Anvisa and Dinavisa sign agreement to combat illegal products

Brazil’s National Health Surveillance Agency (Anvisa) and Paraguay’s National Directorate of Sanitary Surveillance (Dinavisa) have signed a five-year cooperation agreement to combat illegal products and exchange information. The agreement replaces a previous memorandum from March 2024 and focuses on preventing counterfeiting, smuggling, and the irregular circulation of regulated goods.

Key provisions include laboratory test sharing, coordinated control actions in border regions, and data exchange to improve the identification of irregular products. Anvisa President Leandro Safatle stated the goal is to ‘improve the safety profile of products distributed in the Brazilian market,’ noting that the partnership will not create exceptions for the entry of unauthorized Paraguayan products.

The move comes amid a surge in unauthorized medications entering Brazil from Paraguay. Specifically, there has been a rise in the circulation of unregulated versions of tirzepatide, the active ingredient in Eli Lilly’s obesity treatment Mounjaro. Due to the high cost of the original medication, demand for cheaper, unauthorized alternatives has increased. In Foz do Iguaçu, federal seizures of such medications rose by 860.8% in one year, increasing from 7,479 to 71,860 units.