The GCC Guidance for Presenting the SPC, PIL and Labeling ...

Appendix 6: Readability of the label and patient information leaflet (PIL)IntroductionThe main purpose of this document is to provide guidance on how to ensure that the informationon the labelling and patient information leaflet (PIL) is accessible to and can be understood bythose who receive it, so that they can use their medicine safely and appropriately.This document is written to assist applicants and marketing authorizations holders when drawingup the labeling and PIL and preparing the mock-ups or specimens of the sales presentations 1 .The document is intended to apply to all marketing authorization procedures and to all medicinalproducts.1 A mock-up is a copy of the flat artwork design in full colour, presented so that, following cutting and foldingwhere necessary, it provides a replica of both the outer and immediate packaging so that the three dimensionalpresentation of the labelling text is clear. This mock-up is generally referred to as a paper copy and not necessarilyin the material of the sales presentation. A specimen is a sample of the actual printed out outer and immediatepackaging materials and PIL (i.e. the sales presentation).Page 42 of 52