Actu Pharmacovigilance
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Actu Pharmacovigilance
L'actualité réglementaire de la pharmacovigilance en Europe
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Scooped by EVELYNE PIERRON
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European Medicines Agency - Regulatory information - Revision of procedural guidance to reflect update of variations guidelines from the European Commission

EVELYNE PIERRON's insight:

The European Medicines Agency has revised its procedural guidance for pharmaceutical companies to reflect the recent changes to the European Commission’s guidelines on variations to the terms of marketing authorisations for medicines for human and veterinary use. Changes are applicable as of 4 August 2013.

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Rescooped by EVELYNE PIERRON from Actualités monde de la santé
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Implementation of pharmacovigilance legislation

Key information (implementation date) on public consultation regarding pharmacovigilance topics: PSURs, Risk management Plans (RMP), Post Authorisation safety and efficacy Studies

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