{"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":"das-niederlandische-meb-fuhrt-eine-deklarationspflicht-fur-doppelte-zulassungsantrage-ein","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/netherlands-meb-introduces-declaration-requirement-for-duplex-marketing-authorisation-applications\/","title":{"rendered":"Niederl\u00e4ndisches MEB f\u00fchrt Erkl\u00e4rungspflicht ein f\u00fcr \u2026"},"content":{"rendered":"<p>An <strong>11. M\u00e4rz 2026<\/strong>, Die <strong>Arzneimittelbewertungsausschuss (MEB) in den Niederlanden<\/strong> ver\u00f6ffentlicht neu <strong>Leitfaden zur Erkl\u00e4rung<\/strong> f\u00fcr Bewerber, die suchen <strong>Duplex-Vermarktungsgenehmigung<\/strong> f\u00fcr Humanarzneimittel. Die Aktualisierung f\u00fchrt ein formelles Deklarationsverfahren ein, das Folgendes beschreibt: <strong>erg\u00e4nzende regulatorische Bedingungen<\/strong> Diese Voraussetzungen m\u00fcssen f\u00fcr die Genehmigung und die fortlaufende Einhaltung erf\u00fcllt sein. Sie gelten f\u00fcr alle relevanten Antr\u00e4ge ab dem Datum der Ver\u00f6ffentlichung.<\/p>\n<div class=\"row\"  id=\"row-390172954\">\n\n\t<div id=\"col-1707582141\" 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-1664727663\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1664727663 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>Details zum Update<\/h2>\n\t<div id=\"gap-363020305\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-363020305 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Die neuen Richtlinien verlangen von den Antragstellern die Einreichung eines <strong>ausgef\u00fclltes Erkl\u00e4rungsformular<\/strong> als Teil von <strong>Duplex-Marktzulassungsantrag<\/strong>, was die parallele Vermarktung identischer oder eng verwandter Arzneimittel erm\u00f6glicht.<\/p>\n<p>Die Deklaration legt fest <strong>Zusatzbedingungen<\/strong> die Bewerber erf\u00fcllen m\u00fcssen, einschlie\u00dflich Anforderungen in Bezug auf <strong>Produktqualit\u00e4t<\/strong>, <strong>Sicherheits\u00fcberwachung<\/strong>, Und <strong>fortlaufende Compliance-Verpflichtungen<\/strong>. Diese Bedingungen sollen sicherstellen, dass parallel vermarktete Arzneimittel w\u00e4hrend ihres gesamten Lebenszyklus den niederl\u00e4ndischen Regulierungsstandards entsprechen.<\/p>\n<p>Die Anforderung gilt f\u00fcr <strong>alle neuen Anwendungen<\/strong> f\u00fcr die Marktzulassung von Duplex f\u00fcr <strong>Arzneimittel f\u00fcr den menschlichen Gebrauch<\/strong> in den Niederlanden. Obwohl die Leitlinien erst 2026 ver\u00f6ffentlicht wurden, <strong>Die Einhaltungspflicht tritt am 1. Januar 2022 in Kraft.<\/strong>, Das bedeutet, dass die Einhaltung Voraussetzung f\u00fcr den fortgesetzten Marktzugang ist.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1707582141 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1011638417\" 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>Warum es wichtig ist<\/h2>\n\t<div id=\"gap-343274714\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-343274714 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Dieses Update st\u00e4rkt <strong>regulatorische Klarheit<\/strong> durch die Formalisierung der Erwartungen an Zulassungsantr\u00e4ge f\u00fcr Duplexprodukte. Es unterst\u00fctzt <strong>einheitliche Compliance-Standards<\/strong> bei parallel vermarkteten Arzneimitteln und gleichzeitiger St\u00e4rkung <strong>fortlaufende Sicherheits- und Qualit\u00e4ts\u00fcberwachung<\/strong>. Durch die Einf\u00fchrung eines strukturierten Deklarationsverfahrens f\u00f6rdert das MEB auch <strong>Betriebseffizienz<\/strong> und reduziert Unklarheiten bei den Einreichungsanforderungen, wodurch der regulatorische Aufwand im Zusammenhang mit unvollst\u00e4ndigen oder nicht \u00fcbereinstimmenden Antr\u00e4gen minimiert wird.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1011638417 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-308086093\" 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>Wen das betrifft<\/h2>\n\t<div id=\"gap-825595813\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-825595813 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Dieses Update ist relevant f\u00fcr <strong>Regulatorische Angelegenheiten<\/strong>, <strong>Qualit\u00e4tssicherung<\/strong>, <strong>Patientensicherheit<\/strong>, <strong>Recht\/Compliance<\/strong>, Und <strong>Vertriebsteams<\/strong> innerhalb von Pharmaunternehmen, die an der <strong>Entwicklung, Einreichung und Vermarktung von Humanarzneimitteln<\/strong> in den Niederlanden.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-308086093 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1873556019\" 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>N\u00e4chste Schritte<\/h2>\n\t<div id=\"gap-657905030\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-657905030 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Organisationen sollten <strong>\u00dcberpr\u00fcfen Sie die aktualisierte Vorlage f\u00fcr die Erkl\u00e4rung und die erg\u00e4nzenden Bedingungen.<\/strong> um die \u00dcbereinstimmung mit aktuellen und zuk\u00fcnftigen Zulassungsantr\u00e4gen f\u00fcr Duplex sicherzustellen. Intern <strong>Einreichungsabl\u00e4ufe, Dokumentationsstandards und Compliance-Checklisten<\/strong> sollten in Abstimmung mit funktions\u00fcbergreifenden Teams aktualisiert werden, um diesen Anforderungen gerecht zu werden.<\/p>\n<p>Da sich die regulatorischen Anforderungen in den verschiedenen M\u00e4rkten st\u00e4ndig weiterentwickeln, ist es von entscheidender Bedeutung, sich an den l\u00e4nderspezifischen Anforderungen an die Einreichung von Unterlagen zu orientieren.<\/p>\n<p><a href=\"https:\/\/regask.com\/de\/\">RegASK<\/a> ist eine f\u00fchrende agentenbasierte KI-Plattform f\u00fcr regulatorische Analysen und Workflow-Orchestrierung, die globale Unternehmen in stark regulierten Branchen wie Konsumg\u00fcter und Life Sciences dabei unterst\u00fctzt, sich proaktiv in komplexen regulatorischen Umfeldern zu bewegen. Durch die Kombination von fortschrittlicher agentenbasierter KI mit Expertenwissen, <a href=\"https:\/\/regask.com\/de\/\">RegASK<\/a> liefert zeitnahe, vorausschauende und umsetzbare Erkenntnisse sowie eine durchg\u00e4ngige Automatisierung, optimiert Compliance-Prozesse, mindert Risiken und beschleunigt den Marktzugang in mehr als 160 L\u00e4ndern. <a href=\"https:\/\/regask.com\/de\/produkt\/\">Mehr erfahren<\/a> oder <a href=\"https:\/\/regask.com\/de\/demo-buchen\/\">Demo buchen<\/a> Jetzt.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1873556019 > .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-900676056\">\n\n\t<div id=\"col-1603807762\" 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>FAQs<\/h3>\n\t<div id=\"gap-1568089232\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1568089232 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>Was ist die Marktzulassung von Duplex in den Niederlanden?<\/h4>\n\t<div id=\"gap-1113385098\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1113385098 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Es handelt sich um einen Autorisierungsweg, der Folgendes erm\u00f6glicht: <strong>Parallelvermarktung identischer oder eng verwandter Arzneimittel<\/strong> unter bestimmten regulatorischen Bedingungen.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1603807762 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1231791326\" 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>Welche neue Anforderung wurde vom MEB eingef\u00fchrt?<\/h4>\n\t<div id=\"gap-1794594984\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1794594984 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Bewerber m\u00fcssen nun eine <strong>ausgef\u00fclltes Erkl\u00e4rungsformular<\/strong> Beschreibung der Einhaltung von <strong>Zusatzbedingungen<\/strong> als Teil ihrer Bewerbung.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1231791326 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1909690830\" 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>Was umfassen die Zusatzbedingungen?<\/h4>\n\t<div id=\"gap-907762684\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-907762684 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Sie sprechen <strong>Produktqualit\u00e4t<\/strong>, <strong>Sicherheits\u00fcberwachung<\/strong>, Und <strong>fortlaufende Compliance-Verpflichtungen<\/strong> f\u00fcr parallel vermarktete Arzneimittel.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1909690830 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-720461035\" 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>Wie kann RegASK die Einhaltung der Zulassungsvoraussetzungen f\u00fcr Duplex unterst\u00fctzen?<\/h4>\n\t<div id=\"gap-1718505310\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1718505310 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"http:\/\/regask.com\/de\/\">RegASK <\/a>hilft Teams <strong>sich entwickelnden regulatorischen Anforderungen folgen<\/strong>, ausrichten <strong>Einreichungsunterlagen unter Ber\u00fccksichtigung lokaler Bedingungen<\/strong>, und optimieren <strong>Compliance-Workflows<\/strong>, um zeitnahe und pr\u00e4zise Marktzulassungsverfahren zu gew\u00e4hrleisten.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-720461035 > .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\" 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