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Procedure for treatment with cannabis within current regulations

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Changes

A small group of patients may benefit from treatment with cannabis. To use cannabis products that do not have a marketing authorization in Norway, physicians must apply for compassionate use, named patient.

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    Both the Norwegian Directorate of Health and the DMP agree that there is a small group of patients who may benefit from relieving treatment with cannabis. There is no official list of conditions for which the use of cannabis is appropriate, but most patients who are offered such treatment have severe pain that is not adequately relieved by approved medications.

    Approved cannabis medicines and unregistered cannabis products with up to 1% THC

    All physicians who have the right to prescribe medicines in group A can write prescriptions for approved cannabis medicines (Sativex and Epidyolex), and apply for re-approval exemption for unregistered cannabis products containing up to 1% THC.

    Unregistered cannabis products with more than 1% THC are strictly regulated

    Specialists in hospitals can apply for an exemption from approval for unregistered cannabis products that contain more than 1% THC (tetrahydrocannabinol). There is no comprehensive list of which patients are eligible for such treatment. It is the physician who, after an overall assessment, must justify why this treatment is necessary. The authorities have a good overview of the use, since DMP approves the use in each individual case.

    What applications must the physician submit?

    To use unregistered cannabis products, the physician must submit an application for an exemption from approval (preferably via e-prescription). The physician must specify the dosage and quantity or period - and state whether this is the first application for medical cannabis for the patient in question.

    It is no longer necessary to apply to the Norwegian Directorate of Health for the right to prescribe prohibited narcotics.

    Application for approval exemption for unregistered cannabis products with more than 1% THC

    The physician must justify why the patient cannot be treated with a medicine that is approved in Norway (medicinal products regulations §2-5).

    As a general rule, the following applies:

    • The physician has concluded that the patient may benefit from treatment with an unregistered cannabis product.
    • Treatment with approved medicines (including Sativex) has not had sufficient effect, has had side effects or is considered unsuitable by the physician.

    If the patient has already had good effect from an unregistered cannabis product (for example, cannabis plant), the physician can apply to continue this treatment without the patient having to first try Sativex.

    Who manufactures the unregistered cannabis products?

    Many companies offer cannabis products for medical use. So far, Norwegian physicians have applied for an exemption from approval for the following products:

    • Cannabis plant for medical use from the Dutch company "Bedrocan". The production takes place in collaboration with the cannabis agency of the Dutch Directorate of Health (Office of Medicinal Cannabis (OMC)). The products are not approved drugs, but the plant products contain standardized amounts of the active ingredients THC and CBD.
    • Pharmacy-made oils with different concentrations of CBD and/or THC from Glostrup pharmacy (DK).
    • Drops with different concentrations of CBD and/or THC from Stenocare
    • Cannabis medicines that are approved (have MA) in other countries: 
      • Cesamet (nabilone) Synthetic cannabinoid similar to THC. MA in several countries for the treatment of nausea during chemotherapy.
      • Marinol (dronabinol) Synthetic THC. MA in several countries for the treatment of decreased appetite in AIDS and the treatment of nausea during chemotherapy.

    How do Norwegian patients obtain unregistered cannabis products?

    Once the DMP has granted an exemption from approval, the pharmacy delivers the product to the patient. The pharmacy wholesaler must apply to the DMP for an import permit.

    Does the public health system cover cannabis treatment?

    The use of Sativex for MS and the use of Epidyolex for certain forms of epilepsy in children are covered through H-prescription.

    All other use of cannabis is considered experimental treatment. Such experimental treatment is the responsibility of the health institutions. If a physician at a public hospital offers treatment with cannabis, the hospital must also cover the costs of the treatment.

    See the Norwegian Directorate of Health's guide on experimental treatment.

    If physicians outside a public hospital offer experimental treatment with cannabis products, the patient must pay for the treatment themselves. HELFO no longer provides individual support for treatment with cannabis products.

    Medical use of cannabis and driving licenses

    The Norwegian Directorate of Health's “Driving license guide” states that the use of approved medicinal products with cannabis (Sativex and Epidyolex) may be compatible with a class 1 driving license, while all other use of cannabinoid medicinal products is incompatible with driving a motor vehicle.

    See the guide for further conditions. Substances that may affect driving ability (§§ 35–37) - Directorate of Health.

    The county physician may consider applications for exemptions from these rules.

    Changes as of August 5, 2022:

    • We have chosen not to use the term “medical cannabis” since this is used in several meanings.
    • We emphasize that the authorities have not created a list of conditions where experimental use of cannabis products is relevant.
    • We have included short sections on reimbursement of treatment with cannabis and on health requirements for driving licenses.
    • We have removed the link to “Guide for physicians from the Norwegian Directorate of Health and DMP”, and included relevant information from the guide into the text on this page.