KLH-19 version 2
Requirements on authorisation/notification of clinical trials on medicinal products – data required for on the pharmaceutical part of the documentation.
This Guideline supersedes Guideline KLH 19 version 1 as of January 21, 2019.
The guideline is issued on the basis and in accordance with the provisions of Section 55 (7) of Act No. 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (the Act on Pharmaceuticals), as amended, and Annex No. 5 to Decree No. 226/2008 Coll., on the Good Clinical Practice and More Detailed Conditions for Clinical trials on Pharmaceuticals as amended.
The Guideline is for recommendation.