Designation of Shitei Yakubutsu (designated substances), based on the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (hereinafter referred to as the Act). (1960, Law No.145); (2 page(s), in English)

Draft resolution 1291, 28 November 2024; (13 page(s), in Portuguese)

Normative Instruction number 129, 30 March 2022; (16 page(s), in Portuguese)