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 in full size hard copy and in colour or electronically.

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 are requested for initial applications 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, as in the past to check mock-ups rather than specimens but, similarly as for the Human domain, will only review layout, legibility etc. The obligation to ensure that the final packaging exactly mirrors the approved 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.

Reference:

• Packaging 'blue-box' requirements for products authorised via national, mutual recognition or decentralised procedures