{"id":8078,"date":"2025-02-19T12:30:59","date_gmt":"2025-02-19T12:30:59","guid":{"rendered":"https:\/\/els-solutions.com\/cms\/dev\/?p=8078"},"modified":"2025-02-19T12:31:24","modified_gmt":"2025-02-19T12:31:24","slug":"rdc-no-947-anvisa-shifts-to-100-digital-protocol-processes","status":"publish","type":"post","link":"https:\/\/els-solutions.com\/en\/rdc-no-947-anvisa-shifts-to-100-digital-protocol-processes\/","title":{"rendered":"RDC No. 947: Anvisa Shifts to 100% Digital Protocol Processes"},"content":{"rendered":"<p data-pm-slice=\"1 1 []\"><strong data-start=\"42\" data-end=\"66\">As of March 13, 2025<\/strong>, Anvisa will transition all of its processes to a <strong data-start=\"117\" data-end=\"140\">100% digital format<\/strong>, with the submission of paper documents being prohibited. As a result, physical documents will no longer be accepted, eliminating the use of paper.<\/p>\n<h3 data-start=\"290\" data-end=\"329\"><strong data-start=\"290\" data-end=\"329\">What changes with RDC No. 947\/2024?<\/strong><\/h3>\n<p data-start=\"331\" data-end=\"485\">Resolution <strong data-start=\"342\" data-end=\"382\">RDC No. 947, dated December 12, 2024<\/strong>, establishes the full digitization of Anvisa&#8217;s administrative processes with the following objectives:<\/p>\n<ul data-start=\"487\" data-end=\"740\">\n<li data-start=\"487\" data-end=\"561\"><strong>Greater agility<\/strong> in the analysis and response to citizens and businesses.<\/li>\n<li data-start=\"562\" data-end=\"641\"><strong>Reduction of costs<\/strong> related to storage and digitization of physical documents.<\/li>\n<li data-start=\"642\" data-end=\"740\"><strong>Guarantee of authenticity and security<\/strong> of electronic documents, requiring electronic signatures.<\/li>\n<\/ul>\n<h3 data-start=\"742\" data-end=\"789\"><strong data-start=\"742\" data-end=\"789\">Electronic documentation: how will it work?<\/strong><\/h3>\n<p data-start=\"791\" data-end=\"1003\">All documents submitted to Anvisa must be in <strong>digital format<\/strong>, either because they were generated directly in electronic form (e.g., PDFs generated by systems) or because they were digitized from physical versions.<\/p>\n<p data-start=\"1005\" data-end=\"1100\">In both cases, the use of a <strong>valid electronic signature will be required to ensure authenticity<\/strong>.<\/p>\n<h3 data-start=\"1102\" data-end=\"1145\">Types of accepted electronic signatures<\/h3>\n<p data-start=\"1147\" data-end=\"1267\">According to <strong data-start=\"1160\" data-end=\"1203\">Law No. 4,063, dated September 23, 2020<\/strong>, the following types of electronic signatures will be accepted:<\/p>\n<ul data-start=\"1269\" data-end=\"1474\">\n<li data-start=\"1269\" data-end=\"1370\"><strong data-start=\"1271\" data-end=\"1302\">Qualified digital signature<\/strong> \u2013 Made with a digital certificate based on the ICP-Brasil standard.<\/li>\n<li data-start=\"1371\" data-end=\"1474\"><strong data-start=\"1373\" data-end=\"1403\">Advanced digital signature<\/strong> \u2013 Using the <strong data-start=\"1416\" data-end=\"1433\">Gov.Br portal<\/strong> or any other system that may replace it.<\/li>\n<\/ul>\n<p data-start=\"1476\" data-end=\"1625\">Other types of electronic signatures provided by law, according to the regulations or technical specifications of Anvisa&#8217;s electronic filing systems.<\/p>\n<p data-start=\"1627\" data-end=\"1762\"><strong data-start=\"1627\" data-end=\"1641\">Important:<\/strong> If your company needs to submit documents to Anvisa, it is essential to be prepared for this new <strong data-start=\"1739\" data-end=\"1755\">100% digital<\/strong> model.<\/p>\n<p data-start=\"1627\" data-end=\"1762\">Learn more about <strong>Resolution &#8211; RDC No. 947<\/strong> <a href=\"https:\/\/www.in.gov.br\/en\/web\/dou\/-\/resolucao-rdc-n-947-de-12-de-dezembro-de-2024-601438206\">here<\/a><\/p>\n<p data-start=\"1814\" data-end=\"1829\">#anvisasempapel<\/p>\n<p data-start=\"1831\" data-end=\"1877\">If you have any questions, <strong><a href=\"https:\/\/els-solutions.com\/en\/services\/\">ELS Group<\/a><\/strong> can help!<\/p>\n<p data-start=\"1879\" data-end=\"1954\">Contact one of our<strong> <a href=\"https:\/\/els-solutions.com\/en\/where-are-we\/\">ELS consultant<\/a>s<\/strong> or send an email to <strong><a rel=\"noopener\" data-start=\"1933\" data-end=\"1953\">info@elssolutions.pt<\/a><\/strong>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>With Resolution RDC No. 947, Anvisa aims to reduce costs associated with storing and digitizing physical documents, while ensuring the authenticity and integrity of the documents by requiring the use of electronic signatures.<\/p>\n","protected":false},"author":9,"featured_media":8080,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[101,100,54,102,95],"tags":[62,103],"class_list":["post-8078","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-anvisa-en","category-brazil","category-general","category-noticias-en","category-regulations","tag-news","tag-regulations"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>RDC No. 947: Anvisa Shifts to 100% Digital Protocol Processes<\/title>\n<meta name=\"description\" content=\"Starting March 13, 2025, all documents submitted to Anvisa must be filed digitally, with no option for paper submission.\" \/>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta 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