Import Authorization

Workflow steps

1. Import Intent
   You wish to import cannabis-based medicines into Romania. Romania operates a strict named-patient system — imports require specialist physician prescription and ANMDM per-shipment authorization.
   • Licensed Romanian importer / wholesaler
   • Specialist physician named-patient prescription
   • EU-GMP Part I certificate (EEA)
2. ANMDM Import Authorization — Per-shipment
   Apply to ANMDM for per-shipment import authorization. Each shipment requires a separate authorization. Named-patient prescription from a specialist physician (neurology, oncology, or pain) is prerequisite.
   • Specialist physician named-patient prescription
   • Product marketing authorization or compassionate use justification
   • EU-GMP Part I certificate from EEA authority
   • GACP certificate for cultivation site
   • Certificate of Analysis per batch
3. Authorization granted?
   ANMDM reviews application against named-patient requirements and EU-GMP compliance. May request additional clinical justification or documentation.
4. Address ANMDM Queries
   Provide additional clinical justification, updated certificates, or named-patient documentation as requested.
   • Respond within ANMDM-specified timeframe
   • Updated certificates if expired
   • Additional specialist physician support if requested
5. Authorization Issued
   Per-shipment import authorization valid for the specified quantity, product, and named patient only.
   • Original document required at customs
   • Shipment must match authorization exactly
6. Customs Clearance
   Romanian customs processes narcotic import declaration under EU and Single Convention 1961 requirements.
   • Original ANMDM import authorization
   • All shipping documents + COA
   • EU customs declaration for controlled substances
7. Shipment Cleared ✓
   Released to licensed Romanian importer. Product dispensed only through hospital pharmacies against specialist prescription.