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Biological and biosimilar medicinal products have specific characteristics that call for a closer monitoring of their safety profile. Since the current legal framework stems from both European and national regulations, some gaps in the operational field may be expected. The goal of this paper is to identify these gaps and propose changes to the current information systems and pharmacovigilance regulations.

Medicamentos Biológicos e Biossimilares: Descontinuidades no Sistema de Farmacovigilância em Portugal