Q&A: Mock-ups

A ‘mock-up’ is a copy of the flat artwork design in full colour, presented so that, following cutting and folding where necessary, it provides a replica of both the outer and immediate packaging so that the three dimensional presentation of the label text is clear. It is generally referred to as a ‘paper copy’ or ‘computer-generated version’. Mock-ups may be submitted electronically, either in the Part 1 of the dossier as part of a specific submission or to vet.applications@ema.europa.eu in all other cases.

Reference

• The revised checking process of mock-ups and specimens of outer/immediate labelling and package leaflets in the centralised procedure for veterinary medicinal products
• Mock-ups checklist – Guidance for checking mock-ups  

For specific information related to different types of applications, please refer to ‘The revised checking process of mock-ups and specimens of outer/immediate labelling and package leaflets in the centralised procedure for veterinary medicinal products’. In summary, mock-ups are requested for initial applications and applications for transfer of marketing authorisation holder, and on a case-by-case basis for other procedures with major impact on the labelling, e.g. variations, renewals, extensions.

Due to the different nature of the veterinary medicines domain, the Agency will continue to check mock-ups rather than specimens but, similarly as for the human medicines domain, will only review layout, legibility etc. The obligation to ensure that the final printed packaging exactly mirrors the mock-ups rests with the marketing authorisation holder.

References

• The revised checking process of mock-ups and specimens of outer/immediate labelling and package leaflets in the centralised procedure for veterinary medicinal products
• Mock-ups checklist - Guidance for checking mock-ups

When the Agency requests the applicant to submit mock-ups, only one relevant mock-up will be checked, preferably a “worst-case” example, i.e. a three lingual mock-up of the smallest pack size.

See Annex I of The revised checking process of mock-ups and specimens of outer/immediate labelling and package leaflets in the centralised procedure for veterinary medicinal products for details.

Information on packaging for centrally-authorised products and blue box requirements is available in the Notice to Applicants Volume 6C and on the website of the veterinary Coordination Group for Mutual Recognition and Decentralised Procedures (CMDv).

Reference:

• Notice to Applicants Volume 6C Guideline on the packaging information of veterinary medicinal products authorised by the Union
• Packaging ‘blue-box’ requirements and additional information on labelling/package leaflet for products authorised via national, mutual recognition, decentralised or centralised procedures