This webpage contains relevant and up-to-date information relating to veterinary pharmacovigilance that may be of interest to marketing authorisation holders and applicants. Links to the sources of the information are included for ease of access.
New veterinary legislation
On 28 January 2022 the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) and the Commission Implementing Regulation (EU) 2021/1281 came into effect. This new legislation represents a substantial change in how veterinary medicinal products are authorised, monitored and controlled in the European Union. Section 5 of the Regulation addresses pharmacovigilance requirements and in particular, Article 77 sets out the pharmacovigilance responsibilities of the marketing authorisation holder, while Article 78 sets out the responsibilities of the qualified person responsible for pharmacovigilance.
As and from 28 January 2022, marketing authorisation holders are expected to have in place a Summary of the Pharmacovigilance System Master File (PSMF) for their products. This replaces what was formally known as the Detailed Description of the Pharmacovigilance System (DDPS). New applications for marketing authorisation must include a summary of the PSMF (not the actual PSMF).
Guidelines on veterinary good pharmacovigilance practices (VGVP)
A series of guidelines on veterinary good pharmacovigilance practices (VGVP guidelines) have been developed by the European Medicines Agency (EMA). These modules replace Volume 9B of the Notice to Applicants and can be accessed from the EMA website. The links to these modules are included below:
Adverse events and use of Veterinary Dictionary for Drug Related Affairs (VeDDRA) terminology
A Question & Answer document has been published by the EMA describing how adverse events should be described in the product information and can be accessed from the EMA website at the link below:
Questions and answers on describing adverse events in the product information (summary of product characteristics (SPC) and package leaflet (PL))
Adverse events should be described in the product information using approved VeDDRA terms. The list of currently approved VeDDRA terms is published on the EMA website and can be accessed at the link below:
Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products
Eudravigilance
The EMA has published Eudravigilance Veterinary user manuals for EVVT3 (the Union Pharmacovigilance Database) and the Data Warehouse. These are available on the EMA website and can be accessed at the links below:
EVVET - EVWEB User Manual
EVVET – Data Warehouse User Manual
Signal management
An important aspect of the new veterinary legislation relates to the process of ‘signal management’ (Article 81) and marketing authorisation holders and applicants should ensure that they are familiar with what is required. Useful information on the signal management process and how to submit signals is available on the EMA website using the following links:
Guideline on veterinary good pharmacovigilance practices (VGVP) Module: Signal Management
A template signal assessment report for use by marketing authorisation holders when submitting a signal is available here:
Veterinary signal assessment report template for marketing authorisation holders
How to submit pharmacovigilance-related variations not requiring assessment (VNRAs) in the Union Product Database (UPD)
The EMA has published two short videos on how to submit variations not requiring assessment (VNRAs) in the Union Product Database (UPD) which can be viewed below.
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Video 1: How to submit VNRAs related to QPPV information
This video providence guidance for a category C.1 VNRA relating to a change in the name, address or contact details of the Qualified Person responsible for Pharmacovigilance (QPPV).
Video 2: How to submit VNRAs related to PSMF information
This video provides guidance for category C.5 & C.6 VNRAs relating to a change in the location of the Pharmacovigilance System Master File (PSMF) or the introduction of a summary of the PSMF or changes to the summary of the PSMF.
Technical grouping of VNRAs is possible for VNRA categories C1, C5 and C6 provided that the Reference Member State (RMS) is the same for all products included in the grouping and that any nationally-authorised products included are also authorised in the RMS i.e., the same authority is the decision maker for all products that are included in the grouping.