Denmark Cannabis License Guidelines

Danish Medicines Agency

Licensing and Enforcement Criteria

The Danish Medicines Agency (DMA) grants authorization to cultivate and handle cannabis for the purpose of developing cannabis for medicinal use.

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 authorization 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 authorization holder is not willing to cooperate in connection with the supervision of the Danish Medicines Agency and the Danish Agricultural Agency
  • The authorization holder is granted an authorization to handle euphoriant substances with the activity of cannabis cultivation

Denmark Cannabis Law & Compliance

Several laws and ordinances regulate the Denmark medical cannabis industry, as well as the many different steps in the supply chain. These laws range over dispositions for cultivators, manufacturers, distributors and retail dispensaries. The most recent news can be found on these websites:

FAQs

Can you legally get medical cannabis in Denmark today?

Yes, but only if you have a prescription from a doctor and get the products delivered at a pharmacy.

Why has the Danish Medicines Agency not approved more cannabis-based medicines?

The Danish Medicines Agency can only assess and possibly approve more cannabis-based medicines if there are companies that apply to have some preparations approved. The Danish Medicines Agency cannot ask companies to apply for approved medicines.

The initiative must come from a company. The Danish Medicines Agency has approved two medicines with cannabis; Sativex for the treatment of multiple sclerosis and Epidyolex for the treatment of the rare forms of epilepsy Lennox-Gastaut syndrome and Dravet syndrome.

The Danish Medicines Agency has not refused any applications for the approval of medicinal products with cannabis, but we have informed several companies about the procedure.

Can you buy legal cannabis oil in Danis stores or online stores that are not pharmacies?

The cannabis oils sold online can have many different strengths and usually contain both THC and CBD. They are sold both as food, pharmaceuticals and cosmetics. Different legislation applies within the three areas.

If it is cannabis oil for medical use, the answer is no. Cannabis oil for medical use may only be sold at the pharmacy and only to patients with a prescription from a doctor.

For information on the rules for cannabis oils, e.g. as food supplements or as cosmetics we refer to respectively The Danish Veterinary and Food Administration or the Danish Environmental Protection Agency.

Which doctors are allowed to prescribe medical cannabis?

All doctors have the opportunity to prescribe the products included in the medical cannabis trial scheme, but no doctor is obliged to do so. All doctors can prescribe masterfully prepared medicines based on cannabis, but are not obliged to do so.

Sativex may only be prescribed by specialists in neurology.

Epidyolex may only be prescribed by specialists in neurology and pediatrics.

In relation to applications for Marinol and Nabilone for a dispensing permit, the Danish Medicines Agency takes a position on the doctors’ specific applications.

What types of cannabis products can you get in Denmark?

Doctors currently have four options for prescribing products based on cannabis:

  1. Approved Medicines
    There are currently 2 approved medicines containing cannabinoids/cannabidiol. The medicine Sativex, which is an oral cavity spray for the treatment of spasms in multiple sclerosis. Sativex can be prescribed by specialists in neurology for patients with multiple sclerosis. The medicine Epidyolex is an oral solution for the treatment of the rare forms of epilepsy Lennox-Gastaut syndrome and Dravet syndrome. Epidyolex can be prescribed by specialists in neurology and pediatrics 
  2. Medicinal products licensed for dispensing
    The medicinal products Marinol and Nabilone, which contain synthetically produced cannabinoids. The manufacturers of Marinol and Nabilone have not applied for approval in Denmark. Doctors can, however, apply for a dispensing permit for medicines that are not approved in Denmark or that are not sold in Denmark. Marinol and Nabilone can be imported from e.g. USA, if the Danish Medicines Agency grants a Danish doctor’s application for permission to prescribe it to specific patients.
  3. Expertly produced medicine
    Doctors can prescribe expertly produced medicine, for example as capsules or oils with ingredients from cannabis. Magisterially prepared medicines are medicines that are prepared in a pharmacy for the individual patient according to a prescription from a doctor.
  4. Products included in the Medical Cannabis Trial Scheme
    On 1 January 2018, the Act on Medical Cannabis Trial Scheme came into force. This opened up a 4th possibility for doctors to prescribe other types of cannabis products for medical use, for example herbal tea, cannabis oils, etc. The trial scheme started on 1 January 2018 and will run until the end of 2025.

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