The Veterinary Medicines Directorate (VMD) is introducing a new veterinary medicines packaging surveillance scheme from 2 February 2026.
This will change how the VMD assesses and monitors veterinary medicine packaging to ensure proportionate oversight whilst reducing regulatory burden on the animal health industry. By monitoring products already on the market, the regulator can ensure proportionate oversight without unnecessary administrative burden.
What will the scheme assess
Every three months, the VMD will select a group of products for packaging assessment. These products will be sourced from wholesalers, and all packaging components will be reviewed. The assessment will verify that the packaging complies with the approved product information text (QRD) and the principles set out in the Product Literature Standards.
How will assessment findings be reported
The VMD will share the assessment findings with the Market Authorisation Holder (MAH) for the product concerned within the three-month assessment period.
Where non-compliance is identified, the VMD will outline the necessary corrective actions to the MAH. These actions may range from requiring the MAH to update packaging at the next regulatory opportunity for low-severity issues, to requiring submission of a formal variation to correct mock-ups, and in the most severe cases, tracking the issue as a product defect. The timeframe for implementing these actions will depend on the severity of the specific issue(s) identified.
Mock-up assessment changes
As part of the new surveillance scheme supporting regulatory compliance in the market, the VMD has revised its requirements for submitting mock-ups.
From 2 February 2026 mock-ups will no longer be required for G.I.18 Variations Requiring Assessment (VRA) and during a new Marketing Authorisation (MA) procedure.
The VMD will continue to review and approve mock-ups in the following scenarios via a G.I.15.z VRA
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To introduce mock-ups for the first time prior to marketing
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To undertake joint assessment of mock-ups between VMD and HPRA following granting of a new MA
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To assess significant changes to the design or layout of the mock-ups that are unrelated to the summary of product characteristics (SPC)
Where mock-ups are required, only those for the smallest marketed pack size are to be submitted for assessment.
The VMD will not routinely assess or annotate mock-ups for other variation categories. However, these may be requested on a case-by-case basis where we consider that the overall design and readability could be significantly affected.
Ongoing applications affected by these changes
For ongoing G.I.18 VRAs and new MA applications as of 2 February 2026, the VMD will continue to assess mock-ups already requested or received, reviewing all submitted pack sizes. Where an application has not reached mock-up assessment phase, the application will be issued without requiring mock-ups.
Contact
For any queries relating to this news item, please email [email protected].
