The Veterinary Medicines Directorate (VMD) will introduce a new Veterinary Medicines Packaging Monitoring System from 2 February 2026.
This will change the way VMD evaluates and monitors veterinary drug packaging to ensure proper oversight while reducing regulatory burden on the veterinary health industry.
By monitoring products already on the market, regulators can ensure adequate oversight without incurring unnecessary administrative burdens.
Evaluation of veterinary drug packaging
Every three months, VMD selects a group of veterinary drugs for packaging evaluation.
These products are sourced from wholesalers and all packaging components are inspected.
The assessment verifies that the packaging complies with the principles set out in approved product information text (QRD) and product documentation standards.
Report of survey results
The VMD will share the evaluation results with the market authorization holder (MAH) for the animal medicinal product within a three-month evaluation period.
If non-compliance is identified, the VMD will notify the MAH outlining the required corrective actions.
These actions range from requiring manufacturers to update veterinary drug packaging at the next regulatory opportunity for less serious issues, to requiring formal variations to be submitted to correct mock-ups, to tracking issues as product defects in the most serious cases.
Mockup evaluation changes
As part of a new monitoring scheme to support regulatory compliance in the animal health market, VMD has revised its mock-up submission requirements.
From February 2, 2026, mockups will no longer be required for the GI18 Variation Request Assessment (VRA) and new Marketing Authorization (MA) procedures.
VMD will continue to review and approve mockups through the GI15.z VRA in the following scenarios:
Deploying mockups for the first time prior to marketing Conducting a joint evaluation of mockups between VMD and HPRA after granting a new MA Evaluating significant changes in mockup design or layout that are not related to the overview of product characteristics (SPC)
If a mockup is required, only the smallest commercially available pack size will be submitted for evaluation.
VMD does not regularly evaluate or annotate mockups in other variation categories. However, it may be requested on a case-by-case basis if it is considered to have a significant impact on the overall design and readability.
Applications in progress are affected by these changes
For GI18 VRA and new MA applications in progress as of February 2, 2026, VMD will continue to evaluate mockups already requested or received and consider all pack sizes submitted.
If your application has not reached the mockup evaluation stage, your application will be issued without the need for a mockup.
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