{"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-1167598105\">\n\n\t<div id=\"col-1580877960\" 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-1958302862\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1958302862 {\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-1225317457\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1225317457 {\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-1580877960 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-62202470\" 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-1122112506\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1122112506 {\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-62202470 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1616666703\" 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-1044316863\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1044316863 {\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-1616666703 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1999962942\" 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-312770031\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-312770031 {\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-1999962942 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-992072456\" 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-418368254\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-418368254 {\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-992072456 > .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-1090091220\">\n\n\t<div id=\"col-1322642306\" 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-1440522395\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1440522395 {\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-1566296321\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1566296321 {\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-1322642306 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-387892188\" 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-2114016137\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2114016137 {\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-387892188 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-760879427\" 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-1641982948\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1641982948 {\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-760879427 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1703463256\" 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-1010828461\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1010828461 {\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-1703463256 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Le 23 f\u00e9vrier 2026, l&#039;Agence italienne du m\u00e9dicament (AIFA) a publi\u00e9 une version r\u00e9vis\u00e9e de ses lignes directrices pr\u00e9cisant la d\u00e9finition et la classification des m\u00e9dicaments en vente libre et des m\u00e9dicaments sans ordonnance en Italie. Cette mise \u00e0 jour remplace les pr\u00e9c\u00e9dentes directives 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>","protected":false},"author":43,"featured_media":9544,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[518,33,35],"tags":[],"class_list":["post-9541","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-italy-regulations","category-news","category-pharma-biotech-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.7 (Yoast SEO v27.8) - 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\" 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