Medicinal cannabis: access pathways and usage data

Medicinal cannabis included in the ARTG

The Therapeutic Goods Act 1989 - external site (the Act), establishes the regulatory framework for all medicines and medical devices in Australia.

We encourage the use of therapeutic goods that are included in the Australian Register of Therapeutic Goods (ARTG) because these goods must meet strict requirements for quality, safety, efficacy and performance.

There are a small number of medicinal cannabis goods included in the ARTG. The use of these goods must be considered before applying for a SAS approval or AP authority for the supply of any unapproved goods (see below).

Patient access via the Special Access Scheme (SAS) and Authorised Prescriber (AP) pathway

The Act provides a number of mechanisms including the Special Access Scheme (SAS) and the Authorised Prescriber (AP) pathways to enable access to 'unapproved' therapeutic goods, including most types of medicinal cannabis.

Before applying to access an unapproved good through the SAS or AP pathways, prescribers should consider clinically appropriate treatment options that are included in the ARTG.

It is important to note that the TGA has not assessed the quality, safety, efficacy or performance of unapproved goods accessed through the SAS or AP pathways. The sponsor, prescriber and patient (via informed consent) accept all responsibility for any adverse consequence of unapproved goods.

If you’re a health professional and require further information, see Medicinal cannabis: Information for health professionals.

Special Access Scheme (SAS)

• The SAS allows prescribers, including both registered medical and nurse practitioners, to prescribe medicinal cannabis for a single patient on a case-by-case basis.
• SAS A is a notification pathway that allows a registered medical practitioner to access and prescribe unapproved medicinal cannabis for a patient who is seriously ill.
• SAS B is an application pathway through which a prescriber may apply to the TGA for approval to supply unapproved medicinal cannabis for a patient under their care. The prescriber must provide a suitable clinical justification for the use of the therapeutic good, including reasons why products already included in the ARTG are not suitable for the treatment of the relevant patient.

Authorised Prescriber Scheme

• An Australian-registered medical practitioner can apply to the TGA to become an Authorised Prescriber (AP) in certain circumstances.
• An AP can apply for approval of a specific medicinal cannabis category for a class of patients in the practitioner’s immediate care.
• An AP can apply for multiple approvals for different medicinal cannabis categories.
• APs do not need to notify the TGA each time medicinal cannabis is prescribed by them during the approval period (up to 5 years). APs must, however, provide reports every 6 months of patients treated under each AP approval that they hold.
• To become an AP, an Australian-registered medical practitioner must obtain approval from a Human Research Ethics Committee (HREC), or endorsement from an appropriate specialist college, to prescribe the medicinal cannabis.
• Prescribers do not need HREC approval or specialist college endorsement for a medicinal cannabis substance, if the selected substance’s active ingredient category, dosage form, and indication is included in our Authorised Prescriber established history of use lists.

Further information about accessing medicinal cannabis for a patient is available here: Medicinal cannabis: Information for patients.

Import licence and permit requirements

If you are intending to import medicinal cannabis, including if you are a medical practitioner intending to import medicinal cannabis for your patients, you will also need to obtain an import licence and permit. See Importing medicinal cannabis products into Australia - external site. This requirement applies regardless of which access pathway under the Act the medicinal cannabis is intended to be supplied.

Medicinal cannabis access data dashboard

To improve transparency and data accessibility, the TGA publishes de-identified data about SAS approvals and notifications and AP authorities specific to 'unapproved' medicinal cannabis.

You can access the data dashboards via the following links:

• Medicinal cannabis Special Access Scheme data
• Medicinal cannabis Authorised Prescriber Scheme data

Please note the dashboards are best viewed on a desktop. Further:

• The dashboards are updated monthly, with figures correct at the time of publishing. Figures may change to reflect updates from subsequent application cancellations, withdrawals, and amendments.
• The dashboard includes access data since 1992 when the TGA received the first known application under SAS for medicinal cannabis. However, most approvals have occurred since 2016.
• On 22 November 2021, we changed from approving trade name-based medicinal cannabis to category-based products.
• Sativex (nabiximols) and Epidyolex (cannabidiol) are included in the ARTG. Data on the use of these products is not included in the dashboard because the dashboard relates only to unapproved medicinal cannabis.

Patient data

The TGA does not publish figures on the number of patients accessing medicinal cannabis. SAS applications contain only de-identified patient information, and AP six-monthly reports contain no patient details.

Approval and notification numbers do not equal the actual number of patients receiving medicinal cannabis under the SAS and AP pathways. One patient can potentially be associated with:

• multiple AP authorities for different products under the same prescriber;
• multiple SAS approvals for different products;
• repeat SAS approvals for a single product; and
• approvals or authorities for the same product under each scheme.

SAS approvals and AP authorities do not mean that the patient has accessed treatment or continues to access treatment. Following approval, the actual supply of medicinal cannabis is a matter for the registered medical practitioner and their patient. The TGA does not hold prescription data.

Filters can be applied to the data by clicking on the graphs to refine results and capture the desired data. Any filter applied that produces a result less than 10 will display ‘<10’ instead of the exact number to ensure the anonymity of individuals. Filters can be removed by clicking the ‘Clear Selections’ button. Filtered data can be exported into an excel spreadsheet by clicking the ‘Bulk Export’ button.

If you are unable to use the dashboard, please contact: medicinal.cannabis@health.gov.au to access the data in an alternative format.

SAS & AP online system

In order to reduce the administrative burden of making SAS and AP applications, we have created the SAS/AP Online System - external site, which provides a single application point for prescribers to obtain the relevant Commonwealth and state or territory approval or authorities for accessing medicinal cannabis. Where applicable, applications are reviewed by both the TGA and the relevant state or territory within 2 business days of the submission of the required information.

Read more about the SAS and AP Online System.

Quality standard measures

The TGA is responsible for governing the regulatory standards for medicinal cannabis in Australia. Quality controls are implemented through standards such as the Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017 which applies to therapeutic goods that contain, or are manufactured from, any part of the cannabis plant.

TGO 93 provides appropriate regulatory controls to ensure that the quality of medicinal cannabis and ingredients used in the manufacture are of an acceptable standard for patients. For more information, please review the Conforming with the TGO 93 web page.

Scheduling of medicines

The TGA also plays a vital role in the scheduling of medicines in Australia. The schedules are published in the Poisons Standard and are adopted by state and territory jurisdictions to have legal effect.

Scheduling of medicinal cannabis products

Cannabis and tetrahydrocannabinol

Under certain circumstances, cannabis (including seeds, extracts, resins, and the plant or any part of the plant) and tetrahydrocannabinol (when extracted from cannabis) are 'Controlled Drugs' under Schedule 8 of the Poisons Standard when prepared or packed for human therapeutic use.

Access to Schedule 8 medicines must be confirmed with the relevant state or territory noting that laws differ between jurisdictions. For state and territory contact information, please see: Applications and reporting.

Cannabidiol

Cannabidiol (CBD) is one of the cannabinoids which may be extracted from cannabis. From 1 June 2015, cannabidiol has been included under Schedule 4 Prescription Only Medicine of the Poisons Standard when the cannabinoids component in the preparation for therapeutic use contains at least 98% cannabidiol and 2% or less of other cannabinoids found in cannabis.

From 1 February 2021, a new entry was included in the Poisons Standard to enable registered preparations of cannabidiol to be available as Schedule 3 Pharmacist Only medicines. At present, however, there are no products on the ARTG that meet the requirements for this classification.

Other substances

Nabiximols, nabilone, and dronabinol are listed as Controlled Drugs in Schedule 8 of the Poisons Standard. Schedule 8 substances require a prescription from an Australian-registered medical practitioner to obtain and possess within Australia.

Other cannabis products are listed in Schedule 9 of the Poisons Standard. These products are not available under SAS/AP.