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KLH-12 version 4

Requirements for Documentation Relating to Compliance with Good Manufacturing Practice in the Submission of Applications for Clinical Trial Authorisation  

This guideline supersedes the KLH-12 guideline version 3 effective from April 1, 2024.


This guideline describes the requirements for documentation relating to compliance with Good Manufacturing Practice (GMP) submitted with an application for clinical trial authorisation.  It specifies the required documents depending on the status of the investigational medicinal product (authorised vs. unauthorised) and the manufacturing site location (EU/EEA vs. third countries).


In accordance with the provisions of Article 61 of Regulation (EU) No. 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use and repealing Directive 2001/20/EC (Regulation), the manufacturing and import of investigational medicinal products in the Union shall be subject to the holding of an authorisation.

pdf.pngKLH 12 verze 4 EN (04-2024).pdf, soubor typu pdf, (250.27 kB)