- European Medicines Agency — EMA — EU level
Sets EU-GMP guidelines and pharmacovigilance standards across EU member states. Issues guidance; enforcement is national.
- Issues EU-GMP Annexes
- Coordinates CHMP — limited direct cannabis role
- BfArM — Federal — primary authority
Bundesinstitut für Arzneimittel und Medizinprodukte. Primary federal authority for narcotics, import authorization, GMP inspections, and product approvals.
- Issues BtMG §3 import/export authorizations
- Grants AMG manufacturing licenses
- Conducts GMP inspections of foreign sites
- Maintains Federal Narcotics Register
- Federal Opium Inspectorate — Bundesopiumstelle — under BfArM
Division of BfArM responsible for the Federal Opium Register (Bundesopiumstelle). Issues all narcotic licenses and per-shipment authorizations.
- Bayern: LGL — State authority
Landesamt für Gesundheit und Lebensmittelsicherheit. Stricter documentation checks than federal minimums. High inspection frequency.
- Pharmacy inspections
- Additional batch documentation audits
- Enforcement of BtMG at pharmacy level
- NRW: LAGESO — State authority
Highest pharmacy volume state in Germany. Standard federal enforcement. Oversees wholesale distribution in the largest German market.
- Hamburg: BGV — State — port entry
Hamburg port is a primary sea entry point. Standard enforcement but high import processing volume. Key for customs coordination.
- Port entry customs coordination
- BtMG import documentation checks
- Licensed Pharmacies — Final dispensing point
Operate under state Landesapothekerkammer oversight. Dispense medical cannabis against BtM prescriptions. Maintain own BtM register.
- BtM-Rezept required per dispensing
- Controlled substance inventory log
- Monthly reporting to state chamber
- Patients — End recipients
Receive medical cannabis with a valid BtM prescription. No approved indication list — physician discretion applies. GKV reimbursement available subject to insurer prior authorization.