Article summary
The European Commission has opened a consultation into the Commission Implementing Regulation (EU) 520/2012 on the performance of pharmacovigilance activities (IR) after a consultation with the European Medicines Agency and Pharmacovigilance Risk Assessment Committee identified amendments to update provisions in view of new technical standards. The Commission’s consultation aims to inform and consult on these amendments. The deadline for responses is 15 October 2021.
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