5. When is it necessary to submit a mock-up in the implementation of a 2D code?

The submission of a mock-up is required only in case the readability of the packaging is affected (change of font size, large shifts of text, etc.). In such a case, the mock-up may be submitted as part of a variation to/extension of marketing authorisation within the scope of which items 17 and 18 of the labelling are added. If the mock-up is not submitted within the scope of this procedure and the marketing authorisation holder thereafter finds out that the actual implementation of the 2D code on the packaging affects readability thereof, it is necessary to submit the respective mock-up as part of a separate “P” type variation.