{"id":43867,"date":"2020-07-13T15:13:58","date_gmt":"2020-07-13T15:13:58","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-introduces-annual-fee-for-otc-monograph-drug-facilities\/"},"modified":"2020-07-16T13:33:04","modified_gmt":"2020-07-16T13:33:04","slug":"fda-introduces-annual-fee-for-otc-monograph-drug-facilities","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/fr\/fda-introduces-annual-fee-for-otc-monograph-drug-facilities\/","title":{"rendered":"La FDA met en place des frais annuels pour les \u00e9tablissements de produits pharmaceutiques OTC monograph"},"content":{"rendered":"<p>En mars 2020, le pr\u00e9sident des U.S. a sign\u00e9 une r\u00e8glementation li\u00e9e au COVID-19 nomm\u00e9e CARES Act. Cette r\u00e8glementation comprenait une <a href=\"https:\/\/www.fda.gov\/industry\/fda-user-fee-programs\/over-counter-monograph-user-fee-program-omufa\">\u00a0initiative<\/a>\u00a0 qui r\u00e9forme et modernise la fa\u00e7on dont certains produits pharmaceutiques en vente libre, \u00ab\u00a0over-the-counter\u00a0ou OTC\u00bb sont r\u00e8glement\u00e9s aux Etats-Unis.<\/p>\n<p>L\u2019un des composants cl\u00e9s de cette r\u00e9forme des OTC est la r\u00e8glementation \u00ab\u00a0Over-the-Counter Monograph User Fee Act\u00a0\u00bb, ou &#8220;OMUFA&#8221;, qui introduit des frais annuels par \u00e9tablissement pour les \u00e9tablissements de produits OTC monograph, y compris les fabricants \u00e0 fa\u00e7on.\u00a0 Les nouveaux frais FDA appliqu\u00e9s aux \u00e9tablissements sont destin\u00e9s \u00e0 fournir \u00e0 la FDA de nouvelles ressources pour mettre en \u0153uvre des activit\u00e9s sur les monographies OTC, comme d\u2019acc\u00e9l\u00e9rer la revue des soumissions li\u00e9es \u00e0 ces monographies.<\/p>\n<p><strong>Qu\u2019est qu\u2019un \u00e9tablissement de produits OTC Monograph ?<\/strong><\/p>\n<p>L\u2019U.S. Food and Drug Administration (FDA) d\u00e9finit un \u00e9tablissement pharmaceutique de produits OTC Monograph comme un \u00e9tablissement qui fabrique ou transforme une forme finie de produit pharmaceutique non soumis \u00e0 ordonnance, en vente libre et qui peut \u00eatre mis sur la march\u00e9 sans une autorisation de mise sur le march\u00e9 (appel\u00e9s couramment OTC monograph drug). Ceci comprend \u00e9galement les \u00e9tablissements des fabricants de formulations finies de produits pharmaceutiques produisant contractuellement pour le compte de metteurs sur le march\u00e9 de produits OTC monograph.<\/p>\n<p>De plus, les entreprises de sous-traitance OTC (CMO) sont des \u00e9tablissements pharmaceutiques OTC dans lesquels ni le propri\u00e9taire de l\u2019\u00e9tablissement ni ses filiales ne revendent les produits OTC \u00e0 des d\u00e9taillants, grossistes ou consommateurs aux USA.<\/p>\n<p>Selon la FDA, les entreprises dont les activit\u00e9s de fabrication ou transformation sont limit\u00e9es aux actions suivantes ne sont pas consid\u00e9r\u00e9es comme des \u00e9tablissements pharmaceutiques OTC Monograph : production destin\u00e9e \u00e0 la recherche clinique, analyses, ou ajout d\u2019un packaging externe sur des assortiments contenant plusieurs produits, afin de cr\u00e9er des packs, si chaque produit pharmaceutique OTC monograph contenu dans l\u2019assortiment est d\u00e9j\u00e0 emball\u00e9 individuellement avant d\u2019\u00eatre plac\u00e9 dans le pack.<\/p>\n<p><strong>Quel est le montant des frais de la FDA ?<\/strong><\/p>\n<p>La FDA n\u2019a pas encore publi\u00e9 le montant des frais par \u00e9tablissement. Cependant, l\u2019Administration a pr\u00e9cis\u00e9 que les frais pour les sous-traitants (CMOs) seront les deux-tiers du montant total des frais par \u00e9tablissement. Les frais par \u00e9tablissement seront dus 45 jours apr\u00e8s que les montants des frais pour l\u2019ann\u00e9e fiscale 2021 auront \u00e9t\u00e9 publi\u00e9s au registre f\u00e9d\u00e9ral.<\/p>\n<p><strong>Comment se pr\u00e9parer ?<\/strong><\/p>\n<p>La FDA va \u00e9valuer les fees pour un \u00e9tablissement pharmaceutique sur la base des cat\u00e9gories \u00ab business operations qualifiers \u00bb qui ont \u00e9t\u00e9 s\u00e9lectionn\u00e9es dans l\u2019enregistrement de l\u2019\u00e9tablissement. Les \u00e9tablissements pharmaceutiques enregistr\u00e9s \u00e0 la FDA devraient v\u00e9rifier les cat\u00e9gories de business qualifiers s\u00e9lectionn\u00e9es dans leurs enregistrements et s\u2019assurer de leur exactitude avant le d\u00e9but de l\u2019ann\u00e9e fiscale 2021, qui commence le premier octobre 2020.<\/p>\n<p><strong>Assistance pour OMUFA et autres requis relatifs aux OTC<\/strong><\/p>\n<p>Registrar Corp s\u2019engage \u00e0 vous fournir une assistance r\u00e8glementaire de haute qualit\u00e9.\u00a0\u00a0 <a href=\"https:\/\/regstaging.wpengine.com\/contact\/?lead_source=blog\">Contactez-nous<\/a>\u00a0\u00a0 si vous avez besoin d\u2019aide pour d\u00e9terminer comment les nouveaux frais de la FDA vont impacter votre \u00e9tablissement.<\/p>\n<p>Registrar Corp peut enregistrer votre \u00e9tablissement de produits pharmaceutiques OTC ainsi que vos produits OTC, \u00eatre d\u00e9sign\u00e9 comme votre <a href=\"https:\/\/regstaging.wpengine.com\/fda-drugs\/adverse-event\/?lead_source=blog\">Adverse Event Contact<\/a>, et plus encore. Pour en savoir plus sur les services de Registrar Corp pour les produits OTC monograph, contactez-nous au +1-757-224-0177 ou par email \u00e0\u00a0 <a href=\"mailto:info@registrarcorp.com\">info@registrarcorp.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>En mars 2020, le pr\u00e9sident des U.S. a sign\u00e9 une r\u00e8glementation li\u00e9e au COVID-19 nomm\u00e9e CARES Act. Cette r\u00e8glementation comprenait une \u00a0initiative\u00a0 qui r\u00e9forme et modernise la fa\u00e7on dont certains produits pharmaceutiques en vente libre, \u00ab\u00a0over-the-counter\u00a0ou OTC\u00bb sont r\u00e8glement\u00e9s aux Etats-Unis. L\u2019un des composants cl\u00e9s de cette r\u00e9forme des OTC est la r\u00e8glementation \u00ab\u00a0Over-the-Counter Monograph<\/p>\n","protected":false},"author":2,"featured_media":43651,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"content-type":"","om_disable_all_campaigns":false,"inline_featured_image":false,"_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":"","footnotes":""},"categories":[93],"tags":[],"class_list":{"0":"post-43867","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-drugs-fr","8":"entry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.9 (Yoast SEO v25.5) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>La FDA met en place des frais annuels pour les \u00e9tablissements de produits pharmaceutiques OTC monograph - Registrar<\/title>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"La FDA met en place des frais annuels pour les \u00e9tablissements de produits pharmaceutiques OTC monograph\" \/>\n<meta property=\"og:description\" content=\"En mars 2020, le pr\u00e9sident des U.S. a sign\u00e9 une r\u00e8glementation li\u00e9e au COVID-19 nomm\u00e9e CARES Act. Cette r\u00e8glementation comprenait une \u00a0initiative\u00a0 qui r\u00e9forme et modernise la fa\u00e7on dont certains produits pharmaceutiques en vente libre, \u00ab\u00a0over-the-counter\u00a0ou OTC\u00bb sont r\u00e8glement\u00e9s aux Etats-Unis. 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