Guidance

Veterinary Medicines: Apply for and maintain a Joint-Label for use in the UK and Ireland

Guidance for the 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.

What is Joint-labelling?

Joint-labelling is the term used for a single label / leaflet that has been agreed by the UK and Ireland for use on veterinary medicines marketed in their countries.

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.

Scope of the Marketing Authorisations (MA) involved

The products involved in the joint-labelling process must be authorised in the same way, ie. both nationally authorised, or both mutually recognised, via Mutual Recognition Procedure (MRP) or DeCentralised Procedure (DCP).

You cannot apply to get a joint-label for products where one is nationally authorised and the other is mutually recognised. In this case, you should apply to mutually recognise the nationally authorised product. Once done, you may apply for a joint-label.

Joint-label following a new MA procedure

To get a joint-label for a nationally authorised product you must submit a joint-labelling variation.

You can’t apply to get a joint-label at the end of a new national MA application procedure because both countries aren’t involved in the authorisation process.

You can get a joint-label at the end of a new MRP or DCP. It will be assumed that you want a joint-label if both the UK 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:

  Process
Step 1 You submit mock-ups to the UK and IE within 20 days of procedure ending
Step 2 UK and IE decide which country will take the lead
Step 3 The lead country draws up timetable and emails it to you and the other country
Step 4 Day 0 - Timetable begins
Step 5 Day 11 – The lead country sends their comments to the other country using the agreed pro forma
Step 6 Day 17 – The other country adds their comments to the proforma and sends it back to the lead country
Step 7 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.

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.

Step 8 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 at step 3.

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.

Joint-Labelling Variation

You may also get a joint-label as a stand-alone procedure by submitting a joint-labelling variation to both the UK and Ireland. This applies to both mutually recognised and nationally authorised products.

For nationally authorised products, the Summary of Product Characteristics (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.

Joint-Labelling Variation: Mutually Recognised products

  Process
Step 1 You should submit the joint-labelling variation to the UK and Ireland. You should make it clear in your cover letter / email that the purpose of the variation is to get a joint-label for a mutually recognised product
Step 2 The variation will be validated and a lead country agreed
Step 3 The lead country draws up timetable and emails it to you and the other country
Step 4 Day 0 - Timetable begins
Step 5 Day 11 – The lead country sends their comments to the other country using the agreed proforma
Step 6 Day 17 – The other country adds their comments to the proforma and sends it back to the lead country
Step 7 Day 20 – The lead country sends the consolidated list of comments to you, copied to the other country with a request for revised mock-ups. These should be submitted to both countries. The clock stops and enters the company response period.

If there are no comments, or 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.

Step 8 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 at step 3.

Joint-Labelling Variation: Nationally authorised products

This was previously known as a harmonisation variation.

  Process
Step 1 You should submit the joint-labelling variation to the UK and Ireland. You should make it clear in your cover letter / email that the purpose of the variation is to obtain a joint-label for nationally authorised products.
Step 2 The variation will be validated and a lead country agreed. The SPC will be discussed and agreed first followed by the mock-ups
Step 3 The lead country draws up timetable and emails it to you and the other country
Step 4 Day 0 - Timetable begins
Step 5 Day 11 – The lead country sends their comments to the other country using the agreed proforma
Step 6 Day 17 – The other country adds their comments to the proforma and sends it back to the lead country
Step 7 Day 20 – The lead country sends the consolidated list of comments to you, copied to the other country. The clock stops and enters the company response period.

If there are no comments and the SPC is agreed, the lead country requests mock-ups. Once received, the application restarts at step 9.

Step 8 Company Response (within 20 days) – you should return the proforma to both countries indicating agreement or disagreement with the comments. The procedure restarts at step 3.
Step 9 Mock-ups received.
Step 10 The lead country draws up timetable and emails it to you and the other country
Step 11 Day 0 - Timetable begins
Step 12 Day 11 – The lead country sends their comments to the other country using the agreed pro forma
Step 13 Day 17 – The other country adds their comments to the pro forma and sends it back to the lead country
Step 14 Day 20 – The lead country sends the consolidated list of comments to you, copied to the other country with a request for revised mock-ups. These should be submitted to both countries. The clock stops and enters the company response period.

If there are no comments, or 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.

Step 15 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 at step 9.

Maintaining Joint-Labelling

Mutually-Recognised products

The same procedure as the one used to get a joint-label following a new MRP or DCP will be used to maintain a joint-label that changes following a variation or renewal.

Nationally authorised products

To maintain the joint-labelled status of these products you must submit any future variation or renewal applications that affect the SPC or label / leaflet to the UK and Ireland at the same time. Normal application timescales may be suspended during these applications to allow the UK and Ireland to liaise with each other.

If you are submitting a variation to simply make changes to the mock-ups, eg. 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.

You should make it clear in your cover letter / email that the product is joint-labelled.

How to apply

Refer to the apply for a variation in the UK guidance.

To submit a joint-labelling variation you should complete the application form as follows:

  • tick the relevant variation category
  • include a clear, concise description of the variation under scope of change in the present and proposed sections.

For mutually recognised products you must provide:

  • current mock-ups for the UK and Ireland with proposed joint mock-ups

For nationally authorised products you must provide:

  • current SPCs for the UK and Ireland, and a proposed joint SPC

Note that mock-ups are not required at this stage and will be requested once the joint SPC has been agreed.

  • confirmation that none of the proposed changes to the SPC require data to be assessed. See section ‘joint-labelling variation’
  • revised QRD text (UK only)

Variation categories

Mutually Recognised products:

  • UK – Unforeseen Type IB Category C.1.z
  • Ireland – Type IB Category C.II.6(b)

Nationally Authorised products:

  • UK – Unforeseen Type IB Category C.1.z
  • Ireland – Type IB Category C.1.z

QRD Text (nationally authorised products only)

The VMD would like to have agreed QRD (Quality Review of Documents) for all veterinary medicinal products; therefore, we have issued an announcement asking MA holders to submit QRD text for nationally authorised products.

If you do not have agreed QRD text for the product that you wish to get a joint-label for, we recommend that you do so before submitting the joint-labelling variation.

SPCs and product literature

See the SPC and Product Literature guidance page for more details.

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.

Fees

Once an application has passed validation, you will be sent an invoice for the fee.

For further information about fees, see the Application fees for animal medicines page.

The VMD now issues all invoices electronically, so you should provide a valid email address of where to send the invoice; failure to do so will result in your application being rejected.

Contact us

Email: postmaster@vmd.defra.gsi.gov.uk

For queries relating to on-going applications, please contact the relevant person stated on the email sent to you following validation of your application.

Published 15 March 2017