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4. What is the sequence of human-readable data?

The order of the product code (PC) and serial number (SN) does not need to be consistent with the order provided for under article 4 of Commission delegated regulation (EU) 2016/161. Where the size of the packaging allows, it is advisable to show the PC and SN next to the 2D code.

Abbreviations for the product code (PC), serial number (SN), batch number (Lot/č.š./Č. šarže), and expiry date (EXP/Použitelné do) do not have to be provided on the product packaging directly in front of the respective “figure”, but have to be shown in a manner allowing for clear identification of these data elements.

Where the sum total of the two longest dimensions of the packaging is equal to or less than ten centimetres, the elements of the unique identifier do not have to be printed on the packaging in a human readable format.

Delegated acts do not define the batch number and expiry date as human readable data, yet it is mandatory to provide these data on the packaging of all medicinal products, regardless of whether these should bear safety features, or not. The batch number and expiry data do not have to be shown directly next to the 2D code, but where the pack size allows, it is recommended to show these data on the same side as the 2D code.