Australia regulates medicinal cannabis at the federal level through the TGA (medicines) and ODC (narcotics), with additional state-level scheduling requirements. Australia is both a significant importer and a growing exporter. TGA GMP certification is broadly recognised internationally, making Australian-manufactured product well-positioned for global markets.
Medicinal cannabis has been legal in Australia since 2016 under the Narcotics Drugs Act 1967 (amended) and the Therapeutic Goods Act 1989. The TGA manages medicines regulation; the ODC manages narcotic licensing. Cannabis for medicinal use is Schedule 8 (Controlled Drug) under the Poisons Standard.
Dual Federal Licensing — TGA and ODC
Critically, Australia requires two separate federal licenses: TGA (medicines — import permits, GMP clearance, product approvals) and ODC (narcotics — annual license, per-shipment import/export permits). Both must be obtained independently. Overseas suppliers frequently underestimate the ODC layer.
Access Pathways
Most medicinal cannabis is accessed via TGA's unregistered pathways: Special Access Scheme Category B (SAS-B, per patient) or Authorised Prescriber (AP, per prescriber-indication pair). Only Epidyolex (CBD) is fully registered on the ARTG as of 2026. The SAS-B pathway processes most applications within 48 hours.
Prescribing — Who Can Prescribe
Medical practitioners registered with AHPRA may prescribe under SAS-B or once they hold AP status. Nurse practitioners may also prescribe in some states. State-level requirements add additional layers — particularly in Queensland (Authority to Prescribe) and Victoria.
Australia as Exporter
Australia is a growing medicinal cannabis exporter. Australian TGA GMP certificates are recognised in the EU, UK, Israel, Canada, NZ, Switzerland, and Japan under mutual recognition arrangements. ODC export permits are required per shipment. Destination country import authorization must be obtained first.
Key rule: Both a TGA import permit AND an ODC import permit are required per shipment. They are applied for separately with different agencies — allow 4–8 weeks total for new applicants.
ODC Import License & Permit
Annual ODC license required under Narcotic Drugs Act 1967. Plus a per-shipment ODC import permit. New applicants: 4–8 weeks. Renewal: 2–4 weeks. ODC conducts security and fit-and-proper-person assessment for new license applications.
TGA Import Permit
Per-shipment TGA import permit required. Product must be approved under ARTG, SAS, or AP pathway. Manufacturing site must hold TGA GMP clearance. GACP certificate required. Processing: approximately 10 working days for established products.
Required Documentation per Shipment
ODC import permit (original), TGA import permit, Exporting country export authorization, Certificate of Analysis per batch, TGA GMP clearance certificate of manufacturer, GACP certificate of cultivation site, Airway bill, Commercial invoice, Phytosanitary certificate if required.
Entry Points
Sydney (SYD) and Melbourne (MEL) international airports are the primary pharmaceutical import points. Brisbane (BNE) for Queensland supply. Perth (PER) for Western Australia. GDP-compliant handling required — pre-alert to customs broker recommended for Schedule 8 shipments.
Export from Australia
Australian manufacturers are growing exporters. ODC export permit required per shipment. Destination country import authorization must be obtained first and submitted with ODC export permit application. TGA GMP certificate recognised by EU, UK, Israel, Canada, NZ under bilateral arrangements.
Queensland — Additional Import Consideration
Products destined for Queensland distribution face an additional step — Queensland Health Authority to Prescribe (ATP) requirement for non-AP prescribers. Plan supply chain to Queensland accordingly.
Key rule: TGA is a PIC/S founding member — its GMP standard is identical to EU-GMP in practice. EU-GMP Part I certificates are accepted by TGA for finished product imports. TGA GMP certificates are accepted by the EU, UK, and Israel.
TGA GMP for Australian Manufacturers
Australian manufacturers are inspected by TGA and hold TGA Manufacturing Licences with cannabis scope. TGA GMP certificates are valid for Australian supply and broadly recognised internationally (EU, UK, Israel, Canada, NZ, Switzerland, Japan) under MRA/bilateral arrangements.
Overseas Manufacturers — MRA Countries
TGA accepts GMP certificates from EU (all EEA national authorities), MHRA UK, Health Canada, Swissmedic, PMDA Japan, Medsafe NZ, and IMFA Israel. Certificate must specifically cover cannabis-scope manufacturing. EU-GMP Part I accepted for finished product; Part II for API supply to Australian finisher.
Israeli IMFA — Bilateral Arrangement
IMFA-issued GMP certificates are accepted by TGA under a bilateral arrangement. This was extended in October 2025 with validity extended from 2 to 3 years. Israeli manufacturers supply a significant share of the Australian medicinal cannabis import market.
Non-MRA Countries
Manufacturers in countries without TGA recognition (e.g. US FDA) require a TGA overseas GMP inspection before import approval. TGA inspection fees apply. Scheduling can take 6–12 months. Consider EU-based QP certification as an alternative pathway if EU-GMP Part I is held.
GMP Clearance Validity
TGA GMP clearance for overseas sites is typically valid for 3 years (extended from 2 years for Israeli sites in 2025). Must be renewed before expiry. TGA may conduct risk-based inspections of overseas sites during the clearance period.
Note: TGA requires GACP certification for all cannabis cultivation sites supplying the Australian market. Both EU GACP and WHO GACP are accepted. Australian domestic cultivators hold ODC cultivation licences which incorporate GACP requirements.
Accepted GACP Standards
TGA accepts EU GACP (EMEA/HMPC/246816/2006) and WHO GACP 2003 for imported products. Australian domestic cultivators comply with GACP as a condition of their ODC cultivation licence — separate third-party GACP certification is not required for domestic product.
Overseas Cultivators
Overseas cultivation sites supplying the Australian market must hold a current GACP certificate from an ISO 17065-accredited third-party body. Certificate must identify the specific cultivation site by GPS coordinates or cadastral reference.
Certificate Validity
GACP certificates are typically issued for 1–3 years. TGA requires a current certificate for each import permit application. No grace period is granted. Supply must be suspended if the certificate lapses — notify TGA promptly.
ODC Cultivation Licences (Domestic)
Australian cultivators must hold an ODC cannabis cultivation licence in addition to TGA requirements. ODC conducts site inspections and requires GACP-compliant standard operating procedures. Domestic GACP is audited by ODC as part of annual licence renewal.
Chain of Custody
GACP-to-GMP chain of custody must be documented from cultivation site through to the finished product batch. Any change in cultivation site — even within the same license holder — requires notification to TGA and an updated certificate before continued Australian import.
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