Joint labelling for veterinary medicines for use in the UK and Ireland:  Guidance has been published for the veterinary pharmaceutical industry on how to apply for and maintain a joint-label for use on veterinary medicines placed on the market in the UK and Ireland. 

 

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.

 

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, such as C.II.6(b) variation, this will be run on the same timetable as a joint-labelling variation. Do not submit mock-ups under a C.1(z) category.

 

How to apply for a joint-labelling variation

See Variations to a veterinary MASubmission 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 Unforeseen ‘Type IB Category C.1.z’ in the UK and ‘Type IB Category C.II.6(b)’ in 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 Unforeseen ‘Type IB Category C.1.z’ in both the UK and Ireland you must provide current SPCs for the UK and Ireland, and a proposed joint SPC. Revised QRD text will also be required for the UK. You must also confirm that none of the proposed changes to the SPC require 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.

 

Assessment timetables

Following the end of a new MRP or DCP in NI and IE: 

You submit mock-ups to NI and IE within 20 days of the procedure ending. The VMD and HPRA will decide who will take the lead. The lead country draws up timetable and emails it to you and the other country.

 

  • Day 0 – Timetable begins
  • Day 11 – The lead country sends their comments to the other country using the agreed pro forma
  • Day 17 – The other country adds their comments to the proforma and sends it back to the lead country
  • 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 return the proforma and revised mock-ups to both countries indicating agreement or disagreement with the comments. The procedure restarts with the lead country issuing a timetable

 

If there are no comments, or the mock-ups can be approved with minor annotations, the application goes into the national phase where each country issues the authorisation documentation including the agreed joint-label.

If mock-ups are not submitted on time or the revised mock-ups are still incorrect, the MA will be issued with a condition that you must submit a variation to approve mock-ups (Type IB - C.II.6(b)) prior to placing the product on the market for sale and supply.

 

Following the end of a new national procedure in GB and/or NI and IE OR following the end of a new GB national precure submitted in parallel to an EU MRP OR joint-labelling variation: 

You must submit the QRD agreed as part of the counter procedure. If the QRD text is not the same then during an initial 20 days, the VMD and HPRA will consider the differences and if alignment of the text can be reached. If changes are required to the agreed QRD text and assessment of data is needed, you must submit the necessary variation(s) before the joint-labelling variation can proceed. If alignment is not possible you can continue with GB and/or NI only labelling or close the existing procedure without approved packaging.

 

If/once the QRD text is aligned, you must provide mock-ups for assessment. The VMD and HPRA will decide who will take the lead. The lead country draws up timetable and emails it to you and the other country.

  • Day 0 – Timetable begins
  • Day 11 – The lead country sends their comments to the other country using the agreed pro forma
  • Day 17 – The other country adds their comments to the proforma and sends it back to the lead country
  • 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 return the proforma and revised mock-ups to both countries indicating agreement or disagreement with the comments. The procedure restarts with the lead country issuing a timetable

 

How to ‘undo’ a joint-label

If you no longer wish to have a joint-label, please send an email to the VMD and HPRA and we will update our records.

You can update your labels to remove the joint-labelling aspects the next time you submit an application that affects the mock-ups, or by submitting a C.II.6(b) variation to both countries.

 

For further assistance:

Once you have applied, if you wish to discuss specific application points, please contact the people assigned to the application given in the validation passed email.

For all other enquiries email: postmaster@vmd.gov.uk

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