REG-59 version 2

Published: 30. 1. 2026

| Updated: 2. 1. 2026

Requirements for marketing authorisations of medicinal products in respect of risk of transmitting animal spongiform encephalopathy agents

This guideline supersedes guideline REG-59 version 1 with effect from 2nd January 2026.

The guideline is issued on the basis of and in accordance with the provisions of Part 1 of Decree No. 228/2008 Coll.

The guideline is legally binding.