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Feed/DEA2017/2923(DEA)Trade & Economy

EMA pharmacovigilance fees: inflation adjustment (Reg 658/2014)

COMCMT1R-EP1R-C2R-EPCNCADO
Updated 107mo ago
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This procedure updates the fees that pharmaceutical companies must pay to the European Medicines Agency (EMA) for monitoring the safety of medicines (pharmacovigilance). The adjustment is necessary to align the payment amounts with current inflation rates, ensuring the agency has the resources to maintain safety monitoring for human medicines.

This change primarily affects pharmaceutical companies and manufacturers of medicinal products for human use, who will see an increase in the fees payable for safety monitoring activities.