{"id":92666,"date":"2023-07-25T16:46:30","date_gmt":"2023-07-25T19:46:30","guid":{"rendered":"https:\/\/crefito4.org.br\/site\/?p=92666"},"modified":"2023-07-25T16:46:44","modified_gmt":"2023-07-25T19:46:44","slug":"resolucao-rdc-no-63-11","status":"publish","type":"post","link":"https:\/\/crefito4.org.br\/site\/2023\/07\/25\/resolucao-rdc-no-63-11\/","title":{"rendered":"RESOLU\u00c7\u00c3O-RDC N\u00ba 63\/11"},"content":{"rendered":"\t\t
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RESOLU\u00c7\u00c3O-RDC N\u00ba 63\/11Espelho da Norma<\/strong>\u00a0<\/span><\/h1>
Origem:<\/td>MS,ANVISA.<\/td><\/tr>
Norma:<\/td>RES-63<\/td><\/tr>
Letra:<\/td><\/td><\/tr>
Data de Assinatura:<\/td>07\/01\/2011<\/td><\/tr>
Situa\u00e7\u00e3o:<\/td>VIGENTE<\/td><\/tr>
<\/td><\/tr>
Publica\u00e7\u00e3o<\/td>Boletim<\/td><\/tr>
Tipo<\/td>Fonte<\/td>Se\u00e7\u00e3o<\/td>Data de Publ.<\/td>P.<\/td>Col.<\/td>Vol.<\/td>N\u00ba<\/td>P.<\/td>Col.<\/td><\/tr>
PUB<\/td>DOFC<\/td>I<\/td>10\/01\/2011<\/td>57<\/td>2<\/td>0<\/td>0<\/td>0<\/td>0<\/td><\/tr><\/tbody><\/table><\/td><\/tr>
Texto completo:<\/td>http:\/\/bvsms.saude.gov.br\/bvs\/saudelegis\/anvisa\/2011\/res0063_07_01_2011.html<\/a><\/td><\/tr>
Texto completo da Rep:<\/td>http:\/\/<\/td><\/tr>
Ementa:<\/td>CONCEDE \u00c0 EMPRESA GEDEON RICHTER PLC, A CERTIFICA\u00c7\u00c3O DE BOAS PR\u00c1TICAS DE FABRICA\u00c7\u00c3O PARA FINS DE EXPORTA\u00c7\u00c3O PARA O BRASIL.<\/td><\/tr>
Observa\u00e7\u00e3o:<\/td>ESTA RESOLU\u00c7\u00c3O E O ANEXO FORAM PUBLICADOS EM SUPLEMENTO DE 10.01.2011, P\u00c1GINA 36.<\/td><\/tr>
Indexa\u00e7\u00e3o:<\/td>CERTIFICADO DE BOAS PR\u00c1TICAS DE FABRICA\u00c7\u00c3O, EXPORTA\u00c7\u00c3O DE PRODUTOS, PRODUTO FARMAC\u00caUTICO.<\/td><\/tr><\/tbody><\/table><\/td><\/tr><\/tbody><\/table>

RESOLU\u00c7\u00c3O – RE N\u00ba 63, DE 7 DE JANEIRO DE 2011<\/h1>

O Diretor-Presidente Substituto da Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria, no uso das atribui\u00e7\u00f5es que lhe conferem o Decreto de nomea\u00e7\u00e3o de 10 de outubro de 2008 do Presidente da Rep\u00fablica e a Portaria GM\/MS n\u00b0 3.177, de 29 de dezembro de 2008, tendo em vista o disposto no inciso X, do art.13 do Regulamento da ANVISA, aprovado pelo Decreto n\u00b0 3.029, de 16 de abril de 1999, no inciso VIII do art. 16, e no inciso I, \u00a7 1\u00ba do art. 55 do Regimento Interno aprovado nos termos do Anexo I da Portaria n.\u00ba 354 da ANVISA, de 11 de agosto de 2006, republicada no DOU de 21 de agosto de 2006,<\/p>

considerando a solicita\u00e7\u00e3o de inspe\u00e7\u00e3o pela empresa Ach\u00e9 Laborat\u00f3rios Farmac\u00eauticos S.A., CNPJ n.\u00ba 60.659.463\/0001-91 e Autoriza\u00e7\u00e3o de Funcionamento n.\u00ba: 1.00.573-9;<\/p>

considerando ainda o parecer da \u00e1rea t\u00e9cnica e que a empresa foi inspecionada cumprindo os requisitos de Boas Pr\u00e1ticas de Fabrica\u00e7\u00e3o – \u00e1rea farmac\u00eautica, resolve:<\/p>

Art. 1\u00ba Conceder \u00e0 Empresa, na forma de ANEXO, a Certifica\u00e7\u00e3o de Boas Pr\u00e1ticas de Fabrica\u00e7\u00e3o para fins de exporta\u00e7\u00e3o para o Brasil.<\/p>

Art. 2\u00ba A presente Certifica\u00e7\u00e3o ter\u00e1 validade de 2 (dois) anos a partir da sua publica\u00e7\u00e3o.<\/p>

Art. 3\u00ba Esta Resolu\u00e7\u00e3o entra em vigor na data de sua publica\u00e7\u00e3o.<\/p><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

Disp\u00f5e sobre os Requisitos de Boas Pr\u00e1ticas de Funcionamento para os Servi\u00e7os de Sa\u00fade.<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[22],"tags":[],"class_list":["post-92666","post","type-post","status-publish","format-standard","hentry","category-pareceres-e-outros-documentos"],"yoast_head":"\nRESOLU\u00c7\u00c3O-RDC N\u00ba 63\/11 - CREFITO-4<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/crefito4.org.br\/site\/2023\/07\/25\/resolucao-rdc-no-63-11\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"RESOLU\u00c7\u00c3O-RDC N\u00ba 63\/11 - CREFITO-4\" \/>\n<meta property=\"og:description\" content=\"Disp\u00f5e sobre os Requisitos de Boas Pr\u00e1ticas de Funcionamento para os Servi\u00e7os de Sa\u00fade.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/crefito4.org.br\/site\/2023\/07\/25\/resolucao-rdc-no-63-11\/\" \/>\n<meta property=\"og:site_name\" content=\"CREFITO-4\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/Crefito4\/\" \/>\n<meta property=\"article:published_time\" content=\"2023-07-25T19:46:30+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-07-25T19:46:44+00:00\" \/>\n<meta name=\"author\" content=\"M\u00e9dice\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"M\u00e9dice\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. tempo de leitura\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/crefito4.org.br\\\/site\\\/2023\\\/07\\\/25\\\/resolucao-rdc-no-63-11\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/crefito4.org.br\\\/site\\\/2023\\\/07\\\/25\\\/resolucao-rdc-no-63-11\\\/\"},\"author\":{\"name\":\"M\u00e9dice\",\"@id\":\"https:\\\/\\\/crefito4.org.br\\\/site\\\/#\\\/schema\\\/person\\\/30215f3eac599a75e6e5ed4fffc8f025\"},\"headline\":\"RESOLU\u00c7\u00c3O-RDC N\u00ba 63\\\/11\",\"datePublished\":\"2023-07-25T19:46:30+00:00\",\"dateModified\":\"2023-07-25T19:46:44+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/crefito4.org.br\\\/site\\\/2023\\\/07\\\/25\\\/resolucao-rdc-no-63-11\\\/\"},\"wordCount\":333,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/crefito4.org.br\\\/site\\\/#organization\"},\"articleSection\":[\"Pareceres e outros documentos\"],\"inLanguage\":\"pt-BR\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/crefito4.org.br\\\/site\\\/2023\\\/07\\\/25\\\/resolucao-rdc-no-63-11\\\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/crefito4.org.br\\\/site\\\/2023\\\/07\\\/25\\\/resolucao-rdc-no-63-11\\\/\",\"url\":\"https:\\\/\\\/crefito4.org.br\\\/site\\\/2023\\\/07\\\/25\\\/resolucao-rdc-no-63-11\\\/\",\"name\":\"RESOLU\u00c7\u00c3O-RDC N\u00ba 63\\\/11 - 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