New rules ease veterinary regulation.
The Veterinary Medicines Directorate will launch a new packaging surveillance scheme on 2 February 2026. The change aims to protect animal health while reducing regulatory workload for the veterinary medicines industry.
Instead of focusing on pre-approval checks, the regulator will monitor products already on the market. As a result, oversight remains strong without adding extra administrative steps.
How packaging will be assessed
Every three months, the VMD will choose a selection of veterinary medicines for review. The agency will source these products directly from wholesalers.
It will then examine all packaging materials. This includes labels, leaflets, and outer packaging.
The review will confirm that the packaging matches the approved product text. It will also check compliance with Product Literature Standards.
Sharing results with companies
After each assessment cycle, the VMD will share its findings with the relevant Marketing Authorisation Holder. This will happen within the same three-month review period.
If the regulator finds issues, it will explain what action the company must take. Minor issues may only require updates at the next regulatory opportunity. More serious problems may need a formal variation. In rare cases, the VMD may treat the issue as a product defect.
Changes to mock-up submissions
Alongside the new scheme, the VMD has updated its rules on mock-ups. From February 2026, companies will no longer need to submit mock-ups for G.I.18 variations that require assessment or for new marketing authorisations.
This change removes a common source of delay and cost for applicants.
When mock-ups are still required
The VMD will still assess mock-ups in specific cases under a G.I.15.z variation. These include situations where companies introduce mock-ups.
Mock-ups will also be needed for joint reviews with the HPRA after a new authorisation. In addition, significant design or layout changes will still require approval when they are not linked to product characteristics.
When mock-ups are required, companies only need to submit the smallest pack size on the market.
Limited case-by-case reviews
For other types of variations, the VMD will not routinely review mock-ups. However, it may request them if changes could affect design clarity or readability.
This approach allows flexibility while keeping patient and user safety in focus.
What happens to existing applications
Applications already in progress will not be disrupted. For G.I.18 variations and new marketing authorisations submitted before 2 February 2026, the VMD will continue to review any mock-ups it has already requested or received.
It will also assess all submitted pack sizes as part of those ongoing applications.
