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:
-
To introduce mock-ups for the first time prior to marketing
-
To undertake joint assessment of mock-ups between
VMD and HPRA following granting of a new MA
-
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.
