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

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Current effective versionAdopted recommendation
Reference numberEMA/CVMP/PhVWP/552/2003 – Rev.1
Effective from01/01/2014
KeywordsCausality assessment, lack of expected efficacy (LEE)
DescriptionThis 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

Adopted recommendation

Overview of comments


Draft recommendation


Concept paper

Published: 18/10/2013

Published: 18/10/2013


Published: 15/02/2013


Published: 25/07/2012

First version


Adopted guideline
In operation: 15/10/2004 – 01/01/2014

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