Brazil ANVISA, Criteria for the Acceptance of Amendments in Cosmetic Product Registration
On May 29, 2025, the Brazilian Health Regulatory Agency (ANVISA) established new criteria for the acceptance of amendments (additional submitted documents) to registration and post-registration applications for personal hygiene products, cosmetics, and perfumes.
These criteria are based on RDC No. 204/2005, which outlines the procedures applicable to petitions requiring ANVISA’s technical evaluation.
Accordingly, starting from June 9, only amendments submitted before the beginning of the technical evaluation of the application will be accepted. These amendments may include documents that complement or replace those previously submitted.
However, if mandatory documents required at the time of initial submission are missing, their submission at a later date as amendments will not be accepted. In such cases, the application will be rejected due to insufficient documentation.
This measure was introduced considering the potential impact that new documents could have on the integrity and flow of the technical evaluation process.
Please refer to the link below.
Anvisa define novos critérios para aceitação de aditamentos em petições de cosméticos
A partir de 9 de junho, não serão aceitos aditamentos após o início da análise técnica.
www.gov.br
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