Fees for clinical trials
Executive orders regulating fees for clinical trials
Current fees as of 1 June 2023
The Danish Medicines Agency still charges no fee for phase I trials authorised under directive 2001/20, and the fee charged for trials authorised under the regulation is reduced.
In addition, a fee exemption applies to clinical trials of medicines carried out with no or marginal influence from pharmaceutical companies (non-commercial trials) regardless of whether they are authorised under directive 2001/20 or the new regulation.
“No or marginal influence from pharmaceutical companies” means research-initiated trials in which pharmaceutical companies have no influence on the trial design, initiation and completion; nor on the collection and publication of data.
When a commercial applicant submits an IMPD, the B fee in the first column of the table below will be charged. If the applicant believes the A fee should be charged instead even though an IMPD was submitted, we will expect the applicant to state the reasons why in the cover letter submitted with the application.
The provisions on annual fees do not apply to clinical trials for applications received by the Danish Medicines Agency before 1 July 2017. Annual fees are charged in connection with the submission of the annual safety report/DSUR. A single fee will be charged for the number of ongoing trials covered by the report in question.
All fees must be paid to the Danish Medicines Agency no later than one month after receipt of the invoice. Billing details must be provided in the cover letter or alternatively in the “proof of payment section” in CTIS. If certain information is to appear on the invoice, e.g. references to PO numbers or contact persons, these details must be specifically highlighted in the billing details. If no specific billing details are provided, the Danish Medicines Agency will for trials authorised under the directive charge the amount to the applicant (cf. EudraCT) and for trials authorised under the regulation charge the amount to the sponsor.
The clinical trial fees are adjusted annually with changes in the price and wage indices and laid down in the following executive orders:
Executive order no. 102 of 18 January 2022 on fees payable for clinical trials of medicines pursuant to the clinical trial regulation – trials authorised under EU regulation no. 536 536/ 2014 (retsinformation.dk)