The UK’s Veterinary Medicines Directorate (VMD) will introduce a veterinary medicines packaging surveillance scheme on 2 February 2026.
The scheme changes how the VMD checks and monitors packaging, with the aim of maintaining proportionate oversight while reducing unnecessary administrative burden for the animal health industry.
Under the scheme, the VMD will select a set of products for packaging assessment every three months.
The selected products will be obtained from wholesalers, and all packaging components will be examined.
The review will check whether the packaging matches the approved product information text (QRD) and whether it follows the principles in the Product Literature Standards.
VMD will provide the findings to the market authorisation holder (MAH) for the relevant product within the same three‑month assessment period.
If the VMD identifies non-compliance, it will set out the corrective actions the MAH must take.
For lower-severity issues, this may include updating packaging at the next regulatory opportunity. It may also advise submitting a formal variation to correct mock-ups, or, in the most serious cases, treating the issue as a product defect.
The timeframe for completing corrective action will depend on how severe the issue or issues are.
As part of the same changes, the VMD has updated its requirements for mock-up submissions.
From 2 February 2026, mock-ups will no longer be required for G.I.18 variations requiring assessment (VRA) or during a new marketing authorisation (MA) procedure.
However, VMD will continue to review and approve mock-ups via a G.I.15.z VRA when mock-ups are being introduced before marketing, to carry out a joint assessment of mock-ups with HPRA following the granting of a new MA, or when there are significant design or layout changes that are not related to the summary of product characteristics (SPC).
