Information on pharmacovigilance for marketing authorisation holders and applicants
This webpage contains relevant and up-to-date information relating to veterinary pharmacovigilance that may be of interest to marketing authorisation holders (MAH) and applicants. Links to the sources of the information are included for ease of access.
Guidelines on veterinary good pharmacovigilance practices (VGVP)
The European Medicines Agency (EMA) has published a number of guidelines on veterinary good pharmacovigilance practices (VGVP guidelines). The links to these modules are included below:
- Collection and recording of suspected adverse events for veterinary medicinal products
- Signal Management
- Veterinary pharmacovigilance communication
- Pharmacovigilance systems, their quality management systems and pharmacovigilance system master files
- Controls and pharmacovigilance Inspections
- Glossary
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:
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:
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 – Data Warehouse User Manual
Signal management
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
From 1 May 2023, for any signal which has submitted to the IRIS platform of the Union Pharmacovigilance Database and which has been assessed by the MAH as a change to the benefit-risk balance or a new risk requiring change(s) to the product information, MAHs are required to also submit a G.I.19 VRA to the relevant competent authority.
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.
Note on website cookies
Please note that the videos are only available to view if you have selected the relevant preferences in the cookie settings for our website. The videos are also available to view on the EMA’s YouTube account.
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).
Note that the QPPV email address should be
either
- The email of the QPPV as specified in Article 77(8) of Regulation (EU) 2019/6, responsible for tasks in Article 78 (e.g., john.smith@domain.com), and consistent with that included/to be included in the PSMF summary;
or
- A functional email for pharmacovigilance issues when one has been set up by the MAH (e.g., vetqppv@domain.com).
As only one email address may be recorded in the UPD per product, in case of discrepancies between the QPPV email address in UPD and the PSMF summary, the latter should be updated to match the QPPV email in the UPD when the PSMF summary is next changed by a VNRA. Currently, there is no requirement for MAHs to update the PSMF summary.
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 and supergrouping of certain VNRA categories has been introduced to allow these specific VNRAs to be processed in a more timely and efficient manner. Submission of these grouped VNRAs is subject to certain conditions. MAHs are advised to refer to the Best Practice Guide on Variations not requiring assessment for details to ensure their submission is in line with guidance.