Recommendation for the basic surveillance of Eudravigilance veterinary data
| Current effective version |
 Revised 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 |
Published: 04/06/2018 Published: 04/06/2018 Published: 24/02/2017 Published: 20/11/2015 |
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| First version |
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Published: 01/03/2011 Published: 01/03/2011 Published: 03/06/2010 Published: 22/06/2006 |