{"id":47122,"date":"2021-03-30T13:56:02","date_gmt":"2021-03-30T17:56:02","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-publishes-new-otc-monograph-drug-facility-user-fees\/"},"modified":"2021-04-23T13:23:09","modified_gmt":"2021-04-23T17:23:09","slug":"fda-publishes-new-otc-monograph-drug-facility-user-fees","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/fr\/fda-publishes-new-otc-monograph-drug-facility-user-fees\/","title":{"rendered":"La FDA met en place des frais annuels pour les \u00e9tablissements de produits pharmaceutiques OTC monograph"},"content":{"rendered":"<p>Le 26 mars 2021, la Food and Drug Administration (FDA) U.S. a publi\u00e9 la mise en place de nouvelles taxes pour l\u2019ann\u00e9e fiscale (FY) 2021 applicables aux \u00e9tablissements de produits pharmaceutiques en vente libre Over-the-Counter (OTC) monograph. A partir de cette ann\u00e9e, la FDA va demander aux \u00e9tablissements concern\u00e9s de payer une taxe annuelle suivant le programme OTC Monograph User Fee (OMUFA). Ce programme a \u00e9t\u00e9 adopt\u00e9 par la signature en mars 2020 de la loi CARES. La FDA indique que les frais d\u2019\u00e9tablissements pour l\u2019ann\u00e9e fiscale 2021 sont dus 45 jours apr\u00e8s la publication de cette <a href=\"https:\/\/www.federalregister.gov\/documents\/2021\/03\/26\/2021-06361\/fee-rates-under-the-over-the-counter-monograph-drug-user-fee-program-for-fiscal-year-2021\">Federal Register Notice<\/a> (le 10 mai 2021).<\/p>\n<p>Cette Notice remplace la pr\u00e9c\u00e9dente publi\u00e9e en d\u00e9cembre 2020 qui avait \u00e9t\u00e9 <a href=\"https:\/\/public-inspection.federalregister.gov\/2021-00030.pdf\">annul\u00e9e par la FDA<\/a><\/p>\n<p><strong>Quels \u00e9tablissements sont soumis au r\u00e8glement de la taxe<\/strong><strong> OMUFA ?<\/strong><\/p>\n<p>La FDA va \u00e0 pr\u00e9sent demander aux \u00e9tablissements qui fabriquent ou transforment une forme finie de produit pharmaceutique non soumis \u00e0 ordonnance, en vente libre, de payer une taxe annuelle d\u2019\u00e9tablissement pharmaceutique de produits OTC Monograph (MDF). La taxe MDF pour l\u2019ann\u00e9e fiscale 2021 est de $20,322. Les entreprises de sous-traitance OTC (CMO), qui sont des \u00e9tablissements pharmaceutiques OTC dans lesquels ni le propri\u00e9taire de l\u2019\u00e9tablissement ni ses filiales ne revendent les produits finis directement \u00e0 des d\u00e9taillants, grossistes ou consommateurs aux USA, doivent payer les deux-tiers de la taxe MDF. La taxe CMO pour l\u2019ann\u00e9e fiscale 2021 est de $13,548.<\/p>\n<p>La FDA pr\u00e9voit de collecter ces frais aupr\u00e8s des MDFs et CMOs qui \u00e9taient enregistr\u00e9s \u00e0 la FDA ou ont renouvel\u00e9 leurs enregistrements FDA entre le 1<sup>er<\/sup> janvier et le 31 d\u00e9cembre 2020. Les \u00e9tablissements qui se sont enregistr\u00e9s \u00e0 la FDA pour la premi\u00e8re fois le ou apr\u00e8s le 1<sup>er<\/sup> janvier 2021 n\u2019ont pas \u00e0 payer les frais FY 2021 mais seront soumis aux frais de l\u2019ann\u00e9e fiscale 2022 d\u00e8s qu\u2019ils auront \u00e9t\u00e9 publi\u00e9s.<\/p>\n<p>Les frais publi\u00e9s dans la notice de mars 2021 sont plus \u00e9lev\u00e9s que ceux publi\u00e9s dans la notice d\u2019origine de d\u00e9cembre 2020, qui d\u00e9clarait $14,060 pour les MDFs et $9,373 pour les CMOs. Les montants avaient \u00e9t\u00e9 d\u00e9termin\u00e9s sur la base des frais estim\u00e9s pour supporter les co\u00fbts de mise en \u0153uvre des activit\u00e9s sur les monographies OTC et sur l\u2019estimation du nombre d\u2019\u00e9tablissements redevables. Selon la nouvelle notice de mars, \u00ab\u00a0<strong>la FDA ne calculera pas de frais d\u2019\u00e9tablissement OMUFA sur les soci\u00e9t\u00e9s qui se sont enregistr\u00e9es pour la premi\u00e8re fois aupr\u00e8s de la FDA uniquement pour fabriquer des gels hydroalcooliques pendant la p\u00e9riode d\u2019urgence sanitaire COVID-19 public health emergency (PHE), le ou apr\u00e8s 27 janvier 2020<\/strong>\u00a0\u00bb.Dans un email aux industriels, la FDA a d\u00e9clar\u00e9 que \u00ab\u00a0parce que certains \u00e9tablissements fabriquant des gels hydroalcooliques ne seront pas pris en compte dans le calcul, les frais d\u2019\u00e9tablissement pour les entreprises redevables ont augment\u00e9 pour l\u2019ann\u00e9e fiscale 2021 car le nombre de fabricants soumis aux frais OMUFA a diminu\u00e9\u00a0.\u00a0\u00bb<\/p>\n<p>Les frais OMUFA ne s\u2019appliquent pas aux \u00e9tablissements qui fabriquent uniquement des ingr\u00e9dients pharmaceutiques actifs (API), des produits pour tests cliniques, conduisent des tests ou conditionnent sous emballage externe, des produits d\u00e9j\u00e0 conditionn\u00e9s pour une utilisation dans des kits. De m\u00eame, les frais d\u2019\u00e9tablissement ne s\u2019appliquent pas si l\u2019enregistrement d\u2019un \u00e9tablissement pharmaceutique indique que celui-ci a cess\u00e9 toutes ces activit\u00e9s relatives aux produits pharmaceutiques OTC monograph avant le 31 d\u00e9cembre 2019.<\/p>\n<p><strong>Assistance pour OMUFA et autres requis relatifs aux OTC<\/strong><\/p>\n<p>Vous ne savez pas quels frais s\u2019appliquent \u00e0 votre \u00e9tablissement ?\u00a0 Registrar Corp vous aide \u00e0 d\u00e9terminer les frais applicables \u00e0 votre entreprise et facilite le r\u00e8glement \u00e0 la FDA dans le cadre de nos services d\u2019agent U.S. et Registrant Contact. Contactez Registrar Corp par email \u00e0 <a href=\"mailto:info@registrarcorp.com\">info@registrarcorp.com<\/a> ou par t\u00e9l\u00e9phone au +1-7579323565. Vous pouvez \u00e9galement chatter avec un conseiller en r\u00e9glementation 24h\/24 sur \u00a0<a href=\"https:\/\/regstaging.wpengine.com\/livechat\">regstaging.wpengine.com\/livechat<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Le 26 mars 2021, la Food and Drug Administration (FDA) U.S. a publi\u00e9 la mise en place de nouvelles taxes pour l\u2019ann\u00e9e fiscale (FY) 2021 applicables aux \u00e9tablissements de produits pharmaceutiques en vente libre Over-the-Counter (OTC) monograph. A partir de cette ann\u00e9e, la FDA va demander aux \u00e9tablissements concern\u00e9s de payer une taxe annuelle suivant<\/p>\n","protected":false},"author":2,"featured_media":39877,"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":[32],"tags":[],"class_list":["post-47122","post","type-post","status-publish","format-standard","has-post-thumbnail","category-non-classifiee","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=\"Le 26 mars 2021, la Food and Drug Administration (FDA) U.S. a publi\u00e9 la mise en place de nouvelles taxes pour l\u2019ann\u00e9e fiscale (FY) 2021 applicables aux \u00e9tablissements de produits pharmaceutiques en vente libre Over-the-Counter (OTC) monograph. 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