Concept paper for revision of the recommendation for the basic surveillance of EudraVigilance Veterinary data

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Document details

Download document Concept paper for revision of the recommendation for the basic surveillance of EudraVigilance Veterinary data
Reference number EMA/CVMP/PhVWP/590073/2015
Status draft: consultation open
First published 20/11/2015
Last updated 20/11/2015
Consultation start date 20/11/2015
Consultation end date 29/02/2016
Email address for submissions vet-guidelines@ema.europa.eu

Summary

This concept paper describes and discusses the need to revise the CVMP recommendation for the basic surveillance of EudraVigilance Veterinary (EVVet) data (EMA/CVMP/PhVWP/471721/2006) for centrally authorized products (CAPs) taking into account the recent adoption of the recommendation on pharmacovigilance surveillance and providing a comprehensive and streamlined surveillance process involving periodic safety update report (PSUR) assessment and signal detection within the framework of the current legislation. The proposed recommendation is for CAPs. The aim of this document is to enhance the impact of pharmacovigilance by strengthening surveillance activities within the resources available.