UST-32 version 2

EAN Code reporting and registration  

As of 04 June 2018, SÚKL guideline UST-32 EAN Code Reporting and Registration is revoked. The obligation to mark all authorised medicinal products with the European Article Number (EAN), however, continues to be effective, but SÚKL shall no longer register EAN codes.

The obligation to mark all authorised medicinal products with the EAN code is implied by the provision of Section 37, paragraph 1 of Act No 378/2007, as amended.

The allocation of the EAN code and its specification on the labelling is the responsibility of marketing authorisation holders and relevant manufacturers.