- Import Intent
Both the exporting country's export authorization AND AIFA's import authorization must be obtained before shipment. Per-shipment — each delivery requires its own AIFA authorization. SSN reimbursement varies by region.
- Export authorization from origin country
- AIFA import authorization per shipment
- Both authorizations in hand before departure
- Both Authorizations Obtained
Export authorization (origin country) and AIFA import authorization must both be secured before the shipment can depart.
- Origin country export authorization
- AIFA import authorization
- Both must be current at time of shipment
- Prepare Shipping Documentation
Full documentation pack for the shipment into Italy.
- AIFA import authorization (original)
- Origin export authorization
- EU-GMP Part I certificate
- COA per batch
- Airway bill / bill of lading
- EU customs and narcotic declaration
- Italian Customs Entry — Fiumicino / Malpensa
Customs clearance at Rome Fiumicino (FCO) or Milan Malpensa (MXP) — primary entry airports for pharmaceutical imports into Italy. EU customs and narcotic declaration procedures apply.
- AIFA import authorization presented at customs
- EU customs declaration
- Narcotic import declaration
- All shipping documents + COA
- AIFA Clearance
AIFA clearance procedures completed. Product verified against import authorization.
- AIFA verification of product and quantity
- Match against import authorization
- AIFA release for QP review
- QP Release
EU QP at the Italian importing entity certifies the batch for Italian market release.
- QP named on Italian wholesale authorization
- Full batch record reviewed
- QP signature on batch certificate
- Pharmacy Distribution
Distributed to Italian pharmacies via licensed wholesalers. SSN reimbursement varies significantly by region — Toscana and Sicilia cover; others out-of-pocket.
- Italian wholesale distribution
- SSN regional reimbursement varies
- Physician prescription for dispensing
- Available to Patients ✓
Medicinal cannabis available to patients via Italian pharmacies. SSN reimbursement varies by region — a significant access consideration.