Recommendation on harmonising the approach to causality assessment for adverse events to veterinary medicinal products (revision 1)

Current effective version PDF iconAdopted recommendation
Reference number EMA/CVMP/PhVWP/552/2003 – Rev.1
Published 18/10/2013
Effective from 01/01/2014
Keywords Causality assessment, lack of expected efficacy (LEE)

This recommendation provides further guidance on how to carry out causality assessment, based on the principles laid out in Volume 9B of The Rules Governing Medicinal Products in the European Union (EU) – Guidelines on Pharmacovigilance for Medicinal Products for Veterinary Use and includes additional guidance on causality assessment of adverse events classified as off-label and lack of expected efficacy (LEE) concerning pharmaceuticals.

Document history

Revision 1
Current version

PDF iconAdopted recommendation

PDF iconOverview of comments


PDF iconDraft recommendation


PDF iconConcept paper

Published: 18/10/2013

Published: 18/10/2013


Published: 15/02/2013


Published: 25/07/2012

First version

PDF iconAdopted guideline In operation: 15/10/2004 – 01/01/2014

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