Classification of CBD products
Guide for companies that are unsure if a CBD product is classified as a medicine
It is possible to market cannabidiol (CBD) products with a THC-content below 0.2 % in Denmark without contravening the executive order on euphoriant substances. CBD products may, however, be covered by the rules on medicinal products, food products, cosmetic products, etc., and these rules must still be observed.
Some companies find it difficult to determine when these products are classified as medicines. Medicines can only be marketed if a marketing authorisation has been granted by the Danish Medicines Agency.
There are no set limits for how much CBD a product must contain for it to be classified as a medicine The Danish Medicines Agency must therefore make an individual assessment to determine if a CBD product is a medicine.
Medicines contain substances that prevent or treat disease. A product is classified as a medicine if it contains an active substance, or if it is recommended against a disease, or if it is to be used to make a medical diagnosis. It can be products intended to have an infect in or on the body.
If the Danish Medicines Agency determines a CBD product to be a medicine, it may not be sold without permission from the Danish Medicines Agency. Nor may a CBD product which is assessed to be a medicine be sold as a food supplement, a cosmetic product or the like.
Below is a guide to companies wishing to market CBD products on the Danish market:
- Products containing CBD may be classified as a medicine if, for example, the product is to be consumed or applied on the skin and therefore has a real effect on the body or if it is claimed to be a medicinal product. Here you can read more about how the Danish Medicines Agency assesses if a CBD is a medicine.
- If the Danish Medicines Agency assesses that a CBD-containing product is not a medicine, and the company wishes to market it as a food supplement, then the rules of the Danish Food Act must be complied with. The Danish Veterinary and Food Administration can offer guidance on the legislation and rules applicable to the marketing of food supplements. Food supplements must be notified to the Danish Veterinary and Food Administration. Information on CBD in food products is available at the website of the Danish Veterinary and Food Administration.
- If the Danish Medicines Agency assesses that a CBD-containing product is not a medicine, and the company wishes to market it as a cosmetic product, then the company is responsible for the safety of the product. The Danish Environmental Protection Agency can offer guidance on the legislation and rules applicable to the marketing of cosmetic products. You can read more about this on the website of the Danish Environmental Protection Agency (in Danish).
The Ministry of Health has reviewed how other European countries regulate CBD products. This review showed that none of the contributing countries have set limits for how much CBD a product must contain for it to be classified as a medicine. Whether a CBD product is classified as a medicine in other EU countries also depends on an individual assessment pursuant to the Medicinal Products Directive. Each European country assesses if a product has a therapeutic effect and if it is claimed to be a medicinal product.