Fees for the Review of Applications under the CTR

There is a fee for applying for clinical trials of medicinal products under the CTR Regulation.

A single fee is charged to the Danish Medicines Agency and VMK for processing applications under the regulation; the fee is paid to the Danish Medicines Agency according to the provisions as stated here:

Clinical trial fees

Fees must be paid to the Danish Medicines Agency no later than 1 month after receipt of the invoice.

Please note that the same fee is payable regardless of whether you submit Part I and Part II separately (deferred) or simultaneously.

Last updated 01-02-2024

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