Accessing medical cannabis in Australia can feel complex—for both patients and healthcare practitioners.¹ While demand for medical cannabis has grown steadily, it is still considered an ‘unapproved’ therapeutic good under the Therapeutic Goods Administration (TGA) for most conditions.¹ This means that, in most cases, practitioners must first demonstrate that conventional, registered medicines have been tried or deemed unsuitable before turning to medical cannabis.² Yet for many patients, especially those living with chronic pain, conventional treatments provide limited relief³—highlighting the importance of clear, workable access pathways to ‘unapproved’ products.

So how does this work in practice? How do Australian practitioners access medical cannabis for their patients?

Accessing medical cannabis in Australia

There are two primary pathways for accessing medical cannabis in Australia, each with two sub-categories:⁴

• Special Access Scheme
  • Category A notification pathway
  • Category B application pathway
• Authorised Prescriber
  • Established History of Use pathway
  • Standard pathway

Each of these pathways is designed for different clinical scenarios and levels of oversight.
Let’s break them down.

1: Special Access Scheme (SAS)

Through the SAS, Australian-registered practitioners can apply to use an ‘unapproved’ medicine—such as medical cannabis—for an individual patient on a case-by-case basis.²

1.1: SAS-A – notification for a seriously ill patient

SAS-A allows practitioners to prescribe an ‘unapproved’ medicine, such as medical cannabis, for patients who are seriously ill*.² This is a notification pathway – which means prior approval from the TGA is not required.² Compared with SAS-B applications, SAS-A notifications are submitted less frequently.^5,6

*Seriously ill is defined as: someone who is ‘seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment’.²

1.2: SAS-B – application for all other patients

SAS-B allows qualified practitioners to prescribe an ‘unapproved’ medicine for patients who don’t meet the Category A definition.²

When seeking approval to prescribe an unapproved medical cannabis product under the SAS-B pathway, the practitioner must provide clinical justification.⁴

This justification should be succinct yet comprehensive, and include:⁴

• A summary of the patient’s symptoms and/or diagnosis
• Details of prior treatments or procedures that have been trialled or considered, with reasons why therapeutic goods currently included in the Australian Register of Therapeutic Goods (ARTG) are not clinically appropriate
• An appraisal of the anticipated clinical benefits of the proposed treatment weighed against the potential risks

The SAS does not limit applications to specific medical conditions.⁴ The key requirement is that the prescriber has the necessary knowledge of the patient’s condition and of the product they wish to use.⁴

SAS-B is an application pathway – which means an approval letter must be obtained from the TGA before the product can be supplied to the patient.²

2: Authorised Prescriber (AP)

Registered practitioners can apply to the TGA to become APs of certain medical cannabis products for groups of patients they care for.⁷ Approval lasts up to five years, and while practitioners don’t need to notify the TGA each time they prescribe, they must provide reports every six months.⁷ Additional approvals are only needed if the product isn’t already on the Established History of Use list.⁷

2.1: AP – Established History of Use pathway

The TGA’s Established History of Use lists set out which medical cannabis products and conditions have a recognised track record.⁴ This applies only to Category 1 (CBD ≥98%), Category 2 (CBD ≥60% and <98%), and Category 3 (CBD <60% and ≥40%) oral liquids or capsules for a select few conditions, including refractory chronic pain, anxiety, cancer pain, sleep disorders and autism spectrum disorder.⁸ For these, doctors can become APs without needing Human Research Ethics Committee (HREC) approval or specialist college endorsement.⁴

2.2: AP – Standard pathway

For medical cannabis products not included on the TGA’s Established History of Use lists, doctors can apply to become APs via the Standard pathway.⁴

To do so, doctors must first obtain approval from an HREC or endorsement from a specialist college, before lodging their application with the TGA.⁴

HREC approval or specialist college endorsement includes:⁹

• Applying in writing to an HREC or specialist college for endorsement
• Providing evidence to justify use of the unapproved therapeutic good
• Details about the doctors’ training and experience
• Description of the unapproved therapeutic good the doctor intends to prescribe
• Clinical justification for use of the unapproved therapeutic good

To find an HREC, check the list of HRECs registered with the National Health and Medical Research Council.⁹ If an HREC is unavailable, endorsement can be sought from a specialist college.⁹ The specialist college must have expertise relevant to the condition being treated. The list of specialist colleges can be found here.⁹

The infographic below summarises medical cannabis access pathways most commonly accessed in Australia.

Download this infographic here

To apply for the SAS or AP pathway, visit: https://compliance.health.gov.au/sas/

Need help deciding which pathway suits your practice needs? Get step-by-step assistance with your SAS-B or AP application from a SAGED Prescriber Support Specialist. Click here for support.

Use of the SAS and AP pathway

Despite being labelled as complex and time-consuming,¹ the TGA’s dashboard shows that the SAS and AP pathway are well utilised, highlighting ongoing patient demand. In 2024 alone, registered practitioners submitted 177,751 SAS-B applications,⁶ although the SAS-A pathway was less frequently used with 376 SAS-A notifications.⁵ Over the same period, the TGA granted 22,066 AP approvals, with 407,434 treatments initiated under these approvals between July and December 2024.^10,11

Leading conditions for medical cannabis prescription

According to the SAS-A and SAS-B dashboards, chronic pain is the leading condition for which medical cannabis is accessed in Australia, followed by anxiety,^5,6 reflecting their significant health burden.

The Australian Institute of Health and Welfare reported that in 2016, 1.6 million (1 in 5) Australians aged ≥45 years were living with chronic pain.¹² Current pharmacological treatments are often limited in effectiveness, with fewer than 20% of patients achieving ≥50% pain relief.³ In light of these limitations, it is estimated that around 600,000 Australians self-medicate with medical cannabis—most commonly for chronic pain.³

The most common conditions for SAS-A notifications and SAS-B applications in 2024^5,6

Summary

Although the regulatory framework for accessing medical cannabis is perceived as complex time-consuming,¹ the SAS and AP pathways provide routes for doctors to access unapproved products for their patients.⁴ The SAS enables case-by-case approvals, with SAS-A reserved for seriously ill patients² and SAS-B requiring a clinical justification for all other patients.^2,4 The AP pathway allows longer-term prescribing for groups of patients, with applications made via either the Established History of Use pathway or the more rigorous Standard pathway, which requires ethics or specialist college approval.^4,9

Despite perceptions of complexity,¹ these mechanisms are being used extensively.^5,6,10 With 1 in 5 Australians over 45 living with chronic pain—and conventional treatments often falling short—medical cannabis may offer an additional therapeutic option, particularly when conventional treatments provide limited relief.^3,12