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Regulatory Hierarchy

Dutch regulatory structure from IGJ and CCBM to pharmacy

Regulatory Structure Verified 2026-04-20

Workflow steps

  1. Ministry of Health (VWS) — Policy oversight
    Dutch Ministry of Health, Welfare and Sport sets national cannabis policy. Oversees both OMC and IGJ. Controls the government cannabis supply system via OMC.
    • National cannabis policy framework
    • Oversight of OMC tender system
    • Treaty obligations under Single Convention 1961
  2. IGJ — Healthcare Inspectorate
    Inspectie Gezondheidszorg en Jeugd. Medicines regulator — equivalent to MHRA or BfArM. Issues wholesale dealer licenses, GMP inspections, pharmacovigilance.
    • Wholesale Dealer Authorization (WDA)
    • GMP inspections of Dutch manufacturers
    • Pharmacy and distributor licensing
  3. OMC — Office of Medicinal Cannabis
    Bureau for Medicinal Cannabis (OMC/CCBM). Issues per-shipment import/export authorizations. Manages the government tender system for standardised cannabis products supplied to Dutch pharmacies.
    • Per-shipment import authorizations
    • Per-shipment export authorizations
    • Government tender management (Bedrocan varieties)
    • Opium Act Article 8 authorizations
  4. CBG / MEB — Medicines Evaluation Board
    College ter Beoordeling van Geneesmiddelen. Issues marketing authorizations for registered medicinal products. Most cannabis in NL is unregistered — CBG role limited for cannabis currently.
    • Marketing Authorisation for registered products
    • Labeling and package leaflet approval
    • Pharmacovigilance coordination
  5. Licensed Wholesalers — IGJ WDA holders
    IGJ-licensed wholesale dealers distribute cannabis to pharmacies. Must comply with Dutch GDP guidelines. Cannabis must be sourced from OMC or CCBM-authorized imports only.
    • IGJ Wholesale Dealer Authorization
    • GDP compliance
    • Cannabis only from OMC or CCBM-authorized sources
  6. Pharmacies — Dispensing to patients
    Dutch pharmacies dispense medicinal cannabis against physician prescriptions. OMC-contracted products available nationally. Non-OMC products via magistral preparation or import authorization.
    • Pharmacy license from IGJ
    • Prescription required for Schedule 2 cannabis
    • OMC delivery system for standard products
  7. Patients — End recipients
    Receive cannabis via GP or specialist prescription. OMC products reimbursed by some health insurers. Non-OMC products generally not reimbursed. Netherlands has relatively liberal prescribing culture.
Import AuthorizationGMP Pathway