Resolution - RDC number 630, 10 March 2022; (2 page(s), in Portuguese)

Medicine labels: Proposed changes to rules for the new standards replacing TGO 91 and TGO 92; (93 page(s), in English)

Application Process and Requirements for Post-Approval Changes of Biological Products Adopting the World Health Organization Guidelines for Changes to Approved Vaccines and Biotherapeutic Products for Human Use; (91 page(s), in English)