{"id":49730,"date":"2023-06-22T00:00:00","date_gmt":"2023-06-21T22:00:00","guid":{"rendered":"https:\/\/biorius.com\/cosmetic-news\/personne-responsable-aux-etats-unis\/"},"modified":"2024-05-08T11:48:07","modified_gmt":"2024-05-08T09:48:07","slug":"personne-responsable-aux-etats-unis","status":"publish","type":"post","link":"https:\/\/biorius.com\/fr\/cosmetic-news\/personne-responsable-aux-etats-unis\/","title":{"rendered":"Personne responsable aux \u00c9tats-Unis"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\">Lettre d&#8217;information internationale de BIORIUS 006 : <strong>Clarification concernant la d\u00e9finition d&#8217;une personne responsable aux \u00c9tats-Unis<\/strong><\/h2>\n\n<p>Personne responsable aux Etats-Unis : dans notre <a href=\"https:\/\/biorius.com\/regulatory\/mocra\/\">pr\u00e9c\u00e9dent article <\/a>concernant la modernisation du Cosmetic Regulation Act, nous vous informions qu&#8217;une personne responsable devait \u00eatre d\u00e9sign\u00e9e pour chaque produit cosm\u00e9tique mis \u00e0 disposition sur le march\u00e9.<\/p>\n\n<p>La personne responsable doit<\/p>\n\n<ul class=\"wp-block-list\">\n<li>Garantir la s\u00e9curit\u00e9 du produit<\/li>\n\n\n\n<li>Prendre en charge les cas de cosm\u00e9tovigilance, y compris :<ul><li>R\u00e9ception des effets ind\u00e9sirables et des effets ind\u00e9sirables graves<\/li><\/ul><ul><li>D\u00e9claration des effets ind\u00e9sirables graves \u00e0 la FDA<\/li><\/ul><ul><li>Permettre aux autorit\u00e9s comp\u00e9tentes d&#8217;acc\u00e9der aux rapports de cosm\u00e9tovigilance<\/li><\/ul><ul><li>Permettre aux autorit\u00e9s comp\u00e9tentes d&#8217;acc\u00e9der aux informations sur les fragrances et les ar\u00f4mes en cas d&#8217;effet ind\u00e9sirable grave.<\/li><\/ul>\n<ul class=\"wp-block-list\">\n<li>Inclure sur l&#8217;\u00e9tiquette une personne de contact, une adresse, etc. pour recevoir les plaintes des consommateurs.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Notifier les produits cosm\u00e9tiques et :<ul><li>Effectuer le renouvellement annuel de cette notification<\/li><\/ul>\n<ul class=\"wp-block-list\">\n<li>Effectuer une mise \u00e0 jour de la notification en cas de modifications<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Veiller \u00e0 ce que les allerg\u00e8nes apparaissent correctement sur l&#8217;\u00e9tiquette (liste \u00e0 publier par la FDA).<\/li>\n\n\n\n<li>En cas d&#8217;inspection, fournir aux autorit\u00e9s, dans un d\u00e9lai et d&#8217;une mani\u00e8re raisonnables, des preuves de la s\u00e9curit\u00e9 des produits.<\/li>\n\n\n\n<li>Rappel\/retrait de produits \u00e0 la demande des autorit\u00e9s<\/li>\n<\/ul>\n\n<p>D\u00e9but juin, la FDA a donn\u00e9 plus d&#8217;informations sur la localisation de la personne responsable :<\/p>\n\n<ul class=\"wp-block-list\">\n<li>La personne responsable est l&#8217;entit\u00e9 qui met les produits sur le march\u00e9. La personne responsable ne doit pas n\u00e9cessairement se trouver sur le territoire am\u00e9ricain.<\/li>\n\n\n\n<li>Le contact pour la notification des effets ind\u00e9sirables est indiqu\u00e9 sur l&#8217;\u00e9tiquette du produit. Ce contact doit avoir une adresse compl\u00e8te, un num\u00e9ro de t\u00e9l\u00e9phone ou une adresse \u00e9lectronique aux \u00c9tats-Unis.<\/li>\n<\/ul>\n\n<p>Si la personne responsable n&#8217;est pas situ\u00e9e sur le territoire am\u00e9ricain, un agent am\u00e9ricain doit \u00eatre d\u00e9sign\u00e9.<\/p>\n\n<p>L&#8217;agent am\u00e9ricain doit \u00eatre mentionn\u00e9 dans l&#8217;enregistrement de l&#8217;\u00e9tablissement. Il doit r\u00e9sider aux \u00c9tats-Unis et \u00eatre disponible 24 heures sur 24 pour r\u00e9pondre aux questions, aux probl\u00e8mes sanitaires et aux contr\u00f4les ou inspections. L&#8217;agent n&#8217;est pas responsable des produits ni des questions sanitaires. Toutefois, il facilite les communications avec les autorit\u00e9s comp\u00e9tentes.<\/p>\n\n<p>Nous esp\u00e9rons que cela vous sera utile et restons \u00e0 votre disposition pour toute question relative \u00e0 ce sujet. Si vous avez des questions, n&#8217;h\u00e9sitez pas \u00e0 contacter votre CRM<strong>(Customer<\/strong> <strong>Relationship<\/strong> <strong>Manager<\/strong>) ou \u00e0 nous contacter directement : <a href=\"mailto:%20info@biorius.com\">info@biorius.com.<\/a> Nous vous tiendrons au courant des d\u00e9veloppements futurs sur ce sujet.<\/p>\n\n<p><\/p>\n\n<p>Merci \u00e0 <a href=\"https:\/\/www.linkedin.com\/in\/pierre-verachten-a6087aa4\/\">Pierre Verachten<\/a> pour la r\u00e9daction de cet article.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Lettre d&#8217;information internationale de BIORIUS 006 : Clarification concernant la d\u00e9finition d&#8217;une personne responsable aux \u00c9tats-Unis Personne responsable aux Etats-Unis : dans notre pr\u00e9c\u00e9dent article&#8230;<\/p>\n","protected":false},"author":2,"featured_media":43695,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_coblocks_attr":"","_coblocks_dimensions":"","_coblocks_responsive_height":"","_coblocks_accordion_ie_support":"","footnotes":""},"categories":[2290,2396,2397],"tags":[2342,2347,2399,2398,2368],"ppma_author":[2340],"class_list":["post-49730","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-reglementations-cosmetique","category-mocra-fr","category-reglementation-cosmetique-des-etats-unis","tag-cosmetique","tag-cosmetiques","tag-etats-unis","tag-mocra-fr","tag-reglements","author-nicolas-lenaersbiorius-com"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - 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