CASubmissionFee object
Fees for trial submission mandatory
Yes
Fees
Authorisation of a clinical trial: DKK 7628 (≈ € 1020)
Amendments to an authorised trial protocol: DKK 1730 (≈ € 230)
Waiver for academic (non-commercial) studies possible
No
Official guidance on required fees
All fees must be paid to the DHMA no later than one month after receipt of the invoice. When submitting the application (unless applied via DKMAnet), the e-form for invoice details must be completed.
Further details available on DHMA website in section: Medicines & medical devices / Medicines regulation / Clinical trials / Fees
Additional Information
The submission fee applies to all trials comprised by section 88 of the Danish Medicines Act, and the Danish Medicines Agency does not hold the statutory authority to grant any exemptions.
