{"id":9485,"date":"2026-02-16T16:20:31","date_gmt":"2026-02-16T08:20:31","guid":{"rendered":"https:\/\/regask.com\/?p=9485"},"modified":"2026-02-16T16:20:31","modified_gmt":"2026-02-16T08:20:31","slug":"la-autoridad-de-salud-del-reino-unido-mhra-publica-una-guia-sobre-los-requisitos-de-farmacovigilancia-segun-la-cirr-520-modificada-de-2012","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/uk-mhra-issues-guidance-on-pharmacovigilance-requirements-under-amended-cir-520-2012\/","title":{"rendered":"La MHRA del Reino Unido publica una gu\u00eda sobre los requisitos de farmacovigilancia\u2026"},"content":{"rendered":"<p>En <strong>9 de febrero de 2026,<\/strong> el <strong>Agencia Reguladora de Medicamentos y Productos Sanitarios del Reino Unido (MHRA)<\/strong> public\u00f3 una nueva gu\u00eda para los titulares de autorizaciones de comercializaci\u00f3n del Reino Unido que describe c\u00f3mo se aplicar\u00e1n los requisitos de farmacovigilancia tras las modificaciones a <strong>Reglamento de Ejecuci\u00f3n de la Comisi\u00f3n (CIR) 520\/2012.<\/strong> La gu\u00eda refleja la adopci\u00f3n por parte de la Comisi\u00f3n Europea de <strong>Reglamento (UE) 2025\/1466,<\/strong> que revisa el CIR 520\/2012 y entra en vigor a partir de <strong>12 de febrero de 2026,<\/strong> con disposiciones limitadas vigentes a partir de <strong>12 de agosto de 2025.<\/strong> La actualizaci\u00f3n es especialmente relevante para las organizaciones que tienen <strong>Medicamentos autorizados en el Reino Unido<\/strong> en diferentes categor\u00edas bajo el <strong>Marco Windsor. <\/strong><\/p>\n<div class=\"row\"  id=\"row-1347364590\">\n\n\t<div id=\"col-1898659368\" 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-1061292284\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1061292284 {\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-1974483474\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1974483474 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La gu\u00eda explica que <strong>CIR 520\/2012<\/strong> ha sido modificado formalmente por <strong>Reglamento (UE) 2025\/1466,<\/strong> Introduciendo cambios en los requisitos de farmacovigilancia. Tras la implementaci\u00f3n de la<strong> Marco Windsor,<\/strong> Los medicamentos autorizados en el Reino Unido ahora se clasifican como <strong>Categor\u00eda 1<\/strong> o <strong>Categor\u00eda 2,<\/strong> que determina el marco jur\u00eddico aplicable.<\/p>\n<p>De <strong>12 de febrero de 2026, HMR 2012 Anexo 12A<\/strong> y la enmienda <strong>CIR 520\/2012<\/strong> Ya no estar\u00e1n legalmente armonizados en cuanto a las obligaciones de farmacovigilancia. Esta divergencia implica que podr\u00edan aplicarse diferentes requisitos seg\u00fan la categor\u00eda del producto y la estructura de la cartera.<\/p>\n<p>Para reducir la carga regulatoria innecesaria, la MHRA describe <strong>un enfoque pragm\u00e1tico de cumplimiento<\/strong>. Titulares de Autorizaci\u00f3n de Comercializaci\u00f3n con <strong>carteras mixtas<\/strong> Se recomienda a los productos que contengan tanto productos de la categor\u00eda 1 como de la categor\u00eda 2 que apliquen la versi\u00f3n modificada. <strong>CIR 520\/2012<\/strong> en todos los productos autorizados en el Reino Unido. Por el contrario, los titulares con <strong>Productos de categor\u00eda 1<\/strong> <strong>solo<\/strong> puede continuar siguiendo <strong>Anexo 12A del HMR,<\/strong> a menos que tambi\u00e9n tengan <strong>autorizaciones equivalentes de la Uni\u00f3n Europea<\/strong>, en cuyo caso se aplican consideraciones adicionales.<\/p>\n<p>La MHRA tambi\u00e9n se\u00f1ala que las futuras actualizaciones de <strong>Anexo 12A del HMR 2012<\/strong> Puede considerarse que refleja mejor las modificaciones realizadas a <strong>CIR 520\/2012,<\/strong> Aunque no se han confirmado cambios en esta etapa.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1898659368 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-968338979\" 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 de entrada en vigor<\/h2>\n\t<div id=\"gap-1996162236\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1996162236 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La enmienda <strong>Reglamento de Ejecuci\u00f3n (CIR) 520\/2012 de la Comisi\u00f3n,<\/strong> seg\u00fan lo revisado por <strong>El Reglamento (UE) 2025\/1466 se aplica a partir del 12 de febrero de 2026.<\/strong> Sin embargo, <strong>Art\u00edculos 1(7) y 1(9)<\/strong> del reglamento modificativo <strong>entr\u00f3 en vigor antes, el 12 de agosto de 2025. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-968338979 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-628693430\" 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-90083151\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-90083151 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Esta actualizaci\u00f3n introduce <strong>la falta de alineaci\u00f3n entre los marcos jur\u00eddicos de farmacovigilancia del Reino Unido y la UE,<\/strong> creando implicaciones pr\u00e1cticas para la planificaci\u00f3n del cumplimiento. Si bien el enfoque pragm\u00e1tico de la MHRA busca apoyar <strong>claridad regulatoria, eficiencia operativa,<\/strong> y <strong>alineaci\u00f3n digital,<\/strong> Tambi\u00e9n exige que las organizaciones gestionen cuidadosamente los procesos para evitar la aplicaci\u00f3n incorrecta de los requisitos. Los cambios pueden requerir actualizaciones espec\u00edficas de los sistemas de farmacovigilancia, las estructuras de gobernanza y los procedimientos internos, especialmente en organizaciones con carteras de productos complejas o mixtas.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-628693430 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-517929114\" 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-187603586\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-187603586 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La orientaci\u00f3n es relevante para <strong>Farmacovigilancia, Asuntos Regulatorios, Garant\u00eda de Calidad, Cumplimiento,<\/strong> y yo<strong>T o equipos de gobernanza digital<\/strong> involucrado en la gesti\u00f3n de medicamentos autorizados en el Reino Unido y obligaciones regulatorias interjurisdiccionales.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-517929114 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-156694011\" 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-2018350649\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2018350649 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Las organizaciones deben revisar sus <strong>Carteras de productos del Reino Unido<\/strong> para confirmar si los productos est\u00e1n incluidos <strong>Categor\u00eda 1 o Categor\u00eda 2<\/strong> y evaluar la presencia de cualquier <strong>Licencias equivalentes a las de la UE<\/strong>. Los procedimientos internos de farmacovigilancia, los marcos de decisi\u00f3n y los modelos de gobernanza deben cotejarse con las expectativas aclaradas, con una alineaci\u00f3n interfuncional antes de la <strong>12 de febrero de 2026<\/strong> fecha de vigencia para minimizar el riesgo de incumplimiento.<\/p>\n<p>A medida que la divergencia regulatoria aumenta la complejidad operativa, tener una forma estructurada de monitorear los cambios y evaluar su impacto se vuelve cada vez m\u00e1s importante. <strong><a href=\"http:\/\/regask.com\/es\/\">RegASK<\/a> es una plataforma l\u00edder de inteligencia regulatoria y orquestaci\u00f3n de flujos de trabajo con inteligencia artificial de agencia.<\/strong> que empodera a las organizaciones globales en sectores altamente regulados, incluidas las ciencias de la vida, para navegar proactivamente en los cambiantes panoramas regulatorios. Al combinar tecnolog\u00eda avanzada <strong>IA agente con expertos en el circuito, <a href=\"http:\/\/regask.com\/es\/\">RegASK<\/a><\/strong> Proporciona informaci\u00f3n oportuna, predictiva y procesable, ayudando a los equipos a optimizar los procesos de cumplimiento y mantener la supervisi\u00f3n en m\u00e1s de 160 pa\u00edses.<strong> <a href=\"http:\/\/regask.com\/es\/\">M\u00e1s informaci\u00f3n<\/a><\/strong> o <strong><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-156694011 > .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-1409467610\">\n\n\t<div id=\"col-411345650\" 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-56223033\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-56223033 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW240545805 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW240545805 BCX0\">\u00bfQu\u00e9 es el Reglamento de Ejecuci\u00f3n 520\/2012 de la Comisi\u00f3n?<\/span><\/span><span class=\"EOP SCXW240545805 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-1728446296\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1728446296 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW37803039 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW37803039 BCX0\">Se trata de un reglamento de la UE que establece normas detalladas<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW37803039 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW37803039 BCX0\">requisitos de farmacovigilancia<\/span><\/span><\/strong><span class=\"TextRun SCXW37803039 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW37803039 BCX0\">\u00a0para productos medicinales, incluidas las obligaciones de comercializaci\u00f3n\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW37803039 BCX0\">Autorizaci\u00f3n<\/span><span class=\"NormalTextRun SCXW37803039 BCX0\">\u00a0Titulares.<\/span><\/span><span class=\"EOP SCXW37803039 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-411345650 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-58055759\" 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 cambi\u00f3 con el Reglamento (UE) 2025\/1466?<\/h4>\n\t<div id=\"gap-1662529281\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1662529281 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Reglamento (UE) 2025\/1466<strong> modifica el CIR 520\/2012,<\/strong> Revisar los requisitos de farmacovigilancia y aplicarlos desde <strong>12 de febrero de 2026,<\/strong> con disposiciones limitadas vigentes a partir de<strong> 12 de agosto de 2025. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-58055759 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1848757056\" 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 afecta el Marco de Windsor a las obligaciones de farmacovigilancia del Reino Unido?<\/h4>\n\t<div id=\"gap-1372659846\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1372659846 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>El Marco de Windsor introduce <strong>Clasificaciones de categor\u00eda 1 y categor\u00eda 2<\/strong> para productos medicinales autorizados en el Reino Unido, lo que resulta en<strong> diferentes marcos jur\u00eddicos aplicables <\/strong>para farmacovigilancia.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1848757056 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1473134678\" 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>H<span class=\"NormalTextRun SCXW207083187 BCX0\">\u00bfC\u00f3mo puedo?\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW207083187 BCX0\">RegASK<\/span><span class=\"NormalTextRun SCXW207083187 BCX0\">\u00a0ayuda\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW207083187 BCX0\">organizaciones<\/span><span class=\"NormalTextRun SCXW207083187 BCX0\">\u00a0\u00bfC\u00f3mo gestionar estos cambios?<\/span><\/h4>\n\t<div id=\"gap-1604689090\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1604689090 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"http:\/\/regask.com\/es\/\"><strong>RegASK<\/strong><\/a> ayuda a los equipos a realizar un seguimiento <strong>actualizaciones regulatorias,<\/strong> evaluar <strong>impacto espec\u00edfico de la cartera,<\/strong> y coordinar <strong>flujos de trabajo de cumplimiento,<\/strong> permitiendo una gesti\u00f3n m\u00e1s eficiente de los requisitos divergentes de farmacovigilancia del Reino Unido y la UE.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1473134678 > .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 9 February 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance for UK Marketing Authorisation Holders outlining how pharmacovigilance requirements will apply following amendments to Commission Implementing Regulation (CIR) 520\/2012. The guidance reflects the European Commission\u2019s adoption of Regulation (EU) 2025\/1466, which revises CIR 520\/2012 and becomes applicable from 12&#8230;<\/p>","protected":false},"author":41,"featured_media":9486,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,526,35],"tags":[],"class_list":["post-9485","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-united-kingdom-regulations","category-pharma-biotech-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>UK MHRA Issues Guidance on Pharmacovigilance Overview<\/title>\n<meta name=\"description\" content=\"Explore the UK MHRA&#039;s new guidance on pharmacovigilance requirements under amended CIR 520\/2012 for UK 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