- Import Intent
You intend to import medicinal cannabis into Australia. Two separate federal agencies are involved: TGA (medicines regulation) and ODC (narcotic licensing).
- TGA import permit (per shipment)
- ODC import license (annual + per shipment)
- Importer must be TGA licensed manufacturer or sponsor
- Registered or Unregistered?
Is the product on the Australian Register of Therapeutic Goods (ARTG)? Most medicinal cannabis is currently unregistered and accessed via TGA's Special Access Scheme (SAS) or Authorised Prescriber (AP) pathway.
- Registered ARTG Product — Full TGA approval
Product listed on ARTG. Standard import pathway. TGA import permit required per shipment. ODC import license required.
- ARTG registration number
- TGA import permit per shipment
- ODC license and per-shipment permit
- SAS Category B / AP Pathway — Unregistered access
Most Australian medicinal cannabis is accessed via SAS Category B (prescriber applies per patient) or Authorised Prescriber (blanket TGA approval for a prescriber). Importer/sponsor must still hold TGA and ODC licenses.
- SAS-B: prescriber applies to TGA per patient
- AP: TGA grants prescriber ongoing authority
- Sponsor must hold ODC manufacturer/importer license
- Apply: ODC Import License
Office of Drug Control issues narcotic licenses under the Narcotic Drugs Act 1967. Annual license plus per-shipment import permit required.
- Entity must be fit and proper person
- Secure storage at import destination confirmed
- Annual license + per-shipment import permit
- Processing: 4–8 weeks for new applicants
- Apply: TGA Import Permit
Per-shipment import permit from TGA. Product must meet TGA standards for the relevant access pathway.
- Product specifications match ARTG/SAS approval
- Manufacturing site holds TGA-recognised GMP
- GACP certificate for cultivation site
- COA per batch
- Both permits granted?
Both ODC import permit and TGA import permit must be issued before shipment departs origin country.
- Address Deficiencies
Respond to TGA or ODC queries. Common issues: GMP certificate scope, GACP certificate currency, or product specification gaps.
- Shipment Departs
Both permits in hand. Exporting country export authorization also required. Air freight primary — Sydney (SYD) and Melbourne (MEL) are main entry points.
- Australian Border Force Entry
ABF customs clearance. Both TGA and ODC permits presented. Narcotic import declaration filed under Single Convention 1961.
- ODC import permit (original)
- TGA import permit
- All shipping docs + COA
- ABF may conduct physical inspection
- Shipment Cleared ✓
Released to licensed importer. QP or nominated person certifies batch before distribution to pharmacies or hospitals.