Navigating Australia's Regulatory Framework
Federal Oversight: TGA and ODC
Australia's medicinal cannabis supply chain operates under a dual federal regulatory structure. The Therapeutic Goods Administration (TGA) is the primary regulator for therapeutic goods quality, safety and efficacy under the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 2002. The Office of Drug Control (ODC), a separate body within the Department of Health and Aged Care, administers the import and export licensing framework under the Narcotic Drugs Act 1967. Any entity importing medicinal cannabis into Australia must hold a current ODC import permit — one that is product-specific and shipment-specific. There are no blanket standing permits. Each consignment requires its own authorisation.
The ODC permit application process is detailed and time-bound. Applicants must specify the exact product, quantity, supplier, and intended recipient. Processing typically runs 20 to 30 business days from submission of a complete application. Once issued, the permit is tied to the specific product description — any deviation in product name, batch specification or quantity requires a new application. Green Leaf Global manages this process end-to-end, holding active import permits and maintaining the documentary chain required at each stage of entry.
Prescribing Pathways: AP and SAS-B
Medicinal cannabis reaches Australian patients through two principal TGA prescribing pathways, each with different documentation and supply volume implications. The Authorised Prescriber (AP) scheme allows eligible medical practitioners to prescribe a specific unapproved therapeutic good to a class of patients without needing individual TGA approval for each prescription. Authorisation is granted by the TGA (following HREC endorsement or specialist college approval) and allows ongoing prescribing within the approved class. This pathway generates more consistent, predictable demand for wholesalers — an AP can prescribe repeatedly without generating a new SAS application each time.
The Special Access Scheme Category B (SAS-B) pathway requires a treating practitioner to notify the TGA each time they prescribe an unapproved product to an individual patient. While the notification is self-assessed (the TGA does not pre-approve each application), it does create administrative load and can introduce lead-time variability into supply orders. Both pathways flow into the same wholesale supply channel — the prescriber places an order with a pharmacy, the pharmacy sources from a licenced importer/wholesaler. Understanding which pathway a clinic operates on helps Green Leaf Global anticipate order patterns and maintain appropriate stock levels.
Schedule 8 Classification and its Supply Obligations
Medicinal cannabis products are classified as Schedule 8 controlled substances under the Therapeutic Goods (Poisons Standard — October 2021) instrument and its successors. Schedule 8 designation applies federal and state-level controls simultaneously. At the federal level, it triggers ODC oversight for import and export. At the state and territory level, it activates Dangerous Drug (DD) or Drugs of Dependence legislation — each jurisdiction has its own storage, record-keeping, and reporting obligations. In New South Wales, Schedule 8 substances are governed by the NSW Poisons and Therapeutic Goods Act 1966 and the Poisons and Therapeutic Goods Regulation 2008.
For wholesale distributors, Schedule 8 classification means: dedicated secure storage meeting Schedule 8 facility standards; strict chain-of-custody documentation for every movement; and Dangerous Drug Authority (DDA) record-keeping that tracks receipt, supply and disposal at batch level. These obligations apply from the point of import clearance through to the final supply to a licensed pharmacy or prescribing clinic. Wholesalers must reconcile DDA registers against physical stock on a regular basis. Any discrepancy — even a minor packaging variance — must be investigated and reported. Green Leaf Global's storage and distribution framework is built around these obligations. Details of our compliance structure are available on our Compliance page.
NSW Wholesale Poisons Licence
Green Leaf Global holds an active NSW Wholesale Poisons Licence covering both Schedule 4 and Schedule 8 substances. This licence, issued by the NSW Ministry of Health, authorises the storage and wholesale supply of Schedule 8 controlled substances to authorised recipients — specifically licensed pharmacies, hospital pharmacies, and healthcare facilities holding appropriate authority to possess and supply Schedule 8 products. Without this licence, a business cannot lawfully receive, store, or on-supply Schedule 8 medicinal cannabis within NSW, regardless of what ODC permits are in place. The ODC and NSW licences are complementary and both must be current simultaneously.
The Patient Supply Pathway
Understanding the patient supply pathway explains how Green Leaf Global fits into the broader healthcare delivery chain. A GP or specialist prescribes medicinal cannabis — either under AP authority or via SAS-B notification. The patient takes the prescription to a dispensing pharmacy. The pharmacy must source the product from a TGA-registered or TGA-listed product supplier, or in the case of unapproved goods (which most medicinal cannabis products remain), from a licensed importer/wholesaler. The pharmacy places an order with Green Leaf Global. We supply from bonded, Schedule 8-compliant storage under DDA documentation. The pharmacy dispenses to the patient, recording the supply in their own DDA register. The chain of custody runs from our overseas supplier, through our import permit, into our licensed storage, and out to the pharmacy — every link documented and auditable. For clinics and pharmacies looking to open a wholesale account, the process is straightforward.