Contents
Market Overview
Malta established its medical cannabis framework in 2018, introducing legislation that authorised both patient access and commercial cultivation and manufacturing for medicinal and research purposes.
Despite a small population, Malta has a high number of registered medical cannabis patients relative to population size, reflecting both strong patient demand and early regulatory implementation. However, access remains restricted due to product availability and pricing, while domestic production has developed more slowly than anticipated.
The Maltese market is currently supplied through a combination of imports and limited local production, with a significant proportion of medical cannabis flowers imported from Canada. Domestic industrial activity exists but remains modest, as companies continue to navigate high regulatory costs and strict facility requirements.
Regulatory Framework
Malta’s medical cannabis sector is governed by two key legislative instruments introduced in 2018:
- Cannabis for Medicinal and Research Purposes Act (2018)
- Act No. V of 2018 – Drug Dependence (Treatment not Imprisonment) Amendment
These laws collectively legalised the production, cultivation, processing, import, export, and prescription of medical cannabis. Oversight lies with the Malta Medicines Authority (MMA), which issues and regulates licences across the value chain.
Licensing Requirements:
- Letter of Intent (LOI) from the Malta Enterprise or relevant ministry.
- Production licence granted by the Malta Medicines Authority.
- EU-GMP certification for manufacturing facilities (if applicable).
- Facility Security Clearance Certificate from national authorities.
- Annual licensing fee: approximately €70,000, plus a €10,000 initial application fee.
Export rules are focused on finished medical products, though intermediate exports (e.g., bulk flower, oil) are permitted with additional approvals.
Malta’s framework was designed to attract foreign investment and research partnerships, yet high compliance costs and strict oversight have limited the scale of domestic operations to date.
Patient Access
Who Can Prescribe?
Any licensed doctor in Malta may prescribe medical cannabis. Prescriptions are issued on a case-by-case basis, with medical justification required.
Approved Indications:
- Multiple sclerosis
- Chronic pain
- Chemotherapy-induced side effects
- Other “debilitating chronic conditions” (non-acute in nature)
Reimbursement:
- Not reimbursable for most patients.
- Partial reimbursement available for inpatients, covering up to three days post-hospital discharge.
- Low-income or chronic illness patients may qualify for free prescriptions under government support schemes.
The lack of broad reimbursement limits affordability, although Malta’s open prescriber model has contributed to relatively high patient registration rates compared to neighbouring European countries.
Products & Prices
Malta’s product portfolio remains limited but includes a range of imported flowers and oil extracts.
Product Availability (as of February 2025):
- Flower: 23 authorised products
- Oil: 9 authorised products
(Source: Malta Medicines Authority)
Product Characteristics:
- Majority of available flowers are high-THC, with only one high-CBD strain authorised and no balanced THC:CBD varieties.
- Oil formulations offer greater cannabinoid diversity, with varying THC and CBD ratios suitable for chronic pain and neurological disorders.
Prices remain high relative to other European markets, reflecting Malta’s reliance on imports, small domestic scale, and stringent pharmaceutical compliance requirements.functioning in practice, despite legalisation being in place for nearly a decade.
Industry and Domestic Production
Since the introduction of the 2018 Act, Malta has sought to position itself as a Mediterranean centre for medical cannabis production and research, leveraging its EU membership, bilingual workforce, and existing pharmaceutical base.
Several companies have obtained Letters of Intent (LOIs) and production licences, but only a handful have advanced to operational status due to the high cost of EU-GMP compliance and limited export pathways.
While some industrial activity exists — primarily in processing, packaging, and research — the domestic supply chain remains underdeveloped. Imports, primarily from Canada, continue to dominate the Maltese medical cannabis market.
Outlook
Malta’s medical cannabis market is stable but constrained, characterised by strong patient demand, limited product diversity, and modest domestic production.
The country’s pharmaceutical infrastructure and regulatory clarity position it well for long-term development, but high entry costs and limited economies of scale have slowed industry growth.
Further liberalisation of reimbursement schemes and diversification of supply could enhance patient access and attract renewed investment. For now, Malta functions as a small but symbolically significant EU medical cannabis jurisdiction, balancing strict control with growing patient adoption.
