From 1 January 2013, the fees payable for clinical trial applications are established in executive order no. 1409 of 20 December 2012 on application fees for the authorisation of clinical trials (the executive order is in Danish only).
- The application fee for notification of clinical trials is DKK 7,226.
- The fee for substantial protocol amendments is DKK 1,639.
All fees must be paid to the Danish Health and Medicines Authority no later than one month after receipt of the invoice. When submitting your application, please complete and enclose the e-form for invoice details, which you find in the box to the right.
Companies that apply via our DKMAnet extranet need not use the e-form for notification of invoice details as this is integrated in the application form on DKMAnet.