The medicine registration grant administrative act in Brazilian National Health Surveillance Agency

Abstract

Drugs as a special product have to be efficient, safe and present good quality, with the purpose of minimizing the possible risks to the population health which could be verified through a rigorous technical analysis of the register requirements. The aim of this study is to expose medicine registration grant as an administrative act which allows manufacturing rights and the launch of products into the market. Despite being considered an entailed act, some technicians decisions about medicine registration are based on technical discretionary, requiring a well-based technical foundation of the part of the public administration to ensure correct decisions, considering that the procedures are not totally detailed by legislation.