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FOI release

FOI2026/00905 - Adverse event report line

Published 12 August 2026

© Crown copyright 2026

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This publication is available at https://www.gov.uk/government/publications/vmd-foieir-requests-may-2026/foi202600905-adverse-event-report-line

1. Your request

I am writing to make a formal request under the Freedom of Information Act 2000.

I request the following information:

  1. On how many separate occasions was the VMD’s adverse event report line in-operational during the five-year period from 1 April 2016 to 31 March 2021?

  2. For what total cumulative duration (in days, weeks or months, as appropriate) was the adverse event report line in-operational during that same five-year period?

  3. On how many separate occasions was the VMD’s adverse event report line in-operational during the five-year period from 1 April 2021 to 31 March 2026?

  4. For what total cumulative duration (in days, weeks or months, as appropriate) was the adverse event report line in-operational during that same five-year period?

  5. What measures, if any, were put in place to ensure that adverse events could still be reported during any periods when the line was in-operational, and how were those measures communicated to veterinary professionals and members of the public?

2. Our reply

In the five-year period prior to 31 March 2021 and for the period from 1st April 2021 to the present, the VMD has been able to receive adverse event reports from Marketing Authorisation Holders 100% of the time.

The VMD’s online portal for directly reporting suspect adverse events to us was suspended between December 2024 and 19th May 2026, following which an enhanced digital reporting service was implemented. This new digital service for reporting adverse events integrates with our broader pharmacovigilance systems, providing veterinary professionals and members of the public with the ability to directly report adverse events to us as the regulator whilst maintaining data quality standards.

The VMD has also published updated guidance on pharmacovigilance for animal health professionals and animal owners, including information on:

Interim measures were in place during the development of the new service: reports of adverse events for authorised veterinary medicines were made directly to the Marketing Authorisation Holder (MAH) and veterinary professionals and animal owners contacted the VMD directly for cases where MAH identification was challenging or for unauthorised/human medicines.

MAHs have a legal responsibility to establish and maintain a system for collecting, collating and evaluating information in relation to adverse events, which facilitates the coordinated capture of comprehensive adverse event data, including essential follow-up information, required for robust safety assessment.

Under recent updates to the Veterinary Medicines Regulations, MAHs must now submit both serious and non-serious adverse events within 30 days of becoming aware of them. This unified timeline enables them to provide more complete, higher-quality data from the outset, reducing our need for subsequent follow-up enquiries. MAHs are also required to submit periodic reports more frequently than before and must inform us within 1-3 days of urgent suspected emerging safety signals and 30 days for non-urgent signals related to their product.

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