The Danish Medicines Agency is a public authority financed primarily by fees and charges paid by companies. The reason for this is that the Danish parliament has decided that companies must pay for the review services provided to them by the Danish Medicines Agency. The fees and charges cover the costs of review, for example in relation to applications for company authorisations, applications for admission to the Danish Medicines Agency’s list, laboratory controls, inspections and the monitoring of side effects.
These fees enter into force on 1 January 2022 for companies with an authorisation to manufacture cannabis bulk and cannabis primary products, an authorisation to manufacture cannabis intermediate products and an authorisation to cultivate and handle cannabis for the purpose of developing cannabis for medicinal use.
The fees are adjusted annually based on the price and wage indices. The Danish Medicines Agency sends out invoices payable within one month.
The fees are established in Executive order no. 2553 of 20 December 2021 on fees payable for medicinal cannabis and companies manufacturing cannabis, etc. (Danish title: bekendtgørelse nr. 2553 af 20. december 2021 om gebyrer for medicinsk cannabis og cannabisproducerende virksomheder m.v.)
The fees applicable from 1 January 2022 to 31 December 2022 appear from the executive order.