{"id":14683,"date":"2021-08-24T12:34:33","date_gmt":"2021-08-24T15:34:33","guid":{"rendered":"https:\/\/portaldasaudenews.com\/?p=14683"},"modified":"2021-08-24T12:34:33","modified_gmt":"2021-08-24T15:34:33","slug":"anvisa-estabelece-procedimentos-para-importacao-de-vacinas-contra-covid","status":"publish","type":"post","link":"https:\/\/portaldasaudenews.com\/?p=14683","title":{"rendered":"Anvisa estabelece procedimentos para importa\u00e7\u00e3o de vacinas contra Covid"},"content":{"rendered":"<p>&nbsp;<\/p>\n<p>A Anvisa (Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria) estabeleceu, de forma extraordin\u00e1ria e tempor\u00e1ria, os procedimentos para importa\u00e7\u00e3o das vacinas contra covid-19 regularizadas na Ag\u00eancia.<\/p>\n<p>A resolu\u00e7\u00e3o se aplica \u00e0s vacinas que possuem registro sanit\u00e1rio ou autoriza\u00e7\u00e3o de uso emergencial concedidos pela ag\u00eancia, assim como aos insumos utilizados para sua fabrica\u00e7\u00e3o, incluindo IFAs (insumos farmac\u00eauticos ativos) e produtos semielaborados.<\/p>\n<p>O importador deve submeter um peticionamento eletr\u00f4nico de importa\u00e7\u00e3o com um arquivo de documenta\u00e7\u00f5es. Entre os documentos exigidos est\u00e3o fatura comercial; declara\u00e7\u00e3o informando tratar-se de importa\u00e7\u00e3o de vacina covid-19 regularizada na Anvisa para uso por programa de sa\u00fade p\u00fablica ou de seu insumo; laudo anal\u00edtico de controle de qualidade do produto importado (insumo ou produto acabado), documento emitido pela Anvisa que autoriza o uso emergencial da vacina, entre outros.<\/p>\n<p>Al\u00e9m disso, a resolu\u00e7\u00e3o tamb\u00e9m estabelece que caber\u00e1 ao importador:<\/p>\n<ul>\n<li>peticionar junto \u00e0 Anvisa o processo de importa\u00e7\u00e3o, em tempo h\u00e1bil, com anteced\u00eancia \u00e0 chegada da carga ao Brasil;<\/li>\n<li>assegurar e monitorar as condi\u00e7\u00f5es da cadeia de transporte, garantindo que os produtos importados estejam com o prazo de validade vigente e estabelecendo mecanismos para garantir a manuten\u00e7\u00e3o da qualidade das vacinas importadas e o seu adequado armazenamento;<\/li>\n<li>assegurar o monitoramento da temperatura de conserva\u00e7\u00e3o e transporte das vacinas, durante o tr\u00e2nsito internacional, desde o momento do embarque at\u00e9 a chegada ao local de armazenamento do importador;<\/li>\n<li>avaliar os registros de temperatura referentes ao transporte da vacina;<\/li>\n<li>responsabilizar-se pela avalia\u00e7\u00e3o das excurs\u00f5es de temperatura que venham a ocorrer durante o transporte dos produtos importados quanto \u00e0 manuten\u00e7\u00e3o da sua qualidade;<\/li>\n<li>apresentar a documenta\u00e7\u00e3o requerida ao Instituto Nacional de Controle de Qualidade em Sa\u00fade (INCQS);<\/li>\n<li>importar a vacina covid-19 ou seus insumos, conforme as condi\u00e7\u00f5es aprovadas no registro sanit\u00e1rio ou na autoriza\u00e7\u00e3o de uso emergencial;<\/li>\n<\/ul>\n<p>*Com informa\u00e7\u00f5es do Poder 360<\/p>\n<p>Foto: Reprodu\u00e7\u00e3o<\/p>\n","protected":false},"excerpt":{"rendered":"<p>&nbsp; A Anvisa (Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria) estabeleceu, de forma extraordin\u00e1ria e tempor\u00e1ria, os<\/p>\n","protected":false},"author":1,"featured_media":11236,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[52,35],"tags":[],"class_list":["post-14683","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-coronavirus","category-covid-19"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - 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