Clinical trial applications on CD-ROM or via Eudralink

10 May 2011, Updated 16 May 2012

The Danish Medicines Agency prefers to receive clinical trial applications electronically. For example, applicants can submit the application on CD-ROM, an alternate physical storage media or online via Eudralink. These options are explained below.

Applications via DKMAnet

Another possibility is to submit applications about clinical trials in humans via DKMAnet, our access-controlled extranet: Applying for clinical trial authorisations via DKMAnet.

Formats required for CD-ROM and Eudralink submission

Use the following formats if you apply on CD-ROM or via Eudralink:

  • Documents to be included in one PDF file. The file must contain bookmarks for each document included.
  • The maximum file size is 200 MB. If the application is bigger, the IMPD/IB should be included in a separate file.
  • EudraCT XML file.

Application on CD-ROM

If the application is submitted on a CD-ROM or other physical storage media, the applicant must enclose a duly signed cover letter on paper and as a PDF file on the storage media.

Please send the CD-ROMs or alternate physical storage media to: Clinical Trials, Danish Medicines Agency, Axel Heides Gade 1, 2300 Copenhagen S, Denmark.

Application via Eudralink

If you chose to send the documentation via Eudralink, please send it to kf@dkma.dk without password - filling in the subject heading with the name of the sponsor, name of medicinal product and background for the approach.

Eudralink is the European Medicines Agency's (EMA's) system for secure file transfer. To be set up in the system, please send an email to eudralink@ema.europa.eu, stating in the email that you wish to have a Eudralink account. You will subsequently receive a form that you must fill in and submit. Connection to the system is usually established within a few hours.

Documents that can be submitted

In practice, all documents regarding clinical trials are reviewed by the Clinical Trials Department at the Danish Medicines Agency, and the possibility for submission on CD-ROM, other physical storage media or online via Eudralink concerns the following documents:

  • Applications for clinical trials of medicines in humans and animals
  • Applications for amendment of a clinical trial
  • Annual safety reports (ASR, DSUR)
  • End of Trial notification
  • Final clinical study report as well as publications
  • Notifications in general.

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