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EU publishes new drafts of patient information and pharmacovigilance proposals

This article was originally published in SRA

Executive Summary

The European Commission has published the revised proposals on pharmacovigilance and information to patients, following its decision on 2 December last year to separate the two1. The two proposals, which each take the form of a draft directive and draft regulation, have now been sent to the European Parliament and the Council of Ministers for discussion.

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