BRA/1467
WTO/TBT
BR Brazil
  • 11 - Health care technology
2023-03-06
2023-01-11

Medicaments (ICS code(s): 11.120.10)

Draft resolution number 1136, 26 December 2022; (7 page(s), in Portuguese)

This Draft Resolution is regarded to a proposal to define the general guidelines for the pilot implementation of the optimized analysis procedure, based on risk criteria, to confirm the suitability of the documentation submitted to Anvisa for marketing authorization and post-marketing authorization changes to medicines.