{"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":"el-ministerio-de-energia-y-bioseguridad-de-los-paises-bajos-introduce-un-requisito-de-declaracion-para-las-solicitudes-de-autorizacion-de-comercializacion-por-duplicado","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/netherlands-meb-introduces-declaration-requirement-for-duplex-marketing-authorisation-applications\/","title":{"rendered":"El Ministerio de Energ\u00eda y Desarrollo Econ\u00f3mico de los Pa\u00edses Bajos introduce un requisito de declaraci\u00f3n para\u2026"},"content":{"rendered":"<p>En <strong>11 de marzo de 2026<\/strong>, el <strong>Comit\u00e9 de Evaluaci\u00f3n de Medicamentos (MEB) en los Pa\u00edses Bajos<\/strong> public\u00f3 nuevo <strong>gu\u00eda de declaraci\u00f3n<\/strong> para solicitantes que buscan <strong>Autorizaci\u00f3n de comercializaci\u00f3n d\u00faplex<\/strong> para medicamentos de uso humano. La actualizaci\u00f3n introduce un proceso de declaraci\u00f3n formal que describe <strong>condiciones reglamentarias suplementarias<\/strong> Estos requisitos deben cumplirse para obtener la aprobaci\u00f3n y mantener el cumplimiento. Se aplican a todas las solicitudes pertinentes a partir de la fecha de publicaci\u00f3n.<\/p>\n<div class=\"row\"  id=\"row-554326506\">\n\n\t<div id=\"col-1802025703\" 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-1811206763\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1811206763 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>Detalles de la actualizaci\u00f3n<\/h2>\n\t<div id=\"gap-1599222010\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1599222010 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La nueva gu\u00eda exige que los solicitantes presenten un <strong>formulario de declaraci\u00f3n completado<\/strong> como parte de cualquier <strong>Solicitud de autorizaci\u00f3n de comercializaci\u00f3n d\u00faplex<\/strong>, lo que permite la comercializaci\u00f3n paralela de medicamentos id\u00e9nticos o estrechamente relacionados.<\/p>\n<p>La declaraci\u00f3n especifica <strong>condiciones suplementarias<\/strong> que los solicitantes deben cumplir, incluidos los requisitos relacionados con <strong>calidad del producto<\/strong>, <strong>vigilancia de seguridad<\/strong>, y <strong>obligaciones de cumplimiento continuo<\/strong>. Estas condiciones est\u00e1n dise\u00f1adas para garantizar que los medicamentos comercializados en mercados paralelos cumplan con las normas regulatorias holandesas a lo largo de todo su ciclo de vida.<\/p>\n<p>El requisito se aplica a <strong>todas las nuevas solicitudes<\/strong> para autorizaci\u00f3n de comercializaci\u00f3n de Duplex para <strong>medicamentos de uso humano<\/strong> en los Pa\u00edses Bajos. Si bien la gu\u00eda se public\u00f3 en 2026, la <strong>El requisito de cumplimiento efectivo data del 1 de enero de 2022.<\/strong>, lo que significa que el cumplimiento es obligatorio para mantener el acceso al mercado.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1802025703 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-975794506\" 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>Por qu\u00e9 es importante<\/h2>\n\t<div id=\"gap-235843840\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-235843840 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Esta actualizaci\u00f3n fortalece <strong>claridad regulatoria<\/strong> formalizando las expectativas para las solicitudes de autorizaci\u00f3n de comercializaci\u00f3n de Duplex. <strong>est\u00e1ndares de cumplimiento consistentes<\/strong> en todos los medicamentos comercializados en paralelo, al tiempo que se refuerza <strong>Supervisi\u00f3n continua de la seguridad y la calidad<\/strong>. Al introducir un proceso de declaraci\u00f3n estructurado, el MEB tambi\u00e9n promueve <strong>eficiencia operativa<\/strong> y reduce la ambig\u00fcedad en los requisitos de presentaci\u00f3n, minimizando la carga regulatoria asociada con las solicitudes incompletas o desalineadas.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-975794506 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2134740399\" 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>A qui\u00e9n afecta esto<\/h2>\n\t<div id=\"gap-2001222656\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2001222656 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Esta actualizaci\u00f3n es relevante para <strong>Asuntos regulatorios<\/strong>, <strong>Seguro de calidad<\/strong>, <strong>Seguridad del paciente<\/strong>, <strong>Asuntos legales\/Cumplimiento normativo<\/strong>, y <strong>Equipos comerciales<\/strong> dentro de las compa\u00f1\u00edas farmac\u00e9uticas involucradas en la <strong>desarrollo, presentaci\u00f3n y comercializaci\u00f3n de medicamentos para uso humano<\/strong> en los Pa\u00edses Bajos.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2134740399 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-510126565\" 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>Pr\u00f3ximos pasos<\/h2>\n\t<div id=\"gap-1609872215\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1609872215 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Las organizaciones deber\u00edan <strong>Revise la plantilla de declaraci\u00f3n actualizada y las condiciones complementarias.<\/strong> para garantizar la alineaci\u00f3n con las solicitudes de autorizaci\u00f3n de comercializaci\u00f3n de Duplex actuales y futuras. Interno <strong>Flujos de trabajo de env\u00edo, est\u00e1ndares de documentaci\u00f3n y listas de verificaci\u00f3n de cumplimiento.<\/strong> Deber\u00e1 actualizarse en coordinaci\u00f3n con equipos multifuncionales para reflejar estos requisitos.<\/p>\n<p>A medida que los requisitos reglamentarios siguen evolucionando en los distintos mercados, es fundamental mantenerse al d\u00eda con las expectativas de presentaci\u00f3n de informes espec\u00edficas de cada pa\u00eds.<\/p>\n<p><a href=\"https:\/\/regask.com\/es\/\">RegASK<\/a> Es una plataforma l\u00edder de inteligencia regulatoria y orquestaci\u00f3n de flujos de trabajo con IA agentic que permite a organizaciones globales en sectores altamente regulados, como productos de consumo y ciencias de la vida, gestionar de forma proactiva entornos regulatorios complejos. Al combinar IA agentic avanzada con expertos en el sector, <a href=\"https:\/\/regask.com\/es\/\">RegASK<\/a> Proporciona informaci\u00f3n predictiva y procesable oportuna y automatizaci\u00f3n de extremo a extremo, agilizando los procesos de cumplimiento, mitigando riesgos y acelerando el acceso al mercado en m\u00e1s de 160 pa\u00edses. <a href=\"https:\/\/regask.com\/es\/producto\/\">M\u00e1s informaci\u00f3n<\/a> o <a href=\"https:\/\/regask.com\/es\/reservar-una-demostracion\/\">Reservar una demostraci\u00f3n<\/a> ahora.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-510126565 > .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-5678913\">\n\n\t<div id=\"col-1168679163\" 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>Preguntas frecuentes<\/h3>\n\t<div id=\"gap-1042430195\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1042430195 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>\u00bfQu\u00e9 es la autorizaci\u00f3n de comercializaci\u00f3n de Duplex en los Pa\u00edses Bajos?<\/h4>\n\t<div id=\"gap-1282412780\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1282412780 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Es una v\u00eda de autorizaci\u00f3n que permite la <strong>Comercializaci\u00f3n paralela de medicamentos id\u00e9nticos o estrechamente relacionados.<\/strong> bajo condiciones regulatorias espec\u00edficas.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1168679163 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-259726087\" 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>\u00bfCu\u00e1l es el nuevo requisito introducido por la MEB?<\/h4>\n\t<div id=\"gap-1587636763\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1587636763 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Los solicitantes ahora deben presentar un <strong>formulario de declaraci\u00f3n completado<\/strong> describiendo el cumplimiento con <strong>condiciones suplementarias<\/strong> como parte de su solicitud.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-259726087 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1424638216\" 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>\u00bfQu\u00e9 abarcan las condiciones complementarias?<\/h4>\n\t<div id=\"gap-1275138127\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1275138127 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Ellos abordan <strong>calidad del producto<\/strong>, <strong>vigilancia de seguridad<\/strong>, y <strong>obligaciones de cumplimiento continuo<\/strong> para medicamentos comercializados en mercados paralelos.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1424638216 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-112867306\" 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>\u00bfC\u00f3mo puede RegASK contribuir al cumplimiento de los requisitos de autorizaci\u00f3n de comercializaci\u00f3n de Duplex?<\/h4>\n\t<div id=\"gap-191047862\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-191047862 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"http:\/\/regask.com\/es\/\">RegASK <\/a>ayuda a los equipos <strong>Seguimiento de los requisitos reglamentarios en constante evoluci\u00f3n<\/strong>, alinear <strong>Documentaci\u00f3n de presentaci\u00f3n con condiciones locales<\/strong>, y simplificar <strong>flujos de trabajo de cumplimiento<\/strong>, garantizando as\u00ed procesos de autorizaci\u00f3n de comercializaci\u00f3n puntuales y precisos.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-112867306 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>El 11 de marzo de 2026, la Junta de Evaluaci\u00f3n de Medicamentos (MEB) de los Pa\u00edses Bajos public\u00f3 una nueva gu\u00eda de declaraci\u00f3n para los solicitantes de autorizaci\u00f3n de comercializaci\u00f3n doble para medicamentos de uso humano. Esta actualizaci\u00f3n introduce un proceso de declaraci\u00f3n formal que describe las condiciones reglamentarias complementarias que deben cumplirse para la aprobaci\u00f3n y el cumplimiento continuo. Se aplica a todas las solicitudes pertinentes a partir de la fecha\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 v28.0 (Yoast SEO v28.2) - 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\/es\/el-ministerio-de-energia-y-bioseguridad-de-los-paises-bajos-introduce-un-requisito-de-declaracion-para-las-solicitudes-de-autorizacion-de-comercializacion-por-duplicado\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\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\/es\/el-ministerio-de-energia-y-bioseguridad-de-los-paises-bajos-introduce-un-requisito-de-declaracion-para-las-solicitudes-de-autorizacion-de-comercializacion-por-duplicado\/\" \/>\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 minutos\" \/>\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\":\"es\"},{\"@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\":\"es\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/regask.com\\\/netherlands-meb-introduces-declaration-requirement-for-duplex-marketing-authorisation-applications\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@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\":\"The Regulatory AI Operating System for High-Performing Teams\",\"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\":\"es\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\",\"name\":\"RegASK\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@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\",\"https:\\\/\\\/www.crunchbase.com\\\/organization\\\/regask\",\"https:\\\/\\\/www.bloomberg.com\\\/profile\\\/company\\\/1691237D:SP\",\"https:\\\/\\\/pitchbook.com\\\/profiles\\\/company\\\/265004-02\",\"https:\\\/\\\/www.cbinsights.com\\\/company\\\/RegASK\",\"https:\\\/\\\/vimeo.com\\\/RegASK\"],\"legalName\":\"RegASK PTE. LTD.\",\"foundingDate\":\"2018\",\"slogan\":\"Empowering Smarter Regulatory Decisions\",\"description\":\"Agentic AI regulatory intelligence and workflow orchestration platform for Life Sciences and Consumer Products. RegASK combines vertical LLMs, multi-agent AI architecture, and a global community of 1,800+ subject matter experts to deliver regulatory horizon scanning, impact analysis, compliance workflow automation, and audit-ready outputs across 160+ countries.\",\"areaServed\":\"Worldwide\",\"founder\":{\"@type\":\"Person\",\"name\":\"Caroline Shleifer\",\"jobTitle\":\"Founder & CEO\"},\"address\":{\"@type\":\"PostalAddress\",\"streetAddress\":\"79 Science Park Drive, #06-01, Cintech IV\",\"addressLocality\":\"Singapore\",\"postalCode\":\"118264\",\"addressCountry\":\"SG\"},\"contactPoint\":{\"@type\":\"ContactPoint\",\"telephone\":\"+65 6817 6290\",\"contactType\":\"customer service\",\"availableLanguage\":[\"English\",\"French\",\"Japanese\",\"Spanish\",\"Chinese\",\"German\"]},\"numberOfEmployees\":{\"@type\":\"QuantitativeValue\",\"minValue\":50,\"maxValue\":100},\"knowsAbout\":[\"Regulatory Intelligence\",\"Regulatory Compliance\",\"Regulatory Affairs\",\"Workflow Orchestration\",\"Life Sciences Regulation\",\"Consumer Products Regulation\",\"AI-Driven Compliance\"],\"hasCertification\":[{\"@type\":\"Certification\",\"name\":\"ISO\\\/IEC 42001:2023\"},{\"@type\":\"Certification\",\"name\":\"ISO\\\/IEC 27001:2022\"},{\"@type\":\"Certification\",\"name\":\"ISO\\\/IEC 27701\"},{\"@type\":\"Certification\",\"name\":\"ISO\\\/IEC 27018:2019\"},{\"@type\":\"Certification\",\"name\":\"SOC 2 Type II\"}]},{\"@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":"La MEB de los Pa\u00edses Bajos introduce una actualizaci\u00f3n del requisito de declaraci\u00f3n.","description":"Mant\u00e9ngase informado sobre la gu\u00eda actualizada de la MEB de los Pa\u00edses Bajos para la declaraci\u00f3n de solicitudes de autorizaci\u00f3n de comercializaci\u00f3n d\u00faplex de medicamentos.","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\/es\/el-ministerio-de-energia-y-bioseguridad-de-los-paises-bajos-introduce-un-requisito-de-declaracion-para-las-solicitudes-de-autorizacion-de-comercializacion-por-duplicado\/","og_locale":"es_ES","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\/es\/el-ministerio-de-energia-y-bioseguridad-de-los-paises-bajos-introduce-un-requisito-de-declaracion-para-las-solicitudes-de-autorizacion-de-comercializacion-por-duplicado\/","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 minutos"},"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":"es"},{"@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":"La MEB de los Pa\u00edses Bajos introduce una actualizaci\u00f3n del requisito de declaraci\u00f3n.","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":"Mant\u00e9ngase informado sobre la gu\u00eda actualizada de la MEB de los Pa\u00edses Bajos para la declaraci\u00f3n de solicitudes de autorizaci\u00f3n de comercializaci\u00f3n d\u00faplex de medicamentos.","inLanguage":"es","potentialAction":[{"@type":"ReadAction","target":["https:\/\/regask.com\/netherlands-meb-introduces-declaration-requirement-for-duplex-marketing-authorisation-applications\/"]}]},{"@type":"ImageObject","inLanguage":"es","@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":"El sistema operativo de IA regulatoria para equipos de alto rendimiento","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":"es"},{"@type":"Organization","@id":"https:\/\/regask.com\/#organization","name":"RegASK","url":"https:\/\/regask.com\/","logo":{"@type":"ImageObject","inLanguage":"es","@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","https:\/\/www.crunchbase.com\/organization\/regask","https:\/\/www.bloomberg.com\/profile\/company\/1691237D:SP","https:\/\/pitchbook.com\/profiles\/company\/265004-02","https:\/\/www.cbinsights.com\/company\/RegASK","https:\/\/vimeo.com\/RegASK"],"legalName":"RegASK PTE. LTD.","foundingDate":"2018","slogan":"Empowering Smarter Regulatory Decisions","description":"Plataforma de inteligencia regulatoria y orquestaci\u00f3n de flujos de trabajo con IA para ciencias de la vida y productos de consumo. RegASK combina modelos de negocio verticales, arquitectura de IA multiagente y una comunidad global de m\u00e1s de 1800 expertos para ofrecer an\u00e1lisis de horizontes regulatorios, an\u00e1lisis de impacto, automatizaci\u00f3n de flujos de trabajo de cumplimiento y resultados listos para auditor\u00edas en m\u00e1s de 160 pa\u00edses.","areaServed":"Worldwide","founder":{"@type":"Person","name":"Caroline Shleifer","jobTitle":"Founder & CEO"},"address":{"@type":"PostalAddress","streetAddress":"79 Science Park Drive, #06-01, Cintech IV","addressLocality":"Singapore","postalCode":"118264","addressCountry":"SG"},"contactPoint":{"@type":"ContactPoint","telephone":"+65 6817 6290","contactType":"customer service","availableLanguage":["English","French","Japanese","Spanish","Chinese","German"]},"numberOfEmployees":{"@type":"QuantitativeValue","minValue":50,"maxValue":100},"knowsAbout":["Regulatory Intelligence","Regulatory Compliance","Regulatory Affairs","Workflow Orchestration","Life Sciences Regulation","Consumer Products Regulation","AI-Driven Compliance"],"hasCertification":[{"@type":"Certification","name":"ISO\/IEC 42001:2023"},{"@type":"Certification","name":"ISO\/IEC 27001:2022"},{"@type":"Certification","name":"ISO\/IEC 27701"},{"@type":"Certification","name":"ISO\/IEC 27018:2019"},{"@type":"Certification","name":"SOC 2 Type II"}]},{"@type":"Person","@id":"https:\/\/regask.com\/#\/schema\/person\/3a8aaee2c7585284f97ec9e038e36b65","name":"Hannah Nordin","sameAs":["https:\/\/regask.com"]}]}},"_links":{"self":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/posts\/9718","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/users\/32"}],"replies":[{"embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/comments?post=9718"}],"version-history":[{"count":0,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/posts\/9718\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/media\/9719"}],"wp:attachment":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/media?parent=9718"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/categories?post=9718"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/tags?post=9718"}],"curies":[{"name":"Gracias","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}