Mock-ups: full-colour drafts of packaging and leaflet

The Notice to Applicants and EMA's procedural guidance distinguish a mock-up, a flat artwork copy of the pack and leaflet showing the final layout at actual size, from a specimen, which is a sample of the printed packaging as marketed. Mock-ups show how the particulars required by Articles 54, 55 and 59 of Directive 2001/83/EC, the Braille required by Article 56a and any national Blue Box content will actually appear, so that the authority can check legibility, the position of the safety features, the use of colour and the space left for variable data such as batch number and expiry date. The Commission's 2009 guideline on the readability of the labelling and package leaflet gives the design expectations the review applies, including a recommended minimum font size, line spacing and contrast.

In the centralised procedure, EMA asks for mock-ups of the outer and immediate packaging and the leaflet during the assessment, in time for the QRD review that precedes the CHMP opinion, and specimens of the final printed material are sent after the Commission decision. In mutual recognition and decentralised procedures the mock-ups belong to the national phase: each Member State sets whether it wants them, in which format and in which language, and they are submitted with the translations after the procedure closes. Later changes to artwork go through an Article 61(3) notification when they are not connected with the SmPC, and many authorities expect updated mock-ups with it. Some national authorities also review mock-ups for Blue Box content, which is outside the EU text.

What goes wrong: mock-ups are produced from a draft text and then not refreshed when the final product information changes in the last round of the procedure; the artwork is shown at reduced size so a 6-point leaflet looks fine on screen; the Braille is shown as a note rather than as dots in position; the 2D code and human-readable unique identifier are placed where the carton is folded; and national requirements are discovered market by market after the procedure has closed, which pushes launch dates. For multi-country packs, one Member State's objection can hold up every market that shares the artwork.