{"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":"lagence-britannique-mhra-met-a-jour-ses-recommandations-concernant-la-determination-du-statut-limite-et-du-caractere-medicinal-des-produits-cosmetiques-des-complements-alimentaires-et-des-dispo","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/uk-mhra-updates-guidance-on-determining-borderline-products-and-medicinal-status-for-cosmetics-food-supplement-and-medical-devices\/","title":{"rendered":"L\u2019agence britannique de r\u00e9glementation des m\u00e9dicaments et des produits de sant\u00e9 (MHRA) met \u00e0 jour ses recommandations sur la d\u00e9termination des produits limites\u2026"},"content":{"rendered":"<p>Sur <strong>17 octobre 2025,<\/strong> le <strong><a href=\"https:\/\/www.gov.uk\/government\/organisations\/medicines-and-healthcare-products-regulatory-agency\">Agence de r\u00e9glementation des m\u00e9dicaments et des produits de sant\u00e9 (MHRA)<\/a><\/strong> publication de lignes directrices mises \u00e0 jour sur <strong>produits limites,<\/strong> clarifiant comment elle d\u00e9termine si un produit doit \u00eatre r\u00e9glement\u00e9 en tant que <strong>m\u00e9dicament<\/strong> ou rel\u00e8ve d&#039;autres cadres tels que <strong>Dispositifs m\u00e9dicaux, cosm\u00e9tiques, compl\u00e9ments alimentaires, produits \u00e0 base de plantes ou biocides.<\/strong> Cette mise \u00e0 jour est particuli\u00e8rement pertinente pour les fabricants et les vendeurs dont les produits se situent \u00e0 l&#039;intersection de plusieurs r\u00e9gimes r\u00e9glementaires ou font l&#039;objet de plaintes concernant leur commercialisation en tant que m\u00e9dicaments.<\/p>\n<div class=\"row\"  id=\"row-1419252261\">\n\n\t<div id=\"col-1642199695\" 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-915008770\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-915008770 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>Contenu de la mise \u00e0 jour des directives<\/h2>\n\t<div id=\"gap-890828575\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-890828575 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les lignes directrices r\u00e9vis\u00e9es de la MHRA expliquent que la classification des produits est d\u00e9termin\u00e9e sur la base d&#039;un <strong>au cas par cas<\/strong>, l&#039;\u00e9valuation \u00e9tant ax\u00e9e sur plusieurs crit\u00e8res cl\u00e9s, notamment\u00a0:<\/p>\n<ul>\n<li><strong>R\u00e9clamations faites<\/strong> concernant l&#039;objectif ou les avantages du produit<\/li>\n<li><strong>Propri\u00e9t\u00e9s des principes actifs\u00a0<\/strong><\/li>\n<li><strong>Usage pr\u00e9vu\u00a0<\/strong><\/li>\n<li><strong>Pr\u00e9sentation g\u00e9n\u00e9rale aux consommateurs\u00a0<\/strong><\/li>\n<\/ul>\n<p>Un facteur d\u00e9terminant demeure la question de savoir si un produit atteint son effet principal par le biais d&#039;un <strong>mode d&#039;action pharmacologique, immunologique ou m\u00e9tabolique,<\/strong> ce qui indiquerait <strong>\u00e9tat m\u00e9dical<\/strong> conform\u00e9ment \u00e0 la r\u00e9glementation britannique.<\/p>\n<p>Les lignes directrices pr\u00e9cisent en outre que les produits g\u00e9n\u00e9ralement consid\u00e9r\u00e9s <strong>limite<\/strong> inclure:<\/p>\n<ul>\n<li><strong>Produits de beaut\u00e9\u00a0<\/strong><\/li>\n<li><strong>Compl\u00e9ments alimentaires\u00a0<\/strong><\/li>\n<li><strong>Produits \u00e0 base de plantes\u00a0<\/strong><\/li>\n<li><strong>Biocides\u00a0<\/strong><\/li>\n<li><strong>Dispositifs m\u00e9dicaux\u00a0<\/strong><\/li>\n<\/ul>\n<p>O\u00f9 <strong>Les compl\u00e9ments alimentaires ou autres produits non m\u00e9dicinaux font des all\u00e9gations m\u00e9dicinales.,<\/strong> ils peuvent l&#039;\u00eatre <strong>reclass\u00e9s comme m\u00e9dicaments<\/strong> et devenir soumis \u00e0 la l\u00e9gislation sur les m\u00e9dicaments.<\/p>\n<p>La MHRA r\u00e9affirme que les plaintes sont trait\u00e9es par ordre de priorit\u00e9 en fonction de <strong>risques potentiels pour la sant\u00e9 des consommateurs<\/strong>. Bien que l&#039;agence insiste sur le respect volontaire des r\u00e8gles, elle souligne que <strong>Les enqu\u00eates peuvent toujours donner lieu \u00e0 des mesures coercitives si n\u00e9cessaire.\u00a0<\/strong><\/p>\n<p>Pour aider les entreprises \u00e0 obtenir des \u00e9claircissements r\u00e9glementaires, la MHRA continue de fournir des avis officiels par le biais de <strong><a href=\"https:\/\/forms.mhra.gov.uk\/requestborderlineadvice\">Formulaire de conseil en cas limite de m\u00e9dicaments<\/a><\/strong>, qui permet les soumissions couvrant <strong>Jusqu&#039;\u00e0 quatre produits par demande.<\/strong> Les directives indiquent \u00e9galement que <strong>entreprises non britanniques exportant directement vers les consommateurs britanniques<\/strong> peuvent ne pas relever de la comp\u00e9tence de la MHRA, mais ces produits <strong>L&#039;enqu\u00eate pourrait encore se poursuivre.\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1642199695 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-160023659\" 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 limite de retour d&#039;information<\/h2>\n\t<div id=\"gap-227438799\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-227438799 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><strong>Aucune date limite formelle pour les commentaires n&#039;a \u00e9t\u00e9 sp\u00e9cifi\u00e9e.<\/strong> pour cette mise \u00e0 jour des directives.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-160023659 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1731806833\" 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>Qui cela compte<\/h2>\n\t<div id=\"gap-788019377\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-788019377 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Cette mise \u00e0 jour fournit <strong>clart\u00e9 r\u00e9glementaire<\/strong> sur la mani\u00e8re dont les produits \u00e0 la limite de la l\u00e9galit\u00e9 sont \u00e9valu\u00e9s au Royaume-Uni, aidant ainsi les entreprises \u00e0 aligner le d\u00e9veloppement de leurs produits, leurs all\u00e9gations et leur \u00e9tiquetage sur le cadre juridique appropri\u00e9. Des crit\u00e8res plus clairs soutiennent <strong>flux de travail de conformit\u00e9 pr\u00eats pour le num\u00e9rique<\/strong>, r\u00e9duire le risque d&#039;erreur de classification et aider les organisations \u00e0 traiter rapidement les probl\u00e8mes potentiels sans imposer de charge r\u00e9glementaire inutile.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1731806833 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1614665535\" 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-2078124381\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2078124381 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Ces recommandations concernent R<strong>\u00e9quipes des affaires r\u00e9glementaires, de l&#039;assurance qualit\u00e9, de la conformit\u00e9, du d\u00e9veloppement de produits, des affaires juridiques et du num\u00e9rique ou de l&#039;IA<\/strong> Ils participent \u00e0 la classification des produits, \u00e0 l&#039;examen des all\u00e9gations, \u00e0 l&#039;acc\u00e8s au march\u00e9 et \u00e0 la surveillance post-commercialisation des cosm\u00e9tiques, des compl\u00e9ments alimentaires, des dispositifs m\u00e9dicaux et des produits connexes.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1614665535 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1219169896\" 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-436767771\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-436767771 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les organisations devraient<strong> examiner les all\u00e9gations relatives aux produits existants et pr\u00e9vus, \u00e9valuer les propri\u00e9t\u00e9s des ingr\u00e9dients actifs,<\/strong> et \u00e9valuer l\u2019utilisation et la pr\u00e9sentation pr\u00e9vues au regard des crit\u00e8res actualis\u00e9s de la MHRA. Lorsque la classification demeure incertaine, les parties prenantes devraient envisager de soumettre une demande via le <strong>Formulaire de conseil en cas limite de m\u00e9dicaments<\/strong> obtenir un avis r\u00e9glementaire formel avant la mise sur le march\u00e9 ou toute modification des all\u00e9gations.<\/p>\n<p>\u00c0 mesure que les attentes r\u00e9glementaires en mati\u00e8re de classification des produits continuent d&#039;\u00e9voluer, <a href=\"https:\/\/regask.com\/fr\/\"><strong>RegASK<\/strong><\/a> aide les organisations \u00e0 garder une longueur d&#039;avance en surveillant les mises \u00e0 jour des directives, en \u00e9valuant l&#039;impact r\u00e9glementaire sur l&#039;ensemble des portefeuilles de produits et en soutenant la prise de d\u00e9cisions \u00e9clair\u00e9es sur les classifications limites.<\/p>\n<p><a href=\"https:\/\/regask.com\/fr\/\">RegASK<\/a> est un leader <strong>plateforme de renseignement r\u00e9glementaire et d&#039;orchestration des flux de travail d&#039;IA agentique<\/strong> qui permet aux organisations internationales op\u00e9rant dans des secteurs fortement r\u00e9glement\u00e9s, tels que les produits de consommation et les sciences de la vie, d&#039;anticiper et de g\u00e9rer des environnements r\u00e9glementaires complexes. En combinant une IA agentique avanc\u00e9e et l&#039;expertise de sp\u00e9cialistes, <a href=\"https:\/\/regask.com\/fr\/\">RegASK<\/a> Elle fournit des informations pr\u00e9dictives exploitables en temps opportun 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 157 pays.<\/p>\n<p><strong><a href=\"https:\/\/regask.com\/fr\/produit\/\">En savoir plus<\/a> ou <a href=\"https:\/\/regask.com\/fr\/reserver-une-demo\/\">r\u00e9servez une d\u00e9mo maintenant.\u00a0<\/a><\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1219169896 > .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-36499774\">\n\n\t<div id=\"col-77533460\" 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-657528106\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-657528106 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>Quels sont les produits limites selon les directives de la MHRA britannique\u00a0?<\/h4>\n\t<div id=\"gap-77591864\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-77591864 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les produits limites sont ceux qui peuvent relever de la r\u00e9glementation des m\u00e9dicaments ou d&#039;autres cadres r\u00e9glementaires tels que les cosm\u00e9tiques, les compl\u00e9ments alimentaires, les dispositifs m\u00e9dicaux, les produits \u00e0 base de plantes ou les biocides, en fonction de leurs all\u00e9gations, de leur composition et de leur usage pr\u00e9vu.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-77533460 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-750259757\" 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 la MHRA d\u00e9termine-t-elle si un produit est un m\u00e9dicament ?<\/h4>\n\t<div id=\"gap-975113027\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-975113027 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La MHRA \u00e9value des facteurs tels que les all\u00e9gations formul\u00e9es, les propri\u00e9t\u00e9s des ingr\u00e9dients actifs, l&#039;utilisation pr\u00e9vue, la pr\u00e9sentation aux consommateurs et le mode d&#039;action du produit (pharmacologique, immunologique ou m\u00e9tabolique).<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-750259757 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-465997419\" 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>Les compl\u00e9ments alimentaires peuvent-ils \u00eatre r\u00e9glement\u00e9s comme des m\u00e9dicaments au Royaume-Uni\u00a0?<\/h4>\n\t<div id=\"gap-248045846\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-248045846 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Oui. Les compl\u00e9ments alimentaires qui revendiquent des propri\u00e9t\u00e9s m\u00e9dicinales ou qui r\u00e9pondent aux crit\u00e8res d&#039;un mode d&#039;action m\u00e9dicinal peuvent \u00eatre reclass\u00e9s et r\u00e9glement\u00e9s comme des m\u00e9dicaments.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-465997419 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-577958174\" 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 \u00e9quipes \u00e0 g\u00e9rer les classifications de produits limites\u00a0?<\/h4>\n\t<div id=\"gap-2103670773\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2103670773 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"https:\/\/regask.com\/fr\/\">RegASK<\/a> aide les \u00e9quipes \u00e0 suivre les mises \u00e0 jour des directives de la MHRA, \u00e0 \u00e9valuer les risques de classification des produits et \u00e0 rationaliser les flux de travail en mati\u00e8re de veille r\u00e9glementaire et de conformit\u00e9 gr\u00e2ce \u00e0 une IA active combin\u00e9e \u00e0 une supervision d&#039;experts.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-577958174 > .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":41,"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 v27.3 (Yoast SEO v27.3) - 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\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/fr\/lagence-britannique-mhra-met-a-jour-ses-recommandations-concernant-la-determination-du-statut-limite-et-du-caractere-medicinal-des-produits-cosmetiques-des-complements-alimentaires-et-des-dispo\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"UK MHRA Updates Guidance on Determining Borderline Products and Medicinal Status for Cosmetics, Food Supplement and Medical Devices\" \/>\n<meta property=\"og:description\" content=\"Learn about the UK MHRA updates on guidance for borderline products and their medicinal classification in cosmetics and supplements.\" \/>\n<meta property=\"og:url\" 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