ANVISA Changes How Certificate Validity is Counted, Providing Clarity for Renewals
The Brazilian Health Regulatory Agency (ANVISA) has published a crucial update that directly impacts the industry and regulated sector, bringing more clarity and legal certainty to certification processes. From now on, the way the validity period for Good Manufacturing Practice Certificates (CBPF) and Good Distribution and/or Storage Practice Certificates (CBPD) is counted has been changed, with a specific rule for renewals.
The new rules work as follows:
- For new certifications: The 24-month validity period will be counted from the certificate’s date of issuance. Previously, the counting started from the date of the sanitary inspection conducted by ANVISA.
- For certificate renewals: ANVISA has determined that the new 2-year validity period will begin to be counted after the last day of the current certificate’s validity. This ensures that the company is not disadvantaged if the renewal process is completed before the expiration of the current certificate.
Here is a practical example:
If a certificate expires on December 31, 2025, and the renewal is published on October 31, 2025, the new 2-year validity period will only begin on January 1, 2026, and not on October 31, 2025, as was the previous rule.
This change demonstrates ANVISA’s effort to align its processes with the needs of the sector, eliminating possible discrepancies and ensuring the full validity of certificates. Passarini Group emphasizes the importance of closely monitoring ANVISA’s regulatory updates. Remaining in compliance is essential for the success and safety of operations in the sector. Our team is available to help your company understand and adapt to this and other regulations.
ANVISA’s changes require attention and careful planning. Don’t let the complexity of the new rules compromise the validity of your certificates.
Count on Passarini Group to ensure your company is always in compliance. Contact us and discover how we can simplify your regulatory routine. Send an email to contato@passarini.com.br
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