Change of the THC limit as of 1 July 2018
The executive order on euphoriant substances has been changed as of 1 July 2018. The change introduces a threshold limit which makes it possible to produce and sell cannabis-based products containing up to 0.2 % THC without contravening the executive order on euphoriant substances.
The change of the THC limit in the executive order on euphoriant substances does not change anything in the Danish Medicines Act or the assessment of when a product is considered to be a medicinal product. This means that many products containing CBD will still be classified as medicinal products if, for example, the product is to be consumed or applied on the skin and has a real effect on the body or if it is claimed to be a medicinal product.
It is still not allowed to sell medicines without permission from the Danish Medicines Agency, and CBD-containing medicines are still prescription-only medicines.
What are the specific implications of the rule change of the 0.2 % THC limit?
The rule change removes "a bump on the road" for companies wanting to produce or import and sell non-medicinal cannabis products with a low THC content. This could be food products like hemp beer or hemp cookies.
Previously, these products were illegal even if they contained only measurable quantities of THC, the reason being that Denmark until now had a complete ban on the possession of THC-containing products for other than medical and scientific purposes.
As of 1 July 2018, this ban no longer applies in Denmark.
However, the law may still impose rules on food or cosmetic products that must be complied with before products like hemp shampoo and hemp beer with a low THC content can be sold legally.
Products that contain CBD will most likely have to be assessed by the Danish Medicines Agency to determine if they are medicinal products. If they are, it is not legal to sell them without permission from the Danish Medicines Agency.
What the 0.2 % THC limit rule does not change
The rule change does not mean that CBD-containing products become food supplements automatically. It requires a specific assessment of each individual product to determine if it is a medicinal product. You should expect that the vast majority of CBD-containing products are still medicinal products. The Ministry of Health is presently conducting a survey among our neighbouring countries to see how they handle CBD products as practices seem to differ between EU countries.
Assessment of CBD-containing products
The Danish Medicines Agency cannot say in advance if a given CBD-containing product will be classified as a medicinal product. We can only provide information about the products we have specifically examined.
When we are to determine if a specific CBD-containing product is to be classified as a medicinal product, we look at how it is presented and what function it has. The things we examine include the product's active substances, the quantities of active substances and the dosage, the product's physical form, text and images on the pack, comparison with already authorised medicinal products, etc. We cannot say in advance if for example an oil that is based on cannabis will be classified as a medicinal product or a food product. It would require a specific assessment of the active substances, the effect and the application of the specific product.
We have previously assessed products that are based on cannabis. Some of the cannabis products we have classified as medicinal products can be found here.
For reasons of patient safety, medicinal products must go through an authorisation process before they can be sold in Denmark. In the case of cannabis products, it is possible to instead apply for them to be admitted to the medicinal cannabis pilot programme. The sale of both cannabis-containing medicinal products and cannabis products of the pilot programme is only allowed from pharmacies.
If a product is not classified as a medicinal product, but instead classified as say a cosmetic product or food product, companies must be aware that the products must comply with the food legislation or the cosmetics legislation.