VMD Strengthens Pharmacovigilance Framework Whilst Addressing Reporting Concerns
Source: gov.uk (2025-08-13)

VMD outlines plans to strengthen pharmacovigilance framework and confirms interim adverse event reporting routes whilst a new system is developed.

The Veterinary Medicines Directorate (VMD) today outlines its comprehensive approach to veterinary medicine safety monitoring following concerns about changes to adverse event reporting processes, confirming interim measures to ensure continued robust pharmacovigilance.

Maintaining Comprehensive Reporting Options

Whilst developing an enhanced online reporting portal, the VMD has ensured there are sufficient reporting routes in place so that no adverse events go unreported. Veterinary professionals can contact the VMD pharmacovigilance team directly where Marketing Authorisation Holder (MAH) identification proves challenging or if reports concern an unauthorised or human medicine.

We understand stakeholder concerns about reporting accessibility and are committed to maintaining multiple reporting routes,” said Giles Paiba, Head of Pharmacovigilance.

These interim measures ensure comprehensive adverse event reporting whilst we develop improved long-term solutions.

Of approximately 19,000 electronic adverse event reports received by the VMD in 2024, around 86% came through established MAH channels. This demonstrates the criticality of our main reporting route being directly through MAH channels.

Enhanced Regulatory Framework

The VMD’s pharmacovigilance system has previously been strengthened through recent regulatory updates made as part of the 2024 updates to the Veterinary Medicines Regulations. The VMD now receives both serious and non-serious AEs within 30 days of the MAH being made aware of them, to improve data quality and reduce the need for follow-up enquiries. This change enables more comprehensive initial reporting whilst maintaining rigorous safety standards.

Developing Pharmacovigilance Capabilities

The VMD is developing an advanced online adverse event reporting portal, with implementation targeted for early 2026. This system will integrate with existing pharmacovigilance processes to provide more comprehensive safety oversight, and an enhanced and efficient process.

The temporary suspension of the previous direct online reporting tool enables development of a more effective, integrated system. Marketing Authorisation Holders continue to receive and process adverse event reports, providing detailed safety information that undergoes rigorous VMD review and often produces higher quality data due to companies’ ability to conduct thorough follow-up investigations.

To further enhance our pharmacovigilance operations, we are developing two additional systems to improve our assessment capabilities. A new signal management system will integrate safety signals and related data from multiple sources (including VMD’s periodic statistical analysis and searches; MAH reports; APHA alerts and data from other regulators and internal VMD teams). Alongside this, we are developing improved database mining, data comparison and automated incidence calculations. These systems will substantially improve both the quality and volume of our safety assessments.

Addressing Stakeholder Concerns

The VMD has reviewed our guidance to ensure clarity about all available reporting routes and will provide regular progress updates on enhanced reporting capability development.

The VMD strongly encourage veterinary professionals to continue reporting detailed adverse event reports for authorised Veterinary Medicinal Products through MAHs.

If an animal has been given a human medicine or a medicine that is not approved for use in animals, then there would be no animal pharmaceutical company to report these to, therefore you can report these directly to the VMD by e-mailing xxx@xxx.xx (mailto:xxx@xxx.xx) to request a reporting form.

If you no longer have the medicine packaging, you can check if a product is an approved animal medicine and who the medicine marketing authorisation (MA) holder is on the product information database (https://www.gov.uk/check-animal-medicine-licensed).

This approach provides a unified view of product safety profiles, enabling both manufacturers and VMD to make a full risk assessment and respond to emerging safety signals appropriately.

Notes:
- The VMD is the UK’s regulatory authority for veterinary medicines, responsible for promoting animal health and welfare by assuring the safety, quality and efficacy of veterinary medicines.
- Pharmacovigilance encompasses all activities relating to the detection, assessment, understanding and prevention of adverse effects or other problems related to veterinary medicines.