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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

OS000_00_026e_MB Swissmedic eSubmissions platform for applications for the approval of clinical trials (PDF, 228 kB, 15.03.2023)

OS000_00_027e_MB eGov-Portal CT standard functions (PDF, 1 MB, 28.11.2024)

BW101_10_007e_MB Guidance on the Submission Process for Clinical Trials with Medicinal Products (PDF, 460 kB, 30.04.2024)

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.

FO submission form (PDF, 5 MB, 01.11.2024)

Quick guide to the submission form

BW101_10_005e_MB Quick instruction for use of the FO_submission form (PDF, 1 MB, 30.04.2024)

eDok folder structure

OS000_00_012dfe_VZ Template eDok KLV (ZIP, 20 kB, 27.02.2023)

Quick guide to submitting with the eDok folder structure

BW101_10_006e_MB Instructions for filling the eDok_KLV folder structure (PDF, 1 MB, 19.09.2023)

Confirmation form for electronic submission

BW101_10_019e_FO Confirmation electronic submission (AM_KlinV)(AM_KlinV) (DOCX, 359 kB, 13.06.2024)

The most important questions and answers

OS000_00_025e_MB Clinical Trial Application (CTA) Questions and Answers (PDF, 151 kB, 02.05.2022)

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 01.11.2024

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