VMD introduces new packaging surveillance scheme
The regulator will now monitor products which are already on the market.
The Veterinary Medicines Directorate (VMD) is to introduce a new veterinary medicines packaging surveillance scheme, which is expected to streamline the regulation process.
The new scheme, which launches from 2 February 2026, will change how the VMD assesses and monitors medicine packaging. The regulator will now monitor products which are already on the market, ensuring proportionate oversight without unnecessary burden.
Every three months, a selection of products will be chosen for a packaging assessment. The products will be taken from wholesalers, and every packaging component will be reviewed.
The assessment verifies whether the packaging is compliant with approved product information text (QRD) and principles set out in the Product Literature Standards.
Findings will be shared with the Market Authorisation Holder (MAH) within the three-month assessment period. If non-compliance is identified, corrective actions will be sent – varying from updating packaging, submission of a formal variation, and tracking product defects.
The timeframe for implementing actions is dependent on the severity of identified issues.
The VMD will also no longer require mock-ups for G.I.18 Variations Requiring Assessments (VRA) and during a new Marketing Authorisation (MA) procedure. However it will continue to review mock-ups which are introduced prior to marketing, undertake joint assessment of mock-ups ahead of a new MA, and assess significant changes to design or layout which are unrelated to SPCs.
If a mock-up is required, only those which are for the smallest marketed pack size should be submitted.
The VMD says it will not routinely assess or annotate mock-ups for other variation categories. However, it may request other mock-ups on a case-by-case basis.
More details can be found on the VMD website.
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