{"id":1852,"date":"2025-05-09T17:27:44","date_gmt":"2025-05-09T20:27:44","guid":{"rendered":"https:\/\/hefassessoria.com.br\/?p=1852"},"modified":"2025-05-09T17:29:28","modified_gmt":"2025-05-09T20:29:28","slug":"novo-fluxo-ctd-anvisa-30-04-2025","status":"publish","type":"post","link":"https:\/\/hefassessoria.com.br\/home1\/bb6dab58\/public_html\/visao-regulatoria\/novo-fluxo-ctd-anvisa-30-04-2025\/","title":{"rendered":"Novo fluxo para peticionamento de CTD a partir de 30\/04\/2025"},"content":{"rendered":"<div style=\"text-align: justify;\">\n<h2 data-start=\"399\" data-end=\"550\">A RDC 947\/2024 altera o protocolo de peti\u00e7\u00f5es e aditamentos em formato CTD na Anvisa. Entenda o que deve ser eletr\u00f4nico e o que passa a ser manual.<\/h2>\n<p class=\"\" data-start=\"552\" data-end=\"913\">Nas \u00faltimas semanas, muitos dos nossos clientes t\u00eam nos procurado com d\u00favidas sobre as novas regras para o protocolo de peti\u00e7\u00f5es com documenta\u00e7\u00e3o no formato <strong>CTD<\/strong> (<em>Common Technical Document<\/em>) junto \u00e0 Anvisa. A alta demanda por esclarecimentos tamb\u00e9m se refletiu em publica\u00e7\u00e3o recente no portal da pr\u00f3pria Ag\u00eancia, que orienta o setor regulado sobre o novo fluxo.<\/p>\n<p class=\"\" data-start=\"915\" data-end=\"1090\">Diante disso, fomos presencialmente \u00e0 <strong>GEDOC<\/strong> (Ger\u00eancia de Documenta\u00e7\u00e3o da Anvisa) para validar nosso entendimento e confirmar as mudan\u00e7as determinadas pela <strong data-start=\"1070\" data-end=\"1089\">RDC n\u00ba 947\/2024<\/strong>.<\/p>\n<p class=\"\" data-start=\"1092\" data-end=\"1295\">A norma entrou oficialmente em vigor em <strong data-start=\"1132\" data-end=\"1155\">30 de abril de 2025<\/strong> e altera de forma significativa a din\u00e2mica entre <strong data-start=\"1205\" data-end=\"1229\">peti\u00e7\u00f5es eletr\u00f4nicas<\/strong> e <strong data-start=\"1232\" data-end=\"1255\">aditamentos f\u00edsicos<\/strong> com documentos t\u00e9cnicos no formato CTD.<\/p>\n<p class=\"\" data-start=\"1297\" data-end=\"1532\">Com a entrada em vigor da RDC 947\/2024, a l\u00f3gica tradicional foi invertida: agora, a <strong data-start=\"1382\" data-end=\"1437\">peti\u00e7\u00e3o em CTD deve ser protocolada eletronicamente<\/strong>, enquanto o <strong data-start=\"1450\" data-end=\"1497\">aditamento deve ser apresentado fisicamente<\/strong>, conforme esclarecido pela Anvisa.<\/p>\n<p class=\"\" data-start=\"1534\" data-end=\"1800\">A orienta\u00e7\u00e3o foi publicada pela Ag\u00eancia em <strong data-start=\"1577\" data-end=\"1598\">8 de maio de 2025<\/strong>, por meio de not\u00edcia oficial dispon\u00edvel no portal institucional<\/p>\n<p class=\"\" data-start=\"1534\" data-end=\"1800\">(<a class=\"\" href=\"https:\/\/www.gov.br\/anvisa\/pt-br\/assuntos\/noticias-anvisa\/2025\/anvisa-orienta-sobre-protocolo-de-peticoes-no-formato-ctd\" target=\"_new\" rel=\"noopener\" data-start=\"1649\" data-end=\"1781\">Leia aqui<\/a>).<\/p>\n<hr class=\"\" data-start=\"1785\" data-end=\"1788\" \/>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-1864\" src=\"https:\/\/hefassessoria.com.br\/wp-content\/uploads\/2025\/05\/novo-fluxo-ctd-rdc-947-2024-hfempresarial.png\" alt=\"Imagem institucional da H.F Empresarial com fundo azul escuro mostrando o novo fluxo para peticionamento de CTD com base na RDC 947\/2024. Exibe tabela comparativa entre o modelo antigo e o atual para peti\u00e7\u00f5es e aditamentos junto \u00e0 Anvisa.\" width=\"1200\" height=\"630\" title=\"\"><\/p>\n<h2 data-start=\"1807\" data-end=\"1869\">\u2705 Novo fluxo para peti\u00e7\u00f5es com CTD \u2013 A partir de 30\/04\/2025<\/h2>\n<h3 data-start=\"1871\" data-end=\"1943\">1. Peti\u00e7\u00f5es de registro ou p\u00f3s-registro (prim\u00e1rias e secund\u00e1rias):<\/h3>\n<ul data-start=\"1944\" data-end=\"2187\">\n<li class=\"\" data-start=\"1944\" data-end=\"2004\">\n<p class=\"\" data-start=\"1946\" data-end=\"2004\">Devem ser feitas <strong data-start=\"1963\" data-end=\"2001\">exclusivamente por meio eletr\u00f4nico<\/strong>.<\/p>\n<\/li>\n<li class=\"\" data-start=\"2005\" data-end=\"2077\">\n<p class=\"\" data-start=\"2007\" data-end=\"2077\"><strong data-start=\"2007\" data-end=\"2031\">N\u00e3o deve ser enviada<\/strong> nenhuma documenta\u00e7\u00e3o t\u00e9cnica neste momento.<\/p>\n<\/li>\n<li class=\"\" data-start=\"2078\" data-end=\"2187\">\n<p class=\"\" data-start=\"2080\" data-end=\"2187\">A empresa deve incluir apenas <strong data-start=\"2110\" data-end=\"2186\">uma declara\u00e7\u00e3o informando que a documenta\u00e7\u00e3o ser\u00e1 enviada por aditamento<\/strong>.<\/p>\n<\/li>\n<\/ul>\n<h3 data-start=\"2189\" data-end=\"2240\">2. Aditamento CTD (registro ou p\u00f3s-registro):<\/h3>\n<ul data-start=\"2241\" data-end=\"2460\">\n<li class=\"\" data-start=\"2241\" data-end=\"2306\">\n<p class=\"\" data-start=\"2243\" data-end=\"2306\">Deve ser feito <strong data-start=\"2258\" data-end=\"2273\">manualmente<\/strong>, com <strong data-start=\"2279\" data-end=\"2303\">protocolo presencial<\/strong>.<\/p>\n<\/li>\n<li class=\"\" data-start=\"2307\" data-end=\"2460\">\n<p class=\"\" data-start=\"2309\" data-end=\"2460\">Deve conter <strong data-start=\"2321\" data-end=\"2367\">toda a documenta\u00e7\u00e3o t\u00e9cnica no formato CTD<\/strong>, gravada em <strong data-start=\"2380\" data-end=\"2417\">m\u00eddia eletr\u00f4nica (como pen-drive)<\/strong>, conforme o <strong data-start=\"2430\" data-end=\"2449\">Guia n\u00ba 24\/2019<\/strong> da Anvisa.<\/p>\n<\/li>\n<\/ul>\n<hr class=\"\" data-start=\"2462\" data-end=\"2465\" \/>\n<h2 class=\"\" data-start=\"2467\" data-end=\"2494\">? Como era x Como ficou<\/h2>\n<div class=\"_tableContainer_16hzy_1\">\n<div class=\"_tableWrapper_16hzy_14 group flex w-fit flex-col-reverse\" tabindex=\"-1\">\n<table class=\"w-fit min-w-(--thread-content-width)\" data-start=\"2496\" data-end=\"2979\">\n<thead data-start=\"2496\" data-end=\"2616\">\n<tr data-start=\"2496\" data-end=\"2616\">\n<th data-start=\"2496\" data-end=\"2520\" data-col-size=\"sm\">Etapa<\/th>\n<th data-start=\"2520\" data-end=\"2561\" data-col-size=\"sm\">Antes (at\u00e9 30\/04\/2025)<\/th>\n<th data-start=\"2561\" data-end=\"2616\" data-col-size=\"md\">Agora (a partir de 01\/05\/2025)<\/th>\n<\/tr>\n<\/thead>\n<tbody data-start=\"2738\" data-end=\"2979\">\n<tr data-start=\"2738\" data-end=\"2858\">\n<td data-start=\"2738\" data-end=\"2762\" data-col-size=\"sm\">Peti\u00e7\u00e3o (registro\/p\u00f3s)<\/td>\n<td data-col-size=\"sm\" data-start=\"2762\" data-end=\"2803\">Manual, com envio imediato da m\u00eddia<\/td>\n<td data-col-size=\"md\" data-start=\"2803\" data-end=\"2858\">Eletr\u00f4nica, apenas com declara\u00e7\u00e3o<\/td>\n<\/tr>\n<tr data-start=\"2859\" data-end=\"2979\">\n<td data-start=\"2859\" data-end=\"2883\" data-col-size=\"sm\">Aditamento CTD<\/td>\n<td data-col-size=\"sm\" data-start=\"2883\" data-end=\"2924\">Eletr\u00f4nico, apenas com declara\u00e7\u00e3o<\/td>\n<td data-col-size=\"md\" data-start=\"2924\" data-end=\"2979\">Manual, com entrega da m\u00eddia com documenta\u00e7\u00e3o<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<\/div>\n<\/div>\n<div>\n<hr class=\"\" data-start=\"3871\" data-end=\"3874\" \/>\n<\/div>\n<div>\n<h2 data-start=\"2986\" data-end=\"3009\">\u26a0\ufe0f Pontos de aten\u00e7\u00e3o<\/h2>\n<ul data-start=\"3011\" data-end=\"3326\">\n<li class=\"\" data-start=\"3011\" data-end=\"3100\">\n<p class=\"\" data-start=\"3013\" data-end=\"3100\"><strong data-start=\"3013\" data-end=\"3037\">N\u00e3o \u00e9 mais permitido<\/strong> protocolar manualmente peti\u00e7\u00f5es de registro ou p\u00f3s-registro.<\/p>\n<\/li>\n<li class=\"\" data-start=\"3101\" data-end=\"3191\">\n<p class=\"\" data-start=\"3103\" data-end=\"3191\"><strong data-start=\"3103\" data-end=\"3127\">N\u00e3o \u00e9 mais permitido<\/strong> protocolar eletronicamente o aditamento com documenta\u00e7\u00e3o CTD.<\/p>\n<\/li>\n<li class=\"\" data-start=\"3192\" data-end=\"3326\">\n<p class=\"\" data-start=\"3194\" data-end=\"3326\">Todo <strong data-start=\"3199\" data-end=\"3232\">dossi\u00ea t\u00e9cnico no formato CTD<\/strong> deve seguir rigorosamente o <strong data-start=\"3261\" data-end=\"3280\">Guia n\u00ba 24\/2019<\/strong>, sob risco de <strong data-start=\"3295\" data-end=\"3325\">indeferimento ou devolu\u00e7\u00e3o<\/strong>.<\/p>\n<\/li>\n<\/ul>\n<hr class=\"\" data-start=\"3328\" data-end=\"3331\" \/>\n<h2 data-start=\"3333\" data-end=\"3359\">\u2753 Por que isso importa?<\/h2>\n<p class=\"\" data-start=\"3361\" data-end=\"3659\">O novo fluxo impacta diretamente a rotina das \u00e1reas regulat\u00f3rias das ind\u00fastrias que utilizam o modelo <strong data-start=\"3463\" data-end=\"3470\">CTD<\/strong> para submiss\u00f5es junto \u00e0 Anvisa. A invers\u00e3o entre o que \u00e9 eletr\u00f4nico e o que \u00e9 manual exige <strong data-start=\"3562\" data-end=\"3583\">aten\u00e7\u00e3o redobrada<\/strong> para garantir o <strong data-start=\"3600\" data-end=\"3626\">cumprimento dos prazos<\/strong> e a <strong data-start=\"3631\" data-end=\"3658\">conformidade documental<\/strong>.<\/p>\n<p class=\"\" data-start=\"3661\" data-end=\"3836\">Caso tenha d\u00favidas sobre como adaptar seus processos internos a essa nova regra ou precise de apoio na submiss\u00e3o de seus dossi\u00eas, <a href=\"https:\/\/hefassessoria.com.br\/contato\/\"><strong data-start=\"3791\" data-end=\"3833\">entre em contato com a H.F Empresarial<\/strong><\/a>.<\/p>\n<p class=\"\" data-start=\"3838\" data-end=\"3869\">Estamos prontos para te ajudar.<\/p>\n<hr class=\"\" data-start=\"3871\" data-end=\"3874\" \/>\n<p class=\"\" data-start=\"3876\" data-end=\"3967\">? <em data-start=\"3879\" data-end=\"3901\">Artigo de autoria de<\/em><br data-start=\"3901\" data-end=\"3904\" \/><strong data-start=\"3904\" data-end=\"3933\">Cecilia Freitas Rodrigues<\/strong><br data-start=\"3933\" data-end=\"3936\" \/>Advogada | S\u00f3cia-Administradora<\/p>\n<p data-start=\"3876\" data-end=\"3967\">\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>A RDC 947\/2024 altera o protocolo de peti\u00e7\u00f5es e aditamentos em formato CTD na Anvisa. Entenda o que deve ser eletr\u00f4nico e o que passa a ser manual. Nas \u00faltimas semanas, muitos dos nossos clientes t\u00eam nos procurado com d\u00favidas sobre as novas regras para o protocolo de peti\u00e7\u00f5es com documenta\u00e7\u00e3o no formato CTD (Common [&#8230;]\n","protected":false},"author":4,"featured_media":1864,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_joinchat":[],"footnotes":""},"categories":[13],"tags":[56,17,54,59,61,55,57,44,50,58,60],"class_list":["post-1852","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-dicas-regulatorias","tag-aditamento-manual","tag-anvisa","tag-ctd","tag-guia-24-2019","tag-h-f-empresarial","tag-peticionamento-eletronico","tag-protocolo-de-registro","tag-rdc-947-2024","tag-regulacao-sanitaria","tag-submissao-documental","tag-visao-regulatoria"],"_links":{"self":[{"href":"https:\/\/hefassessoria.com.br\/home1\/bb6dab58\/public_html\/wp-json\/wp\/v2\/posts\/1852","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/hefassessoria.com.br\/home1\/bb6dab58\/public_html\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/hefassessoria.com.br\/home1\/bb6dab58\/public_html\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/hefassessoria.com.br\/home1\/bb6dab58\/public_html\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/hefassessoria.com.br\/home1\/bb6dab58\/public_html\/wp-json\/wp\/v2\/comments?post=1852"}],"version-history":[{"count":14,"href":"https:\/\/hefassessoria.com.br\/home1\/bb6dab58\/public_html\/wp-json\/wp\/v2\/posts\/1852\/revisions"}],"predecessor-version":[{"id":1871,"href":"https:\/\/hefassessoria.com.br\/home1\/bb6dab58\/public_html\/wp-json\/wp\/v2\/posts\/1852\/revisions\/1871"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/hefassessoria.com.br\/home1\/bb6dab58\/public_html\/wp-json\/wp\/v2\/media\/1864"}],"wp:attachment":[{"href":"https:\/\/hefassessoria.com.br\/home1\/bb6dab58\/public_html\/wp-json\/wp\/v2\/media?parent=1852"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/hefassessoria.com.br\/home1\/bb6dab58\/public_html\/wp-json\/wp\/v2\/categories?post=1852"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/hefassessoria.com.br\/home1\/bb6dab58\/public_html\/wp-json\/wp\/v2\/tags?post=1852"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}