Joint assessment for veterinary medicines for use in the UK and Ireland
Guidance for the veterinary pharmaceutical industry on how to apply for and maintain a shared-label for use on veterinary medicines placed on the market in the UK and Ireland.
Eligible Marketing Authorisations and criteria
Joint assessment is the term used for a procedure where the Irish National Competent Authority (HPRA) and VMD will collaborate on the assessment of a shared mock-up, for use on veterinary medicines marketed in their countries.
Joint assessment of labelling can be achieved between Great Britain (GB) and Ireland (IE), Northern Ireland (NI) and IE or all three - GB, IE and NI. You should also refer to the HPRA guidance.
The products involved in the joint assessment procedure must:
- hold Marketing Authorisations (MAs) in both the UK, or part of, and Ireland
- have product information requirements which are the same
To obtain joint assessment, the Summary of Product Characteristics (SPC) and QRD must be identical in the relevant territories. To maintain joint assessment the SPC/QRD must remain harmonised. You can apply following issue of a new MA or retrospectively for existing MAs, whether authorised by EU or national procedures.
You can opt out of joint assessment, but the UK and Ireland will conduct independent assessments and cannot help you maintain the harmonised nature of the labels/leaflets.
Joint assessment of labels following a new MA procedure
Joint assessment of labels with Ireland can only be carried out as a G.I.15.z variation (VRA-R).
For new MA applications, once the MA has been issued, you will need to submit subsequent G.I.15.z VRA-R applications to both the VMD and HPRA in parallel, prior to marketing.
Centrally Authorised Products
Mock-ups for Centrally Authorised Products (CAPs) submitted to IE and NI are not assessed by national competent authorities; however, they must reflect the agreed QRD text and observe “blue box” requirements.
Mock-ups submitted in support of an equivalent GB national application will be assessed by the VMD by way of a G.I.15.z VRA-R in accordance with our national requirements and standard 20-day timetable.
Introducing joint assessment for existing MAs
To be eligible for a joint assessment of authorised products, the product information must be identical in both the UK and IE. Where the QRD for the products involved are not the same, these will need to be harmonised first before labels can be jointly assessed. We will not permit any changes to the SPC that requires data to be assessed. You should simultaneously submit a U.II.z.d VRA to the VMD and the corresponding variation in IE.
You should make it clear in your application that the purpose of the variation is to request harmonised product information to facilitate shared labels. If / once the QRD is aligned, mock-ups should be submitted for assessment via a G.I.15.z VRA-R.
Maintaining joint-labelling
Joint assessment of mock-ups with Ireland can only be carried out as a G.I.15.z VRA-R, where the requirement for joint assessment is indicated on the application form.
It is your responsibility to ensure your QRDs are harmonised in Great Britain, Northern Ireland and Ireland territories (as applicable).
The VMD only routinely assess mock-ups for G.I.15.z VRA-R but we may request them on a cases-by-case basis, following other variations, if the overall design and readability are significantly affected. For further information on when HPRA require assessment of the labelling and package leaflet for veterinary medicinal products, see HPRA’s website.
Submission of mock-ups
Only the mock-ups representing worst case in terms of readability for each label/outer package (usually the smallest pack size) and the package leaflet need be submitted for approval. Should you submit a mock-up package containing additional pack sizes, you will be asked to remove these. For further information on HPRA requirements, see HPRA’s website.
Fees
Once an application has passed validation, you will be sent an invoice for the fee by email so you must provide a valid email address in your application.
See Payment of application fees for veterinary medicines.
Joint Assessment timetable
The VMD and HPRA will decide who will lead the assessment. The lead country draws up the timetable and emails it to you and the other country.
- Day 0 – Assessment begins
- By day 11 – The lead country sends their comments to the other country
- By day 17 – The other country adds their comments and sends it back to the lead country
- By day 20 – The lead country sends the consolidated list of comments to you, copied to the other country and requests revised mock-ups, if needed. These should be submitted to both countries. The clock stops and enters the company response period
- Company Response (within 20 days) – you should provide revised mock-ups to both countries indicating agreement or disagreement with the comments. The procedure restarts with the lead country issuing a new 20-day assessment timetable
If there are no comments, or the mock-ups can be approved with minor annotations, the mock-ups will be approved. In the unlikely event that we are unable to reach agreement, your application will be refused.
Contact us
Once you have applied, to discuss specific application points contact the people assigned to the application given in the validation passed email.
For all other enquiries email: postmaster@vmd.gov.uk
Updates to this page
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Updated to reflect changes to the process for submitting mock up product labelling effective from 02/02/26.
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Updated to reflect changes to the VMR
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Updated VMD and HPRA guidance and templates on acceptable text for joint-labelled veterinary medicines in the UK and Ireland.
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First published.