The Danish Medicines Agency prefers to receive clinical trials applications on CD-ROM, other digital storage media or online via Eudralink.
The requested file format is as follows:
- Documents to be included in one PDF file. The file must contain bookmarks for each document included
- The maximum file size is 40 MB. If the application is bigger, the IMPD/IB should be included in a separate file
- EudraCT XML file
If the application is submitted on a CD-ROM or other physical digital storage media, a duly signed cover letter must be included in paper form and as a PDF file on the storage media.
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 system. 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.
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 report on the trial results as well as publications
- Notifications in general
Please send the CD-ROMs or alternate physical storage media to: Clinical Trials, Danish Medicines Agency, Axel Heides Gade 1, 2300 Copenhagen S, Denmark.
