{"id":9541,"date":"2026-02-25T10:58:43","date_gmt":"2026-02-25T02:58:43","guid":{"rendered":"https:\/\/regask.com\/?p=9541"},"modified":"2026-02-25T10:58:43","modified_gmt":"2026-02-25T02:58:43","slug":"la-aifa-de-italia-actualiza-la-guia-sobre-la-clasificacion-de-medicamentos-de-venta-libre-y-sin-receta","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/italys-aifa-updates-guidance-on-otc-and-non-prescription-medicine-classification\/","title":{"rendered":"La AIFA de Italia actualiza la gu\u00eda sobre medicamentos de venta libre y sin receta\u2026"},"content":{"rendered":"<p>En <strong>23 de febrero de 2026, <\/strong>el<strong> Agencia Italiana de Medicamentos (AIFA)<\/strong> public\u00f3 una gu\u00eda revisada que aclara la <strong>Definici\u00f3n y clasificaci\u00f3n de medicamentos de venta libre (OTC) y sin receta (SOP)<\/strong> En Italia. La actualizaci\u00f3n sustituye las directrices previas del Ministerio de Salud y afecta a fabricantes, distribuidores y partes interesadas en el registro y la comercializaci\u00f3n de productos farmac\u00e9uticos.<\/p>\n<div class=\"row\"  id=\"row-1345714937\">\n\n\t<div id=\"col-1905079094\" 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-406406861\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-406406861 {\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-489694558\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-489694558 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La nueva gu\u00eda introduce <strong>definiciones revisadas y principios de clasificaci\u00f3n<\/strong> Para medicamentos OTC y SOP, proporcionando criterios m\u00e1s claros para distinguir productos<strong> no sujeto a prescripci\u00f3n m\u00e9dica<\/strong>. Tambi\u00e9n se establece <strong>requisitos reglamentarios<\/strong> que se aplican a estas categor\u00edas, con implicaciones para <strong>presentaciones reglamentarias, pr\u00e1cticas de etiquetado, <\/strong>y<strong> estrategias de acceso al mercado.<\/strong> Es posible que sea necesario actualizar los productos existentes. <strong>revisado o reclasificado<\/strong> para alinearse con los criterios actualizados.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1905079094 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1385258142\" 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-1847779958\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1847779958 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La orientaci\u00f3n se hace efectiva <strong>30 d\u00edas despu\u00e9s de la publicaci\u00f3n del Aviso en el Diario Oficial de la Rep\u00fablica Italiana<\/strong> que hace referencia al comunicado del sitio web de la AIFA. Las partes interesadas deben consultar el Diario Oficial para determinar el cumplimiento exacto de la fecha de inicio.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1385258142 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1408048529\" 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-404682772\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-404682772 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Al sustituir las directrices anteriores y aclarar los criterios de clasificaci\u00f3n, la actualizaci\u00f3n fortalece <strong>claridad regulatoria<\/strong> y apoya <strong>cumplimiento consistente<\/strong> en las carteras OTC y SOP. Unas definiciones m\u00e1s claras permiten <strong>una alineaci\u00f3n regulatoria m\u00e1s eficiente<\/strong> y ayudar a minimizar la carga innecesaria mientras se mantiene el cumplimiento <strong>etiquetado y acceso al mercado<\/strong> caminos.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1408048529 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1413311086\" 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-1281306190\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1281306190 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Esta actualizaci\u00f3n es relevante para <strong>Garant\u00eda de Calidad, Asuntos Regulatorios, Legal y Cumplimiento, Seguridad del Paciente, Comercial y Marketing, <\/strong>y<strong> equipos de I+D<\/strong> Gesti\u00f3n de productos OTC y SOP en Italia.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1413311086 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-642399081\" 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-1697247980\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1697247980 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Las partes interesadas deber\u00edan <strong>supervisar el Diario Oficial<\/strong> para la fecha de publicaci\u00f3n, <strong>revisar las carteras de productos actuales<\/strong> en relaci\u00f3n con los criterios revisados, y <strong>coordinar de manera interfuncional<\/strong> para identificar cualquier producto que requiera reclasificaci\u00f3n o actualizaciones de la documentaci\u00f3n y el etiquetado.<\/p>\n<p>A medida que los equipos eval\u00faan los impactos de la cartera y los plazos vinculados con el aviso del Diario Oficial, <a href=\"http:\/\/regask.com\/es\/\"><strong>RegASK<\/strong><\/a> Puede respaldar el seguimiento proactivo y la revisi\u00f3n estructurada. <a href=\"http:\/\/regask.com\/es\/\"><strong>RegASK<\/strong><\/a> es una plataforma l\u00edder de inteligencia regulatoria y orquestaci\u00f3n de flujo de trabajo con inteligencia artificial (IA) que permite a las organizaciones globales en sectores altamente regulados, incluidos productos de consumo y ciencias biol\u00f3gicas, navegar de manera proactiva en panoramas regulatorios complejos. <strong>Al combinar la IA avanzada de Agentic con expertos en el sector, <a href=\"http:\/\/regask.com\/es\/\">RegASK<\/a><\/strong> 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=\"http:\/\/regask.com\/es\/\"><strong>M\u00e1s informaci\u00f3n <\/strong><\/a>o<a href=\"https:\/\/regask.com\/es\/reservar-una-demostracion\/\"><strong> Reserve una demostraci\u00f3n ahora.\u00a0<\/strong><\/a><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-642399081 > .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-2091495116\">\n\n\t<div id=\"col-553493119\" 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-184964024\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-184964024 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>\u00bfCu\u00e1l es el alcance de la gu\u00eda actualizada de la AIFA sobre medicamentos de venta libre y SOP?<\/h4>\n\t<div id=\"gap-1554401259\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1554401259 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La gu\u00eda aclara las definiciones, los principios de clasificaci\u00f3n y los requisitos reglamentarios para los medicamentos de venta libre y sin receta comercializados en Italia.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-553493119 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1525131566\" 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\u00e1ndo entran en vigor las nuevas directrices de la AIFA?<\/h4>\n\t<div id=\"gap-10245165\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-10245165 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Tiene efecto <strong>30 d\u00edas<\/strong> despu\u00e9s de que el Aviso se publique en el Diario Oficial de la Rep\u00fablica Italiana haciendo referencia al comunicado del sitio web de la AIFA.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1525131566 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-661355400\" 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 equipos deber\u00edan evaluar el impacto de esta actualizaci\u00f3n?<\/h4>\n\t<div id=\"gap-816200116\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-816200116 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Los equipos de Garant\u00eda de Calidad, Asuntos Regulatorios, Legales y de Cumplimiento, Seguridad del Paciente, Comercial y Marketing e I+D deben evaluar las implicaciones.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-661355400 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1012414402\" 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 las organizaciones a responder a esta actualizaci\u00f3n?<\/h4>\n\t<div id=\"gap-2088969810\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2088969810 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"http:\/\/regask.com\/es\/\"><strong>RegASK<\/strong><\/a> puede ayudar a los equipos <strong>Monitorear las publicaciones del Diario Oficial, mapear los productos a criterios actualizados, <\/strong>y<strong> coordinar revisiones interfuncionales<\/strong> para garantizar una implementaci\u00f3n oportuna y conforme.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1012414402 > .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 February 23, 2026, the Italian Medicines Agency (AIFA) published revised guidance clarifying the definition and classification of over-the-counter (OTC) and non-prescription (SOP) medicines in Italy. The update replaces prior Ministry of Health guidelines and affects pharmaceutical manufacturers, distributors, and stakeholders involved in product registration and commercialization.<\/p>","protected":false},"author":43,"featured_media":9544,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,518,35],"tags":[],"class_list":["post-9541","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-italy-regulations","category-pharma-biotech-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.6 (Yoast SEO v27.7) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Italy\u2019s AIFA Updates Guidance on OTC Regulations<\/title>\n<meta name=\"description\" content=\"Italy&#039;s AIFA updates guidance on OTC and non-prescription medicine classification, impacting stakeholders and product registration.\" \/>\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\/la-aifa-de-italia-actualiza-la-guia-sobre-la-clasificacion-de-medicamentos-de-venta-libre-y-sin-receta\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Italy\u2019s AIFA Updates Guidance on OTC and Non-Prescription Medicine Classification\" \/>\n<meta property=\"og:description\" content=\"Italy&#039;s AIFA updates guidance on OTC and non-prescription medicine classification, impacting stakeholders and product registration.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/es\/la-aifa-de-italia-actualiza-la-guia-sobre-la-clasificacion-de-medicamentos-de-venta-libre-y-sin-receta\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta 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