Questions about medicinal cannabis

Information for patients/citizens

Medicinal cannabis is a medicine. There are strict conditions that a product must meet in order to be licensed as a medicine.

Medicines containing medicinal cannabis can only be sold in (hospital) pharmacies in Belgium.

Sativex is a licensed medicine containing medicinal cannabis. Pharmaceutical preparations containing cannabidiol (CBD) are also medicines. A pharmacist can dispense this medicine to patients with a prescription from a doctor.

Belgian pharmacies are not legally permitted to dispense other forms of cannabis for medicinal purposes*. Only recognised and authorised medicines, such as Sativex or a pharmaceutical compound containing CBD, are permitted.

*Royal Decree of 11 June 2015 regulating products containing one or more tetrahydrocannabinols.

Sativex is a medicine based on a cannabis extract and contains delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). This medicine is the only medicinal cannabis product available on the Belgian market.

Sativex is used by multiple sclerosis (MS) patients to relieve symptoms of muscle stiffness (muscle spasticity). Spasticity means that there is increased muscle tension, making muscles feel stiffer or less flexible. This means that it is more difficult than usual to move the muscles. Sativex is prescribed if other medicines have not relieved the muscle stiffness in MS patients, or insufficiently.

More information about possible side effects, how to use the medicine, whether you can use it during pregnancy, etc. can be found in the medicine information sheet about medicinal cannabis on FarmaInfo.

Yes, your chemist can prepare a pharmaceutical compound with CBD if your doctor prescribes it. Your pharmacist must adhere to strict rules when preparing the medicine.

Pharmaceutical compounds containing only THC are banned. The maximum amount of d9-THC that a preparation containing CBD may contain is 0.1 %.

Sativex is subject to a restricted medical prescription. This means that it can only be prescribed by a medical specialist who has experience in treating the conditions for which this medicine is intended. Your doctor must also have experience with this treatment in order to prescribe a pharmaceutical compound containing CBD. The FAMHP recommends that patients discuss this with their treating doctor.

Special condition for Sativex
Sativex is only reimbursed if it meets the following conditions:
-   prescribed by a neurologist or neuropsychiatrist;
-   prescribed for the indication multiple sclerosis (MS);
-   delivery in a hospital pharmacy.
A request for approval must always be submitted to the consulting doctor. For more information, please consult the regulatory texts with the reimbursement conditions (this is the responsibility of the NIHDI):
-   chapter IV §7850100;
-   chapter IV § 7850200.

If Sativex is collected from a pharmacy open to the public, it will therefore not be reimbursed.

Sativex is only reimbursed for multiple sclerosis (MS). The necessary studies and clinical trials to demonstrate that Sativex is also indicated for pain relief have not yet been completed. If the results of these studies and clinical trials are positive, the marketing authorisation holder for Sativex can submit an application to the FAMHP to add 'pain relief' to the indications for Sativex. After evaluating the file, the FAMHP may grant the extension of the indication. The NIHDI will then decide whether Sativex will be reimbursed for the new indication if the marketing authorisation holder submits a reimbursement application.

Under Belgian legislation, it is also possible to submit an application for a medical emergency programme. Thanks to an emergency programme, a patient can use an authorised medicine for an indication that is not yet authorised. Contact the marketing authorisation holder via the treating doctor to submit such an application.*

Pharmaceutical compounds with CBD
Since 1 May 2025, pharmaceutical compounds based on CBD have been eligible for reimbursement when used in combination with clobazam for:
- Dravet syndrome (severe myoclonic epilepsy of infancy), for the treatment of tonic-clonic seizures, under certain conditions described in paragraph 34.A;
- the adjuvant treatment of epileptic seizures associated with Lennox-Gastaut syndrome in patients aged 2 years or older who simultaneously meet certain conditions described in paragraph 34.B.

A pharmaceutical compound containing CBD can be dispensed in a pharmacy open to the public with reimbursement if the patient has authorisation from the insurance organisation. The application for authorisation is submitted to the health insurance fund by a specialist in the treatment of epilepsy in children, as specified in the reimbursement conditions.

*Article 6 quater, § 1, 3°, of the Act of 25 March 1964 on medicines, and Article 108 of the Royal Decree of 14 December 2006 on medicines for human and veterinary use.

Yes, a pharmacist in a pharmacy open to the public may dispense medicinal cannabis to a patient who has a prescription from a doctor. Sativex is a licensed medicine containing medicinal cannabis. Pharmaceutical compounds containing cannabidiol (CBD) are also medicines. When dispensed in a pharmacy open to the public, Sativex is not reimbursable. Reimbursement is only possible if Sativex is dispensed in a hospital pharmacy. A pharmaceutical compound containing CBD may be reimbursed for certain indications () if it is dispensed in a pharmacy open to the public and the patient has authorisation from their insurance organisation.

Yes, but bringing these preparations into Belgium is not allowed if the THC content in these preparations exceeds 0.3 % (which will usually be the case).

Doctors enjoy therapeutic freedom and can, in principle, prescribe these preparations. Anyone with a doctor's prescription could legally purchase it from a foreign pharmacy where it can be dispensed (to foreign patients).

If the THC content exceeds 0.3 %, these preparations are subject to the legislation on narcotics/psychotropic substances in Belgium. These substances may only be brought into Belgium with a validated Schengen declaration in the patient's name. This is a document validated by the government of the country where the patient is domiciled and allows the patient to cross the border with narcotics. In Belgium, the FAMHP is responsible for validating these Schengen declarations.

As the supply of these preparations is prohibited in Belgium, the FAMHP does not validate Schengen declarations for bringing them into the country.*
The police may therefore seize these preparations.**

*oyal Decree of 11 June 2015 regulating products containing one or more tetrahydrocannabinols.

** 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.

Medicinal cannabis may cause drowsiness or dizziness, which can affect your judgement and ability to perform certain tasks. In rare cases, it can also cause short-term loss of consciousness.

Do not drive or operate machinery when using medicinal cannabis for the first time. Wait until you are taking the same dose every day and know how the medicine affects you. Even if you are used to medicinal cannabis and the dose is stable, avoid driving or operating machinery if you feel drowsy or dizzy.

When in doubt, it’s best to avoid driving vehicles or operating machinery.

More information about driving under the influence of medicines and about the influence of medicines on saliva tests performed in traffic is available.

No. Associations that combine individual cultivation for personal consumption by their members are illegal and punishable by law. This is because they facilitate the use of narcotics by others.
Furthermore, engaging in these activities in the context of an association constitutes an aggravating circumstance as referred to in the Act of 24 February 1921.*

*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.

If you have any questions about medicinal cannabis, please contact your doctor or pharmacist.

You can also find information for patients in the medicine information leaflet or under the topic of medicinal cannabis on FarmaInfo

If you cannot find the answer to your specific questions about medicinal cannabis, you can contact the FAMHP via info.medcannabis@fagg.be.

Information for pharmacists and doctors

Sativex is subject to a restricted medical prescription. This means that it can only be prescribed by a medical specialist who has experience in treating the conditions for which this medicine is intended.. As a doctor, you must also have experience with this treatment in order to prescribe a pharmaceutical compound containing CBD.

Unlawfully prescribing narcotics/psychotropic substances that can cause, maintain or exacerbate dependence (cannabis > 0.3 % THC or THC itself) is punishable by law.*

Special condition for Sativex
Sativex is only reimbursed if it:
-   is prescribed by a neurologist or neuropsychiatrist;
-   is prescribed for the indication multiple sclerosis (MS);
-   is dispensed in a hospital pharmacy.
A request for approval must always be submitted to the consulting doctor. For more information, please consult the regulatory texts with the reimbursement conditions (this is the responsibility of the NIHDI):
-   chapter IV §7850100;
-   chapter IV § 7850200.

If Sativex is collected from a pharmacy open to the public, it will not be reimbursed.

Sativex is only reimbursed if it is used for multiple sclerosis (MS). The necessary studies and clinical trials to demonstrate that Sativex is also indicated for pain relief have not yet been completed. If the results of these studies and clinical trials are positive, the marketing authorisation holder for Sativex can submit an application to the FAMHP to add 'pain relief' to the indications for Sativex. After evaluating the file, the FAMHP may grant the extension of the indication. The NIHDI will then decide whether Sativex will be reimbursed for the new indication if the marketing authorisation holder submits a reimbursement application.*

Under Belgian legislation, it is also possible to submit an application for a medical emergency programme. Thanks to an emergency programme, a patient can use an authorised medicine for an indication that is not yet authorised. If you are the treating doctor, contact the marketing authorisation holder to submit such an application.

*Article 6 quater, § 1, 3°, of the Act of 25 March 1964 on medicines, and Article 108 of the Royal Decree of 14 December 2006 on medicines for human and veterinary use.

A pharmacist in a pharmacy open to the public may, just like a hospital pharmacy, dispense Sativex to a patient who has a valid prescription from a doctor. In this case, Sativex is not reimbursed. Reimbursement is only possible if Sativex is dispensed in a hospital pharmacy. A pharmaceutical compound containing CBD may be reimbursed if it is dispensed in a pharmacy open to the public and the patient has authorisation from their insurance organisation.

A pharmacy open to the public, just like a hospital pharmacy, can dispense a pharmaceutical compound containing CBD to a patient who has a valid prescription from a doctor. Since 1 July 2024, there has been a specific monograph for cannabidiol (07/2024: 3151) included in the European Pharmacopoeia (Ph. Eur.). This monograph defines the maximum amount of tetrahydrocannabinol that the raw material may contain, namely a maximum of 0.1 % ∆9-THC.

There are various raw materials for CBD with a licence number and raw materials with a certificate of analysis.

A pharmacist can order Sativex through a wholesaler.

A pharmacist can order the raw material through a wholesaler or directly from the distributor of the licensed raw material.

To make a pharmaceutical compound based on CBD, the pharmacist can only use:

raw materials with a licence number;
raw materials with a certificate of analysis signed by a laboratory recognised by the Minister for Public Health.

For CBD, both raw materials with a licence number and raw materials with a certificate of analysis are available. The list of licensed raw materials and the list of recognised laboratories is available on our website.

To make a pharmaceutical compound based on CBD, the pharmacist can only use:

raw materials with a licence number;
raw materials with a certificate of analysis signed by a laboratory recognised by the Minister for Public Health.

Since January 2025, pharmacists must base their pharmaceutical compounds with CBD on the specific monograph (07/2024: 3151) of the European Pharmacopoeia. This monograph defines the maximum amount of THC that the raw material may contain, namely 0.1 % ∆9-THC. THC is responsible for the well-known psychoactive and addictive effects of cannabis, which is why its use is strictly regulated.

If you have any questions about medicinal cannabis, please contact info.medcannabis@fagg.be.

More information for patients is available in the medicine information leaflet and under the topic of medicinal cannabis on FarmaInfo

Information about clinical trials with medicinal cannabis.

A pharmaceutical company can start a clinical trial with medicinal cannabis provided that the application meets the criteria set out in European Regulation 536/2014 (Clinical Trials Regulation) and that approval for the clinical trial is given in the Clinical Trials Information System (CTIS). More information can be found on the FAMHP website.

For a clinical trial with cannabis in Belgium, various licences must be applied for, depending on the distribution situation of the Investigational Medicinal Product (IMP) containing cannabis (extract):

1. Direct distribution to Belgian pharmacies

Pharmacies are exempt from an activity licence for narcotics/psychotropic substances.
If the IMP comes from abroad, the pharmacy must apply for an import licence.

2. Distribution via an intermediary Belgian distributor to Belgian pharmacies

The distributor must have a prior activity licence for narcotics/psychotropic substances.
If the IMP comes from abroad, the distributor must apply for an import licence.