As of March 13, 2025, Anvisa will transition all of its processes to a 100% digital format, with the submission of paper documents being prohibited. As a result, physical documents will no longer be accepted, eliminating the use of paper.
What changes with RDC No. 947/2024?
Resolution RDC No. 947, dated December 12, 2024, establishes the full digitization of Anvisa’s administrative processes with the following objectives:
- Greater agility in the analysis and response to citizens and businesses.
- Reduction of costs related to storage and digitization of physical documents.
- Guarantee of authenticity and security of electronic documents, requiring electronic signatures.
Electronic documentation: how will it work?
All documents submitted to Anvisa must be in digital format, either because they were generated directly in electronic form (e.g., PDFs generated by systems) or because they were digitized from physical versions.
In both cases, the use of a valid electronic signature will be required to ensure authenticity.
Types of accepted electronic signatures
According to Law No. 4,063, dated September 23, 2020, the following types of electronic signatures will be accepted:
- Qualified digital signature – Made with a digital certificate based on the ICP-Brasil standard.
- Advanced digital signature – Using the Gov.Br portal or any other system that may replace it.
Other types of electronic signatures provided by law, according to the regulations or technical specifications of Anvisa’s electronic filing systems.
Important: If your company needs to submit documents to Anvisa, it is essential to be prepared for this new 100% digital model.
Learn more about Resolution – RDC No. 947 here
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If you have any questions, ELS Group can help!
Contact one of our ELS consultants or send an email to info@elssolutions.pt.
