On January 12, the National Health Surveillance Agency (ANVISA, in Spanish) launched the process of external consultation to draw up the 2021-2023 Regulatory Agenda. The regulatory proposals in the agenda include the formalization of the National System of Pharmacovigilance. The consultation is scheduled to end on January 22. The final agenda should be published in April. Access the public consultation by clicking here.
Formalizing the pharmacovigilance system will involve greater coordination between the entities making up the National Health Surveillance System with a view to improving the results of pharmacovigilance activities, a proposal formerly incorporated in the previous Agenda which has now been included in the new version.
The consultation also proposes regulating good practices regarding the preparation of unitary doses and the unitarization of medicine doses in the 2021-2023 period. Currently these tasks may only be performed at private pharmacies in hospital units or their equivalent in premises providing medical assistance. The process also contemplates ways of ensuring that deaf and deaf-blind people can access information on medicine labeling.