{"id":9356,"date":"2026-01-20T16:10:07","date_gmt":"2026-01-20T08:10:07","guid":{"rendered":"https:\/\/regask.com\/?p=9356"},"modified":"2026-01-29T19:59:22","modified_gmt":"2026-01-29T11:59:22","slug":"la-mhr-del-reino-unido-actualiza-las-directrices-para-determinar-el-estado-limite-de-los-productos-y-el-estado-medicinal-de-los-cosmeticos-suplementos-alimenticios-y-dispositivos-medicos","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/uk-mhra-updates-guidance-on-determining-borderline-products-and-medicinal-status-for-cosmetics-food-supplement-and-medical-devices\/","title":{"rendered":"La MHRA del Reino Unido actualiza las directrices para determinar la producci\u00f3n lim\u00edtrofe\u2026"},"content":{"rendered":"<p>En <strong>17 de octubre de 2025,<\/strong> el <strong><a href=\"https:\/\/www.gov.uk\/government\/organisations\/medicines-and-healthcare-products-regulatory-agency\">Agencia Reguladora de Medicamentos y Productos Sanitarios (MHRA)<\/a><\/strong> public\u00f3 una gu\u00eda actualizada sobre <strong>productos l\u00edmite,<\/strong> aclarar c\u00f3mo se determina si un producto debe ser regulado como tal <strong>producto medicinal<\/strong> o cae bajo otros marcos como <strong>dispositivos m\u00e9dicos, cosm\u00e9ticos, complementos alimenticios, productos a base de hierbas o biocidas.<\/strong> La actualizaci\u00f3n es particularmente relevante para los fabricantes y vendedores cuyos productos se encuentran en la intersecci\u00f3n de m\u00faltiples reg\u00edmenes regulatorios o son objeto de quejas por ser comercializados como medicamentos.<\/p>\n<div class=\"row\"  id=\"row-1031393586\">\n\n\t<div id=\"col-813601369\" 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-275440405\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-275440405 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>Qu\u00e9 cubre la gu\u00eda actualizada<\/h2>\n\t<div id=\"gap-18320301\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-18320301 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La gu\u00eda revisada de la MHRA explica que la clasificaci\u00f3n del producto se determina en funci\u00f3n de: <strong>caso por caso<\/strong>, con una evaluaci\u00f3n centrada en varios criterios clave, entre ellos:<\/p>\n<ul>\n<li><strong>Reclamaciones realizadas<\/strong> sobre el prop\u00f3sito o los beneficios del producto<\/li>\n<li><strong>Propiedades de los ingredientes activos\u00a0<\/strong><\/li>\n<li><strong>Uso previsto\u00a0<\/strong><\/li>\n<li><strong>Presentaci\u00f3n general a los consumidores\u00a0<\/strong><\/li>\n<\/ul>\n<p>Un factor determinante sigue siendo si un producto logra su efecto principal a trav\u00e9s de un <strong>modo de acci\u00f3n farmacol\u00f3gico, inmunol\u00f3gico o metab\u00f3lico,<\/strong> lo que indicar\u00eda <strong>estado medicinal<\/strong> bajo las regulaciones del Reino Unido.<\/p>\n<p>La gu\u00eda aclara adem\u00e1s que los productos com\u00fanmente considerados <strong>l\u00edmite<\/strong> incluir:<\/p>\n<ul>\n<li><strong>Productos cosm\u00e9ticos\u00a0<\/strong><\/li>\n<li><strong>Complementos alimenticios\u00a0<\/strong><\/li>\n<li><strong>productos a base de hierbas\u00a0<\/strong><\/li>\n<li><strong>Biocidas\u00a0<\/strong><\/li>\n<li><strong>dispositivos m\u00e9dicos\u00a0<\/strong><\/li>\n<\/ul>\n<p>D\u00f3nde <strong>Los complementos alimenticios u otros productos no medicinales hacen afirmaciones medicinales,<\/strong> ellos pueden ser <strong>reclasificados como medicamentos<\/strong> y quedar sujetos a la legislaci\u00f3n sobre medicamentos.<\/p>\n<p>La MHRA reitera que las quejas se priorizan en funci\u00f3n de <strong>riesgos potenciales para la salud del consumidor<\/strong>. Si bien la agencia enfatiza el cumplimiento voluntario, se\u00f1ala que <strong>Las investigaciones a\u00fan pueden conducir a medidas coercitivas cuando sea necesario.\u00a0<\/strong><\/p>\n<p>Para apoyar a las empresas que buscan claridad regulatoria, la MHRA contin\u00faa brindando opiniones formales a trav\u00e9s de <strong><a href=\"https:\/\/forms.mhra.gov.uk\/requestborderlineadvice\">Formulario de asesoramiento sobre medicamentos en situaci\u00f3n l\u00edmite<\/a><\/strong>, que permite presentaciones que cubran <strong>hasta cuatro productos por consulta.<\/strong> La gu\u00eda tambi\u00e9n se\u00f1ala que <strong>empresas no brit\u00e1nicas que exportan directamente a consumidores del Reino Unido<\/strong> pueden quedar fuera de la jurisdicci\u00f3n de la MHRA, pero dichos productos <strong>Todav\u00eda podr\u00eda investigarse.\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-813601369 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-64174519\" 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>Fecha l\u00edmite para comentarios<\/h2>\n\t<div id=\"gap-409219646\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-409219646 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><strong>No se ha especificado un plazo formal para la retroalimentaci\u00f3n<\/strong> para esta actualizaci\u00f3n de orientaci\u00f3n.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-64174519 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-89863890\" 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 le importa<\/h2>\n\t<div id=\"gap-1969196365\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1969196365 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Esta actualizaci\u00f3n proporciona <strong>claridad regulatoria<\/strong> sobre c\u00f3mo se eval\u00faan los productos dudosos en el Reino Unido, ayudando a las empresas a alinear el desarrollo, las afirmaciones y el etiquetado de los productos con el marco legal adecuado. Criterios m\u00e1s claros respaldan <strong>flujos de trabajo de cumplimiento preparados para lo digital<\/strong>, reducir el riesgo de clasificaci\u00f3n err\u00f3nea y ayudar a las organizaciones a abordar posibles problemas de forma temprana sin una carga regulatoria innecesaria.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-89863890 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1784855272\" 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>Para qui\u00e9n es relevante<\/h2>\n\t<div id=\"gap-2094204820\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2094204820 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La orientaci\u00f3n es relevante para R<strong>Asuntos regulatorios, control de calidad, cumplimiento, desarrollo de productos, legal y equipos digitales o de inteligencia artificial.<\/strong> involucrado en la clasificaci\u00f3n de productos, revisi\u00f3n de reclamos, acceso al mercado y monitoreo posterior a la comercializaci\u00f3n de cosm\u00e9ticos, suplementos, dispositivos m\u00e9dicos y productos relacionados.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1784855272 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1859152757\" 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-1491711158\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1491711158 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Las organizaciones deber\u00edan<strong> Revisar las afirmaciones de productos existentes y planificadas, evaluar las propiedades de los ingredientes activos,<\/strong> y evaluar el uso y la presentaci\u00f3n previstos seg\u00fan los criterios actualizados de la MHRA. Si la clasificaci\u00f3n sigue sin estar clara, las partes interesadas deber\u00edan considerar presentar una solicitud a trav\u00e9s de <strong>Formulario de asesoramiento sobre medicamentos en situaci\u00f3n l\u00edmite<\/strong> para obtener una opini\u00f3n regulatoria formal antes de la colocaci\u00f3n en el mercado o cambios en las reclamaciones.<\/p>\n<p>A medida que las expectativas regulatorias en torno a la clasificaci\u00f3n de productos contin\u00faan evolucionando, <a href=\"https:\/\/regask.com\/es\/\"><strong>RegASK<\/strong><\/a> Ayuda a las organizaciones a mantenerse a la vanguardia mediante el monitoreo de actualizaciones de orientaci\u00f3n, la evaluaci\u00f3n del impacto regulatorio en las carteras de productos y el respaldo a la toma de decisiones informada sobre clasificaciones l\u00edmite.<\/p>\n<p><a href=\"https:\/\/regask.com\/es\/\">RegASK<\/a> es un l\u00edder <strong>Plataforma de inteligencia regulatoria y orquestaci\u00f3n de flujos de trabajo con inteligencia artificial de Agentic<\/strong> que permite a las organizaciones globales en sectores altamente regulados, como productos de consumo y ciencias de la vida, gestionar de forma proactiva entornos regulatorios complejos. Al combinar la 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 157 pa\u00edses.<\/p>\n<p><strong><a href=\"https:\/\/regask.com\/es\/producto\/\">M\u00e1s informaci\u00f3n<\/a> o <a href=\"https:\/\/regask.com\/es\/reservar-una-demostracion\/\">Reserve una demostraci\u00f3n ahora.\u00a0<\/a><\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1859152757 > .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-1969603243\">\n\n\t<div id=\"col-1159191588\" 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-897555296\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-897555296 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>\u00bfQu\u00e9 son los productos l\u00edmite seg\u00fan las directrices de la MHRA del Reino Unido?<\/h4>\n\t<div id=\"gap-1128995616\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1128995616 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Los productos l\u00edmite son aquellos que pueden quedar bajo la regulaci\u00f3n de medicamentos u otros marcos como cosm\u00e9ticos, suplementos alimenticios, dispositivos m\u00e9dicos, productos herbales o biocidas, dependiendo de sus afirmaciones, composici\u00f3n y uso previsto.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1159191588 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1348675932\" 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 determina la MHRA si un producto es un medicamento?<\/h4>\n\t<div id=\"gap-1165292279\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1165292279 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La MHRA eval\u00faa factores que incluyen las afirmaciones realizadas, las propiedades del ingrediente activo, el uso previsto, la presentaci\u00f3n a los consumidores y si el producto act\u00faa a trav\u00e9s de medios farmacol\u00f3gicos, inmunol\u00f3gicos o metab\u00f3licos.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1348675932 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-201492895\" 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>\u00bfPueden regularse los complementos alimenticios como medicamentos en el Reino Unido?<\/h4>\n\t<div id=\"gap-1891442280\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1891442280 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>S\u00ed. Los complementos alimenticios que contienen afirmaciones medicinales o cumplen los criterios de modo de acci\u00f3n medicinal pueden reclasificarse y regularse como medicamentos.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-201492895 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1167359493\" 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 ayudar a los equipos que gestionan clasificaciones de productos l\u00edmite?<\/h4>\n\t<div id=\"gap-1469251953\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1469251953 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"https:\/\/regask.com\/es\/\">RegASK<\/a> ayuda a los equipos a realizar un seguimiento de las actualizaciones de orientaci\u00f3n de la MHRA, evaluar los riesgos de clasificaci\u00f3n en todos los productos y optimizar los flujos de trabajo de inteligencia regulatoria y cumplimiento utilizando IA de agente combinada con supervisi\u00f3n de expertos.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1167359493 > .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 17 October 2025, the Medicines &amp; Healthcare products Regulatory Agency (MHRA) published updated guidance on borderline products, clarifying how it determines whether a product should be regulated as a medicinal product or falls under other frameworks such as medical devices, cosmetics, food supplements, herbal products, or biocides. The update is particularly relevant for manufacturers&#8230;<\/p>","protected":false},"author":43,"featured_media":9413,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[37,33,526,39],"tags":[],"class_list":["post-9356","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-personal-care-cosmetics","category-news","category-united-kingdom-regulations","category-medical-devices-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>UK MHRA Updates Guidance on Borderline Product Classification<\/title>\n<meta name=\"description\" content=\"Learn about the UK MHRA updates on guidance for borderline products and their medicinal classification in cosmetics and supplements.\" \/>\n<meta name=\"robots\" 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