Brazilian Hemovigilance Guidelines
Anvisa launches Brazilian Hemovigilance Guidelines and Brazilian Hemovigilance Report
The guidelines describes the new conceptual and operational framework for the National Hemovigilance System in Brazil, formulated for each one of the blood cycle steps. It is based on the regulations in force for the technical and health procedures of hemotherapy.
The report presents the national consolidated data from 2007 to 2014. It was developed based on the notifications of adverse events to the use of blood and its components.
The Brazillian Health Regulatory Agency (Anvisa) was created by Law 9782, enacted in 1999. It is a governmental regulatory agency characterized by its administrative independence, financial autonomy, and the stability of its directors. Anvisa is ruled by a Collegiate Board of Directors composed of five members.
In the federal public administrative structure, the agency is connected to the Ministry of Health, with whom a periodic management contract is signed.
Anvisa’s primary goal is to protect and promote public health, by exercising health surveillance over products and services, including processes, ingredients and technologies that pose any health risks.
The agency is also responsible for health control in ports, airports and borders, as well as for establishing relations with the Ministry of International Affairs and with foreign organisms and institutions to deal with international affairs regarding health surveillance.