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Commission proposes 'fairer' mixed fee system to cover EMA's pharmacovigilance costs

This article was originally published in SRA

Executive Summary

Following strong criticism over its 2012 proposals for EU pharmacovigilance fees, and suggestions earlier this year that it was considering a flat fee system instead, the European Commission has gone for a compromise: a mixture of a flat fee and a range of individual payments for procedures such as safety referrals and periodic safety update reports (PSURs)1-4.

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