Development authorisation

11 March 2022

The Danish Medicines Agency grants authorisations to cultivate and handle cannabis for the purpose of developing cannabis for medicinal use pursuant to section 2(2) of the Executive order on euphoriant substances (Danish title: bekendtgørelse af lov om euforiserende stoffer); this executive order regulates the cultivation of cannabis and the general handling of euphoriant substances.

The Danish Medicines Agency will issue an authorisation to cultivate and handle cannabis for the purpose of developing cannabis for medicinal use under the development scheme subject to the following:

  • The application has been completed correctly and contains all relevant information.
  • Based on a pharmaceutical assessment, specifically of the project description, the Danish Medicines Agency finds it probable that the project can contribute to the development 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 any agricultural conditions therein.
  • The Danish National Police, taking the applicant's personal circumstances into account, has no reservations about the granting of the application.
  • The Danish Medicines Agency has completed their inspection with a satisfactory result.

An authorisation to cultivate and handle cannabis for the purpose of developing cannabis for medicinal use will be issued on the following terms:

  • In order to maintain the authorisation, it is required that no changes to the circumstances of the company on which the authorisation was issued are made 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 within 14 days of the expiry of every quarter according to the executive order on euphoriant substances.

For the purpose of control and on presentation of valid identification, the Danish Medicines Agency and the Danish Agricultural Agency must have access to the premises where cannabis is being handled; likewise, any information and documentation must be disclosed on request. The Danish Medicines Agency may at any time revoke the authorisation if:

  • the special scheme is terminated or substantially changed;
  • the rules on the handling of euphoriant substances are breached;
  • cannabis is passed on without justification;
  • the authorisation holder is not willing to cooperate in connection with the supervision of the Danish Medicines Agency and the Danish Agricultural Agency; or
  • the authorisation holder is granted an authorisation to handle euphoriant substances with the activity of cannabis cultivation.

Applying for an authorisation to cultivate cannabis under the development scheme

The documents to be submitted with your application appear from the guide to the application form available below under Application guidelines. The guidelines also tell you how to complete the form and provides guidance on the project description.

You can find the application form below under the heading Form. Please send the application form and accompanying documents to Send an email.

Inspection of companies in the development scheme

Companies that apply for an authorisation to cultivate and handle cannabis for the purpose of developing cannabis for medicinal use must be ready for the inspection at the time of submission. This applies to applications for a new authorisation and applications for variation of an existing authorisation. Before granting the authorisation to cultivate and handle cannabis for the purpose of developing cannabis for medicinal use, the Danish Medicines Agency will assess if it is necessary to inspect the applicant company before granting the authorisation. No authorisation is granted before the Danish Medicines Agency has verified that the company has followed-up sufficiently on any deficiencies identified by the inspection.

Companies holding an authorisation to cultivate and handle cannabis for the purpose of developing cannabis for medicinal use are also checked regularly by the Danish Medicines Agency.

Application guidelines

Application for an authorisation to cultivate and handle cannabis for the purpose of developing cannabis for medicinal use (in Danish).

Guidelines on project description for an application for an authorisation to cultivate and handle cannabis for the purpose of developing cannabis for medicinal use (in Danish only).

Form

Form to apply for an authorisation to cultivate and handle cannabis for the purpose of developing cannabis for medicinal use (in Danish).

Security guidelines

Tool for assessing risk

Recommendations for security of companies that manufacture medicinal cannabis (PDF) (in Danish only)

Legislation

Executive order on euphoriant substances

Fees

An application fee and an annual fee are charged for company authorisations under the pilot programme and development scheme.

You can see the current fees and find links to the rules on fees on the page Fees payable for medicinal cannabis and companies cultivating cannabis, etc.

One fee is charged for each site (geographical locality) where activities take place.

List of authorised companies

List of companies authorised to manufacture cannabis intermediate products (Excel)