Brazil Clarifies Rules for Accepting Amendments to Cosmetic Registration Applications

On May 29, 2025, the Brazilian Health Regulatory Agency (Anvisa) announced new criteria for accepting addenda to cosmetic registration application. These criteria, set to streamline the evaluation process, will take effect on June 9, 2025.¹

The implementation of the new criteria is grounded in Resolution RDC No. 204/2005, which regulates the procedures for applications reviewed by Anvisa's technical sectors. This resolution defines an "addendum" as any supplementary material voluntarily submitted to an application, intended solely to enhance understanding of the subject—in this context, cosmetic products—without altering the original scope of the request.

Under the new criteria effective June 9, 2025, Anvisa will accept addenda to cosmetic registration applications only if they are submitted before the agency initiates its technical review of the submitted documentation. These addenda may provide complementary information, or substitute previously submitted documents. However, the submission of mandatory documents not included in the original filing will not be accepted, and the corresponding application will be rejected due to insufficient initial documentation. Once the application transitions to the "Under Analysis" status, the submission of any new information will no longer be permitted, in order to avoid procedural disruption during the review process.

To ensure proper understanding and implementation of the new criteria, Anvisa has provided the following operational summary:

Timing of Addendum Submission	Addendum Type	Acceptance Status
Before technical analysis begins	The addendum contains optional or mandatory documents that supplement or replace those submitted in the original application.	Accepted
Before technical analysis begins	The addendum introduces mandatory documents omitted from the original application.	Not accepted, with the application rejected accordingly
After technical analysis begins	The addendum includes new information or modifications to the original application.	Not accepted

Brazil Clarifies Rules for Accepting Amendments to Cosmetic Registration Applications

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