Drug database
REG-29 version 5
Methodology of Medicinal Product Name Acceptability Assessment for the Purposes of Marketing Authorisation Procedure
This Guideline supersedes Guideline REG-29 version 4 as of 1 July 2025.
This Guideline has been issued in order to facilitate navigation in the area of medicinal product names (hereinafter referred to as “names”) and rules governing name creation and 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 guideline on medicinal product name acceptability assessment shall apply to all medicinal products authorised via the national and MR/DC procedures, regardless of their classification for supply. This Guideline is not applicable to the names of medicinal products authorised via the centralised procedure (the names of these products are governed by the EMA/CHMP/287710/2014 guideline).