Recommendation for the basic surveillance of Eudravigilance veterinary data

Current effective version PDF iconRevised recommendation
Reference number EMA/CVMP/PhVWP/171122/2016
Published 04/06/2018
Effective from 01/06/2018
Keywords

Veterinary pharmacovigilance, surveillance, adverse event, adverse reaction, lack of expected efficacy, side-effect.

Description

This 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

PDF iconRevised recommendation

Overview of comments

Draft guideline

PDF iconConcept paper

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

Published: 04/06/2018

Published: 24/02/2017

Published: 20/11/2015

First version

PDF iconAdopted recommendation

 

Overview of comments

Draft recommendation

PDF iconConcept paper

Published: 01/03/2011

Published: 01/03/2011

Published: 03/06/2010

Published: 22/06/2006

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