Recommendation on management and assessment of periodic safety update reports (PSURs) of veterinary medicinal products

Current effective version PDF iconAdopted recommendation
Reference number EMEA/CVMP/PhVWP/4550/2006
Published 21/10/2008
Effective from 01/01/2009
Keywords

Veterinary medicinal product, safety, pharmacovigilance, suspected adverse reaction (SAR), suspected lack of efficacy, periodic safety update report (PSUR), assessment, competent authority.

Description

This recommendation aims to facilitate assessors' scientific and regulatory assessment of PSURs, and the standardisation of the format of PSUR Assessment Reports (AR) across the EU, regardless of the marketing authorisation procedure. The objective of this harmonisation is to ensure that PSUR ARs are of high quality and contain necessary information in a well-organised format.

The recommendation is addressed to national competent authority assessors of PSURs.


Document history

Current version

PDF iconAdopted recommendation

PDF iconOverview of comments

PDF iconConcept paper

Published: 21/10/2008

Published: 21/10/2008

Published: 13/07/2005


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