Homepage About us Guidelines and Forms Authorising of medicinal products REG-84 version 8

REG-84 version 8

Electronically submitted applications regarding marketing authorisation

This guideline supersedes guideline REG–84 version 7 with the effect from July 1 2024.

The Guideline is issued in accordance with the provision of Section 3 paragraph 1 of Decree no. 228/2008 Coll.

The Guideline is for recommendation.

Its content is based on legal requirements and EMA and CMDh recommendations which are legally binding.