Labelling Procedure

The joint labelling procedure involves co-ordination of approval of final colour mock-ups for veterinary medicines between Ireland and the UK. 

The procedure enables marketing authorisation holders to create one set of mock ups for both countries. It is applicable for products authorised via a European procedure (a mutual recognition procedure (MRP) or decentralised procedure (DCP) in which Ireland and the UK are both involved. An application for joint labelling can be submitted during the MRP or DCP.

Both countries co-ordinate the assessment of mock-ups during the national phase of the procedure.  No technical assessment is carried out as part of this procedure as the Summary of Product Characteristics and label text will have been agreed during the European procedure. No additional fees are incurred in using the procedure during the MRP/DCP. 

Nationally authorised products can be joint labelled via the submission of a type I.B C.II.6 variation. The SPC must be harmonised in Ireland and the UK in this instance. This variation category should also be used if submitting mock ups for joint assessment after the MRP/DCP has concluded.

Further information about the use of the procedure is available from the Clarification Paper on Joint labelling between IE & UK

Product Literature Standard

The product literature standard is a guide for applicants when creating mock-ups for submission to Ireland and the UK.

It includes requirements and guidance that are common to both the VMD and the HPRA. Separate Annexes have been created that deal with requirements that are specific to the individual competent authorities; Annex A deals with the requirements specific to the VMD and Annex B deals with the requirements that are specific to the HPRA.

This document has been agreed with the assessors of the VMD and the HPRA as well being discussed with industry representatives.

Product Literature Standard 

Mock-up Review Process

Mock-ups are assessed against:

  • the agreed QRD text (if available) or the agreed SPC (if no QRD)
  • the PLS
  • any other information provided by or discussed with you.

Mock-up submitted should not deviate from the agreed QRD text and / or SPC. 

In exceptional cases, you may be allowed to deviate from the above, but you MUST contact the relevant authority to discuss this before submitting your mock-ups. Not doing so will greatly delay the approval of your mock-ups, which will then delay issue of the application.

The following are not assessed by the VMD or HPRA and, therefore should not be submitted with applications:

  • Shipping packs
  • Datasheets, including Material Safety DATA Sheets (MSDSs)
  • Packaging for wholesalers that do not include any labels
  • Display packaging
  • Promotional material

 

Timescales

Mock-ups will be assessed and signed-off within 20 days of receipt of correct versions*.

*The above does not apply for national variations and national renewals, because mock-ups are reviewed during the assessment process; there is not separate ‘mock-up’ phase.

Review

If the mock-ups contain errors, or are not suitable, you will receive a comments document listing any proposed changes. You should update the mock-ups to incorporate the proposed changes and return revised versions as soon as possible.

You will only receive one comments document. If the revised mock ups are still incorrect a condition will be applied to the authorisation to introduce corrected mock ups under the cover of a suitable national variation.

For joint labelled products, the UK and IE will agree the proposed changes before sending them to you. Further information about joint labelling is available on the VMD (GOV.UK) and HPRA websites.

If only minor amendments are needed mock-ups will not be requested. Annotated mock ups will be issued by the VMD when minor changes have been made during a procedure. HPRA will issue the updated QRD with the expectation only those changes will be made to the packaging.

No Mock-Ups

If you do not want to submit mock-ups (for certain pack sizes), or mock-ups are not submitted within the deadlines set, your application can be issued on the condition that mock-ups will be submitted for assessment under cover of a national C.II.6(b) Type IB variation category.

What Changes Require Variations

Any change that may affect the legibility of the mock-up must be approved by way of a variation, for example: You should only submit the mock ups for the packaging/labelling that is affected.

  • Changes to the colouring of the product literature
  • New corporate design of packaging
  • New container type / size
  • Changes to the layout of the package
  • Introduction of multilingual packs for an already approved authorised product

 

Changes that do not affect the font size, layout, legibility, do not require a variation, for example a change to the barcode, logo (assuming same size). 

If you are in doubt about whether a variation is needed, please contact notification@vmd.defra.gsi.gov.uk at the VMD or vetinfo@hpra.ie at the HPRA. 

If you submit a revised mock-up showing the proposed change and the VMD/HPRA agrees that no variation is required; we will confirm this with you. This does not mean the VMD/HPRA has assessed or approved the mock-up provided; simply that the proposed change can be made without the need for a variation. You are not required to submit revised mock-ups to the VMD/HPRA once the change has been made.

Joint-Labelling

If you make any changes to country specific information only, you do not need to submit the variation to the country not affected. Neither country requires copies