e9es en 2026, <strong>L&#039;obligation de conformit\u00e9 effective remonte au 1er janvier 2022.<\/strong>, ce qui signifie que le respect de ces r\u00e8gles est obligatoire pour continuer \u00e0 acc\u00e9der au march\u00e9.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1976466804 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-389160935\" 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-1435295071\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1435295071 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Cette mise \u00e0 jour renforce <strong>clart\u00e9 r\u00e9glementaire<\/strong> en formalisant les attentes relatives aux demandes d&#039;autorisation de mise sur le march\u00e9 Duplex. Cela soutient <strong>normes de conformit\u00e9 coh\u00e9rentes<\/strong> sur les m\u00e9dicaments commercialis\u00e9s en parall\u00e8le tout en renfor\u00e7ant <strong>surveillance continue de la s\u00e9curit\u00e9 et de la qualit\u00e9<\/strong>. En introduisant une proc\u00e9dure de d\u00e9claration structur\u00e9e, le MEB favorise \u00e9galement <strong>efficacit\u00e9 op\u00e9rationnelle<\/strong> et r\u00e9duit l&#039;ambigu\u00eft\u00e9 des exigences de soumission, minimisant ainsi la charge r\u00e9glementaire associ\u00e9e aux demandes incompl\u00e8tes ou mal align\u00e9es.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-389160935 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2091697999\" 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>Qui est concern\u00e9 ?<\/h2>\n\t<div id=\"gap-1043766653\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1043766653 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Cette mise \u00e0 jour est pertinente pour <strong>Affaires r\u00e9glementaires<\/strong>, <strong>Assurance qualit\u00e9<\/strong>, <strong>S\u00e9curit\u00e9 des patients<\/strong>, <strong>Juridique\/Conformit\u00e9<\/strong>, et <strong>\u00e9quipes commerciales<\/strong> au sein des entreprises pharmaceutiques impliqu\u00e9es dans le <strong>d\u00e9veloppement, soumission et commercialisation de m\u00e9dicaments \u00e0 usage humain<\/strong> aux Pays-Bas.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2091697999 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-972232240\" 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-1204417905\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1204417905 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les organisations devraient <strong>Veuillez examiner le mod\u00e8le de d\u00e9claration mis \u00e0 jour et les conditions suppl\u00e9mentaires<\/strong> afin de garantir la conformit\u00e9 avec les demandes d&#039;autorisation de mise sur le march\u00e9 de Duplex, actuelles et \u00e0 venir. Interne <strong>flux de travail de soumission, normes de documentation et listes de contr\u00f4le de conformit\u00e9<\/strong> Elle devrait \u00eatre mise \u00e0 jour en coordination avec les \u00e9quipes transversales afin de refl\u00e9ter ces exigences.<\/p>\n<p>Face \u00e0 l&#039;\u00e9volution constante des exigences r\u00e9glementaires sur les diff\u00e9rents march\u00e9s, il est essentiel de rester en phase avec les attentes de soumission sp\u00e9cifiques \u00e0 chaque pays.<\/p>\n<p><a href=\"https:\/\/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 agentique, qui permet aux organisations internationales des secteurs fortement r\u00e9glement\u00e9s, tels que les produits de consommation et les sciences de la vie, d&#039;anticiper les complexit\u00e9s r\u00e9glementaires. En combinant une IA agentique avanc\u00e9e et l&#039;expertise de sp\u00e9cialistes, <a href=\"https:\/\/regask.com\/fr\/\">RegASK<\/a> Elle fournit en temps opportun des informations pr\u00e9dictives exploitables et une automatisation de bout en bout, rationalisant les processus de conformit\u00e9, att\u00e9nuant les risques et acc\u00e9l\u00e9rant l&#039;acc\u00e8s au march\u00e9 dans plus de 160 pays. <a href=\"https:\/\/regask.com\/fr\/produit\/\">En savoir plus<\/a> ou <a href=\"https:\/\/regask.com\/fr\/reserver-une-demo\/\">r\u00e9server une d\u00e9mo<\/a> maintenant.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-972232240 > .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-332380289\">\n\n\t<div id=\"col-216745516\" 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-1641346270\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1641346270 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>Qu\u2019est-ce que l\u2019autorisation de mise sur le march\u00e9 Duplex aux Pays-Bas\u00a0?<\/h4>\n\t<div id=\"gap-992317563\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-992317563 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Il s&#039;agit d&#039;une voie d&#039;autorisation qui permet <strong>commercialisation parall\u00e8le de m\u00e9dicaments identiques ou tr\u00e8s similaires<\/strong> sous certaines conditions r\u00e9glementaires.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-216745516 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1711765725\" 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>Quelle est la nouvelle exigence introduite par le MEB\u00a0?<\/h4>\n\t<div id=\"gap-8674591\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-8674591 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les candidats doivent maintenant soumettre un <strong>formulaire de d\u00e9claration d\u00fbment rempli<\/strong> d\u00e9crivant la conformit\u00e9 avec <strong>conditions suppl\u00e9mentaires<\/strong> dans le cadre de leur candidature.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1711765725 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1188768194\" 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>Que couvrent les conditions suppl\u00e9mentaires\u00a0?<\/h4>\n\t<div id=\"gap-1131280983\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1131280983 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Ils s&#039;adressent <strong>qualit\u00e9 du produit<\/strong>, <strong>surveillance de la s\u00e9curit\u00e9<\/strong>, et <strong>obligations de conformit\u00e9 continues<\/strong> pour les m\u00e9dicaments commercialis\u00e9s en parall\u00e8le.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1188768194 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1043143555\" 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>Comment le RegASK peut-il contribuer \u00e0 la conformit\u00e9 aux exigences d&#039;autorisation de mise sur le march\u00e9 Duplex\u00a0?<\/h4>\n\t<div id=\"gap-1192205802\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1192205802 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"http:\/\/regask.com\/fr\/\">RegASK <\/a>aide les \u00e9quipes <strong>suivre l&#039;\u00e9volution des exigences r\u00e9glementaires<\/strong>, aligner <strong>Documentation de soumission avec conditions locales<\/strong>, et rationaliser <strong>flux de travail de conformit\u00e9<\/strong>, garantissant des processus d&#039;autorisation de mise sur le march\u00e9 rapides et pr\u00e9cis.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1043143555 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Le 11 mars 2026, l\u2019Agence n\u00e9erlandaise d\u2019\u00e9valuation des m\u00e9dicaments (MEB) a publi\u00e9 de nouvelles lignes directrices relatives aux d\u00e9clarations \u00e0 l\u2019intention des demandeurs d\u2019autorisation de mise sur le march\u00e9 en double appellation (Dual AMM) pour les m\u00e9dicaments \u00e0 usage humain. Cette mise \u00e0 jour introduit une proc\u00e9dure de d\u00e9claration formelle d\u00e9crivant les conditions r\u00e9glementaires suppl\u00e9mentaires \u00e0 respecter pour l\u2019approbation et le maintien de la conformit\u00e9. Elle s\u2019applique \u00e0 toutes les demandes concern\u00e9es \u00e0 compter de cette date\u2026<\/p>","protected":false},"author":32,"featured_media":9719,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,39,35,562],"tags":[],"class_list":["post-9718","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-medical-devices-insights","category-pharma-biotech-latest-insights","category-netherlands-regulations"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.4 (Yoast SEO v28.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Netherlands MEB Introduces Declaration Requirement Update<\/title>\n<meta name=\"description\" content=\"Stay informed about the Netherlands MEB&#039;s updated declaration guidance for Duplex marketing authorisation applications for medicines.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/fr\/lagence-neerlandaise-meb-introduit-une-exigence-de-declaration-pour-les-demandes-dautorisation-de-mise-sur-le-marche-en-double\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Netherlands MEB Introduces Declaration Requirement for Duplex Marketing Authorisation Applications\" \/>\n<meta property=\"og:description\" content=\"Stay informed about the Netherlands MEB&#039;s updated declaration guidance for Duplex marketing authorisation applications for medicines.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/fr\/lagence-neerlandaise-meb-introduit-une-exigence-de-declaration-pour-les-demandes-dautorisation-de-mise-sur-le-marche-en-double\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2026-03-25T09:20:33+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/netherlands-meb-introduces-declaration-requirement-duplex-marketing-authorisation-applications.png\" \/>\n\t<meta property=\"og:image:width\" content=\"800\" \/>\n\t<meta property=\"og:image:height\" content=\"600\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Hannah Nordin\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Hannah Nordin\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/netherlands-meb-introduces-declaration-requirement-for-duplex-marketing-authorisation-applications\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/netherlands-meb-introduces-declaration-requirement-for-duplex-marketing-authorisation-applications\\\/\"},\"author\":{\"name\":\"Hannah Nordin\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/3a8aaee2c7585284f97ec9e038e36b65\"},\"headline\":\"Netherlands MEB Introduces Declaration Requirement for 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