ANVISA Resolution on Labeling Changes

The Collective Board of the National Health Surveillance Agency (ANVISA) has adopted a Resolution, which was adopted in a meeting on December 8, 2023. The Resolution, published in the Official Gazette of the Union nº 180, of September 21, 2023, Section 1, page. 177, outlines the simplified procedure for changing labeling for compliance with articles 15 and 16, as well as warnings and restrictions of use. The amendment must be petitioned under a specific subject code and must be filed within the deadline established in art. 47 of the Resolution. The resolution comes into force on January 2, 2024, and the amendment must be filed under the specified subject code.