KLH-19 version 2

KLH-19 version 2

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

KLH-19_version2.pdf, soubor typu pdf, (129.6 kB)

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.