The Danish Medicines Agency receives a lot of questions from companies about the legislation and marketing of cannabis-containing products.
The cannabis plant (Cannabis indica L., Cannabis sativa L.) contains a number of cannabinoids, including delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Whereas THC is the euphoria-inducing component in cannabis, and therefore known in connection with marijuana applications, CBD has been observed to have antispasmodic, muscle relaxant and anti-anxiety effects.
Cannabis is used in a variety of products, some containing cannabis seed oil, others containing plant parts or extracts from the plant. Products that contain cannabis may be covered by different statutes, including rules on medicines, food products and cosmetics, depending on the content and presentation of the product and other product-specific matters.
Legislation governing cannabis-containing products
In Denmark, cannabis-containing products, especially those with CBD, may be classified as medicines. The specific assessment of whether or not a product is a medicine is a national concern, and it may differ from country to country.
In Denmark, products containing CBD may be classified as a medicine under the definition of a medicinal product.
A medicinal product means any product that
- is presented as a suitable product for the treatment or prevention of disease in human beings or animals (section 2(i)(a) of the Danish Medicines Act), or
- may be used in or administered to humans or animals to restore, change or modify physiological functions by having a pharmacological, immunological or metabolic effect or to make a medical diagnosis (section 2(i)(b) of the Danish Medicines Act).
A product is a medicine if it meets either of these definitions.
If a cannabis product is intended to be used for prevention or treatment of a disease, it may thus be covered by the presentation criteria of the medicinal product definition (cf. section 2 (i)(a) of the Danish Medicines Act). Some CBD products are marketed as being good for illness, such as pain or cramps, while others are recommended to maintain health.
Oral products containing active substances from cannabis, e.g. CBD, could have a pharmaceutical effect. CBD is an active pharmaceutical substance that affects specific receptors in the central nervous system through a pharmacological effect. Thus, oral products containing CBD may, depending on the circumstances, be covered by the function criteria of the medicinal product definition (cf. section 2(i)(b) of the Danish Medicines Act).
Another thing to bear in mind is that products produced from cannabis might also contain THC, and if the THC content is higher than 0.2%, the product may also be comprised by the rules on euphoriant substances.
Marketing of CBD-containing medicines in Denmark
The Danish Medicines Agency’s key tasks are to authorise and supervise pharmaceutical companies and medicines and to monitor the manufacture, import, distribution and marketing of medicines.
The marketing of CBD-containing medicines basically follows the same rules as any other medicines. Thus, the marketing of medicines requires that each individual medicine is licensed and that the company intending to market the medicine has been authorised You can find more information on these pages: Licensing of medicines and Company authorisations and registrations.
Illegal and legal medicines containing CBD and/or THC in Denmark
In the past few years, we have sadly seen numerous products containing CBD and THC, primarily CBD oil, being sold online or imported to Denmark. These products could be illegal medicines that fail to meet the Danish Medicines Agency’s quality and safety requirements. Illegal CBD-containing medicines appear on the List of medicines banned from sale in Denmark.
There are four ways to obtain CBD- and THC-containing products in Denmark; they are:
- Two authorised products containing CBD and/or THC. The medicines Sativex, oromucosal spray, and Epidiolex, oral solution; the first is used for the treatment of symptom-alleviation in adult patients with moderate to severe spasticity due to multiple sclerosis (MS), the latter for epilepsy.
- Through application for a compassionate use permit from the Danish Medicines Agency, so that a patient can use a medicine authorised in other countries, in case it is not marketed in Denmark.
- A prescription for a magistral medicinal product containing cannabis prepared by a pharmacy for a specific patient.
- Through the medicinal cannabis pilot programme. The programme allows doctors to prescribe a new type of cannabis products that were not previously legal in Denmark. The products comprised by the pilot programme are called medicinal cannabis. These often appear in the form of dried cannabis flowers, cannabis oils, capsules, tablets, etc., and they must all be prescribed by a doctor. You can read more about medicinal cannabis here.
Other statues governing cannabis-containing products
Products containing cannabis may be regulated by other statutes. For example, food products or cosmetics could contain cannabis:
The Danish Veterinary and Food Administration provides
What statutes do cannabis-containing products belong to?
Cannabis-containing products could be covered by different statutes, including the rules on medicines, cosmetics and food products.
Products for application on the skin, e.g. lotion, cream and shampoo for care and beautification may be cosmetics covered by the rules of the Danish Environmental Protection Agency (see information from the Danish Environmental Protection Agency about cannabis-containing products.
If a product is to be used as a food supplement to promote health or in cooking, e.g. cooking oil, it may be a food product and thus covered by the rules of the Danish Veterinary and Food Administration. Furthermore, if it is an oral CBD-containing product giving rise to absorption with subsequent CBD effect or the product is to be used for prevention or treatment of disease, it might also fall under the scope of the Danish Medicines Act. Furthermore, if the THC content is higher than 0.2%, the product might also be covered by the rules on euphoriant substances.
Which cannabinoids does the cannabis plant contain?
The cannabis plant contains many different cannabinoids, of which we know most about the substances cannabinoid (CBD) and tetrahydrocannabinol (THC).
Are all CBD-containing products medicines?
Basically, oral products that contain CBD giving rise to absorption with subsequent CBD effect will be considered medicines depending on the specific circumstances. Furthermore, if a product is to be used for prevention or treatment of disease, it may also fall under the scope of the Danish Medicines Act.
Have upper and lower limits been set for CBD content in the products?
No, there are no fixed limits. It requires a specific assessment of each product to determine if the product is covered by the definition of the Danish Medicines Act.
Is it legal to market products containing CBD if the THC value is under 0.2%?
Products produced from cannabis with a THC content of ≤0.2% are not considered to be regulated euphoriant substances, but other rules may apply, e.g. rules on medicines, food supplements or cosmetics. The marketing of such products could thus be illegal if for instance the rules of the Danish Medicines Act are breached.
Is a licence and authorisation required to market CBD-containing products?
If the specific product is a medicine, each individual product must be licensed, and the company must be authorised. You can find more information on these pages: Licensing of medicines and Company authorisations and registrations.
Are legal CBD-containing products available in Denmark?
The only legal CBD-containing products for oral use are all prescription-only and must be prescribed by a doctor. Comprehensive guidance on cannabis is available at our website – for example via our Questions and answers on cannabis and Classification of CBD products.