A Legal Overview to Medical Cannabis in Australia.

A guide for medical cannabis companies.

Medicinal cannabis has been lawfully available in Australia since 2016, yet it remains among the most heavily regulated products a business can supply. Two features explain the complexity.

• The first is that cannabis is a controlled substance, so its cultivation and manufacture are licensed by the Commonwealth under the Narcotic Drugs Act 1967 (Cth).

• The second is that almost every medicinal cannabis product supplied in this country is unapproved, meaning it has never been assessed by the Therapeutic Goods Administration and reaches patients only through exceptional access pathways.

This guide explains the chain of authorisations that runs from cultivation to prescription, and the scrutiny the sector is presently under.

A judge's gavel resting on a sound block in front of green cannabis plants

How cannabis is classified

The Poisons Standard determines how a substance may be supplied. Cannabis generally sits in Schedule 9 as a prohibited substance, but medicinal cannabis products are treated differently according to their composition:

• Schedule 8, controlled drugs, covers medicinal cannabis products containing tetrahydrocannabinol, and carries the strictest prescribing controls

  
  

• Schedule 4, prescription only, covers cannabidiol products where cannabidiol makes up at least ninety-eight per cent of the cannabinoid content

  
  

• Schedule 3, pharmacist only, has been available since February 2021 for low-dose cannabidiol at up to 150 milligrams a day

  
  

The Schedule 3 pathway deserves a note, because it is more theoretical than real. It is open only to products registered on the Australian Register of Therapeutic Goods, and as at August 2026 no low-dose cannabidiol product has been registered. Pharmacist-only cannabidiol therefore exists in the Poisons Standard but not on any pharmacy shelf.

Licensing cultivation and manufacture

A business that wishes to grow cannabis or manufacture medicinal cannabis products must be licensed by the Office of Drug Control. The regime was substantially reformed with effect from December 2021, replacing the former separate cultivation, production and manufacture licences with a single medicinal cannabis licence that specifies the activities authorised.

Licences are now generally perpetual, and the assessment of what a business may actually do, and in what quantities, has moved to the permit stage. A licence therefore establishes eligibility, while it is the permit that authorises the activity itself.

The requirements are demanding. An applicant, together with its directors and business associates, must satisfy a fit and proper person test directed to character, honesty and integrity, financial stability and corporate structure.

Manufacture attracts a further layer. A manufacturer of medicinal cannabis medicines requires a licence under Part 3-3 of the Therapeutic Goods Act 1989 (Cth) and must comply with good manufacturing practice, and the products themselves must meet the standard for medicinal cannabis made under that Act. Import and export are separately licensed and permitted, and unprocessed cannabis cannot be exported.

The access pathways for patients

Registration

The first access pathway for medical cannabis is via TGA registration.

Only two medicinal cannabis medicines have been registered on the Register following full evaluation by the TGA. Nabiximols, marketed as Sativex, was registered in 2012 for spasticity in multiple sclerosis and is not listed on the Pharmaceutical Benefits Scheme. Cannabidiol, marketed as Epidyolex, was registered in 2020 as adjunctive therapy for seizures associated with two rare epilepsy syndromes, and has been listed on the Scheme for Dravet syndrome since May 2021.

Every other medicinal cannabis product supplied in Australia, and there are more than a thousand of them, is unapproved. The TGA has not evaluated it for quality, safety or efficacy, and it reaches patients only through one of the pathways below.

The Special Access Scheme

The Special Access Scheme permits a practitioner to obtain an unapproved product for an individual patient. It operates in three categories:

• Category A allows notification after the fact for patients who are seriously ill, meaning death is reasonably likely within months without treatment (Therapeutic Goods Act 1989 (Cth) s 18(1))

  
  

• Category B requires an application to the TGA and its approval before supply, supported by clinical justification (s 19(1)(a))

  
  

• Category C permits notification for products and indications on an established history of use list

  
  

Category B carries the great majority of medicinal cannabis supply, and the volumes are substantial. Approvals rose from roughly 58,000 in 2020 to more than 177,000 in 2024, which gives some sense of how far an exceptional pathway has become the ordinary route to treatment.

Authorised prescribers

The alternative is authorisation of the practitioner rather than approval of each patient. An authorised prescriber may supply a specified class of product to a specified class of patient without applying individually each time (s 19(5)). Authorisation has traditionally required the endorsement of a human research ethics committee or a specialist college, but since 2021 that requirement has been relaxed for cannabidiol and balanced products prescribed to adults for refractory chronic pain or refractory anxiety.

State and Territory requirements

Commonwealth approval is necessary but never sufficient. Because most medicinal cannabis products are Schedule 8 controlled drugs, a practitioner must also comply with the drugs and poisons legislation of the State or Territory in which they practise, and the requirements differ.

In Victoria, prescribing is governed by the Drugs, Poisons and Controlled Substances Act 1981 (Vic). Since February 2022, a treatment permit is no longer required to prescribe a Schedule 8 medicinal cannabis product to a patient who is not drug dependent, which removed a significant administrative burden. A permit remains necessary for a patient who is drug dependent. Practitioners must also check SafeScript, Victoria's real-time prescription monitoring system, before prescribing. The Secretary retains power to grant, refuse, suspend and cancel permits and authorities under the Act, and certain decisions are reviewable by the Victorian Civil and Administrative Tribunal.

Other jurisdictions vary, for example, Queensland has gone furthest in streamlining, permitting practitioners to prescribe both cannabidiol and tetrahydrocannabinol products without a separate State approval.

Most jurisdictions now accept a single combined application through the TGA's online portal, which handles Commonwealth and State approval together.

What's next

Medicinal cannabis sits at the intersection of narcotics control, therapeutic goods regulation and State health law, and a business or practitioner must satisfy each of them independently. A licence to cultivate does not authorise manufacture, an approval to supply does not authorise a prescription, and Commonwealth authority does not displace State requirements.

With the TGA signalling that the current access framework requires reform, and with regulators actively examining prescribing practices, promotional conduct and product quality, this is an area where compliance positions should be reviewed rather than assumed.

Seeking further advice

For more on the topics raised in this guide, please review our further guides on how TGA and ARTG regulation shapes patent strategy, advertising therapeutic goods, and the special access pathways, as they are published.

If you need specific advice, please contact Wayne Condon at Biopharmalex. Wayne is one of Australia's most experienced life sciences and intellectual property lawyers, and has acted in many of the leading pharmaceutical patent cases of the past three decades.

This guide states the law at July 2026 and is general information only, not legal advice.