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 September 11, 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).

This guideline serves as a recommendation.

• KLH-12_version4 (pdf, 110 kB)