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Regulatory Hierarchy

Israeli regulatory structure from MOH to patient

Regulatory Structure Verified 2026-04-20

Workflow steps

  1. Ministry of Health (MOH) — Policy and oversight
    Israeli Ministry of Health sets national medical cannabis policy. Oversees IMFA. Issues the legal framework under the Dangerous Drugs Ordinance and MOH directives.
    • National cannabis policy framework
    • Oversight of IMFA licensing program
    • Patient access policy — quota setting
  2. IMFA — Israel Medical Cannabis Agency
    Primary regulatory authority for medical cannabis in Israel. Issues all IMCA licenses (cultivation, manufacturing, distribution, export, dispensing). Conducts GMP/GACP inspections.
    • Issues IMCA licenses across supply chain
    • GMP inspections — IMFA-issued certificates accepted by EU, UK, AUS, CA
    • Per-shipment export permits
    • Domestic patient quota management
  3. IMFA — GMP Inspectorate — Manufacturing oversight
    IMFA GMP inspections are conducted to a standard that is bilaterally recognized by the EMA network, MHRA, TGA, and Health Canada. IMFA GMP certificates are the primary credential for Israeli export.
    • EU-GMP Part I and Part II inspections conducted
    • Bilateral recognition with EMA, MHRA, TGA
    • Cannabis-specific GMP scope required
  4. IMFA — Licensing — IMCA license management
    Issues all IMCA licenses. Currently ~120 licensed entities in Israel across cultivation, manufacturing, and distribution. License renewal is annual.
    • Cultivation licenses (indoor, outdoor, greenhouse)
    • Manufacturing licenses (finished product, API, extract)
    • Distribution and export licenses
  5. Licensed Manufacturers — IMCA holders
    ~60 active manufacturing license holders in Israel as of 2026. Most are vertically integrated (cultivation + manufacturing). EU-GMP certification is near-universal among export-oriented manufacturers.
    • IMCA manufacturing license
    • EU-GMP Part I or Part II certificate
    • GACP certificate for cultivation site
    • Batch release by qualified person
  6. Licensed Pharmacies / Dispensaries — Domestic dispensing
    IMFA-licensed pharmacies and cannabis dispensaries. Domestic patients receive cannabis via prescription against MOH quota. Strict chain of custody from manufacturer to patient.
    • IMFA dispensing license
    • Patient prescription and quota management
    • Cold chain if applicable
    • Monthly reporting to IMFA
  7. Patients (Domestic) — ~120,000 licensed patients
    Israel has approximately 120,000 licensed medical cannabis patients as of 2026 — one of the highest per-capita rates globally. Patients receive a government quota and purchase from licensed dispensaries or pharmacies.
Export AuthorizationGMP Pathway