In Section 37, paragraph 1 of Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals), as amended, the words “European Article Number (EAN)” have been replaced with the words “internationally recognised identification standard”. This corresponds to the EAN code or the 2D code. If the medicinal product is to be dispensed without medical prescription and is not listed under Annex II to Commission delegated regulation (EU) 2016/161 (on so called “black list”), its packaging may continue to show the EAN code, or the EAN code may be replaced with the 2D code at the discretion of the marketing authorisation holder.
In respect of products for which the provision of a unique identifier in the form of a 2D code is mandatory after 9 February 2019, the packaging may also continue to display the EAN code, unless readability is adversely affected. Nevertheless, wherever practicable, for these products SÚKL recommends to opt for the presentation of the 2D code only, and to limit the parallel provision of both the EAN code and the 2D code to the shortest period possible.
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