Denmark

Medical cannabis pilot launched January 2018. Made permanent January 2021. Operated by DKMA under the Medical Cannabis Act. Any GP or specialist may prescribe since 2021 reform. Growing patient population — estimated 15,000+ active prescriptions in 2026.

DKMA maintains a list of approved cannabis products eligible for import. Products not on this list require a named patient authorization — a more complex pathway. Suppliers must submit a product approval application to DKMA before applying for import licenses.

Importers require a DKMA wholesale dealer authorization and narcotic handling license. Per-shipment import license required. EU-GMP Part I certificate and GACP certificate required for all applications.

Any licensed Danish physician may prescribe. Reimbursement limited — primarily out-of-pocket for patients. Danish regions manage hospital formulary decisions independently. Copenhagen has the highest patient concentration.

Denmark has no significant domestic cannabis production for medical use — it is a pure importing market. Primary suppliers are Germany, Netherlands, Israel, and Canada.

Step 1: Product approval submission to DKMA (4–8 weeks for new products). Step 2: Per-shipment import license from DKMA (~3 weeks for approved products). Both steps required before first shipment. Subsequent shipments of approved products only need Step 2.

DKMA import license (original), EU-GMP Part I certificate (cannabis scope), GACP certificate, COA per batch (QP signed), Exporting country export authorization, Airway bill, Commercial invoice.

Copenhagen Kastrup Airport (CPH) is the primary entry point. Standard EU customs procedures. Narcotic import declaration under Single Convention 1961.

All finished cannabis imported into Denmark must be manufactured under EU-GMP Part I. Certificate from EEA authority or PIC/S body required. GMP certificate must be submitted with the DKMA product approval application.

EEA national authorities (ANSM, IMB, BfArM etc.) certificates accepted directly. PIC/S members (TGA, Health Canada, MHRA, IMFA) accepted under bilateral arrangements. Cannabis scope required.

EU QP named on Danish importer's wholesale authorization certifies each batch. English-language batch certificates accepted by DKMA — Danish language not required.

EU GACP and WHO GACP accepted. ISO 17065-accredited third-party certification required. Certificate must be current at product approval application and each import license application.

1–3 year certificates. DKMA requires current certificate — no grace period. Build renewal audits into the annual compliance calendar well ahead of expiry.