{"id":51377,"date":"2018-10-24T11:40:58","date_gmt":"2018-10-24T14:40:58","guid":{"rendered":"https:\/\/www.pharmaceutical.com.br\/?p=51377"},"modified":"2022-01-27T14:08:49","modified_gmt":"2022-01-27T17:08:49","slug":"o-que-significa-ae-afe-e-sngpc","status":"publish","type":"post","link":"https:\/\/pharmaceuticalconsultoria.com\/o-que-significa-ae-afe-e-sngpc\/","title":{"rendered":"O que significa AE, AFE e SNGPC?"},"content":{"rendered":"

Quem precisa de Autoriza\u00e7\u00e3o Especial (AE)? … Quando \u00e9 preciso ter Autoriza\u00e7\u00e3o de Funcionamento (AFE) antes de solicitar Autoriza\u00e7\u00e3o Especial (AE)? O que \u00e9 SNGPC?<\/p>\n

O que \u00e9 Autoriza\u00e7\u00e3o Especial de Empresa (AE)?<\/h4>\n

Autoriza\u00e7\u00e3o Especial de Empresa (AE) \u00e9 o ato de compet\u00eancia da Anvisa que permite o exerc\u00edcio de atividades que envolvam insumos farmac\u00eauticos, medicamentos e subst\u00e2ncias sujeitas a controle especial, bem como o plantio, cultivo e colheita de plantas das quais possam ser extra\u00eddas subst\u00e2ncias sujeitas a controle especial, mediante comprova\u00e7\u00e3o de requisitos t\u00e9cnicos e administrativos espec\u00edficos constantes da\u00a0RDC n\u00b0 16 \/ 2014<\/a>.<\/p>\n

A empresa que n\u00e3o tiver a autoriza\u00e7\u00e3o de funcionamento do \u00f3rg\u00e3o sanit\u00e1rio competente cometer\u00e1 infra\u00e7\u00e3o sanit\u00e1ria e estar\u00e1 sujeita a pena de advert\u00eancia, interdi\u00e7\u00e3o, cancelamento de autoriza\u00e7\u00e3o e de licen\u00e7a e\/ou multa, de acordo com os termos da\u00a0Lei n\u00ba 6.437\/1977<\/a>.<\/p>\n

Quem precisa de Autoriza\u00e7\u00e3o Especial (AE)?<\/h4>\n

A Autoriza\u00e7\u00e3o Especial (AE) \u00e9 exigida para as atividades de armazenamento, distribui\u00e7\u00e3o, embalagem, expedi\u00e7\u00e3o, exporta\u00e7\u00e3o, extra\u00e7\u00e3o, fabrica\u00e7\u00e3o, fracionamento, importa\u00e7\u00e3o, produ\u00e7\u00e3o, purifica\u00e7\u00e3o, reembalagem, s\u00edntese, transforma\u00e7\u00e3o e transporte, ou qualquer outra, para qualquer fim, envolvendo\u00a0subst\u00e2ncias sujeitas a controle especial ou com os medicamentos que as contenham, segundo o disposto na\u00a0Portaria SVS\/MS n\u00ba 344\/1998<\/a>, e na\u00a0Portaria SVS\/MS n\u00ba 6\/1999<\/a>.<\/p>\n

O que \u00e9 uma AFE?<\/h4>\n

Trata-se de uma autoriza\u00e7\u00e3o expedida pela Anvisa \u2013 Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria, autorizando as Farm\u00e1cias e Drogarias para o com\u00e9rcio de medicamentos ao p\u00fablico. Todos os estabelecimentos que comercializem medicamentos ao p\u00fablico.<\/p>\n

Quando \u00e9 preciso ter Autoriza\u00e7\u00e3o de Funcionamento (AFE) antes de solicitar Autoriza\u00e7\u00e3o Especial (AE)?<\/h4>\n

A Autoriza\u00e7\u00e3o Especial (AE) a ser obtida para as atividades de armazenamento, distribui\u00e7\u00e3o, embalagem, expedi\u00e7\u00e3o, exporta\u00e7\u00e3o, extra\u00e7\u00e3o, fabrica\u00e7\u00e3o, fracionamento, importa\u00e7\u00e3o, produ\u00e7\u00e3o, purifica\u00e7\u00e3o, reembalagem, s\u00edntese, transforma\u00e7\u00e3o e transporte de medicamentos e insumos farmac\u00eauticos destinados a uso humano est\u00e1 condicionada \u00e0 concess\u00e3o de AFE, ou seja, somente empresa com AFE pode solicitar AE.<\/p>\n

ATEN\u00c7\u00c3O: A EMPRESA QUE TRABALHA COM MEDICAMENTOS CONTROLADOS PRECISA TER AFE ATIVA PARA SOLICITAR AE.<\/p>\n

A AE a ser obtida para as atividades que n\u00e3o estejam enquadradas no art. 3\u00ba da\u00a0RDC n\u00b0 16\/2014\u00a0n\u00e3o est\u00e1 condicionada \u00e0 concess\u00e3o de AFE, ou seja, mesmo se n\u00e3o tiver AFE a empresa pode peticionar AE.<\/p>\n

Importante:\u00a0Quanto a empresas que executam atividades n\u00e3o sujeitas ao controle de Vigil\u00e2ncia Sanit\u00e1ria como, por exemplo, empresas do ramo veterin\u00e1rio ou empresas de componentes eletr\u00f4nicos, a AFE n\u00e3o \u00e9 condicionante para a concess\u00e3o da AE.<\/p>\n

O que \u00e9 o Sistema Sngpc?<\/h4>\n

O Sistema Nacional de Gerenciamento de Produtos Controlados \u2013 SNGPC \u00e9 um instrumento informatizado para captura e tratamento de dados sobre produ\u00e7\u00e3o, com\u00e9rcio e uso de subst\u00e2ncias ou medicamentos sujeitos a controle especial.<\/p>\n

O SNGPC monitora as movimenta\u00e7\u00f5es de entrada\u00a0(compras e transfer\u00eancias)e sa\u00edda(vendas,transforma\u00e7\u00f5es, transfer\u00eancias e perdas) de\u00a0medicamentos comercializados em farm\u00e1cias e drogarias privadas do pa\u00eds, particularmente os medicamentos sujeitos \u00e0 Portaria n\u00ba 344, de 12 de maio de 1998, como os entorpecentes e antipsicotr\u00f3picos, e os antimicrobianos.<\/p>\n

O sistema substituiu de forma gradual, entre 2007 e 2008, a escritura\u00e7\u00e3o tradicional (manual \u2013 livro de registros \u2013 ou informatizada), em que as informa\u00e7\u00f5es ficavam apenas na empresa, pela escritura\u00e7\u00e3o obrigatoriamente eletr\u00f4nica, com transmiss\u00e3o dos dados para a Anvisa.<\/p>\n

O monitoramento dos h\u00e1bitos de prescri\u00e7\u00e3o e consumo desses medicamentos no pa\u00eds possibilita contribuir com decis\u00f5es regulat\u00f3rias e a\u00e7\u00f5es educativas a serem promovidas pelos entes que comp\u00f5em o Sistema Nacional de Vigil\u00e2ncia Sanit\u00e1ria.<\/p>\n

 <\/p>\n

Fonte: ANVISA – Ag\u00eancia Nocional de Vigil\u00e2ncia Sanit\u00e1ria<\/p>\n","protected":false},"excerpt":{"rendered":"

Quem precisa de Autoriza\u00e7\u00e3o Especial (AE)? … Quando \u00e9 preciso ter Autoriza\u00e7\u00e3o de Funcionamento (AFE) antes de solicitar Autoriza\u00e7\u00e3o Especial […]<\/p>\n","protected":false},"author":6,"featured_media":77011,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_joinchat":[],"footnotes":""},"categories":[591],"tags":[],"yoast_head":"\nO que significa AE, AFE e SNGPC? - Pharmaceutical Consultoria<\/title>\n<meta name=\"description\" content=\"Empresa de consultoria farmac\u00eautica especializada em marketing farmac\u00eautico magistral. 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