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HMA updates guide on renewal of drug authorisations in light of EU pharmacovigilance law

This article was originally published in SRA

Executive Summary

The Heads of Medicines Agencies in the EU has significantly updated its guideline on how applicants and member states should handle renewals of drug marketing authorisations under the mutual recognition and decentralised procedures1. The update pertains to the new requirements introduced by the EU pharmacovigilance legislation (Directive 2010/84/EU)2.

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