Applications for clinical trials for medicinal products

Here you will find important information on the technical requirements for submitting applications for clinical trials for medicinal products.

For a valid submission, please submit the following documents:

A) Electronic submission via the KLV portal

  • zip-file with documents in eDok folder structure

B) Paper submission by postal mail

  • CD/DVD with the documents in the eDok folder structure
  • Complete paper dossier

C) Electronic submission by postal mail

  • CD/DVD with the documents in the eDok folder structure
  • Confirmation form for electronic submission

Please refer to the following guidelines and templates for detailed information:

Instructions for the submission process

Submission form
The PDF form can be opened, edited and saved with the free 'Adobe Acrobat Reader' version 10 or higher. The latest version is recommended.

Quick guide to the submission form

eDok folder structure

Quick guide to submitting with the eDok folder structure

Confirmation form for electronic submission

The most important questions and answers


Inhouse News

09.06.2023

Applications for clinical trials with medicinal products and ATMPs (advanced therapy medicinal products) can be submitted via portal from 19 June 2023

The development of the new eGov portal function for electronic submission of applications for clinical trials with medicinal products and ATMPs is in its final phase. The new application is currently being tested with selected participants in a pilot phase. From 19 June 2023, the new portal for clinical trials with medicinal products and ATMPs will be available to all sponsors, investigators, research institutions and their contractual partners for fully electronic submission of applications. Further information will be provided here.

Last modification 11.09.2024

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