Regulatory Hierarchy

Workflow steps

1. Ministry of Health (MOH) — Policy and narcotic licensing
   Czech Ministry of Health sets national cannabis policy and issues narcotic handling licenses. Oversees SÚKL.
   • National cannabis access policy
   • Narcotic license issuance
   • Quota management under Single Convention
2. SÚKL — State Institute for Drug Control
   Primary medicines regulator. Issues import authorizations, wholesale dealer licenses, and GMP inspection reports. Czech EU-GMP enforcement authority.
   • Per-shipment import authorizations
   • Wholesale dealer authorizations
   • GMP inspections (participates in EU network)
3. Licensed Wholesalers — SÚKL WDA holders
   SÚKL-licensed wholesale dealers distribute cannabis to pharmacies. Must comply with Czech GDP requirements.
   • SÚKL wholesale authorization
   • MOH narcotic handling license
   • GDP compliance
4. Czech Pharmacies — Dispensing
   Pharmacies dispense cannabis against physician prescriptions. No specialist restriction — any licensed Czech physician may prescribe since 2022 reform.
   • Pharmacy license
   • Narcotic dispensing register
   • Prescription required — any physician since 2022
5. Patients — ~30,000+ licensed patients
   Receive cannabis via physician prescription. Health insurance does not reimburse cannabis — out-of-pocket costs. Growing patient population since 2022 access expansion.