{"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-1988433797\">\n\n\t<div id=\"col-1675886573\" 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-2097101439\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2097101439 {\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-694480951\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-694480951 {\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-1675886573 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-205161088\" 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-1147084138\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1147084138 {\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-205161088 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-298328139\" 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-1930609884\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1930609884 {\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-298328139 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-39797112\" 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-2071965889\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2071965889 {\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-39797112 > .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-806200698\">\n\n\t<div id=\"col-946698477\" 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-1741023476\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1741023476 {\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-742442733\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-742442733 {\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-946698477 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1635698304\" 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-987106638\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-987106638 {\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-1635698304 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1952539100\" 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-1712628995\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1712628995 {\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-1952539100 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1834800676\" 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-1841259806\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1841259806 {\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-1834800676 > .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 March 11, 2026, the Medicines Evaluation Board (MEB) in the Netherlands published new declaration guidance for applicants seeking Duplex marketing authorisation for human medicinal products. The update introduces a formal declaration process outlining supplementary regulatory conditions that must be met for approval and ongoing compliance. It applies to all relevant applications from the date&#8230;<\/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 v27.3 (Yoast SEO v27.5) - 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 &hellip;\",\"datePublished\":\"2026-03-25T09:20:33+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/netherlands-meb-introduces-declaration-requirement-for-duplex-marketing-authorisation-applications\\\/\"},\"wordCount\":664,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/netherlands-meb-introduces-declaration-requirement-for-duplex-marketing-authorisation-applications\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/03\\\/netherlands-meb-introduces-declaration-requirement-duplex-marketing-authorisation-applications.png\",\"articleSection\":[\"Regulatory News\",\"Medical Devices\",\"Pharma and Biotech\",\"Netherlands\"],\"inLanguage\":\"fr-FR\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/netherlands-meb-introduces-declaration-requirement-for-duplex-marketing-authorisation-applications\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/netherlands-meb-introduces-declaration-requirement-for-duplex-marketing-authorisation-applications\\\/\",\"name\":\"Netherlands MEB Introduces Declaration Requirement Update\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/netherlands-meb-introduces-declaration-requirement-for-duplex-marketing-authorisation-applications\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/netherlands-meb-introduces-declaration-requirement-for-duplex-marketing-authorisation-applications\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/03\\\/netherlands-meb-introduces-declaration-requirement-duplex-marketing-authorisation-applications.png\",\"datePublished\":\"2026-03-25T09:20:33+00:00\",\"description\":\"Stay informed about the Netherlands MEB's updated declaration guidance for Duplex marketing authorisation applications for medicines.\",\"inLanguage\":\"fr-FR\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/regask.com\\\/netherlands-meb-introduces-declaration-requirement-for-duplex-marketing-authorisation-applications\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\\\/\\\/regask.com\\\/netherlands-meb-introduces-declaration-requirement-for-duplex-marketing-authorisation-applications\\\/#primaryimage\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/03\\\/netherlands-meb-introduces-declaration-requirement-duplex-marketing-authorisation-applications.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/03\\\/netherlands-meb-introduces-declaration-requirement-duplex-marketing-authorisation-applications.png\",\"width\":800,\"height\":600,\"caption\":\"Netherlands Meb Introduces Declaration Requirement Duplex Marketing Authorisation Applications\"},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/regask.com\\\/#website\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"name\":\"RegASK\",\"description\":\"Empowering Smarter Regulatory Decisions\",\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/regask.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"fr-FR\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\",\"name\":\"RegASK\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/RegASK-Logo-Dark-Round.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/RegASK-Logo-Dark-Round.png\",\"width\":401,\"height\":401,\"caption\":\"RegASK\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/RegASKRegulatoryAffairs\\\/\",\"https:\\\/\\\/x.com\\\/ASKRegASK\",\"https:\\\/\\\/www.linkedin.com\\\/company\\\/RegASK\\\/\",\"https:\\\/\\\/www.youtube.com\\\/@RegASK\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/3a8aaee2c7585284f97ec9e038e36b65\",\"name\":\"Hannah Nordin\",\"sameAs\":[\"https:\\\/\\\/regask.com\"]}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Le minist\u00e8re n\u00e9erlandais des Affaires \u00e9conomiques (MEB) introduit une mise \u00e0 jour des exigences de d\u00e9claration","description":"Restez inform\u00e9(e) des lignes directrices mises \u00e0 jour du MEB n\u00e9erlandais concernant la d\u00e9claration des demandes d&#039;autorisation de mise sur le march\u00e9 duplex pour les m\u00e9dicaments.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/regask.com\/fr\/lagence-neerlandaise-meb-introduit-une-exigence-de-declaration-pour-les-demandes-dautorisation-de-mise-sur-le-marche-en-double\/","og_locale":"fr_FR","og_type":"article","og_title":"Netherlands MEB Introduces Declaration Requirement for Duplex Marketing Authorisation Applications","og_description":"Stay informed about the Netherlands MEB's updated declaration guidance for Duplex marketing authorisation applications for medicines.","og_url":"https:\/\/regask.com\/fr\/lagence-neerlandaise-meb-introduit-une-exigence-de-declaration-pour-les-demandes-dautorisation-de-mise-sur-le-marche-en-double\/","og_site_name":"RegASK","article_publisher":"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","article_published_time":"2026-03-25T09:20:33+00:00","og_image":[{"width":800,"height":600,"url":"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/netherlands-meb-introduces-declaration-requirement-duplex-marketing-authorisation-applications.png","type":"image\/png"}],"author":"Hannah Nordin","twitter_card":"summary_large_image","twitter_creator":"@ASKRegASK","twitter_site":"@ASKRegASK","twitter_misc":{"Written by":"Hannah Nordin","Est. reading time":"3 minutes"},"schema":{"@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 &hellip;","datePublished":"2026-03-25T09:20:33+00:00","mainEntityOfPage":{"@id":"https:\/\/regask.com\/netherlands-meb-introduces-declaration-requirement-for-duplex-marketing-authorisation-applications\/"},"wordCount":664,"publisher":{"@id":"https:\/\/regask.com\/#organization"},"image":{"@id":"https:\/\/regask.com\/netherlands-meb-introduces-declaration-requirement-for-duplex-marketing-authorisation-applications\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/netherlands-meb-introduces-declaration-requirement-duplex-marketing-authorisation-applications.png","articleSection":["Regulatory News","Medical Devices","Pharma and Biotech","Netherlands"],"inLanguage":"fr-FR"},{"@type":"WebPage","@id":"https:\/\/regask.com\/netherlands-meb-introduces-declaration-requirement-for-duplex-marketing-authorisation-applications\/","url":"https:\/\/regask.com\/netherlands-meb-introduces-declaration-requirement-for-duplex-marketing-authorisation-applications\/","name":"Le minist\u00e8re n\u00e9erlandais des Affaires \u00e9conomiques (MEB) introduit une mise \u00e0 jour des exigences de d\u00e9claration","isPartOf":{"@id":"https:\/\/regask.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/regask.com\/netherlands-meb-introduces-declaration-requirement-for-duplex-marketing-authorisation-applications\/#primaryimage"},"image":{"@id":"https:\/\/regask.com\/netherlands-meb-introduces-declaration-requirement-for-duplex-marketing-authorisation-applications\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/netherlands-meb-introduces-declaration-requirement-duplex-marketing-authorisation-applications.png","datePublished":"2026-03-25T09:20:33+00:00","description":"Restez inform\u00e9(e) des lignes directrices mises \u00e0 jour du MEB n\u00e9erlandais concernant la d\u00e9claration des demandes d&#039;autorisation de mise sur le march\u00e9 duplex pour les m\u00e9dicaments.","inLanguage":"fr-FR","potentialAction":[{"@type":"ReadAction","target":["https:\/\/regask.com\/netherlands-meb-introduces-declaration-requirement-for-duplex-marketing-authorisation-applications\/"]}]},{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/regask.com\/netherlands-meb-introduces-declaration-requirement-for-duplex-marketing-authorisation-applications\/#primaryimage","url":"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/netherlands-meb-introduces-declaration-requirement-duplex-marketing-authorisation-applications.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/netherlands-meb-introduces-declaration-requirement-duplex-marketing-authorisation-applications.png","width":800,"height":600,"caption":"Netherlands Meb Introduces Declaration Requirement Duplex Marketing Authorisation Applications"},{"@type":"WebSite","@id":"https:\/\/regask.com\/#website","url":"https:\/\/regask.com\/","name":"RegASK","description":"Favoriser des d\u00e9cisions r\u00e9glementaires plus intelligentes","publisher":{"@id":"https:\/\/regask.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/regask.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"fr-FR"},{"@type":"Organization","@id":"https:\/\/regask.com\/#organization","name":"RegASK","url":"https:\/\/regask.com\/","logo":{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/regask.com\/#\/schema\/logo\/image\/","url":"https:\/\/regask.com\/wp-content\/uploads\/2024\/10\/RegASK-Logo-Dark-Round.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2024\/10\/RegASK-Logo-Dark-Round.png","width":401,"height":401,"caption":"RegASK"},"image":{"@id":"https:\/\/regask.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","https:\/\/x.com\/ASKRegASK","https:\/\/www.linkedin.com\/company\/RegASK\/","https:\/\/www.youtube.com\/@RegASK"]},{"@type":"Person","@id":"https:\/\/regask.com\/#\/schema\/person\/3a8aaee2c7585284f97ec9e038e36b65","name":"Hannah Nordin","sameAs":["https:\/\/regask.com"]}]}},"_links":{"self":[{"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/posts\/9718","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/users\/32"}],"replies":[{"embeddable":true,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/comments?post=9718"}],"version-history":[{"count":0,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/posts\/9718\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/media\/9719"}],"wp:attachment":[{"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/media?parent=9718"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/categories?post=9718"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/tags?post=9718"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}