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complianceODClicensingAustralia

ODC Licence Types Explained: Cultivate, Manufacture, Import, Export, Research

BudMate

If you’re entering the Australian medicinal cannabis market, you’ll quickly run into a wall of acronyms: ODC, NDA, TGA, GMP, ARTG. Before any of that makes sense, you need to understand the foundational layer — what the Office of Drug Control (ODC) actually licences, and which licence applies to your operation.

This post covers every major ODC licence type under the Narcotic Drugs Act 1967 (Cth), what each one permits, and what the application process actually involves. No fluff.

Why the ODC, and not just the TGA?

The TGA and the ODC both regulate medicinal cannabis in Australia, but they regulate different things.

The TGA is responsible for the therapeutic quality of cannabis products — it approves products for clinical use (via the ARTG or Special Access Scheme), sets manufacturing standards (GMP), and oversees the TGO 93 testing requirements that every product must meet.

The ODC sits under the Department of Health and is responsible for controlling the supply chain — who can cultivate, produce, manufacture, import, export, or research cannabis. This authority comes from Australia’s obligations under international drug control conventions (specifically the 1961 Single Convention on Narcotic Drugs).

You need both in your corner. A TGA approval without an ODC licence means you can’t legally handle the product. An ODC licence without TGA compliance means you can’t legally sell it.

The five ODC licence categories

1. Medicinal Cannabis Licence (Cultivation & Production)

Who needs it: Growers and producers cultivating cannabis plants or producing cannabis plant material for medicinal purposes.

What it covers:

  • Cultivating cannabis plants
  • Producing cannabis plant material (harvesting, drying, trimming)
  • Supplying raw material to manufacture licence holders

A Medicinal Cannabis Licence does not permit processing into finished products — that requires a separate Manufacture Licence (see below). Most large-scale cultivators hold both.

Key requirements:

  • Demonstrated secure premises and site controls
  • Fit and proper person assessment (criminal history, financial standing, business history — applied to the applicant and all relevant associates)
  • Ongoing compliance with the ODC’s security and record-keeping obligations

Cost and timeline:

  • Application fee: approximately $60,000 (non-refundable once paid)
  • Annual licence charge: approximately $28,310
  • Assessment target: ~9 months (up to 195 working days)

This is not a fast or cheap process. Budget for it early, and have your site, SOPs, and key personnel documents ready before you submit.

2. Cannabis Research Licence

Who needs it: Entities conducting research specifically into the horticultural and infrastructure aspects of cultivating cannabis — strain development, growing systems, yield optimisation.

What it covers:

  • Cultivating cannabis for horticultural and infrastructure research
  • Supplying cannabis to Manufacture Licence holders for further research

What it does not cover:

  • Clinical or medicinal product research — that requires a Manufacture Licence holder to be involved
  • Manufacturing or processing cannabis into any finished form

The Cannabis Research Licence is a narrower instrument than most people expect. If your research involves anything beyond the plant itself — testing extracts, developing formulations, running clinical trials — you’ll need a Manufacture Licence or a partnership with one.

3. Narcotic Drugs Manufacture Licence (Cannabis)

Who needs it: Anyone manufacturing medicinal cannabis products — extracts, tinctures, oils, capsules, or any other processed form.

What it covers:

  • Manufacturing medicinal cannabis products from raw plant material
  • Conducting medicinal cannabis product research (including clinical trial supply)
  • Manufacturing for export (combined with an export licence/permit)

GMP is mandatory. The TGA is responsible for GMP licensing, and you must hold a current TGA GMP licence for the relevant scope of manufacture before the ODC will issue or renew a Manufacture Licence. These two regulatory pathways run in parallel — start both early.

What it does not cover:

  • Cultivating raw plant material (you’ll need a Medicinal Cannabis Licence or a supply agreement with one)

Most vertically integrated operators hold a Medicinal Cannabis Licence and a Manufacture Licence. Some manufacturers source raw material from separate cultivators and hold only the Manufacture Licence.

4. Import Licence + Per-Shipment Import Permit

Who needs it: Any business importing medicinal cannabis products into Australia — finished dose forms, bulk APIs, or raw plant material.

How the two-tier system works:

  • The licence is your standing permission to import. It’s valid for up to 12 months and specifies the products and quantities you’re authorised to import.
  • The permit is required for each individual shipment. You apply for a permit before every consignment arrives.

This distinction catches many first-time importers off guard. Having a licence does not mean you can import — you need a permit for every shipment, for every substance type.

Key requirements:

  • Your application must specify the products and quantities you intend to import
  • The overseas exporter must already hold the appropriate licence/approval in their country
  • Imports are restricted to medicinal or scientific use
  • From 1 March 2025, new substances added to Schedule 4 of the Customs (Prohibited Imports) Regulations 1956 require both an ODC licence and a per-shipment permit

Permit processing timeline: The ODC targets 20 business days from receipt of a complete application, though most permits are processed within 10 days. High-demand periods can stretch this — plan your import schedule accordingly, and never leave permit applications to the last minute.

5. Export Licence + Per-Shipment Export Permit

Who needs it: Australian manufacturers or producers exporting medicinal cannabis products internationally.

How the two-tier system works: Same structure as imports — a standing export licence plus a per-consignment permit.

The ARTG requirement is critical:

  • The product must be registered or listed on the Australian Register of Therapeutic Goods (ARTG) before the ODC will issue an export licence and permit
  • Export Only products must be listed on the ARTG and cannot be supplied domestically (including duty-free)
  • At least one step of manufacture must occur in Australia for Export Only products

Additional requirement: The exporter must demonstrate that adequate supply of medicinal cannabis to Australian patients is maintained. You can’t strip the domestic supply to serve export markets.

State/territory licence: You’ll also need a state or territory licence that permits possession, supply, and wholesale of medicinal cannabis in your jurisdiction — the ODC licence alone is not sufficient.

Licences vs. permits: the distinction that matters

It’s worth being explicit about this because confusion here causes real operational problems:

LicencePermit
FrequencyAnnual (renewed)Per activity / per shipment
What it authorisesThe type of activityA specific instance of that activity
Processing time~9 months~10–20 business days
ExampleImport LicenceImport Permit for Shipment #47

You need both. The licence doesn’t replace the permit, and the permit has no force without the licence.

The fit and proper person test

Every ODC licence application triggers a fit and proper assessment — applied not just to the applicant entity but to every relevant associate: directors, major shareholders, key personnel.

The ODC considers:

  • Criminal history (Australia and internationally)
  • Financial history and current standing
  • Business history and capacity to comply
  • Connections and associates

Licence holders must remain fit and proper for the entire duration of the licence. If circumstances change — a new director, a financial event, a criminal charge — the ODC must be notified and may reassess.

This isn’t bureaucratic box-ticking. It’s designed to prevent the licensing scheme from being used as cover for diversion into illegal markets, and the ODC takes it seriously.

Which licence do you need?

If you are…You need…
Growing cannabis plants for medicinal supplyMedicinal Cannabis Licence
Processing plants into products (oils, extracts, capsules)Narcotic Drugs Manufacture Licence + TGA GMP
Researching cultivation techniques or infrastructureCannabis Research Licence
Bringing finished products into AustraliaImport Licence + per-shipment Import Permit
Sending Australian products overseasExport Licence + per-shipment Export Permit (+ ARTG listing)
Running clinical trials with cannabis productsManufacture Licence (or partnership with holder)

Many businesses need more than one. A vertically integrated operation — growing, processing, and exporting — would typically hold a Medicinal Cannabis Licence, a Manufacture Licence, a TGA GMP licence, a state/territory licence, and an Export Licence, plus permits for every export consignment.

What this means for your compliance stack

The permit-per-shipment requirement is where most import and export operations feel the pain. It means:

  • Every import or export generates a compliance event
  • Permits must be applied for in advance — there’s no retrospective approval
  • A delayed permit application = a delayed shipment
  • Documentation errors (wrong product, wrong quantity, wrong substance schedule) can invalidate a permit

The COA, the shipment manifest, the ODC permit, and the import/export documentation all need to align. A discrepancy between any of these at the border is not an administrative error — it’s a regulatory breach.

This is the problem BudMate is built to solve: keeping every document, permit, and certificate synchronised so that compliance never becomes the reason your shipment stalls.

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