Regulatory Hierarchy

Workflow steps

1. URPL — Office for Registration of Medicinal Products
   Primary medicines regulator. Issues import authorizations, product registrations, wholesale licenses. Poland's EU-GMP enforcement authority.
   • Per-shipment import authorizations
   • Product marketing authorizations
   • Wholesale dealer authorizations
   • GMP inspection participation (EU network)
2. GIF — Main Pharmaceutical Inspectorate
   Główny Inspektorat Farmaceutyczny. Issues narcotic handling authorizations, conducts pharmacy and wholesale inspections.
   • Narcotic handling licenses
   • GDP inspections
   • Pharmacy compliance oversight
3. Ministry of Health — Policy oversight
   Sets national pharmaceutical policy. Oversees both URPL and GIF. Poland's cannabis access remains politically sensitive — policy changes can affect access.
   • National cannabis access policy
   • Reimbursement decisions (very limited for cannabis)
   • Treaty obligations
4. Licensed Wholesalers — GIF/URPL licensed
   URPL and GIF-licensed wholesale dealers distribute to pharmacies.
   • URPL wholesale authorization
   • GIF narcotic handling license
   • GDP compliance
5. Pharmacies — Dispensing — access barriers remain
   Polish pharmacies may dispense cannabis against physician prescriptions. Access barriers remain: poor reimbursement, limited prescriber awareness, and pharmacy stock availability issues mean patients often struggle despite legal access.
   • Pharmacy license
   • GIF narcotic dispensing authorization
   • Prescription required — any physician since 2017