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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 April 1, 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 version 3 EN (04-2024).pdf, soubor typu pdf, (170.13 kB)