{"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":"italie-aifa-met-a-jour-ses-recommandations-sur-la-classification-des-medicaments-en-vente-libre-et-sans-ordonnance","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/italys-aifa-updates-guidance-on-otc-and-non-prescription-medicine-classification\/","title":{"rendered":"L&#039;AIFA italienne met \u00e0 jour ses recommandations sur les m\u00e9dicaments en vente libre et sans ordonnance\u2026"},"content":{"rendered":"<p>Sur <strong>23 f\u00e9vrier 2026, <\/strong>le<strong> Agence italienne des m\u00e9dicaments (AIFA)<\/strong> des lignes directrices r\u00e9vis\u00e9es ont \u00e9t\u00e9 publi\u00e9es afin de clarifier les <strong>d\u00e9finition et classification des m\u00e9dicaments en vente libre (OTC) et des m\u00e9dicaments sans ordonnance (SOP)<\/strong> En Italie. Cette mise \u00e0 jour remplace les directives pr\u00e9c\u00e9dentes du minist\u00e8re de la Sant\u00e9 et concerne les fabricants, les distributeurs et les acteurs du secteur pharmaceutique impliqu\u00e9s dans l&#039;enregistrement et la commercialisation des produits.<\/p>\n<div class=\"row\"  id=\"row-2139637817\">\n\n\t<div id=\"col-81473819\" 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-517139673\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-517139673 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>D\u00e9tails de la mise \u00e0 jour<\/h2>\n\t<div id=\"gap-139725059\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-139725059 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les nouvelles directives introduisent <strong>d\u00e9finitions r\u00e9vis\u00e9es et principes de classification<\/strong> pour les m\u00e9dicaments en vente libre et les m\u00e9dicaments sur ordonnance, en fournissant des crit\u00e8res plus clairs pour distinguer les produits<strong> non soumis \u00e0 prescription m\u00e9dicale<\/strong>. Il expose \u00e9galement <strong>exigences r\u00e9glementaires<\/strong> qui s&#039;appliquent \u00e0 ces cat\u00e9gories, avec des implications pour <strong>soumissions r\u00e9glementaires, pratiques d&#039;\u00e9tiquetage, <\/strong>et<strong> Strat\u00e9gies d&#039;acc\u00e8s au march\u00e9.<\/strong> Les produits existants pourraient devoir \u00eatre modifi\u00e9s. <strong>r\u00e9vis\u00e9 ou reclass\u00e9<\/strong> pour se conformer aux crit\u00e8res mis \u00e0 jour.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-81473819 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-347355390\" 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>Date d&#039;entr\u00e9e en vigueur<\/h2>\n\t<div id=\"gap-429438281\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-429438281 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les directives entrent en vigueur <strong>30 jours apr\u00e8s la publication de l&#039;avis au Journal officiel de la R\u00e9publique italienne<\/strong> qui fait r\u00e9f\u00e9rence au communiqu\u00e9 publi\u00e9 sur le site web de l&#039;AIFA. Les parties prenantes doivent consulter le Journal officiel pour v\u00e9rifier la conformit\u00e9 exacte de la date de d\u00e9but.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-347355390 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-802326221\" 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>Pourquoi c&#039;est important<\/h2>\n\t<div id=\"gap-1189616653\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1189616653 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>En rempla\u00e7ant les directives pr\u00e9c\u00e9dentes et en clarifiant les crit\u00e8res de classification, la mise \u00e0 jour renforce <strong>clart\u00e9 r\u00e9glementaire<\/strong> et soutient <strong>conformit\u00e9 constante<\/strong> pour les portefeuilles OTC et SOP. Des d\u00e9finitions plus claires permettent <strong>alignement r\u00e9glementaire plus efficace<\/strong> et contribuer \u00e0 minimiser les charges inutiles tout en assurant la conformit\u00e9 <strong>\u00e9tiquetage et acc\u00e8s au march\u00e9<\/strong> voies.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-802326221 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1525723788\" 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>\u00c0 qui cela s&#039;adresse-t-il ?<\/h2>\n\t<div id=\"gap-1888123832\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1888123832 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Cette mise \u00e0 jour est pertinente pour <strong>Assurance qualit\u00e9, affaires r\u00e9glementaires, juridique et conformit\u00e9, s\u00e9curit\u00e9 des patients, commercial et marketing, <\/strong>et<strong> \u00e9quipes de R&amp;D<\/strong> Gestion des produits OTC et SOP en Italie.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1525723788 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1676361222\" 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>Prochaines \u00e9tapes<\/h2>\n\t<div id=\"gap-1265980203\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1265980203 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les parties prenantes devraient <strong>Surveillez le Journal officiel<\/strong> pour la date de publication, <strong>examiner les portefeuilles de produits actuels<\/strong> par rapport aux crit\u00e8res r\u00e9vis\u00e9s, et <strong>coordonner de mani\u00e8re interfonctionnelle<\/strong> identifier les produits n\u00e9cessitant une reclassification ou une mise \u00e0 jour de leur documentation et de leur \u00e9tiquetage.<\/p>\n<p>Alors que les \u00e9quipes \u00e9valuent les impacts sur le portefeuille et les \u00e9ch\u00e9anciers li\u00e9s \u00e0 l&#039;avis du Journal officiel, <a href=\"http:\/\/regask.com\/fr\/\"><strong>RegASK<\/strong><\/a> peut prendre en charge le suivi proactif et l&#039;examen structur\u00e9. <a href=\"http:\/\/regask.com\/fr\/\"><strong>RegASK<\/strong><\/a> est une plateforme de pointe d&#039;intelligence r\u00e9glementaire et d&#039;orchestration des flux de travail bas\u00e9e sur l&#039;IA agentielle, qui permet aux organisations mondiales des secteurs hautement r\u00e9glement\u00e9s, notamment les produits de consommation et les sciences de la vie, de naviguer de mani\u00e8re proactive dans des environnements r\u00e9glementaires complexes. <strong>En combinant une IA agentique avanc\u00e9e avec des experts impliqu\u00e9s, <a href=\"http:\/\/regask.com\/fr\/\">RegASK<\/a><\/strong> Elle fournit en temps opportun des informations pr\u00e9dictives exploitables et une automatisation de bout en bout, rationalisant les processus de conformit\u00e9, att\u00e9nuant les risques et acc\u00e9l\u00e9rant l&#039;acc\u00e8s au march\u00e9 dans plus de 160 pays. <a href=\"http:\/\/regask.com\/fr\/\"><strong>En savoir plus <\/strong><\/a>ou<a href=\"https:\/\/regask.com\/fr\/reserver-une-demo\/\"><strong> r\u00e9servez une d\u00e9mo maintenant.\u00a0<\/strong><\/a><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1676361222 > .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-496413071\">\n\n\t<div id=\"col-189544506\" 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>FAQ<\/h3>\n\t<div id=\"gap-1368959684\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1368959684 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>Quel est le champ d&#039;application des directives actualis\u00e9es de l&#039;AIFA sur les m\u00e9dicaments en vente libre et les m\u00e9dicaments soumis \u00e0 prescription m\u00e9dicale ?<\/h4>\n\t<div id=\"gap-1504496077\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1504496077 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Ces lignes directrices clarifient les d\u00e9finitions, les principes de classification et les exigences r\u00e9glementaires applicables aux m\u00e9dicaments en vente libre et sans ordonnance commercialis\u00e9s en Italie.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-189544506 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-770407233\" 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>Quand les nouvelles directives de l&#039;AIFA entreront-elles en vigueur\u00a0?<\/h4>\n\t<div id=\"gap-1400788419\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1400788419 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Cela prend effet <strong>30 jours<\/strong> apr\u00e8s la publication de l&#039;avis au Journal officiel de la R\u00e9publique italienne faisant r\u00e9f\u00e9rence \u00e0 la publication sur le site web de l&#039;AIFA.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-770407233 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-173199109\" 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>Quelles \u00e9quipes devraient \u00e9valuer l&#039;impact de cette mise \u00e0 jour\u00a0?<\/h4>\n\t<div id=\"gap-1234590401\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1234590401 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les \u00e9quipes Assurance qualit\u00e9, Affaires r\u00e9glementaires, Juridique et conformit\u00e9, S\u00e9curit\u00e9 des patients, Commercial et marketing, et R&amp;D doivent \u00e9valuer les implications.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-173199109 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-466447638\" 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>Comment RegASK peut-il aider les organisations \u00e0 r\u00e9agir \u00e0 cette mise \u00e0 jour\u00a0?<\/h4>\n\t<div id=\"gap-96842288\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-96842288 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"http:\/\/regask.com\/fr\/\"><strong>RegASK<\/strong><\/a> peut aider les \u00e9quipes <strong>surveiller les publications du Journal officiel, cartographier les produits selon les crit\u00e8res mis \u00e0 jour, <\/strong>et<strong> coordonner les revues interfonctionnelles<\/strong> pour garantir une mise en \u0153uvre rapide et conforme.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-466447638 > .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":41,"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 v27.3 (Yoast SEO v27.5) - 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\/fr\/italie-aifa-met-a-jour-ses-recommandations-sur-la-classification-des-medicaments-en-vente-libre-et-sans-ordonnance\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\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\/fr\/italie-aifa-met-a-jour-ses-recommandations-sur-la-classification-des-medicaments-en-vente-libre-et-sans-ordonnance\/\" \/>\n<meta property=\"og:site_name\" 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