Compliance Is the Foundation, Not a Checkbox

An ODC import permit is issued by the Office of Drug Control under the Narcotic Drugs Act 1967 and authorises the importation of a specific controlled substance — such as medicinal cannabis — in a defined quantity from a named overseas supplier. Each permit is product-specific and shipment-specific. It stipulates the product description, cannabinoid specification, maximum importable quantity, country of origin, and the licensed premises to which goods must be delivered. A separate permit is required for each shipment or product variation. Permits typically take 20 to 30 business days to issue and must be presented at customs clearance. Operating without a current, valid permit for the specific product being imported is a criminal offence under the Narcotic Drugs Act 1967.

TGA compliance for an importer means operating within the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 2002. As a product sponsor, an importer is responsible for ensuring that goods meet applicable standards before supply — including that they are manufactured to Good Manufacturing Practice (GMP) by a facility holding the appropriate TGA or equivalent overseas GMP clearance. Importers must maintain records sufficient to support TGA audit, ensure labelling and packaging meet TGA requirements, and ensure that any product included on the Australian Register of Therapeutic Goods (ARTG) is supplied within the terms of its registration or listing. For goods supplied under the Special Access Scheme or Authorised Prescriber pathway — which is the common mechanism for unapproved medicinal cannabis — the sponsor must ensure the product meets the relevant access conditions. TGA compliance is not a one-time certification; it is an ongoing obligation that applies to every batch and every transaction.

The NSW Wholesale Poisons Licence is issued by the NSW Ministry of Health under the Poisons and Therapeutic Goods Act 1966. It authorises the holder to wholesale Schedule 4 and Schedule 8 substances to authorised persons — including pharmacists, medical practitioners, and other licensed wholesalers. Holding a Schedule 8 wholesale licence imposes strict obligations around stock security, record-keeping, and reporting. Not every business can hold this licence; applicants must demonstrate that their premises, security arrangements, and business practices meet the Ministry's standards. The licence is subject to annual renewal and ongoing compliance monitoring. Green Leaf Global holds an active NSW Wholesale Poisons Licence covering both Schedule 4 and Schedule 8, which authorises us to wholesale medicinal cannabis products within the terms of the licence to authorised recipients in NSW.

Good Manufacturing Practice (GMP) is the set of manufacturing quality standards required by the TGA under the Therapeutic Goods Act 1989. For overseas manufacturers supplying product to Australian importers, TGA requires that the facility hold an overseas GMP clearance — either through a bilateral recognition arrangement (such as the PIC/S mutual recognition framework) or by direct TGA audit. GMP certification covers facility standards, equipment qualification, batch manufacturing records, quality management systems, and release testing protocols. Green Leaf Global verifies GMP status by obtaining the manufacturer's TGA overseas GMP clearance certificate prior to any procurement, confirming currency directly on the TGA online register, and reviewing site master files and manufacturing authorisations as part of our supplier qualification process. We do not accept product from manufacturers whose GMP clearance has lapsed or is under suspension. This requirement applies regardless of price or availability pressure.

A compliant Certificate of Analysis (COA) for an imported medicinal cannabis product must include: the product name and batch number matching exactly what appears on the ODC import permit; the name and accreditation number of the testing laboratory (NATA-accredited or equivalent recognised overseas accreditation); the date of testing; a full cannabinoid profile including THC and CBD concentrations expressed as a percentage of total weight or per unit dose; microbiological results (total aerobic count, yeast and mould, specified pathogens) where applicable to the product form; heavy metal concentrations where required; pesticide residue results where applicable; and a pass or fail determination against the product specification. The COA must be batch-specific — a generic or averaged document does not satisfy TGA or ODC requirements. GLG reviews every COA against the relevant permit specification before any stock is released for distribution. Where a COA is unclear or incomplete, the batch is quarantined pending resolution with the manufacturer.

The Drugs of Dependence and Addiction (DDA) register — sometimes referred to as the Dangerous Drugs register — is a transaction-level record of all Schedule 8 stock movements. In NSW, the obligation to maintain the register is imposed by the Poisons and Therapeutic Goods Act 1966 and the Poisons and Therapeutic Goods Regulation 2008. Every receipt and dispatch of a Schedule 8 substance must be recorded, including the date, quantity, batch number, and the identity of the counterparty. The register must be maintained in a format that allows stock reconciliation at any point. Wholesale licence holders are responsible for their own register; pharmacists are responsible for their own pharmacy register. GLG maintains a complete DDA register covering every inbound receipt and outbound transfer. We provide supporting delivery documentation to wholesale customers in a format designed to support their own DDA entries — including date, quantity, batch number, and our licence details as the dispatching party.

Schedule 8 classification as a drug of addiction under the Poisons Standard imposes specific physical security requirements for storage. In NSW, these are specified in the Poisons and Therapeutic Goods Regulation 2008. Schedule 8 substances must be stored in a locked safe or cabinet that meets defined construction standards — typically a steel safe of specified minimum dimensions and door and locking mechanism standards. Storage areas must be accessible only to authorised persons, and access must be documented. Where Schedule 8 goods also require temperature control — as is the case with most medicinal cannabis products — the storage environment must simultaneously meet both the security requirement and the temperature specification stated in the product's approved or submitted dossier. This creates a specific infrastructure requirement that not all general pharmaceutical storage facilities can satisfy. GLG's storage arrangements, operated through our licensed partners, are specifically designed and validated to meet both obligations concurrently.

Cold-chain compliance means maintaining an unbroken, documented temperature-controlled environment from the point of manufacture through to final delivery at the licensed premises. For medicinal cannabis products, the manufacturer's COA and product specification define the required storage and transport temperature range — commonly 2–8°C for some formulations, or controlled room temperature (15–25°C) for others. Cold-chain compliance requires temperature-mapped and validated storage facilities, validated transport containers or refrigerated vehicles, continuous temperature loggers with tamper-evident data available for audit, and documented handover procedures at each transfer point. A break in the cold chain — even a brief excursion — may render a batch non-compliant for supply until a disposition assessment has been completed by the manufacturer or the quality responsible person. GLG works exclusively with logistics partners who operate validated cold-chain infrastructure and provide complete temperature excursion records for every consignment as a standing contractual requirement.

GLG maintains a complete documentation package for every batch supplied, including: the ODC import permit, the customs entry documents, the batch-specific COA, temperature records for storage and transport, and chain-of-custody records covering every transfer from receipt to dispatch. On request, we compile and provide this documentation pack to authorised providers to support their own regulatory audit obligations — whether with the TGA, the relevant state health department, AHPRA, or an accreditation body. We understand that prescribers and pharmacies have their own record-keeping obligations under both state and federal instruments, and our internal systems are structured to make that documentation support as straightforward as possible. Documentation requests can be made through your account contact or via the enquiry form at greenleafglobal.com.au. We respond to documentation requests within one business day.

If a batch fails testing or the COA does not match the ODC import permit specification, the batch is immediately quarantined and is not released for supply under any circumstances. GLG does not supply goods under a pending COA status or on the basis of a preliminary result. Depending on the nature and extent of the discrepancy, the response may include: notifying the ODC if the variation falls outside the tolerances permitted under the import permit; conducting a formal investigation with the overseas manufacturer through our quality agreement process; arranging for independent re-testing at a NATA-accredited Australian laboratory at GLG's cost; and, where destruction is determined to be the required outcome, arranging for destruction under supervision in accordance with ODC requirements and NSW Ministry of Health requirements for Schedule 8 substances. Authorised providers who have placed an order against the affected batch are notified promptly, and we work to source an alternative compliant batch from our supply network where possible. This process is non-negotiable — no consideration of schedule, cost, or patient demand changes the outcome when a batch does not meet its specification.