Brazil's Resolution RDC No. 801

Brazil's Resolution RDC No. 801, issued on June 2, 2023, establishes provisions for the permission of using, marketing, and distributing vaccines and drugs authorized for emergency use. The resolution builds upon Resolution RDC No. 688/2022, which outlines the procedures and requirements for maintaining existing authorizations and new requests for temporary authorization for emergency use (AUE) of medicines and vaccines against Covid-19. This resolution aims to address the ongoing SARS-COV-2 pandemic and covers products manufactured until May 21, 2023.

Article 1: Permission for Use, Sale, and Distribution

According to Article 1 of RDC No. 801, all batches of vaccines and medicines that received authorization for emergency use before May 21, 2023, as per Resolution RDC No. 688/2022, are permitted for use, sale, and distribution. However, this authorization applies only to products manufactured by May 21, 2023. It is essential that the products are within their validity period to be eligible for use, commercialization, and distribution.

§ 1: Validity Period

The use, commercialization, and distribution of products under this resolution are subject to the condition that they are within their validity period.

§ 2: Change in Benefit-Risk Ratio

In the event that the National Health Surveillance Agency (Anvisa) decides to modify the benefit-risk ratio of medicines and vaccines authorized for emergency use on May 21, 2023, in a manner that adversely affects their use, commercialization, and distribution, the permissions granted by this rule shall cease to be valid.

Article 2: Effective Date

This resolution shall come into effect on the date of its publication.