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

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.”

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