EMA Publish Guidance on On-Pack Design and Labelling

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Pack design and labelling ensure that the critical information necessary for the safe use of a medicine is legible, easily accessible and that users of medicines can easily assimilate this information so that any risk of confusion and error is minimised.
For non-prescription medicines the clear identification and selection of the appropriate medicine is very important, especially in cases where there is no pharmacist intervention, therefore, pack design and labelling are considered key elements to ensure the safe use of this type of medicines.
The information which should be included on the labelling and package leaflet is provided in Title V of Directive 2001/83/EC. In addition, the details on the display and readability of such information on the printed materials are included in the Guideline on the readability of the labelling and package leaflet of medicinal products for human use (Revision 1, 12 January 2009) (hereinafter “Readability guideline”). However, due to the different supply arrangements for non-prescription medicines across Europe, some of the principles of the presentation of the content of the labelling and package leaflet differ among Member States, in particular on the ones regarding the acceptability of symbols/pictograms and any additional information compatible with the Summary of Product Characteristics (SmPC).
A consultation with Member States on national practices regarding pack design and labelling for non-prescription medicines has taken place and this document summarises the basic recommendations/principles1 to guide applicants and marketing authorisation holders when preparing the mock-ups and specimens of the sales presentations2 of non-prescription medicines within the centralised procedure. It is acknowledged that national practices on pack design for non-prescription medicines differ across Member States, therefore, the recommendations included in this document should be considered in this context.

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