Regulatory Hierarchy

Workflow steps

1. Danish Medicines Agency (DKMA) — Lægemiddelstyrelsen
   Primary medicines regulator. Manages product approvals, import licenses, GMP inspections. Denmark's EU-GMP enforcement authority.
   • Product approvals (approved product list)
   • Per-shipment import licenses
   • GMP inspections — EU network participant
   • Narcotic import/export licensing
2. Ministry of Health — Policy oversight
   Sets national cannabis access policy. Established and extended the medical cannabis pilot program. Oversees DKMA.
   • National access policy
   • Annual program review
   • Treaty obligations under Single Convention
3. Danish Regions — 5 healthcare regions
   Denmark's 5 regions (Regions) manage hospital supply and some reimbursement decisions. Hospital procurement of cannabis may differ from community pharmacy.
   • Regional formulary decisions for hospital supply
   • Tender processes for bulk hospital procurement
4. Pharmacies — Community dispensing
   Licensed Danish pharmacies dispense against GP or specialist prescriptions. DKMA-approved products available nationally.
   • Danish pharmacy license
   • Prescription required
   • Narcotic dispensing register
5. Patients — End recipients
   Any GP or specialist may prescribe since 2021 reform. Reimbursement limited — primarily out-of-pocket. Growing patient base since permanent program established.