VMD to improve pharmacovigilance framework
A new reporting tool is expected to be released in 2026.
The Veterinary Medicines Directorate (VMD) has shared new plans to improve its veterinary medicine safety monitoring process.
It has also announced a number of interim measures, after receiving concerns about changes to adverse event reporting processes.
As part of its measures to improve pharmacovigilance, the regulatory authority has committed to the development of an enhanced online reporting tool. The system, which will integrate existing processes, is expected to be released in 2026.
The VMD is working to develop two additional systems to improve its assessments.
The first process is a signal management system. This will integrate safety signals, as well as sourcing related data from the VMD’s periodic statistical analysis and searches; MAH reports; and APHA alerts.
It is also developing its database mining, data comparison and automated incidence calculations.
In the meantime, it says it has maintained reporting routes to ensure adverse events continue to be reported. If Marketing Authorisation Holder (MAH) identification is challenging, or the report is of an unauthorised or human medicine, veterinary professionals are urged to contact the VMD’s pharmacovigilance team directly.
Recent regulatory updates, made to the Veterinary Medicines Regulations in 2024, are also said to have strengthened the VMD’s reporting systems. It now receives serious and non-serious reports of adverse events within 30 days of the MAH being notified.
The VMD says this improves data quality, reduces follow-up enquiries and enables more comprehensive initial reporting.
Amidst these changes, the VMD has encouraged veterinary professionals to continue submitting detailed reports for authorised Veterinary Medicinal Products through MAHs. Meanwhile, concerns about human medicines and unauthorised medicines should be sent directly to adverse.events@vmd.gov.uk to request a reporting form.
The regulatory authority say it has reviewed its guidance to provide clarity on the available reporting routes, and will continue to provide regular progress updates on the development of the new systems.
Giles Paiba, head of pharmacovigilance, said: “We understand stakeholder concerns about reporting accessibility and are committed to maintaining multiple reporting routes,
“These interim measures ensure comprehensive adverse event reporting whilst we develop improved long-term solutions.”
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Companies marketing medicines for small pets exempt from authorisation must submit their annual return to the Veterinary Medicines Directorate (VMD) by 30 November 2026.
