Applications and reporting for unapproved medicinal cannabis

This page provides prescribers with information on how to access an unapproved medicinal cannabis product using the SAS or Authorised Prescriber pathways; as well as the reporting requirements.

Submission by a health practitioner

SAS applications and notifications must be submitted by certain registered health practitioners.

Health practitioners who are considering treating a patient with an 'unapproved' therapeutic good must acknowledge that it has not been evaluated for quality, safety or efficacy and it has not been approved by the TGA. The TGA cannot guarantee the quality, safety or efficacy of an 'unapproved' product.

The prescribing health practitioner must consider the available evidence to support the use of the unapproved product and any potential risks for the individual patient.

The responsibilities of the prescribing health practitioner include adhering to relevant standards of good medical practice and obtaining informed consent. The prescribing health practitioner also accepts responsibility for the use of an 'unapproved' therapeutic good and any associated adverse reactions.

Read more about responsibilities and how to prescribe an unapproved therapeutic good.

How to apply - SAS & Authorised Prescriber Online System

To access unapproved medicinal cannabis products, make your submission through the SAS and AP Online System - external site. 

Prescribers can submit applications to both the TGA and their State or Territory Health Department simultaneously. We will send a single correspondence containing both the TGA and relevant state or territory decision letter, after respective evaluations have been completed, within 48 hours (2 business days) of having received all the information required to make a decision.

• Register an account in the SAS & Authorised Prescriber Online System - external site
• Access the SAS & Authorised Prescriber Online System - external site

Authorised Prescribers can also submit their patient six monthly reports using the System.

Read more abouot the SAS and AP Online System.

Submission of SAS and Authorised Prescriber applications by active ingredient

From 22 November 2021, SAS and Authorised Prescriber submissions for unapproved medicinal cannabis products are made by active ingredient under a category based on cannabinoid content, rather than by brand (trade) name. This approach aims to reduce administrative burden for prescribers and allow flexibility in brand substitution as needed, for example in the event of product shortage or discontinuation.

The prescriber should include product details including specific cannabinoid content in the prescription and may wish to include the product's trade name where clinically necessary. For further information regarding prescribing and obtaining specific products under the five categories see 'Medicinal cannabis products by active ingredients'.

Categories of medicinal cannabis products

The cannabidiol (CBD) content determines the category of a medicinal cannabis product.

Category 1 - CBD medicinal cannabis product (CBD ≥98%)

CBD content is 98% or greater

A medicinal cannabis product is category 1 when all of the following apply:

• Schedule 4 Prescription Only medicines as per the Poisons Standard; and
• cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and
• any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine
• the medicine contains no other active ingredients.

Category 2 - CBD dominant medicinal cannabis product (CBD ≥60% and <98%)

CBD content is at least 60% but less than 98%

A medicinal cannabis product is category 2 when all of the following apply:

• Schedule 8 Controlled Drugs as per the Poisons Standard; and
• cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and
• other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine
• the medicine contains no other active ingredients.

Category 3 - Balanced medicinal cannabis product (CBD <60% and ≥40%)

CBD content is at least 40% but less than 60%

A medicinal cannabis product is category 3 when all of the following apply:

• Schedule 8 Controlled Drugs as per the Poisons Standard; and
• cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and
• other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine
• the medicine contains no other active ingredients.

Category 4 - THC dominant medicinal cannabis product (THC 60-98%)

CBD content is at least 2% but less than 40%

A medicinal cannabis product is category 4 when:

• Schedule 8 Controlled Drugs as per the Poisons Standard; and
• other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise 60% or more and 98% or less of the total cannabinoid content of the medicine; and
• cannabidiol derived from cannabis comprises 2% or more and less than 40% of the total cannabinoid content of the medicine
• the medicine contains no other active ingredients.

Category 5 - THC medicinal cannabis product (THC >98%)

CBD content is less than 2%

A medicinal cannabis product is category 5 when:

• Schedule 8 Controlled Drugs as per the Poisons Standard; and
• cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise more than 98% of the total cannabinoid content of the medicine; and
• cannabidiol comprises less than 2% less of the total cannabinoid content of the medicine
• the medicine contains no other active ingredients.

Obtaining medicinal cannabis products

The TGA does not supply therapeutic goods. Before notifying or applying to TGA under the SAS and AP schemes, applicants should check with the intended sponsor (or supplier) to ensure that they are prepared to supply the product.

If the product is available from an Australian supplier, the prescribing health practitioner or someone acting on their behalf (e.g. pharmacist) should contact the sponsor to organise supply. Within an institution such as a hospital, supply may be arranged through the pharmacy department.

We recognise that prescribing by active ingredient for medicinal cannabis products can be difficult for prescribers and pharmacists due to the complexity of available product preparations.

To support health care professionals in prescribing and supplying medicinal cannabis products, we have published a list of available medicinal cannabis products (by trade name) according to the active ingredient categories included in TGA approval letters. Sponsor details are also included to facilitate patient access.

For more information on a particular product, please contact the product sponsor.

View medicinal cannabis products by active ingredient category

Information for prescribers

SAS and Authorised Prescriber submissions for medicinal cannabis products are made by active ingredient category. However, prescriptions must be written for a product. It is the prescriber's responsibility to issue a prescription to the patient in accordance with relevant state or territory legislation.

Prescriptions for medicinal cannabis products:

• must include active ingredient name/s, strength, dosing amount and frequency
• include quantity of medication and number of repeats (if applicable)
• may include brand (trade name) of the medicine where clinically necessary
• may include any other formulation details clinically necessary
• must be in accordance with relevant state and territory legislation
• must be in accordance with the TGA approval

Prescribers may wish to refer to the list of medicinal cannabis products by active ingredient category.

Information for pharmacists

SAS and Authorised Prescriber submissions for medicinal cannabis products are made by active ingredient category. However this does not mean pharmacists can substitute between any product included in that category.

In dispensing a medicine, pharmacists:

• must comply with all legislation relevant to the practice of pharmacy in the jurisdiction where the practice occurs
• ensure that dispensing is done in accordance with the prescriber's intentions
• not dispense a prescription without satisfying themselves that it is safe, appropriate and lawful to supply the medicine. Where clarification is required, the patient or their agent should be consulted and if necessary, the prescriber contacted
• undertake brand substitution only in accordance with regular practice and in accordance with the Pharmacy Board of Australia Guidelines for dispensing of medicines
• meet professional standards that are determined by the Pharmacy Board of Australia

Pharmacists may wish to contact the relevant state and territory health department for further information.

Extemporaneous compounding of medicinal cannabis products

Pharmacists can extemporaneously compound a medicinal cannabis product for a particular person on prescription. From 28th April 2022, extemporaneous compounding of medicinal cannabis products can only occur with a prescription based on approvals under either the Special Access Scheme (SAS) or Authorised Prescriber (AP) pathway.

Information for prescribers and pharmacists

• SAS and AP submissions are required be made on the basis of the active ingredient category of cannabinoid content and the dosage form of the final product.
• Details regarding the preparation of an extemporaneously compounded product should be provided on the prescription.
• Pharmacists involved in the compounding of medicines should consider applicable State and Territory requirements, including requirements under the Health Practitioner Regulations Law.
• Pharmacists should also consider the Pharmacy Board of Australia Guidelines on compounding of medicines - external site. These guidelines include detailed guidance on when it is appropriate for a medicine to be compounded and the requirements to be complied with when compounding medicines.
• Prescribers and pharmacists should consider individual legal and professional responsibilities when a compounded medicine is prescribed and subsequently compounded and dispensed.

Quality standards

Medicinal cannabis products are required to comply with Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017 - external site, which provides for minimum quality requirements for medicinal cannabis products. Further information can be obtained in the guidance document, Conforming with Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017.

For each product they compound and dispense, pharmacists must:

• ensure that the product conforms to all of the requirements of TGO 93, and
• maintain records demonstrating that the product conforms to all of the requirements of TGO 93.

Advertising

Medicinal cannabis products are Prescription Only medicines, hence its advertising is prohibited under the Act. For more guidance in relation to the advertising of medicinal cannabis products (including extemporaneously compounded products) see the Advertising guidance for businesses involved with medicinal cannabis products.

Apply for a licence and permission to import, if necessary

Cannabis, cannabis resin, extracts, oils and tinctures of cannabis, and cannabinoids (including cannabidiol and tetrahydrocannabinols) are captured under the Customs (Prohibited Imports) Regulations 1956 - external site. A licence and permission to import is required prior to importing any product containing these substances.

The Office of Drug Control (ODC) hosts a list of manufacturers and suppliers of medicinal cannabis products - external site on its website. Some suppliers may have stock available in Australia removing the need for the medical practitioner, or pharmacist acting on behalf of the medical practitioner to arrange for import. Please see the ODC website for more information.

If a medicinal cannabis product has not already been imported by the sponsor, a medical practitioner, or pharmacist acting on behalf of the medical practitioner, can apply for a licence and permission to import - external site.

Please contact the ODC - external site for further information regarding the application process.

State and territory requirements

Approval or permission from state or territories may be required to prescribe medicinal cannabis products.

It is the responsibility of the prescribing practitioner to know the legislative requirements of the state or territory in which they are practising.

Contact the relevant state or territory health department for further information. Contact details for each Australian state & territory are available below: