Mock-up assessment no longer required
The Veterinary Sciences Department (VSD) has revised its requirements for submitting mock-ups for new marketing authorisation and variation applications.
From the 1st of March 2026, the HPRA will no longer require submission of mock-ups for review and approval for any veterinary medicinal product application type.
This change arises as a result engagement with stakeholders and the successful implementation of a risk-based mock-up surveillance programme by the HPRA. The new policy will reduce administrative burden for both the HPRA and Marketing Authorisation Holders (MAH), whilst ensuring that appropriate regulatory oversight of product labelling on the market is maintained. Nevertheless, the HPRA reserves the right to request submission of mock-ups during a procedure, where it is deemed necessary.
The surveillance programme
The surveillance programme has been in place for two years and is operated by authorised officers who collect samples from any point in the Irish supply chain. Samples are examined for compliance with their registered product information, readability and determining if they can be used as per instructions in the package leaflet. The assessment findings are shared with the MAH and in cases of non-compliance, the necessary corrective actions are communicated to the MAH. More information on the sampling and analysis of veterinary medicines may be found on the HPRA website (Sampling and analysis of medicines for animal use).
MAH Responsibility
It is the responsibility of the MAH to ensure that:
The mock-ups accurately reflect the agreed QRD texts and national requirements.
The font size used is appropriate and that all elements of the mock-ups are legible.
The mock-ups are in compliance with the Guide to Preparation of Mock-ups for Veterinary Medicinal Products available on the HPRA website.
Guide to preparation of Mock ups for Veterinary Medicinal Products v5
PDF : 164 KB | 01/05/2024 View tracked changesOngoing applications affected by these changes
As of the 1st March 2026:
For ongoing new marketing authorisation or variation applications the VSD will complete assessment of mock-ups already received.
For recently issued new marketing authorisations for which a G.I.15z variation has been requested but not yet received, submission of the variation will no longer be required, and the MAH should prepare the mock-ups in accordance with point 3 above.
Where a new marketing authorisation application has not reached mock-up assessment phase, the marketing authorisation will be issued without requiring or requesting mock-ups.
Joint-labelled veterinary medicinal products
The operation of the joint-labelling procedure as agreed between the HPRA and Veterinary Medicines Directorate (VMD) will continue. For products eligible for a joint-label (Guide to joint-labelling for veterinary medicinal products for use in Ireland and the UK), the MAH should prepare the mock-ups in accordance with point 3 above but will no longer be required to submit them to the HPRA for approval. However, mock-ups should continue to be submitted to the VMD according to agreed VMD policy for mock-up submission.
Voluntary submission of mock-ups for assessment
An MAH may, on a voluntary basis, submit a G.I.15z VRA, for review and approval of mock-ups if they wish the HPRA to conduct an assessment of their mock-ups for a product.