Clinical trial applications via Eudralink

Updated 13 June 2024

We prefer to receive applications for clinical trials, digitally. Applicants can either send it via email or electronically via Eudralink to Clinical Trials.

Submission via Eudralink is described below:


For ongoing applications approved under the directive, the Danish Medicines Agency does not accept electronic submissions via other secure file transfer systems.

Guidelines for formats

When submitting an application via Eudralink, the format is as follows:

  • Documents should be in PDF format in one file. The file should contain bookmarks for each document.

  • The maximum file size is 200 MB. If the application is larger, the IMPD/IB should be included in a separate file.

  • EudraCT XML file.

Application via Eudralink

If you send the application via Eudralink, it should be sent to Clinical Trials, without a password. The subject field should be filled in with EudraCT number, Sponsor name, Product name and reason for the inquiry.

EudraLink is the European Medicines Agency's (EMA) system for secure file transfer. You can access EudraLink by creating a user account on EMA’s website. Subsequently you can log in to EMA's service desk and apply for access to EudraLink. Typically, you can be set up within a few hours.