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Access to medicinal cannabis products: frequently asked questions (FAQs)

21 August 2018

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.

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Consumers

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 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.

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.

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.

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.

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.

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.

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.

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.

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

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.

There are a number of mechanisms to enable access to unapproved medicinal cannabis products including:

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.

Further information on the SAS online system and details on the submission of medicinal cannabis applications can be found at: Special Access Scheme online system

Standard SAS forms can be used as required and are available on the SAS webpage. If using these application forms, a separate application may need to be made to the relevant state or territory health department depending on the circumstances. All prescribers are strongly encouraged to be aware of any state or territory requirements prior to prescribing unapproved medicinal cannabis products.

Applications for AP use the standard forms available on the Authorised prescriber page.

No. Any unapproved medicinal cannabis product can be potentially be 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.

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.

Depending on the product, both Commonwealth and state/territory approval is required. Prescribers should confirm local requirements with their state/territory health department.

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 SAS guidance for health practitioners and sponsors for more detailed information about what information to include in a SAS application.

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.

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.

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.

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.

No.

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

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.

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 consumers or health professionals.

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.

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.

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.

Yes

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. If they are satisfied that their unapproved medicinal cannabis product(s) meet the requirements of the standard, they should complete the declaration form available on the TGA website to declare that their medicinal cannabis product(s) meets this standard. 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.

The form is submitted to the TGA via email to medicinal.cannabis@health.gov.au. The form should be accompanied by a cover letter authorising the TGA to use the declaration for any notification or application received for that product.

Please note that a new form should be completed and submitted to the TGA prior to the supply of any new unapproved medicinal cannabis products in Australia, and also following any material change to medicinal cannabis products (including cannabis plants used in their manufacture) that were the subject of a previous declaration of conformity provided to the TGA where that change could have affected the quality of the products (for example, a change in the manufacturing process or formulation of the product).

Alternatively, you may supply the declaration form to the medical practitioner for them to submit to the TGA as part of their notification or application.

For clinical trials, the declaration should be submitted to the Australian clinical trial sponsor in the case of Clinical Trial Notifications (CTN) and Clinical Trials Exemption (CTX) applications. The medical practitioner or clinical trial sponsor (as relevant) is required to submit this form as supportive documentation to the TGA with their application or notification, as applicable. For more information on where to find and how to submit the form, please see the Forms web page.