Contents
Market Overview
Belgium maintains one of Europe’s most restrictive medical cannabis frameworks, with only pure CBD permitted for medical use under magistral preparations. All other cannabis-derived products containing THC remain prohibited for prescription or sale.
Although CBD itself was never explicitly illegal, it existed in a legal grey area for several years until 2019, when the Belgian authorities formally recognised its distinction from THC and reclassified it as a non-narcotic substance. This clarification provided the legal foundation for magistral CBD prescriptions and compounding within pharmacy settings.
At present, both general practitioners and medical specialists may prescribe CBD-based magistral preparations at their discretion, offering limited therapeutic flexibility for patients with conditions that may benefit from cannabidiol-based treatment.
Regulatory Framework
Under Belgian law, only magistral preparations—those compounded individually by a pharmacist according to a physician’s prescription—are permitted for medical use. The Federal Agency for Medicines and Health Products (FAMHP) oversees the control and authorisation of substances used in these preparations.
- The only authorised active pharmaceutical ingredient (API) for magistral cannabis preparations is pure CBD.
- Products containing any measurable level of THC are strictly prohibited.
- Pharmacists must source CBD APIs from approved suppliers, and all preparations must comply with the Belgian Pharmacopoeia and Good Manufacturing Practice (GMP) standards.
The current legal framework does not allow for the commercial production or distribution of finished medical cannabis products, nor does it permit imported cannabis-based medicines beyond those approved by the European Medicines Agency, such as Sativex, which remains available under a restricted prescription pathway.
Patient Access
Who Can Prescribe?
Both general practitioners (GPs) and medical specialists in Belgium are authorised to prescribe CBD magistral preparations. There are no defined restrictions on which medical fields can issue such prescriptions, though in practice, prescribing remains rare and typically limited to neurology, pain management, and palliative care settings.
Product Forms:
Magistral CBD preparations are typically available in two dosage forms:
- Oil formulations, prepared in varying concentrations of CBD
- Capsule forms, designed for precise dosing and patient convenience
These are compounded on an individual basis by licensed magistral pharmacists using pure CBD APIs.
Conditions Treated:
There is no official list of approved medical indications. CBD magistral preparations are prescribed off-label, most commonly for conditions such as:
Inflammatory or autoimmune conditions
Chronic or neuropathic pain
Epileptic disorders
Anxiety and sleep disturbances
Industry Landscape
Belgium currently lacks a formal medical cannabis market or domestic production infrastructure. The absence of THC-containing products and restrictive prescribing framework have prevented meaningful commercial development.
However, Belgium’s pharmaceutical expertise and central EU location have made it a strategic base for clinical research and logistics within Europe’s broader cannabis supply chain. Several international companies maintain offices or research partnerships in Belgium focused on cannabinoid science, regulatory affairs, or product formulation.
Outlook
Belgium’s approach to medical cannabis remains highly conservative, focusing solely on CBD-based preparations and avoiding any broader legalisation of THC-containing medicines.
While there is limited public or political momentum for reform, Belgium could gradually expand its framework in line with neighbouring EU states such as France and Germany—particularly as EU-level harmonisation on medical cannabis standards evolves.
For now, the country’s medical cannabis ecosystem remains minimal in scale, functioning primarily through prescription CBD compounding and isolated research initiatives rather than a structured national programme.
