KLH-19 version 3

Requirements on authorisation of clinical trials on medicinal products – data required for the pharmaceutical part of the documentation

This guideline supersedes the KLH-19 guideline, version 2, effective from September 11, 2024.

This guideline specifies the requirements for the quality part of the documentation submitted with the application for authorisation of a clinical trial. The guideline is issued on the basis of and in accordance with the provisions of Sections 51 and 56 of Act No. 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals), as amended.

This guideline serves as a recommendation.

• KLH-19_version3 (pdf, 77 kB)