{"id":105138,"date":"2024-08-23T16:29:49","date_gmt":"2024-08-23T19:29:49","guid":{"rendered":"https:\/\/www.fatosefotosnews.com.br\/mpox-anvisa-simplifica-regra-para-importacao-de-vacina-e-medicamento\/"},"modified":"2024-08-23T16:29:49","modified_gmt":"2024-08-23T19:29:49","slug":"mpox-anvisa-simplifica-regra-para-importacao-de-vacina-e-medicamento","status":"publish","type":"post","link":"https:\/\/www.fatosefotosnews.com.br\/?p=105138","title":{"rendered":"Mpox: Anvisa simplifica regra para importa\u00e7\u00e3o de vacina e medicamento"},"content":{"rendered":"<p><meta name=\"robots\" content=\"noindex\"><mreta name=\"googlebot\" content=\"noindex\"><\/p>\n<div class=\"Noticia_Foto fato\">\n<figure class=\"foto-legenda\" style=\"position: relative\">\n<div class=\"foto-legenda-img\"> <img fetchpriority=\"high\" decoding=\"async\" src=\"https:\/\/i0.statig.com.br\/bancodeimagens\/7z\/8h\/kf\/7z8hkffa7cawch6i906jkdoat.jpg\" width=\"652\" height=\"408\" alt=\"Mpox: Anvisa simplifica regra para importa\u00e7\u00e3o de vacina e medicamento\" title=\"Mpox: Anvisa simplifica regra para importa\u00e7\u00e3o de vacina e medicamento\"> <\/div><figcaption class=\"foto-legenda-citacao\"> <cite>Ag\u00eancia Brasil<\/cite> <\/p>\n<div class=\"foto-legenda-citacao-text\">Mpox: Anvisa simplifica regra para importa\u00e7\u00e3o de vacina e medicamento<\/div>\n<\/figcaption><\/figure>\n<\/p>\n<\/div>\n<p>A diretoria colegiada da <a href=\"https:\/\/www.gov.br\/anvisa\/pt-br\">Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa)<\/a> aprovou resolu\u00e7\u00e3o que dispensa registro e autoriza\u00e7\u00e3o excepcional de importa\u00e7\u00e3o de medicamentos e vacinas adquiridos pelo Minist\u00e9rio da Sa\u00fade para preven\u00e7\u00e3o ou tratamento da <a href=\"https:\/\/gpsbrasilia.com.br\/vacina-brasileira-contra-a-mpox-esta-proxima-dos-testes-em-humanos\/\">mpox<\/a> . <img decoding=\"async\" src=\"https:\/\/agenciabrasil.ebc.com.br\/ebc.png?id=1609062&#038;o=node\"> <\/p>\n<p>A norma, aprovada por unanimidade, tem car\u00e1ter provis\u00f3rio e excepcional e permite que a pasta solicite a dispensa de registro de medicamentos e vacinas que j\u00e1 tenham sido aprovados para preven\u00e7\u00e3o ou tratamento da doen\u00e7a pelas seguintes autoridades reguladoras internacionais:<\/p>\n<p>\u2013 Organiza\u00e7\u00e3o Mundial da Sa\u00fade (OMS);<\/p>\n<p>\u2013 Ag\u00eancia Europeia de Medicamentos (EMA);<\/p>\n<p>\u2013 Administra\u00e7\u00e3o de Alimentos e Medicamentos dos Estados Unidos (FDA);<\/p>\n<p>\u2013 Ag\u00eancia Reguladora de Medicamentos e Produtos de Sa\u00fade do Reino Unido (MHRA);<\/p>\n<p>\u2013 Ag\u00eancia de Produtos Farmac\u00eauticos e Equipamentos M\u00e9dicos\/Minist\u00e9rio da Sa\u00fade, Trabalho e Bem-estar do Jap\u00e3o (PMDA\/MHLW);<\/p>\n<p>\u2013 Ag\u00eancia Reguladora do Canad\u00e1 (Health Canada).<\/p>\n<p>Em nota, a Anvisa destacou que as condi\u00e7\u00f5es de uso e distribui\u00e7\u00e3o dos medicamento e vacinas a serem importados devem ser as mesmas aprovadas e publicizadas pelas autoridades reguladoras listadas.<\/p>\n<blockquote>\n<p>\u201cO medicamento ou vacina deve ter todos os locais de fabrica\u00e7\u00e3o, incluindo linhas e forma farmac\u00eautica, aprovados por autoridades reguladoras membros do Esquema de Coopera\u00e7\u00e3o em Inspe\u00e7\u00e3o Farmac\u00eautica.\u201d<\/p>\n<\/blockquote>\n<p>Ainda de acordo com o comunicado, o pedido de dispensa de registro ser\u00e1 avaliado prioritariamente pelas \u00e1reas t\u00e9cnicas da ag\u00eancia e a decis\u00e3o dever\u00e1 ocorrer em at\u00e9 sete dias \u00fateis.<\/p>\n<blockquote>\n<p>\u201cA norma prev\u00ea um rito simplificado e priorit\u00e1rio para a importa\u00e7\u00e3o dos medicamentos e vacinas, semelhante ao modelo j\u00e1 adotado para as importa\u00e7\u00f5es via Covax Facility\u201d, destacou a Anvisa, ao se referir \u00e0 uma alian\u00e7a internacional conduzida pela OMS para acelerar o desenvolvimento e a produ\u00e7\u00e3o de vacinas contra covid-19.<\/p>\n<\/blockquote>\n<p> <strong>P\u00fablico-alvo<\/strong> <\/p>\n<p>Segundo a ag\u00eancia, o minist\u00e9rio ficar\u00e1 respons\u00e1vel por estabelecer grupos classificados como vulner\u00e1veis e priorit\u00e1rios para o uso de medicamentos e vacinas para mpox. Caber\u00e1 \u00e0 pasta, ainda, o monitoramento dos insumos importados e dos pacientes, al\u00e9m da divulga\u00e7\u00e3o de orienta\u00e7\u00f5es para servi\u00e7os de sa\u00fade, notifica\u00e7\u00f5es de eventos adversos e queixas t\u00e9cnicas.<\/p>\n<blockquote>\n<p>\u201c[O minist\u00e9rio] tamb\u00e9m dever\u00e1 assegurar que os medicamentos ou vacinas atendam \u00e0s condi\u00e7\u00f5es aprovadas pela autoridade sanit\u00e1ria internacional e garantir que as vacinas somente sejam utilizadas ap\u00f3s sua libera\u00e7\u00e3o pelo Instituto Nacional de Controle de Qualidade em Sa\u00fade da Funda\u00e7\u00e3o Oswaldo Cruz (INCQS\/Fiocruz).\u201d<\/p>\n<\/blockquote>\n<p>Os medicamentos e vacinas adquiridos por meio desta resolu\u00e7\u00e3o poder\u00e3o ser utilizados at\u00e9 o final do seu prazo de validade.<\/p>\n<blockquote>\n<p>\u201cCom a aprova\u00e7\u00e3o da norma, a Anvisa tem como objetivo a simplifica\u00e7\u00e3o documental e a agilidade do processo de importa\u00e7\u00e3o, de modo a facilitar o acesso da popula\u00e7\u00e3o brasileira aos medicamentos ou vacinas j\u00e1 aprovados por outra autoridade regulat\u00f3ria internacional para o tratamento ou preven\u00e7\u00e3o da mpox. A medida \u00e9 fundamental para o enfrentamento da Emerg\u00eancia de Sa\u00fade P\u00fablica de Import\u00e2ncia Internacional, declarada novamente pela OMS no \u00faltimo dia 14 de agosto.\u201d<\/p>\n<\/blockquote>\n<p>The post <a href=\"https:\/\/gpsbrasilia.com.br\/mpox-anvisa-simplifica-regra-para-importacao-de-vacina-e-medicamento\/\">Mpox: Anvisa simplifica regra para importa\u00e7\u00e3o de vacina e medicamento<\/a> first appeared on <a href=\"https:\/\/gpsbrasilia.com.br\">GPS Bras\u00edlia &#8211; Portal de Not\u00edcias do DF<\/a> .<\/p>\n<p id=\"infocoweb_fonte\" class=\"infocoweb_fonte\">Fonte: <a target=\"_blank\" href=\"http:\/\/ultimosegundo.ig.com.br\/parceiros\/gps-brasilia\/2024-08-23\/mpox--anvisa-simplifica-regra-para-importacao-de-vacina-e-medicamento.html#ba0de472-aabd-484e-a8c7-6b076e659de4\" rel=\"noopener\">Nacional<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Ag\u00eancia Brasil Mpox: Anvisa simplifica regra para importa\u00e7\u00e3o de vacina e medicamento A diretoria colegiada da Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa) aprovou resolu\u00e7\u00e3o que dispensa registro e autoriza\u00e7\u00e3o excepcional de importa\u00e7\u00e3o de medicamentos e vacinas adquiridos pelo Minist\u00e9rio da Sa\u00fade para preven\u00e7\u00e3o ou tratamento da mpox . A norma, aprovada por unanimidade, tem car\u00e1ter [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":105139,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_angie_page":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_themeisle_gutenberg_block_has_review":false,"page_builder":"","footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[167],"tags":[309,6612,2174,5465,7885,472],"class_list":["post-105138","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-geral","tag-anvisa","tag-importa","tag-medicamento","tag-regra","tag-simplifica","tag-vacina"],"acf":[],"nelio_content":{"autoShareEndMode":"never","automationSources":{"useCustomSentences":false,"customSentences":[]},"efiAlt":"","efiUrl":"","followers":[5],"highlights":[],"isAutoShareEnabled":true,"networkImageIds":[],"permalinkQueryArgs":[],"series":[],"suggestedReferences":[]},"yoast_head":"<!-- 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