Recommendation for the basic surveillance of Eudravigilance veterinary data

  • Email
  • Help
Current effective versionRevised recommendation
Reference numberEMA/CVMP/PhVWP/171122/2016
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


How helpful is this page?

Average rating:

 Based on 31 ratings

Add your rating:

See all ratings
6 ratings
6 ratings
6 ratings
6 ratings
7 ratings

Tell us more