Clinical trial applications on via Eudralink
The Danish Medicines Agency prefers to receive clinical trial applications electronically. For example, applicants can submit the application 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 Eudralink submission
Use the following formats if you apply 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 via Eudralink
If you chose to send the documentation via Eudralink, please send it to firstname.lastname@example.org 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 email@example.com, 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 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.