REG-96 version 2

This Guideline supersedes guideline REG-96 version 1 as of 1 July 2025 and is applicable to all submissions containing mock-ups.

REG-96 version 2

This Guideline has been issued in order to facilitate navigation in the area of medicinal product packaging graphic design submissions (hereinafter referred to as “mock-ups”) and the rules governing their assessment with regard to public health protection, patient safety, and legislative requirements.

The Guideline is issued by the State Institute for Drug Control (hereinafter referred to as the “Institute” or “SÚKL”) in compliance with the below-listed legal regulations.

The Guideline is of recommendatory in nature.

Nevertheless, its content is based, inter alia, upon the requirements stipulated by legislation and EMA guidance, which are legally binding.

The Institute reserves the right to adjust the assessment practice based on experience or newly established safety concerns.

The objective of mock-up assessment, as adjusted, is to safeguard straightforward and unequivocal identification of the medicinal product by anyone who will be using or handling the medicinal product. Straightforward and unequivocal identification is, inter alia, important for the elimination of potential medication errors and confusion in the use of the medicinal product.

This Guideline applies to all medicinal products authorised via the national and MR/DC procedures, regardless of their classification for supply. It is also applicable to the mock-ups of parallel imported medicinal products.

The assessment of mock-ups is considered a matter of national assessment and it is not possible to refer to assessments performed by other Member States.

This Guideline shall not apply to mock-ups of medicinal products authorised via the centralised procedure (the submission of these mock-ups is governed by guideline EMA/305821/2006).

This Guideline shall not apply to mock-ups of individually imported batches of medicinal products placed on the market with texts on labelling in a language other than Czech (in compliance with Section 3(6)(b) of the Marketing Authorisation Decree).

Please note that food supplements, medical devices, and medicinal products are governed by various legislation, and therefore the requirements for the efficacy, purity and quality of starting materials as well as finished products differ across those product categories. For this reason, mock-ups proposed for medicinal products should always significantly differ from other products from other categories of the same manufacturer/holder.

This Guideline does not set forth rules for the submission of medicinal product samples.

Package leaflet mock-ups are generally not required. The package leaflet should only contain the approved text, without any other graphic elements (except for non-specific graphic elements or graphic elements approved in the PL text, such as instructions for use, as applicable). The layout, font size, colour and type are up to the holder. General recommendations and requirements are outlined in the Guideline on Readability.