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.

What are mock-ups

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’.

EMA does not check specimens for veterinary medicines, which are samples of the actual printed outer and immediate packaging materials and package leaflet, i.e. the 'sales presentation'.

The marketing authorisation holder is responsible for ensuring the final printed packaging exactly mirrors the mock-ups.

Checklist

A checklist is available to help marketing authorisation applicants and holders prepare mock-ups that comply with applicable requirements. This summarises critical labelling elements.

Mock-ups checklist - Guidance for checking mock-ups

Reference Number: EMA/102667/2014 Rev.2

When to submit mock-ups

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.

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

AdoptedReference Number: EMA/14522/2007 Rev.3

How to submit mock-ups

Applicants should submit mock-ups in Part 1 of their application dossier via the eSubmission Gateway / Web Client.  

Guidance on using the system is available on the Veterinary eSubmission website.

If EMA requests a mock-up outside of a specific procedure, applicants should send it via Service Now by selecting Veterinary Regulatory > Pre-Submission-Vets.