Medicines and other products based on cannabis or cannabidiol

The use of medicinal cannabis is strictly regulated in Belgium and limited to specific situations. This webpage provides answers to questions on the current legislation, the medicinal cannabis products available and the conditions under which these products can be prescribed, dispensed and used.

What is medicinal cannabis?

Medicinal cannabis includes products that:

come from the cannabis plant;
meet the legal definition of a medicine.

‘Come from the cannabis plant' means that these products contain a part of the cannabis plant, such as flowers, leaves or extracts. As a result, they contain active ingredients derived from the cannabis plant (cannabinoids), the most important of which are cannabidiol (CBD) and tetrahydrocannabinol (THC). CBD is known for its potential analgesic and calming effects, while THC causes the psychoactive and potentially addictive effects of cannabis.

A product meets the legal definition of a medicine if it:

is presented as a means of treating or preventing a disease;
has a pharmacological, immunological or metabolic effect when administered to people.

Not all medicinal cannabis is legally available in Belgium.

Which products are legal?

In Belgium, one cannabis-based speciality is currently licensed as a medicine and available: Sativex (Jazz Pharmaceuticals Ireland Ltd.). Sativex contains both CBD and THC. Another speciality, Epidyolex (Jazz Pharmaceuticals Ireland Ltd.), which contains CBD, was granted a marketing authorisation (MA) in 2019, but is not currently sold on the Belgian market.
Pharmacists may also dispense pharmaceutical compounds based on the pharmaceutical raw material CBD, provided they comply with the applicable regulations.

What is not legal?

Foods such as lollipops, cakes or brownies and food supplements containing parts of the cannabis plant, which are advertised for pain relief or sleep problems, fall under medicinal cannabis because they contain part of the cannabis plant and claim to have a medical effect. However, bear in mind that these products are not authorised as medicines in Belgium and are therefore sold illegally.

Other cannabis-based products

There are also products such as industrial hemp (for the construction or textile sector), food products (including food supplements) and cosmetics based on Cannabis sativa. These products based on Cannabis sativa may only be placed on the market if they comply with the applicable specific legislation. However, these products do not fall under the definition of medicinal cannabis, as they are not medicines. More information on these products can be found in the section 'Questions about other cannabis-based products and foods'.

The difference between medicines, food supplements and cosmetic products, and how you can recognise the differences between these products, can be found in this topic on FarmaInfo.
These products may sometimes also contain synthetic cannabinoids. These substances are not derived from the plant, they are synthetically produced. They are not classified as medicinal cannabis, but can be dangerous.

What is the most important legislation?

Act of 24 February 1921 on the trade in toxic substances, sedatives and narcotics, psychotropic substances, disinfectants and antiseptics, and substances that can be used for the illegal manufacture of narcotics and psychotropic substances.
This is the basic law that serves as the legal basis for the implementing decrees that regulate the prescription, administration or delivery of substances such as medicinal cannabis. It also stipulates the penalties applied when these measures are violated.
Royal Decree of 11 June 2015 regulating products containing one or more tetrahydrocannabinols.
This decree prohibits the delivery of pharmaceutical and officinal preparations containing tetrahydrocannabinols.
Royal Decree of 6 September 2017 regulating narcotics and psychotropic substances.
This decree subjects cannabis and THC to oversight and control measures, such as a licence requirement for the possession of these substances or activities involving them. It also provides for exceptions for legitimate medicinal use, such as sale by pharmacists or possession by patients.

What is the competence of the FAMHP?

The Federal Agency for Medicines and Health Products (FAMHP) is responsible for medicines. All products based on medicinal cannabis that meet the definition of a medicine therefore fall under the competence of the FAMHP.
Pharmaceutical companies can only sell specialities containing medicinal cannabis if they have a marketing authorisation (MA). An MA in Belgium can be granted by the FAMHP or by the European Medicines Agency (EMA). The specialities can only be dispensed in (hospital) pharmacies.
There are two specialities containing medicinal cannabis that have a marketing authorisation in Belgium: Epidyolex and Sativex.

Epidyolex (containing CBD) received a marketing authorisation from the EMA in 2019. The marketing authorisation holder subsequently decides in which European Member States the medicinal product will be sold. Epidyolex is not currently sold on the Belgian market.
Sativex (contains CBD and THC) is currently the only medicinal cannabis product sold in Belgium.

Pharmaceutical preparations containing CBD also fall under the authority of the FAMHP. These products can only be prepared in (hospital) pharmacies.
Other products containing CBD or parts of a cannabis plant with a d9-THC and THC acid content not exceeding 0.3 % fall under the authority of the FPS Public Health, Food Chain Safety and Environment. More information on this matter can be found in the section 'Questions about other cannabis-based products and foods'.

What is the Cannabis Information Office?

The Cannabis Information Office is a unique counter for advising people and handling questions about medicinal cannabis. The Cannabis Information Office can also offer support to pharmaceutical companies with questions about clinical trials, for example in drawing up protocols, providing guidance with applications and answering questions about licences. It is also possible to request scientific and technical advice.
If you have any questions, please contact info.medcannabis@fagg.be.