This page contains answers to frequently asked questions about access to 'unapproved' medicinal cannabis products in Australia.
The Special Access Scheme (SAS) refers to arrangements which provide for the importation and/or supply of a therapeutic good not included on the Australian Register of Therapeutic Goods (ARTG) for a single patient, on a case-by-case basis.
Authorised Prescriber (AP) refers to circumstances under which a medical practitioner is granted authority to become an 'Authorised Prescriber' of a specified unapproved therapeutic good (or class of unapproved therapeutic goods) to specific patients (or classes of recipients) with a particular medical condition.
Consumers
What are medicinal cannabis products and what does it mean if they are 'unapproved'?
The term 'medicinal cannabis' describes a range of cannabis preparations intended for therapeutic use, including:
- pharmaceutical cannabis preparations, such as oil, tinctures and other extracts
- untreated cannabis (raw and dried cannabis)
- cannabis resin (hashish), natural and synthetic cannabinoids
All medicines imported into, supplied in and exported from Australia must be entered in the Australian Register of Therapeutic Goods (ARTG), unless special conditions apply. Any medicine not on the ARTG is considered an 'unapproved therapeutic good'. Unapproved therapeutic goods can potentially be accessed using one of the access schemes administered by the TGA, including the SAS.
What should I expect the doctor to tell me if they are considering using an unapproved medicinal cannabis product?
Before a doctor considers prescribing an unapproved medicinal cannabis product, you should be informed of the following:
- the product is not approved in Australia and (potentially) other countries
- the quality, safety and efficacy have not been assessed by the TGA
- the possible benefits of treatment and any risks and side effects that are known
- available alternative treatments using approved products.
This information, along with adequate knowledge of the condition being treated, the treatment options, the likelihood of recovery and the long-term prognosis, is necessary to ensure that you (as either the patient or the patient's legal guardian) are able to make an informed decision regarding treatment.
Your doctor must get your informed consent before applying to the TGA to access an unapproved medicinal cannabis product. Informed consent should be freely given and obtained in line with good medical practice, and it should be in writing unless there are good reasons to the contrary.
Which medical conditions or diseases are medicinal cannabis products able to treat?
There are no restrictions imposed by the TGA on the indication/s for which a health practitioner may apply to access an unapproved medicinal cannabis product for their patient. For more information please see the overview of medicinal cannabis and the SAS sections of our website.
The TGA has developed educational materials in conjunction with the states/territories for doctors to support them in determining whether prescribing medicinal cannabis products is appropriate and beneficial for the patient, as well as information on how to use the available access schemes. See our medicinal cannabis - guidance documents page.
Can any doctor submit an application or notification to the TGA on my behalf to access unapproved medicinal cannabis products?
Your doctor should have appropriate qualifications and/or expertise to treat the condition for which the proposed product would be used. If your doctor is not a specialist in the condition and is submitting an application, then depending on the circumstances, the TGA may ask for a report from the appropriate treating specialist on the use and suitability of the medicinal cannabis product for you and your particular condition.
In many cases your doctor must also be approved by their state/territory health department before they can prescribe medicinal cannabis products. States and territories have different restrictions on who can prescribe these products and the doctor should check local requirements with the relevant state/territory.
Why does my doctor need to gain approval from the Commonwealth and the state/territory government (if applicable) before I can access medicinal cannabis?
Both the Commonwealth Government and state and territory governments have a role in the importation, supply and prescription of medicinal cannabis products to patients.
The importation and supply of unapproved medicinal cannabis products is governed by the Commonwealth Government.
Your state or territory government may consider whether the medicinal cannabis product is being appropriately prescribed by the individual prescriber and whether the product is being prescribed to an appropriate patient.
How long does it take to review my application to access medicinal cannabis that was submitted to the TGA by my doctor?
The TGA decision timeframe is generally around 2 working days once all the relevant information required by the TGA to assess the application is provided by your medical practitioner.
My doctor has received approval to supply a medicinal cannabis product to treat my condition. Will I now receive the product?
TGA is not involved in the actual supply of products accessed through the SAS. The person or company that is responsible for supplying the product (the sponsor), is under no obligation to supply your doctor with the unapproved medicinal cannabis product, even if your doctor has been given approval or authorisation to supply it. In these instances, your doctor may need to seek an alternative supply of the same product or an alternative product, noting that an alternative product may require them to submit a new application to the TGA.
If applicable, your doctor must also be approved by their state/territory health department before they can prescribe medicinal cannabis products in their state/territory. Doctors should contact their state/territory health department if they are unsure of local requirements.
Is the medical cannabis product I am receiving quality controlled?
The TGA has established quality standards for medicinal cannabis products that companies who import, manufacture and supply medicinal cannabis products in Australia are required to meet. However, TGA cannot vouch for the quality, safety and effectiveness of unapproved products because they have not been evaluated by us.
Can I personally import medicinal cannabis products for treatment of myself or my family members?
Personal import of medicinal cannabis products is subject to strict controls including import permit requirements from the Office of Drug Control and applicable state and territory requirements. Please see Medicinal cannabis - importation and the traveller's exemption for general information.
Medical practitioners
I have been asked by a patient to prescribe an unapproved medicinal cannabis product. Do I have an obligation to prescribe it?
The responsibility and decision to prescribe any therapeutic good, including unapproved products rests with the prescriber. You have the right to decline to prescribe a medicinal cannabis product if you believe there is insufficient clinical justification or evidence to support the safe and effective use of the product.
It is important to note that the prescriber and patient (or patient's parents or guardian) through informed consent accept responsibility for any adverse consequence of therapy using an unapproved medicinal cannabis product.
I would like to prescribe a medicinal cannabis product, what access pathway should I use?
There are a number of mechanisms to enable access to unapproved medicinal cannabis products including:
- access for individual patients through either:
- access as part of a clinical trial.
How do I submit a SAS application for an unapproved medicinal cannabis product?
As of 30 July 2018 an online system was introduced to enable the submission of SAS applications and notifications electronically. The TGA has collaborated with state and territory health departments to streamline the application process for access to unapproved medicinal cannabis products in Australia.
The SAS online system allows prescribers in certain states and territories to submit an application to both the Commonwealth and the relevant state/territory health department simultaneously.
Read more about the SAS and AP Online System.
All prescribers are strongly encouraged to be aware of any state or territory requirements prior to prescribing unapproved medicinal cannabis products.
How do I submit an AP application form?
Read more about the SAS and AP Online System.
Will the TGA only allow me to access a particular product?
No. Any unapproved medicinal cannabis product can be potentially accessed under the SAS or AP scheme. It is the responsibility of the prescriber to specify which product they wish to access. The TGA does not maintain a list of unapproved medicinal cannabis products.
Are there specific medical conditions for which the TGA will allow access to medicinal cannabis?
No. It is the responsibility of the prescriber to determine whether the specific product is suitable for the condition being treated based on clinical justification and evidence. The TGA has published guidance documents that prescribers may find useful when considering treatment with medicinal cannabis.
Do I need both TGA (Commonwealth) and state/territory approval to use medicinal cannabis?
Depending on the product, both Commonwealth and state/territory approval is required. Prescribers should confirm local requirements with their state/territory health department.
What level of clinical evidence is expected to support an application to access medicinal cannabis for my patient(s)?
The efficacy and safety data submitted in support of the application should be weighed against the seriousness of the condition. Please also include details of intended monitoring of the patient once treatment commences. Please see the Special Access Scheme (SAS): Guidance for health practitioners for more detailed information about what information to include in a SAS application.
Does the TGA publish a list of Authorised Prescribers?
For privacy reasons, the TGA does not publish a list of Authorised Prescribers who have been authorised to supply medicinal cannabis products under the Therapeutic Goods Act 1989.
Furthermore, in Australia doctors are not allowed to advertise to the public that they are able to prescribe a particular medicine. This is not just a matter relating to the Therapeutic Goods legislation, but also to the standards upheld by the Australian Health Practitioner Regulation Agency and the Medical Board of Australia and goes to matters of medical ethics and good medical practice.
The TGA has approved or authorised my application to become an Authorised Prescriber but the state/territory has not granted me the necessary approval to treat a named patient with the product I have been authorised to supply. Can I still use the product on the named patient?
Authorisation from the TGA to supply a specific medicinal cannabis product to treat the class of patients as per the authorisation does not override any state/territory requirements.
What is the relevance of the Standard for Medicinal Cannabis (TGO No. 93)?
Compliance with this standard provides an assurance to the medical practitioner that the product they intend to prescribe to their patient(s) meet a high standard of quality, consistent with what is expected of a pharmaceutical grade product.
Am I required to complete the form declaring that the medicinal cannabis product conforms with the Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017?
No. The sponsor/manufacturer should complete this form and submit it to the TGA directly or to you, the medical practitioner, for you to submit to the TGA as supporting documentation for your SASB or AP application.
Does the TGA charge a fee to process my notification or application to access medicinal cannabis products through the SAS or the AP scheme?
No.
I have submitted a notification through SAS (Category A) or obtained approval/authorisation to supply the unapproved medicinal cannabis product through the SAS (Category B)/ AP scheme. What if the sponsor of the goods will not supply it?
A sponsor is under no obligation to supply an unapproved product merely because it has been notified to, approved or authorised under the SAS or the AP scheme respectively.
You are advised to contact the sponsor and ensure that they will agree to supply once appropriate approvals are received before making a notification or application to the TGA.
Sponsors and manufacturers of medicinal cannabis products
I am interested in obtaining general marketing status for my medicinal cannabis product(s). What is required for me to register my medicinal cannabis product on the ARTG?
The Therapeutic Goods Act 1989 requires that medical products imported into, supplied in, or exported from Australia must be included on the ARTG. In order for a prescription medicine to be included on the ARTG, a sponsoring company is required to submit an application to the TGA. A submission to register a prescription medicine consists of:
- data that support the quality, safety and efficacy of the product for its intended use
- completed forms
- payment of fees.
More information on how to register a prescription medicine can be found on the TGA website.
Am I able to advertise my unapproved medicinal cannabis product?
No. The advertising of prescription only medicines (including medicinal cannabis preparations) to the public is prohibited.
Prescription medicines not included on the ARTG are considered unapproved therapeutic goods and cannot be advertised in Australia to the public.
Am I required to supply a medicinal cannabis product to a medical practitioner if he/she has notified the TGA or obtained approval/authorisation to supply the product through the SAS or the AP scheme?
A sponsor is under no obligation to supply an unapproved product merely because it has been notified, approved or authorised under the SAS or the AP scheme respectively.
Does the TGA have any quality standards for medicinal cannabis products that my product(s) need to conform to?
Yes. There are various standards that apply to medicinal cannabis products, including Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017.
The TGA has published a guidance document that provides a plain English explanation on how to apply the requirements set out in Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017, to assist sponsors in complying with their regulatory obligations.
Am I required to conduct all the tests specified in Schedule 1 of TGO 93 on every batch of cannabis plant used in the manufacture of my medicinal cannabis product(s)?
Reduced or rotational testing of the cannabis plant used in the manufacture of the product can be carried out provided that this is justified on good manufacturing practice grounds. For example, a manufacturer may be able to justify reducing or not conducting pesticide testing if no pesticides are used in the cultivation of the cannabis plant. The manufacturer should ensure that the product, if tested by the TGA laboratories, will meet all the requirements of the standard.
Do these apply equally to imported and Australian manufactured products?
Yes
Will the TGA evaluate my raw material and finished product specifications to ensure these comply with the Standard for Medicinal Cannabis?
No. The manufacturer is required to review their raw material and finished product specifications against the requirements of the Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017. The TGA may ask for a representative certificate of analysis for review to ensure compliance with the TGO93. Medicinal cannabis products, like all therapeutic goods may be subject to testing by the TGA to confirm compliance with applicable standards.