Q&A: Mock-ups

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Once a veterinary product has received approval from the Commission (the “Commission Decision”) all further procedures connected with the product will fall under “Post-Authorisation Procedures”.

This guidance provides an overview for a number of procedures that occur frequently and addresses a number of questions which Marketing Authorisation Holders (MAHs) may have.

Additional information

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1. What are 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.


2. When do I have to submit mock-ups and in which format / languages? Rev. July 2015

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.


3. Which languages does the Agency check?

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.

4. Where can I get information on the Blue Box requirements?



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