{"id":54791,"date":"2022-03-18T10:32:13","date_gmt":"2022-03-18T14:32:13","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-announces-otc-monograph-drug-facility-user-fees-for-2022\/"},"modified":"2022-03-25T15:22:42","modified_gmt":"2022-03-25T19:22:42","slug":"fda-announces-otc-monograph-drug-facility-user-fees-for-2022","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/pt\/fda-announces-otc-monograph-drug-facility-user-fees-for-2022\/","title":{"rendered":"A FDA Anuncia As Novas Taxas De Usu\u00e1rios Da Instala\u00e7\u00f5es da Monografia OTC para 2022"},"content":{"rendered":"

Em 14 de mar\u00e7o de 2022, a Administra\u00e7\u00e3o de Alimentos e Medicamentos dos Estados Unidos (FDA) anunciou as novas tarifas para o programa de taxa de Medicamentos (OTC) para o Ano Fiscal (FY) 2022. As taxas para os estabelecimentos para o ano fiscal 2022 expiram em 1 junho de 2022.<\/p>\n

Em 2021, a FDA come\u00e7ou a coletar informa\u00e7\u00f5es das tarifas anuais de estabelecimentos de medicamentos OTC sob o programa OMUFA, estabelecido pela aprova\u00e7\u00e3o da assist\u00eancia, ajuda e seguran\u00e7a econ\u00f4mica do coronav\u00edrus de mar\u00e7o. A FDA estabelece que as taxas de OMUFA estabelecimento s\u00e3o usadas para ajudar a financiar atividades regulat\u00f3rias que permitam \u00e0 FDA aderir \u00e0s linhas de tempo de revis\u00e3o de envio, com o objetivo de melhorar o acesso p\u00fablico aos medicamentos OTC.<\/p>\n

\n

Voc\u00ea n\u00e3o tem certeza sobre qual \u00e9 a taxa que se aplica \u00e0 sua propriedade de medicamentos? A Registar Corp pode ajudar.<\/h3>\n

Os especialistas regulamentares do Registro Corp podem ajudar a determinar as taxas de OMUFA aplic\u00e1veis para o estabelecimento de drogas OTC e facilitar o pagamento ao FDA como parte de nossos servi\u00e7os de agente e registro dos Estados Unidos.<\/p>\n

Para mais informa\u00e7\u00f5es, ligue para o +1-757-224-0177, ou envie-nos um e-mail no info@registricorcorp.com<\/a> , ou chate com um consultor regulador as 24 horas o dia no link regstaging.wpengine.com\/livechat<\/a>.<\/p>\n

Obtenha Assist\u00eancia<\/a><\/p>\n<\/div>\n

Como as taxas OMUFA foram alteradas em 2022 desde 2021? Leia para obter mais detalhes sobre taxas crescentes.<\/p>\n

2022 Taxas Para as Instala\u00e7\u00f5es de OMUFA<\/strong><\/p>\n

A FDA requer que os estabelecimentos que fabricam ou processem uma forma de dosagem final de um medicamento de monografia OTC devem pagar uma taxa anual (MDF). A taxa de MDF para o ano fiscal 2022 \u00e9 de US $ 24.178,00.<\/p>\n

Contratos as Organiza\u00e7\u00f5es de Fabrica\u00e7\u00e3o (CMOS) s\u00e3o instala\u00e7\u00f5es de medicamentos sob monografia OTC, onde nem o propriet\u00e1rio nem os afiliados vendem o medicamento produzido nessas instala\u00e7\u00f5es diretamente para atacadistas, varejistas ou consumidores. O CMOS deve pagar dois ter\u00e7os da taxa de MDF regular. A taxa CMO para o ano fiscal 2022 \u00e9 de US $ 16.119.00.<\/p>\n

Tanto o MDF quanto as taxas CMO para 2022 aumentaram 19% a partir de 2021. O FDA atribui muito o aumento das tarifas para uma diminui\u00e7\u00e3o no n\u00famero de instala\u00e7\u00f5es respons\u00e1veis pela taxa, uma diminui\u00e7\u00e3o na rela\u00e7\u00e3o MDF para a CMO, e os ajustes para a infla\u00e7\u00e3o. A FDA tamb\u00e9m aumenta as taxas para cobrir as reservas operacionais necess\u00e1rias para sustentar o programa atrav\u00e9s da FY 2023.<\/p>\n

A FDA afirmou que os fabricantes de sanitizantes de m\u00e3o que distribu\u00edram produtos desinfetados \u00e0 m\u00e3o sob a emerg\u00eancia de sa\u00fade p\u00fablica da Covid-19 (PHE) continuar\u00e3o a ser isentos das taxas das instala\u00e7\u00f5es de OMUFA: A FDA n\u00e3o avaliar\u00e1 as taxas das instala\u00e7\u00f5es OMUFA a empresas que foram registradas pela primeira vez no FDA em ou ap\u00f3s 27 de janeiro de 2020. A Declara\u00e7\u00e3o de Sa\u00fade P\u00fablica pelo Covid-19 (PHE) exclusivamente para a fabrica\u00e7\u00e3o de produtos desinfetantes das m\u00e3os OTC durante o PHE”.<\/p>\n

As taxas de OMUFA tamb\u00e9m n\u00e3o se aplicam a estabelecimentos que apenas fabricam ingredientes farmac\u00eauticos ativos (API) produzem suprimentos de pesquisa cl\u00ednica, conduzem testes ou colocam cont\u00eaineres externos em produtos j\u00e1 embalados para uso em um kit. Al\u00e9m disso, como apenas medicamentos humanos est\u00e3o sujeitos a taxas de OMUFA, estabelecimentos que apenas fabricam medicamentos animais est\u00e3o isentos.<\/p>\n

\n

Voc\u00ea n\u00e3o tem certeza sobre qual \u00e9 a taxa que se aplica \u00e0 sua propriedade de medicamentos? A Registar Corp pode ajudar.<\/h3>\n

Os especialistas regulamentares do Registro Corp podem ajudar a determinar as taxas de OMUFA aplic\u00e1veis para o estabelecimento de drogas OTC e facilitar o pagamento ao FDA como parte de nossos servi\u00e7os de agente e registro dos Estados Unidos.<\/p>\n

Para mais informa\u00e7\u00f5es, ligue para o +1-757-224-0177, ou envie-nos um e-mail no info@registricorcorp.com<\/a> , ou chate com um consultor regulador as 24 horas o dia no link regstaging.wpengine.com\/livechat<\/a>.<\/p>\n

Obtenha Assist\u00eancia<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Em 14 de mar\u00e7o de 2022, a Administra\u00e7\u00e3o de Alimentos e Medicamentos dos Estados Unidos (FDA) anunciou as novas tarifas para o programa de taxa de Medicamentos (OTC) para o Ano Fiscal (FY) 2022. As taxas para os estabelecimentos para o ano fiscal 2022 expiram em 1 junho de 2022. Em 2021, a FDA come\u00e7ou<\/p>\n","protected":false},"author":30,"featured_media":54772,"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":[96],"tags":[],"class_list":{"0":"post-54791","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-drugs-pt","8":"entry"},"yoast_head":"\nA FDA Anuncia As Novas Taxas De Usu\u00e1rios Da Instala\u00e7\u00f5es da Monografia OTC para 2022 - 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=\"pt_PT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"A FDA Anuncia As Novas Taxas De Usu\u00e1rios Da Instala\u00e7\u00f5es da Monografia OTC para 2022\" \/>\n<meta property=\"og:description\" content=\"Em 14 de mar\u00e7o de 2022, a Administra\u00e7\u00e3o de Alimentos e Medicamentos dos Estados Unidos (FDA) anunciou as novas tarifas para o programa de taxa de Medicamentos (OTC) para o Ano Fiscal (FY) 2022. 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