{"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-1004499833\">\n\n\t<div id=\"col-127662553\" 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-1086742787\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1086742787 {\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-904351113\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-904351113 {\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-127662553 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1736495922\" 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-1141233395\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1141233395 {\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-1736495922 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1838023470\" 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-1331165587\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1331165587 {\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-1838023470 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1457615654\" 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-1095292376\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1095292376 {\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-1457615654 > .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-2004625231\">\n\n\t<div id=\"col-74155516\" 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-729242934\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-729242934 {\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-750671388\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-750671388 {\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-74155516 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1922394268\" 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-966761751\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-966761751 {\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-1922394268 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-355390302\" 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-1348445323\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1348445323 {\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-355390302 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1471986357\" 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-199344653\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-199344653 {\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-1471986357 > .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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