IRACM

Brazil: Department of Justice waivers several safety rules to facilitate rare medicine imports -

Présentation et Définitions Clés

The Department of Justice has given temporary approval for Global Health SA, a management company, to import three highly expensive medicines, without prior health agency (ANVISA) monitoring, to treat rare diseases. The temporary approval applies to Febrazyme, Myozyme and Aldurazyme. The decision is of concern for ANVISA who affirms that without medicine monitoring, it is impossible to ensure medicine quality and safety. “A company which has not received authorization to import and distribute medicines cannot guarantee that the products will be correctly stored and transported. In other words, people who take these medicines could run a serious health risk.”

Source : www.istoedinheiro.com.br

Back to previous

Ressources et Documentation Complémentaire

Retrouvez l'ensemble des études, alertes et rapports d'analyse publiés par l'IRACM dans notre section documentaire.