Medicaments (ICS code(s): 11.120.10)

Draft resolution 1179, 20 July 2023;; (13 page(s), in Portuguese)

This Draft Resolution contains provisions on the sanitary requirements for the market authorization of industrialized medicines for human use. It is important to highlight that, when the absence or incompleteness of national market authorization, andas long as there is no incompatibility, the adoption of guides and guidelines by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)