Medicinal Cannabis Supply in Australia

Australia's medicinal cannabis market is one of the most tightly regulated and fastest-growing in the world. Green Leaf Global is licensed at every stage of the supply chain — from ODC-permitted import to Schedule 8 wholesale distribution to authorised providers.

ODC Import Permit DCS-25-IMP-5295 NSW Sch 4 & Sch 8 Licence TGA Compliant GMP Sourced
The Australian Market

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.

At a Glance
Active
ODC Import Permit DCS-25-IMP-5295
Sch 4 + Sch 8
NSW Wholesale Poisons Licence
GMP Only
All product sourced from GMP-certified facilities
End-to-End
Full supply chain traceability — import to pharmacy
NATA / Equivalent
Independent batch CoA on every consignment
Cold-Chain
Temperature-controlled storage and delivery
Authorisations & Standards

GLG's Australian Credentials

Every authorisation we hold is maintained as a current, auditable instrument — not a historical footnote. Our operating credentials reflect the requirements of the TGA, ODC, and NSW Ministry of Health simultaneously.

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ODC Import Permit DCS-25-IMP-5295
Active ODC import permit issued under the Narcotic Drugs Act 1967. Authorises the importation of medicinal cannabis products from approved overseas suppliers into Australia. Product-specific and maintained in continuous good standing with the Office of Drug Control.
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NSW Wholesale Poisons Licence (Sch 4 + Sch 8)
Issued by the NSW Ministry of Health under the Poisons and Therapeutic Goods Act 1966. Authorises wholesale storage and supply of Schedule 4 and Schedule 8 controlled substances, including medicinal cannabis, to licensed pharmacies and authorised healthcare facilities in NSW.
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TGA Therapeutic Goods Act 1989 Compliance
All product handled by Green Leaf Global complies with the requirements of the Therapeutic Goods Act 1989 and associated Therapeutic Goods Regulations 2002. Our import and wholesale activities sit within the TGA's regulatory framework for unapproved therapeutic goods supplied via the SAS-B and Authorised Prescriber pathways.
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GMP-Only Sourcing
We source exclusively from overseas manufacturers holding current Good Manufacturing Practice (GMP) certification recognised under Australian regulatory standards. GMP certification is a condition of our ODC permit and a non-negotiable supplier qualification criterion. No product enters our supply chain from a non-GMP source.
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Batch Tested — Independent CoA
Every consignment is accompanied by a Certificate of Analysis (CoA) from an independent, accredited laboratory — NATA-accredited or international equivalent. CoAs are reviewed against permit specifications prior to clearance, with particular attention to cannabinoid profile, THC levels, and batch identification matching the import permit exactly.
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Cold-Chain Storage & Delivery
Products requiring temperature-controlled handling are stored and transported under validated cold-chain conditions. Storage facilities comply with Schedule 8 physical security requirements and temperature monitoring protocols. Delivery is conducted via carriers operating validated cold-chain logistics, with temperature excursion reporting at every stage.
How It Works

The Australian Supply Chain

Five stages. Every one documented, auditable, and compliant with ODC, TGA, and NSW licensing obligations. This is not a simplified diagram — it is the actual sequence of actions, documents, and regulatory touchpoints for every consignment Green Leaf Global handles.

1

ODC Import Permit Secured

Prior to ordering, Green Leaf Global applies to the Office of Drug Control for a product-specific import permit under the Narcotic Drugs Act 1967. The application specifies the product name, cannabinoid profile, quantity, country of origin, overseas supplier, and intended storage location in Australia. The ODC reviews the application — typically 20 to 30 business days — and, if satisfied, issues a numbered import permit valid for the specified consignment. This permit is the legal authority for the goods to enter Australia. Without it, customs clearance cannot be obtained. We hold current permit DCS-25-IMP-5295 and manage forward applications on a rolling basis to ensure supply continuity.

2

Overseas Supplier Dispatch & Pre-Shipment CoA

Our GMP-certified overseas supplier prepares the consignment to the exact specifications on the ODC import permit. A pre-shipment Certificate of Analysis from an accredited independent laboratory is obtained for each batch. The CoA is reviewed by Green Leaf Global prior to authorising shipment — any deviation in cannabinoid profile, THC content, batch number or product description against permit specifications stops the shipment at this point. Goods are shipped under temperature monitoring, with cold-chain protocols activated where required by product stability data. Shipping documentation — commercial invoice, packing list, airway bill — is prepared to reference the ODC permit number on each document.

3

Australian Customs Clearance

On arrival in Australia, the consignment is presented to Australian Border Force with the ODC import permit, commercial invoice, and CoA. The permit is matched against the goods — product description, quantity and supplier must correspond exactly to what is authorised. Border Force may inspect physically or release based on documentation. Once cleared, the goods are released into the custody of the licensed importer — Green Leaf Global — and transported directly to our Schedule 8-compliant storage facility. The NSW Ministry of Health is notified of the receipt of Schedule 8 goods in accordance with our Wholesale Poisons Licence conditions. DDA receiving records are created at this point.

4

Schedule 8 Storage & Inventory Management

Goods are held in licensed storage meeting Schedule 8 physical security requirements — dedicated DD safe, access-controlled facility, temperature monitoring where applicable. Each batch is recorded in the DDA register by batch number, quantity received, date received, and permit number. Stock is segregated by product and batch. Inventory is reconciled on a regular basis against DDA records. Any discrepancy between physical count and DDA register is investigated immediately and notified to the NSW Ministry of Health if the cause cannot be determined. Our 3PL storage partner operates under the same licence conditions and is subject to audit by GLG and the NSW Ministry of Health.

5

Wholesale Supply to Pharmacies & Authorised Prescribers

Upon receipt of a valid wholesale order from a licensed pharmacy or authorised healthcare facility, Green Leaf Global processes the supply under DDA documentation. Each supply is recorded in the DDA register — pharmacy name, licence number, quantity, batch number, date of supply. A DDA supply authority or equivalent documentation accompanies the goods. The pharmacy receives the product, records the receipt in their own DDA register, and dispenses to patients holding valid prescriptions from Authorised Prescribers or under the SAS-B pathway. Green Leaf Global retains DDA records for the statutory period and makes them available for inspection by the NSW Ministry of Health on request. The audit trail from import permit through to pharmacy supply is complete, unbroken, and archived.

Questions

Frequently Asked Questions

Specific questions about how the Australian regulatory framework applies to wholesale supply, and how to establish a supply relationship with Green Leaf Global.

What licences does Green Leaf Global hold to operate as a medicinal cannabis wholesaler in Australia?

Green Leaf Global holds two primary Australian authorisations. First, an active ODC import permit (DCS-25-IMP-5295) issued by the Office of Drug Control under the Narcotic Drugs Act 1967, which authorises the importation of specified medicinal cannabis products from overseas GMP-certified suppliers. Second, a NSW Wholesale Poisons Licence (Schedule 4 and Schedule 8) issued by the NSW Ministry of Health under the Poisons and Therapeutic Goods Act 1966, which authorises the storage and wholesale supply of Schedule 8 controlled substances to licensed pharmacies and authorised healthcare facilities. Both licences are current and maintained in good standing. All activity is conducted in compliance with the Therapeutic Goods Act 1989.

What is the difference between the Authorised Prescriber pathway and SAS-B, and does it affect how we order from you?

The Authorised Prescriber (AP) pathway allows a TGA-endorsed practitioner to prescribe a specific medicinal cannabis product to a class of patients on an ongoing basis without individual TGA notifications. The Special Access Scheme Category B (SAS-B) pathway requires the prescribing practitioner to submit a notification to the TGA each time they prescribe an unapproved product to a specific patient. From a wholesale supply perspective, both pathways result in the same transaction — a pharmacy places an order with us and we supply under DDA documentation. The AP pathway tends to generate more predictable, recurring orders. SAS-B orders can be more variable. We accommodate both. If your clinic or pharmacy operates primarily under the AP model, we recommend establishing a standing order arrangement to simplify procurement.

Can any pharmacy order from Green Leaf Global, or are there qualification requirements?

To purchase Schedule 8 medicinal cannabis from Green Leaf Global, a pharmacy must hold a current pharmacy licence and a valid authority to possess and supply Schedule 8 substances in their state or territory. In NSW, this means holding a Pharmacy Approval under the Poisons and Therapeutic Goods Regulation and complying with DDA storage requirements. We conduct a qualification check before establishing a new wholesale account — this involves verifying licence details with the relevant state or territory authority and confirming that the pharmacy has appropriate Schedule 8 storage infrastructure in place. The process is not onerous. Authorised prescribing clinics and specialist facilities holding appropriate Schedule 8 authority may also be eligible to order directly under certain circumstances. Contact us to discuss your specific situation.

How long does it take to receive an order once placed?

Orders filled from existing in-country stock are typically dispatched within one to two business days of receipt of a valid purchase order. Delivery timeframes from our NSW storage facility depend on the destination state — NSW pharmacies generally receive orders within one to two business days of dispatch. Interstate deliveries typically run two to four business days via temperature-monitored courier. Where a product is not in current stock and requires a new import cycle, the lead time includes the ODC permit application period (20 to 30 business days), plus overseas manufacturing and shipping time, plus customs clearance. We strongly recommend that high-volume accounts discuss forward planning and stock reservation with us to avoid supply interruptions. We proactively manage our import pipeline to minimise out-of-stock events for regular accounts.

What documentation do you provide with each wholesale supply?

Each wholesale supply from Green Leaf Global is accompanied by a tax invoice, a DDA supply record or equivalent Schedule 8 authority documentation required under applicable state or territory legislation, and the Certificate of Analysis for the relevant batch. The CoA is from an independent accredited laboratory and confirms cannabinoid profile, batch number, and compliance with product specifications. Where product is subject to cold-chain requirements, a temperature log for the transport leg may also be provided. All documentation is retained by Green Leaf Global for the statutory record-keeping period. Pharmacies receiving product are required to record the receipt in their own DDA registers and should retain our supply documentation for inspection purposes.

What does "GMP-sourced" mean in practice, and why does it matter?

Good Manufacturing Practice (GMP) is a set of internationally recognised standards for pharmaceutical manufacturing — covering facility design, quality control systems, documentation, batch traceability, and product release procedures. In the Australian medicinal cannabis context, the TGA expects that therapeutic goods sourced from overseas manufacturers come from facilities that are GMP-certified, either by a recognised international regulatory authority or through direct TGA audit. The ODC also considers GMP standing when assessing import permit applications. Practically, GMP certification means the product has been manufactured under controlled and auditable conditions — reducing the risk of contamination, mislabelling, or cannabinoid profile variance. Every supplier in Green Leaf Global's supply chain holds current GMP certification. We verify this prior to onboarding any supplier and monitor certification currency on an ongoing basis. Details of our compliance framework are available on request.

Are your products listed on the ARTG, or are they supplied as unapproved therapeutic goods?

The majority of medicinal cannabis products currently available in Australia — including those distributed by Green Leaf Global — are supplied as unapproved therapeutic goods under the TGA's access pathways (SAS-B and Authorised Prescriber), rather than as ARTG-registered or ARTG-listed products. This is the standard model for the Australian medicinal cannabis market at present. A small number of products have achieved ARTG registration, but most products remain in the unapproved category. Supply of unapproved goods is lawful where the supply is made to, or on behalf of, a patient holding a valid prescription under an approved pathway. Our supply chain documentation reflects this structure — every supply is linked to a prescribing pathway authorisation. We are monitoring the ARTG registration landscape closely and will update our product portfolio as the regulatory environment evolves.

How do I open a wholesale account with Green Leaf Global?

The process for opening a wholesale account is straightforward. Contact us via the enquiry form on our Contact page or email admin@greenleafglobalimport.com with your pharmacy or facility name, your state or territory pharmacy licence number (or Schedule 8 authority reference), your ABN, and the name and contact details of the responsible pharmacist or authorised person. We will verify your licence details and confirm the Schedule 8 authority held for your premises. Once verified, we will issue account terms, a wholesale supply agreement, and onboard you into our ordering system. For pharmacies joining a dispensing network or clinic group, we can arrange group account arrangements. The entire onboarding process typically takes three to five business days from receipt of complete documentation.

Get Started

Ready to Open a Wholesale Account?

Green Leaf Global supplies Schedule 8 medicinal cannabis to licensed pharmacies, hospital pharmacies, and authorised healthcare facilities across Australia. Contact us to begin the account qualification process — typically three to five business days from receipt of your documentation.

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