What is medicinal cannabis in Australia?
Medicinal cannabis refers to cannabis-based products that have been manufactured and evaluated to meet the standards of a pharmaceutical product and are used under the supervision of a healthcare practitioner for an appropriate medical indication. In Australia, medicinal cannabis is regulated by the Therapeutic Goods Administration (TGA) as part of the broader therapeutic goods framework.
The cannabis plant contains a range of compounds including cannabinoids such as tetrahydrocannabinol (THC) and cannabidiol (CBD), as well as terpenes and other phytochemical compounds. Different products vary in their cannabinoid profile, formulation, and intended route of administration. The available product forms include oils, capsules, dried flower, and topicals, among others.
Dried flower products intended for inhalation require a suitable medical device — typically a vaporiser — that is itself regulated separately as a medical device under the TGA's device framework. The device and the cannabis product are therefore subject to separate but parallel regulatory processes.
All access to medicinal cannabis products in Australia requires a valid prescription from a qualified healthcare practitioner. The TGA does not allow the purchase or use of cannabis-based products without this prescription, regardless of the access pathway used. Patients cannot self-prescribe or obtain these products through general retail channels.
Medicinal cannabis products used in Australia must meet applicable standards for quality, safety, and manufacturing. This distinguishes them from illicit cannabis, which carries no such regulatory oversight. The regulatory framework is designed to ensure that patients who are prescribed these products receive goods that have been assessed against defined standards.
Because the regulatory landscape continues to evolve — with new products entering the market, new AP approvals being granted, and an increasing number of products receiving ARTG listings — patients and healthcare practitioners are encouraged to consult the current TGA guidance rather than relying solely on any single published summary.
How the TGA regulates access
The TGA oversees all therapeutic goods in Australia, including medicines and medical devices. It operates under the Therapeutic Goods Act 1989 (Cth) and applies this framework to medicinal cannabis products regardless of which access pathway is used to reach the market.
For medicinal cannabis, the TGA manages access through several distinct pathways depending on whether a product holds an ARTG listing. Most medicinal cannabis products currently access the Australian market as unapproved therapeutic goods through the Special Access Scheme (SAS) or the Authorised Prescriber (AP) scheme, though a growing number are now listed on the ARTG.
The TGA sets quality, safety, and efficacy standards that products must meet regardless of the pathway used. This includes requirements around Good Manufacturing Practice (GMP), product testing, labelling, and record-keeping. Sponsors — the companies responsible for bringing products to market — bear responsibility for ensuring their products meet these requirements.
Both the medicines (the cannabis products themselves) and any associated medical devices (such as vaporisers used for dried flower administration) are subject to regulatory oversight, but under different frameworks. Medicines and medical devices are assessed under distinct classification and approval processes, even though both fall under the Therapeutic Goods Act 1989.
The TGA's regulatory framework also includes post-market surveillance, adverse event reporting, and the ability to take compliance action where products or sponsors do not meet the required standards. This ongoing oversight applies throughout the product lifecycle, not just at the point of initial approval or listing.
Healthcare practitioners who prescribe medicinal cannabis under unapproved pathways are responsible for ensuring their prescribing is consistent with TGA requirements and with applicable state or territory laws governing controlled substances. Pharmacists dispensing these products are similarly subject to state and territory regulatory requirements in addition to federal TGA obligations.
The Special Access Scheme (SAS)
The Special Access Scheme allows patients to access therapeutic goods that are not included in the ARTG for individual patient use. It is designed to provide a pathway for patients who have a clinical need for a product that has not yet received standard regulatory approval or listing in Australia.
The SAS operates through two main categories. Category A (SAS-A) applies to patients who are seriously ill with a condition that is immediately life-threatening or causes serious, permanent disability. Under SAS-A, the treating practitioner can supply or administer an unapproved product without prior TGA approval, but must notify the TGA within 28 days of first supply.
Category B (SAS-B) is the pathway more commonly used for medicinal cannabis. Under SAS-B, the prescribing doctor submits an application to the TGA before supply. The application describes the patient, the clinical indication, the proposed treatment approach, and the specific product to be used. The TGA then reviews the application and makes a decision.
SAS-B approval is specific to the individual patient and the specific product identified in the application. If the prescriber wishes to change the product, or if a new patient requires the same product, a separate application is generally required. This per-patient, per-product structure means that SAS-B can involve ongoing administrative requirements for busy practices.
Decisions under SAS-B are typically made within a defined timeframe, and the TGA publishes guidance on expected processing times. In practice, the decision time can vary. Prescribers working regularly with medicinal cannabis may find that the Authorised Prescriber pathway, once established, reduces per-patient administrative requirements.
Prescribers should consult the current TGA guidance on the Special Access Scheme before initiating an application, as requirements, forms, and processes are subject to update. The TGA website is the authoritative source for current SAS requirements.
The Authorised Prescriber scheme
The Authorised Prescriber (AP) scheme allows a medical practitioner to be approved by the TGA to prescribe a specified unapproved therapeutic good to a class of patients under their direct clinical care, without applying for individual SAS-B approvals for each patient. This makes the AP pathway particularly useful for practitioners who regularly prescribe specific medicinal cannabis products.
To become an Authorised Prescriber for a particular medicinal cannabis product, a doctor must apply to the TGA and provide evidence supporting the proposed clinical use. In many cases, this involves endorsement from a human research ethics committee (HREC) or a specialist college. The TGA then reviews the application and, if satisfied, grants AP status for the specified product and patient population.
Once AP approval is in place, the prescriber can prescribe the specified product to suitable patients within the approved indication without additional TGA approval per patient. The prescriber is responsible for patient monitoring and for reporting adverse events and treatment outcomes to the TGA as required under the AP conditions.
AP status is granted for specific products and specific patient populations. Prescribing outside the terms of the AP approval — for example, to a different patient group or for a different indication — is not covered by the AP approval and would require a separate application or use of the SAS pathway.
The AP pathway can significantly reduce administrative burden for practitioners who regularly prescribe specific medicinal cannabis products to appropriate patients. From a patient perspective, once a practitioner holds AP status for a relevant product, the process of obtaining a prescription can be more straightforward than under SAS-B.
Pharmacists dispensing medicinal cannabis under an AP prescription follow standard pharmacy dispensing procedures, subject to applicable state or territory controlled drugs and poisons legislation. State and territory requirements vary, and pharmacists should be familiar with the requirements in their jurisdiction.
ARTG-listed products
A growing number of medicinal cannabis products have been approved for inclusion on the ARTG. When a product holds an ARTG listing, a prescriber can prescribe it without needing to use the SAS or AP pathway for that product — the product itself has been approved for supply by registered healthcare practitioners in Australia.
Achieving ARTG listing requires the sponsor to provide the TGA with evidence of the product's quality, safety, and efficacy. The standard of evidence required depends on the registration pathway and the product's classification. ARTG registration is generally a more demanding process than access through SAS or AP, but it provides the product with a more secure regulatory status.
Even where a medicinal cannabis product is ARTG-listed, patients still require a valid prescription from a healthcare practitioner. ARTG listing does not make these products available over the counter or through general retail. The prescription requirement remains in place for all medicinal cannabis products, regardless of their regulatory status.
ARTG listing also makes products eligible for consideration for inclusion in the Pharmaceutical Benefits Scheme (PBS). However, as of the time this article was written, no medicinal cannabis products are PBS-subsidised in Australia, meaning patients generally bear the full cost of these products out of pocket. This may change over time as the evidence base and policy environment evolve.
The ARTG is a public register. Verification of a product's ARTG status, sponsor details, and listed indication can be done via the TGA's public ARTG search tool at tga.gov.au. This is the most reliable way to confirm the current regulatory status of a specific product, as entries may be updated, suspended, or cancelled.
For healthcare professionals and pharmacists, confirming ARTG status before dispensing or prescribing is a standard part of due diligence. The public ARTG search tool provides the current record, including any conditions of registration or listing that apply to the product.
The role of the device
When the prescribed medicinal cannabis product is dried flower intended for inhalation, a suitable medical device is required to administer it. The method of administration for dried cannabis flower is vaporisation, which requires a device capable of heating the material to a temperature sufficient to release cannabinoids without combustion.
The TGA regulates vaporisation devices used for medicinal cannabis administration as medical devices, separately from the cannabis product itself. This means that both the medicine and the device are subject to regulatory oversight, but each follows its own distinct regulatory pathway under the Therapeutic Goods Act 1989.
A medical-grade vaporiser that holds an ARTG listing as a medical device has been assessed by the TGA against the Essential Principles for medical devices, which cover safety and performance requirements. This assessment is conducted under the device classification framework, which assigns devices to risk classes based on their intended use and associated risks.
Consumer-grade vaporisers that are not listed on the ARTG as medical devices have not undergone this TGA device assessment. The distinction between a medical device listed on the ARTG and an unlisted consumer product is relevant for healthcare practitioners and pharmacists when advising patients on appropriate device selection.
The Grenco Medical Elite II Vaporiser holds ARTG Entry 526764 as a Class IIb medical device intended for vaporising cannabis flowers and inhaling cannabinoids derived from them, for the appropriate medical indication as prescribed by a healthcare practitioner. This ARTG entry can be verified at the TGA website using the public ARTG search tool.
Device selection is a clinical and practical decision to be made between the patient and their prescriber. Factors relevant to device selection may include the prescribed product form, the patient's clinical situation, ease of use, and hygiene and maintenance requirements. Healthcare practitioners are best placed to advise patients on these considerations.
For practitioners unfamiliar with available registered devices, reviewing the ARTG for medical devices with an intended purpose relevant to medicinal cannabis vaporisation provides a starting point for understanding the landscape of TGA-assessed options available in Australia.