Drug database
REG-60 version 2
Requirements for marketing authorisations of medicinal products in the manufacture of which substances derived from human blood or its constituents have been used
This guideline supersedes guideline REG-60 version 1 with effect from 26th June 2026.
The guideline is issued on the basis of and in accordance with the provisions of Act No. 378/2007 Coll., on Pharmaceuticals and on Amendments to Certain Related Acts (the Pharmaceuticals Act), as amended, Decree No. 228/2008 Coll., on the Marketing Authorisation of Medicinal Products, as amended, and Decree No. 143/2008 Coll., on the Establishment of Detailed Requirements for Ensuring the Quality and Safety of Human Blood and Its Constituents (Decree on Human Blood), as amended.
The guideline is legally binding.