Recommendation for the basic surveillance of Eudravigilance veterinary data

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Current effective versionRevised recommendation
Reference numberEMA/CVMP/PhVWP/171122/2016
Published04/06/2018
Effective from01/06/2018
KeywordsVeterinary pharmacovigilance, surveillance, adverse event, adverse reaction, lack of expected efficacy, side-effect
DescriptionThis is the first revision of the recommendation for the basic surveillance of EudraVigilance Veterinary (EVVet) data. The main aim of the revision is to improve the overall pharmacovigilance surveillance process, where possible, by integrating periodic safety update report (PSUR) evaluation and signal detection processes based on EVVet data and using risk-based principles.


Document history

Superseeding document

Current version

Revised recommendation
 


Overview of comments
 

Draft guideline
 

Concept paper

Published: 04/06/2018
Effective from: 01/06/2018  
 

Published: 04/06/2018
 

Published: 24/02/2017
 

Published: 20/11/2015

First version

Adopted recommendation

 

Overview of comments
 

Draft recommendation
 

Concept paper

Published: 01/03/2011

 

Published: 01/03/2011
 

Published: 03/06/2010
 

Published: 22/06/2006

 

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