Mock-ups for veterinary medicines
The European Medicines Agency (EMA) operates a checking process of the printed materials used in the packaging and labelling of centrally authorised veterinary medicines.
This aims to improve the quality of the printed materials that animal healthcare professionals, farmers and pet owners receive with a medicine. The printed materials include the outer and inner packaging of the medicine, and the printed package leaflet.
EMA may review mock-ups of the packaging and labelling of medicines authorised via the centralised procedure, both before the medicine is marketed and following certain changes to the medicine's authorisation.
Mock-ups are copies of the flat artwork design in full colour, presented so as to provide a replica of both the outer and immediate packaging, following cutting and folding where necessary, so the three-dimensional presentation of the label text is clear.
They are also referred to as the ‘computer-generated version’.
Applicants are recommended to submit mock-ups as part of the following procedures:
- Initial marketing authorisation application
- Transfer of marketing authorisation holder
- Other procedures with a major impact on the labelling, on a case-by-case basis
Further guidance on these different procedure types is available in the document below, including when to submit multilingual versions.
Guidance on using the system is available on the Veterinary eSubmission website.