Brazil Profile Updated with New Expiration Date for Public Health Emergency Requirements and Clarifications to Safety Reporting Requirements
August 16, 2022
The Brazil profile in ClinRegs was updated with the following information:
- Inclusion of Ordinance No. 913, which declared an end to Brazil’s public health emergency related to COVID-19 as of May 22, 2022 (See Scope of Assessment and Timeline of Review)
- Inclusion of Resolution No. 683, which extends the validity of Resolution No. 573 to May 21, 2023 (See Scope of Assessment and Timeline of Review)
- Clarification of sponsor safety reporting timeline requirements for suspected unexpected serious adverse events occurring in Brazil and for other types of adverse events (See Safety Reporting)
Sources Added During this Update:
(Regulation) Ordinance GM/MS No. 913 of April 22, 2022 (OrdNo913 – Portuguese) (Effective May 22, 2022)
Ministry of Health
(Regulation) Resolution of the Collegiate Board - RDC No. 683 of May 12, 2022 (ResNo683 - Portuguese) (Effective May 22, 2022)
ANVISA, Ministry of Health