Applying for clinical trial authorisations via DKMAnet

Updated 05 May 2017

Problems sending applications via DKMAnet

Unfortunately, you may experience problems when you are sending clinical trial applications etc. via DKMAnet.

We recommend that you send notifications on CD-ROM or other device or by mail, e.g. via Eudralink

DKMAnet is a shared portal for applications for clinical trials on medicinal products to both the Danish Medicines Agency and the Scientific Ethical Committee System. Applications for clinical trials are submitted via this portal to both authorities. The portal is divided into four services containing forms in which the applicant provides relevant information and attaches documentation in PDF format.

Applicants can apply for a new clinical trial authorisation and for authorisation to amend an ongoing clinical trial, and documentation related to the surveillance of ongoing trials as well as general notifications can be submitted to both authorities.

It provides better data safety as you are submitting documents via an encrypted connection.

If you represent a company, CRO or the like, you can read more about access to DKMAnet below.

Clinical trials and DKMAnet

There are four different clinical trial services available to pharmaceutical companies on DKMAnet:

  1. Application for new clinical trial authorisation (CTA)
  2. Application to amend an authorised clinical trial
  3. Safety surveillance of authorised clinical trial 
    Annual safety reports (ASR/DSUR) 
    Change of trial status (ended trial, temporarily halted trial, or premature trial closure) 
    Other safety-related information
  4. Notification about authorised clinical trial 
    Final clinical study report and publication 
    Extension of trial period relative to the date approved on the Danish authorisation
    New trial sites/change of trial sites (including updated XML file)
    Change of principal/coordinating investigator (including updated XML file) 
    Change of CRO/applicant 
    Other notifications

To the extent possible, the forms collect data from the EudraCT application form (which is to be uploaded as an XML file). The documentation must be attached in PDF format and take up no more than 80 MB.

Questions and answers on clinical trials and DKMAnet

Read about clinical trials and DKMAnet: Clinical trials and DKMAnet - questions and answers

In the box to the right, you can find guidance notes on how to submit information to the Danish Medicines Agency concerning clinical trials of medicines via DKMAnet.

Quick Guide to clinical trials and DKMAnet

The quick guide gives you an introduction to DKMAnet and an overview of which functions to use when you want to submit documentation via DKMAnet Quick guide to clinical trials and DKMAnet

Access to DKMAnet for companies

To gain access to DKMAnet, the company must appoint a security administrator (please see the form in the box to the right). Before appointment, the security administrator must have an employee signature from Nets DanID installed on his/her computer. The employee signature must be registered in the name of the company.

A Digital Signature is ordered from the Nets DanID hjemmeside

Security administrators and users working for companies that do not have a Danish company registration number must be issued a CUG certificate from the Danish Medicines Agency (please see the form in the box to the right).

Questions and answers

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