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 by postal mail

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

B) Paper submission by postal mail

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

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

Last modification 01.06.2022

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