Fees
The Danish Medicines Agency (DKMA) is a public authority financed primarily by fees and charges received from companies. This follows from a decision of the Danish parliament according to which companies must pay for the reviews that the Danish Medicines Agency carries out for them. The fees and charges cover the costs of review, for example in relation to company authorisations, applications for admission of products to the DKMA list, laboratory controls, inspections and the monitoring of side effects.
For companies holding an authorisation to manufacture cannabis bulk and cannabis primary products, an authorisation to manufacture cannabis intermediate products and an authorisation to cultivate cannabis with a view to producing cannabis suitable for medicinal use, these fees enter into force on 1 January 2022.
The fees are adjusted annually with changes in the price and wage indices. The Danish Medicines Agency sends out invoices payable within one month.
Fees
Application fees and annual fees as stipulated in the executive order on fees payable for medicinal cannabis and companies manufacturing cannabis, etc.
| Application type | Description | DKMA item number | Fees in 2024 |
|---|---|---|---|
| Application for manufacturing authorisation with cultivation activity | Manufacture of cannabis bulk and cannabis primary products with cultivation activity | 7001/7002 | DKK 141,339 |
| Application for manufacturing authorisation without cultivation activity | Manufacture of cannabis bulk and cannabis primary products without cultivation activity | 7012 | DKK 135,254 |
| Application for authorisation to manufacture intermediate products | Production of cannabis intermediate products | 7003 | DKK 76,399 |
| Application for authorisation under the development scheme | Cultivation and handling of cannabis with a view to producing cannabis suitable for medicinal use | 7004 | DKK 47,391 |
| Annual fee for manufaturing authorisation with cultivation activity | Manufacture of cannabis bulk and cannabis primary products with cultivation activity | 7005/7006 | DKK 58,145 |
| Annual fee for manufaturing authorisation without cultivation activity | Manufacture of cannabis bulk and cannabis primary products without cultivation activity | 7013 | DKK 45,102 |
| Annual fee for intermediate product manufacturer authorisation | Production of cannabis intermediate products | 7007 | DKK 45.102 |
| Annual fee for authorisation under the intermediate scheme | Cultivation and handling of cannabis with a view to producing cannabis suitable for medicinal use | 7008 | DKK 14,431 |
| Application for admission of a cannabis intermediate product produced from an imported cannabis primary product | 7009 | DKK 53,569 | |
| Application for admission of a cannabis intermediate product produced from a cannabis primary product | 7010 | DKK 137,253 | |
| Annual fee for a cannabis intermediate product and its related primary product admitted to the list | 7011 | DKK 38,367 |