PHARMACEUTICAL PRODUCTS (HS code(s): 30); Pharmaceutics (ICS code(s): 11.120)

Draft resolution 1180, 24 July 2023; (13 page(s), in Portuguese)

This draft resolution contains provisions on the conditions and procedures for registering pre-pandemic influenza vaccines, updating to a pandemic strain and authorization for the use, marketing and monitoring of pandemic influenza vaccines. It is important to highlight that, when the absence or incompleteness of national regulation, 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)