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Regulatory Hierarchy

Maltese dual regulatory structure — medical and industrial cannabis

Regulatory Structure Verified 2026-04-20

Workflow steps

  1. Medicines Authority (Malta) — Medical cannabis regulation
    Regulates medicinal cannabis as a medicine. Issues import licenses, wholesale authorizations, GMP compliance. Malta's EU-GMP enforcement body.
    • Medical cannabis import licenses
    • Wholesale dealer authorizations
    • GMP inspections (EU network)
    • Pharmacovigilance
  2. MMCA — Malta Medical Cannabis Authority
    Regulates industrial cannabis cultivation, production, and export in Malta. Malta has positioned itself as an EU cannabis hub. MMCA licenses cover cultivation and manufacturing for export.
    • MMCA cultivation licenses
    • MMCA production licenses
    • Export authorization for industrial cannabis
    • Quality standards for export
  3. Ministry of Health — Policy oversight
    Sets medical cannabis access policy. Oversees Medicines Authority. Malta has been progressive on cannabis policy — adult use also legal since 2021 under separate framework.
    • National medical cannabis policy
    • Oversight of both Medicines Authority and MMCA
  4. Pharmacies / Hospitals — Dispensing
    Licensed Maltese pharmacies dispense against specialist prescriptions. Small island market — limited number of pharmacies but growing specialist prescribing base.
    • Pharmacy license from Medicines Authority
    • Prescription required
    • Narcotic register maintained
  5. Patients — End recipients
    Receive cannabis via specialist prescription. Growing patient population. Health insurance coverage limited — primarily out-of-pocket.
Import AuthorizationGMP Pathway