Regulatory Hierarchy

Workflow steps

1. Ministry of Health — Ministère de la Santé
   Primary regulator for the small Luxembourg medicinal cannabis market. Sets national access policy and oversees import authorizations. Luxembourg is EEA — applies EU-GMP framework.
   • National medicinal cannabis policy
   • Import authorizations
   • EEA treaty obligations
2. Division of Pharmacy and Medicines — Operational arm
   Operational division under Ministry of Health. Processes import applications, manages named-patient programs, coordinates with EEA regulatory network.
   • Import application processing
   • Named-patient program administration
   • GMP certificate verification
3. Pharmacies — Dispensing
   Licensed Luxembourg pharmacies dispense against specialist prescriptions. Small national market — limited number of pharmacies and importers.
   • Luxembourg pharmacy license
   • Prescription required
   • Narcotic dispensing register
4. Patients — End recipients
   Receive cannabis via specialist prescription. Named-patient program similar to ANSM-style process. Small patient population.