VMD and HPRA guidance on acceptable text for joint-labelled veterinary medicines in the UK and Ireland
Joint VMD-HPRA guidance explaining additional information permissible on the labelling and package leaflet of veterinary medicines jointly labelled for the UK and Irish market.
The Veterinary Medicines Directorate (VMD) and Health Products Regulatory Authority (HPRA) have developed guidance clarifying the acceptable information that may appear on joint labels for veterinary medicines authorised in the UK and Ireland.
This , updated 5 February 2024, should be applied by Marketing Authorisation Holders 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.
This position has been agreed following communication with our respective stakeholders in the interest of ensuring the continued availability of veterinary medicinal products on both the Irish and UK markets.
Additionally, to support continued joint-labelling, the VMD has reviewed and updated the national to be used by applicants seeking a new GB and/or NI-national MA application, or for applicants seeking to submit a G.I.18 VRA to update their existing product information to the latest templates.
This version 2 template is available to download from our GOV.UK guidance page on Summary of Product Characteristics and product literature for veterinary medicines.
To support understanding of the changes made, a track change version is also available to download . Further information on the implementation of this interim national template under the VMD’s “airgap” mitigations is available in the Mitigation explainer: Labelling text guidance.
Please note:
- the above guidance and version 2 national template are effective for new MA applications and G.I.18 variations received from 13 June 2023.
- for ongoing applications received prior to 13 June 2023, applicants will be offered the opportunity to convert their QRD text to be in accordance with the version 2 template as part of our list of questions.
- for ongoing applications nearing the end of the assessment phase, or already in mock-up phase, where there are no further timetabled question opportunities, the agreed QRD text and mock-ups will continue to be compliant with the version 1 template.
The VMD also grant MAHs up to 12-months from the date of approval of a G.I.18 VRA to implement the labelling changes.
This exceptional extension is only applicable to changes agreed under a G.I.18 VRA and does not apply in instances where the G.I.18 VRA is grouped with additional changes to the product information.
For all queries concerning this joint guidance, please email postmaster@vmd.gov.uk.
Last updated 8 February 2024 + show all updates
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Updated referenced VMD and HPRA guidance on acceptable text for joint-labelled veterinary medicines in the UK and Ireland.
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First published.