Regulatory Hierarchy

Workflow steps

1. HALMED — Agency for Medicinal Products and Medical Devices of Croatia
   Primary regulator for all medicines including cannabis. Issues import authorizations, manages named-patient approvals. Croatia is EEA — accepts EU-GMP and participates in EEA regulatory network.
   • Import authorizations per shipment
   • Named-patient approvals
   • GMP recognition — EEA network
   • Pharmacovigilance
2. Ministry of Health — Policy oversight
   Sets national medicinal cannabis policy. Hospital-led dispensing system. Sativex is licensed; other products via named-patient pathway.
   • National drug policy
   • Oversight of HALMED
   • EEA treaty obligations
3. Hospital Pharmacies — Dispensing
   Cannabis medicines dispensed through hospital pharmacies in Croatia. Hospital-led system — community pharmacy access limited.
   • Hospital pharmacy license
   • Specialist prescription required
   • Controlled substance register
4. Specialist Physicians — Prescribers
   Only specialist physicians (neurology, oncology, pain medicine) may prescribe cannabis medicines.
   • Specialist qualification
   • Named-patient authorization for unlicensed products
   • Documented treatment failure of conventional therapies
5. Patients — End recipients
   Receive cannabis via specialist prescription. Sativex is licensed; other products via named-patient pathway.