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. At present the centralised procedure (CAPs). The revised recommendation is primarily intended for regulators to evaluate pharmacovigilance data from marketing authorisation holders (MAHs) who elect to submit all their adverse event (AE) reports (including non-expedited) electronically. The revised recommendation
was piloted during the consultation process. The experience gained from the pilot, together with the comments received during the public consultation have been taken into account to further refine the proposals outlined in this document. Further simplification of the PSUR structure, focusing on a critical evaluation of the benefit-risk balance of the product and complemented by a complete electronic dataset form the basis of this revised recommendation for continuing to improve surveillance of CAPs.


Revised recommendation for the basic surveillance of EudraVigilance Veterinary (EVVet) data for centrally authorised products (CAPs)