A bula de medicamentos e a regulação de suas configurações em termos de forma e conteúdo no Brasil

Abstract

The medicine package leaflet (MPL) is a technical - scientific document regulated by the government, directed at health professionals and patients in order to inform and instruct its users about the use of a medicine. Considering the importance and complexity of the MPL technical - scientific information for its users, there have been changes in the regulation of MPL's content and representative elements. It is questionable, however, which representation the MPL technical - scientific information assumed for users' comprehension. In order to identify and analyze the various configurations the MPL has undergone over time due to the influence of regulatory frameworks, we looked at the representations the MPL technical - scientific information has taken to become adaptable to users' comprehension. A qualitative study was conducted, focused on surveying, identifying, organizing and reading the legal instruments that constitute the MPL national regulatory framework, observing changes in the regulation over time. The results show that its regulation has a legal history, which has been developing for seven decades, along with the establishment of institutions in health and health surveillance by the government. It is also observed that, in spite of MPL's regulatory process development occurring over long periods of time, since the foundation of the National Agency for Sanitary Surveillance (1999) and its public inquiries, this process started to be renewed and improved with a little more frequency. Thus, in the last ten years, MPL regulation has become more specific, regarding form and content.