Development scheme for the cultivation and handling of medicinal cannabis
On 1 January 2018, a special development scheme for the cultivation of cannabis in Denmark was introduced. Under the scheme, companies can apply for a cannabis cultivation and handling licence with a view to producing cannabis suitable for medicinal use.
The development scheme runs in parallel with the four-year medicinal cannabis pilot programme.
The special development scheme applies only to applications for cultivation and production of cannabis for medicinal use. Applications for commercial cultivation of cannabis (industrial hemp) with a content of up to 0.2 % THC for other purposes than the production of cannabis for medicinal use should be submitted to the Danish Agricultural Agency as previously.
On 1 July 2018, the executive order on the cultivation, production and distribution of cannabis bulk and production of cannabis primary products entered into force. This means that companies can now apply for a licence to produce medicinal cannabis for the pilot programme and for patients in Denmark and for export. Read more about this in the Pilot programme. Cannabis developed under the development scheme cannot be used in the pilot programme.
Applying for a licence to cultivate cannabis under the development scheme
In the application process, the application form: "Application for a cannabis cultivation and handling licence with a view to producing cannabis suitable for medicinal use" is used. The form is in Danish only. Please enclose a detailed project description with the application form and send it to email@example.com
The project description must include a detailed account of your plans for cannabis cultivation and production. The purpose is to demonstrate that you will produce a consistent and standardised product of the required quality that can be included in the medicinal cannabis pilot programme. The project description must describe the safety measures you will take in connection with the cultivation and processing of cannabis. The project description must provide evidence that the production will result in cannabis that can be included in the medicinal cannabis pilot programme or possibly in the manufacture of medicinal products.
Please see these guidelines (in Danish only) for information on how to fill out the application for a cannabis cultivation and handling licence with a view to producing cannabis suitable for medicinal use.
The following guidelines list the required elements of the project description: Guidelines on project description for an application for a cannabis cultivation and handling licence with a view to producing cannabis suitable for medicinal use (in Danish only).
Conditions for obtaining a licence under the development scheme
We will issue a licence for the cultivation and handling of cannabis for medicinal use under the development scheme subject to the following:
- The application form is completed correctly.
- Based on a pharmaceutical assessment, specifically of the project description, the Danish Medicines Agency finds it probable that the project can contribute to the production of cannabis products for the medicinal cannabis pilot programme or possibly for the manufacture of medicinal products.
- The Danish Agricultural Agency does not object to the agricultural conditions.
- The Danish National Police, taking the applicant's personal circumstances into account, has no reservations in granting the application.
- The Danish Medicines Agency har carried out an inspection with satisfactory results
Terms for licences issued
A cannabis cultivation and handling licence with a view to producing cannabis suitable for medicinal use will be issued on the following terms:
For the purpose of control and on presentation of valid identification, the Danish Medicines Agency and the Danish Agricultural Agency must have access to premises where cannabis is being handled; likewise, any information and documentation must be disclosed on request.
- In order to maintain the licence, it is required that no changes are made to the circumstances of the company on which the license was issued without the Danish Medicines Agency's prior approval.
- The rules established in the executive order on euphoriant substances must be strictly observed.
- Quarterly records of cannabis usage must be submitted to the Danish Medicines Agency by the tenth day of every quarter according to the executive order on euphoriant substances.
The Danish Medicines Agency may at any time revoke the licence if:
- the special scheme is closed.
- the cultivation and production activities are not carried out as described in the project description.
- the rules on the handling of euphoriant substances are not observed.
- cannabis is passed on without justification.
- the licence holder is not willing to cooperate in connection with control conducted by relevant authorities.
The export of medicinal cannabis under the development scheme is only permitted for analysis purposes. Any export of euphoriant substances, cannabis included, is subject to import and export certificates, and the company must have been granted an authorisation, pursuant to the rules on euphoriant substances, which covers export for analysis purposes.