Ireland’s Health Products Regulatory Authority (HPRA) and the UK’s Veterinary Medicines Directorate (VMD) have produced guidance clarifying the acceptable information that can appear on joint labels for veterinary medicines authorised in the UK and Ireland.
The joint labelling procedure – which has been in operation for more than 20 years – has faced challenges following the UK’s departure from the EU. This interim guidance will bridge the gap between the implementation of Regulation (EU) 2019/6, and the Veterinary Medicines Regulation which is currently under revision and would applicable for Great Britain.
The guidance should be applied where the agreed labelling and package leaflet texts have been approved in Ireland in accordance with Regulation (EU) 2019/6 and where a shared label with GB or the UK is sought. There will also be specific requirement for labels for use in Northern Ireland only.
A spokeperson for the HPRA said this agreement was made: “in the interest of ensuring the continued availability of veterinary medicinal products on both Irish and UK markets.”
Further reading:
Joint HPRA/VMD Guide to Acceptable Texts for Joint Labelling for Veterinary Medicinal Products for use in Ireland and the UK
Marketing Authorisation Applications NATIONAL SPC/QRD TEMPLATE V2 – updated 13/06/23
Mitigation explainer: Labelling text
VMD and HPRA guidance on acceptable text for joint-labelled veterinary medicines in the UK and Ireland
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