Veterinary Medicines Directorate
Eligible Marketing Authorisations and criteria
Joint-labelling allows for a single label/leaflet that has been agreed by the VMD, on behalf of the UK, and the Health Products Regulatory Authority (HPRA), on behalf of Ireland, for use on veterinary medicines marketed in their countries.
Joint labelling could be achieved between GB and IE, NI and IE or all three - GB, IE and NI. You should also refer to the HPRA guidance.
The products involved in the joint-labelling process must:
- hold Marketing Authorisations (MAs) in both the UK, or part of, and Ireland, or new national and EU procedure MA applications (as applicable for GB/NI) be submitted to both the VMD and the HPRA at the same time
- be held by the same Marketing Authorisation Holder (MAHs), or MAHs belonging to the same parent company
- have product information which is the same
To obtain joint labelling, the Summary of Product Characteristics (SPC) and QRD must be identical in the relevant territories. This can be achieved by applying for a harmonisation variation in both countries. To maintain joint labelling the SPC/QRD must remain harmonised. You can apply either at the end of a new MA procedure or retrospectively for existing MAs, whether authorised by EU or national procedures.
You may use a dual-label, but the UK and Ireland will not help you maintain the harmonised nature of the labels/leaflets unless they have been officially joint-labelled.
See
Joint-label following a new MA procedure
For new EU procedure MAs, it will be assumed that you want a joint-label if both NI and Ireland are involved in the procedure. If not, you should make this clear when submitting the mock-ups. Following the end of a new MRP or DCP, you should submit mock-ups to the VMD and HPRA within 20 days of procedure ending.
For new MA applications submitted in parallel to GB and the EU, or for national MA applications submitted to the UK (or part of) and IE, you can request joint-labelling as part of these applications. However, as the procedures will be assessed separately, we cannot guarantee that joint-labelling will be achieved at the end of the assessment.
See Timetables, below, for more information on the procedure.
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 a parallel GB national application will be assessed by the VMD in accordance with our national requirements and standard 20 day timetable.
Joint-labelling variation
You may also get a joint-label as a stand-alone procedure by submitting a joint-labelling variation to both the VMD and HPRA, whether authorised by EU or national procedures.
For nationally authorised products, the SPC for the products involved will not be the same, so these will need to be harmonised first before a joint-label can be agreed. You cannot make any changes to the SPC that requires data to be assessed. In this case, you should submit the appropriate variation(s) and wait for these to be approved before submitting the joint-label variation. If such changes are identified during assessment, the joint-label variation will be refused, and you will be asked to resubmit once the changes have been made.
Mutually recognised products
You should submit the joint-labelling variation to the VMD and HPRA. You should make it clear in your application that the purpose of the variation is to get a joint-label for a mutually recognised product. See Timetables, below, for more information on the procedure once the application has been validated.
Nationally authorised products
You should submit the joint-labelling variation to the VMD and HPRA. You should make it clear in your application that the purpose of the variation is to obtain a joint-label for nationally authorised products. During the first timetable the SPC will be discussed and agreed. Once this is complete the lead country will request mock-ups and the timetable process starts again.
See Timetables, below, for more information on the procedure once the application has been validated.
Maintaining joint-labelling
Mutually recognised products
Following a procedure that changes your mutually recognised product SPC or Label/leaflet, it will be assumed that you want to maintain your joint-label if both NI and Ireland are involved. If not, you should make this clear when submitting the mock-ups to the VMD and HPRA, which should be within 20 days of procedure ending.
Nationally authorised products
You must submit any future applications that affect the SPC or label/leaflet to the VMD and HPRA at the same time. You should make it clear in your application that the product is joint-labelled.
Normal application timescales may be suspended during these applications to allow the Agencies to liaise with each other.
If you are submitting a variation to simply make changes to the mock-ups that do not affect the approved label text, this will be run on the same timetable as a joint-labelling variation.
How to apply for a joint-labelling variation
See Variations to a veterinary MA, Submission of applications to an animal medicines and SPC and Product Literature for further guidance. You should also refer to the HPRA guidance.
You should include in the application a clear, concise description of the variation under scope of change.
Mutually recognised products
Using the variation category G.I.15 VRA in both the UK and Ireland, you must provide the current mock-ups for the UK and Ireland with the proposed joint mock-ups.
Nationally authorised products
Using the variation category G.I.15 VRA in both the UK and Ireland you must provide current SPCs for the UK and Ireland, and a proposed jointSPC. Revised QRD text will also be required for the UK. You must also confirm that none of the proposed changes to theSPCrequire data to be assessed.
Mock-ups are not required at this stage and will be requested once the joint SPC has been agreed.
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 Application fees for animal medicines.