Access to medicinal cannabis products: questions and answers

17 June 2017
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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 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 be accessed using one of the relevant access schemes administered by the TGA.

Before a doctor considers prescribing an unapproved medicinal cannabis product, you should be informed of the following:

  • that 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
  • the possible benefits of treatment and any risks and side effects that are known
  • any alternative treatments using approved products which are available.

This information, along with adequate knowledge of the condition, 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 get access to 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.

The TGA is developing 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.

Your doctor must be approved by their state/territory health department, as relevant, before they can prescribe medicinal cannabis products in that jurisdiction.

Your doctor must also have appropriate qualifications and/or expertise for the proposed conditions for which the proposed product would be used. If your doctor is not a specialist in the condition and is submitting an application, then the TGA would expect a report from an appropriate specialist on the use and suitability of the medicinal cannabis product for you for your particular condition to be included with the application.

Both the Commonwealth Government and state and territory governments have a role in the importing, supply and prescribing of medicinal cannabis products to patients.

The importing and supply of unapproved medicinal cannabis products is governed by the Commonwealth Government. When considering an application for a prescriber to access unapproved medicinal cannabis products, the Commonwealth will consider whether the prescriber has the appropriate expertise to prescribe the product and the suitability of the product to treat the patient's medical condition. The quality of the product proposed to be prescribed and the appropriateness of the manufacturing quality standards that have been applied to the product will also be considered.

Your state or territory government will also consider whether the medicinal cannabis product is being appropriately prescribed for the patient's condition as well as looking at the suitability of the individual prescriber and the particular patient. This will require a balance between managing increasing community interest in using medicinal cannabis products, with the risks and safety issues associated with the use of an unapproved product, including that for some patients these medicines may not work and may have side effects.

Note: that even though a SAS A notification can be submitted to the TGA by any Australian registered medical practitioner, most states and territories will only consider applications completed by a specialist or that have the support of a specialist. Please check with your state/territory on whether you would be eligible to prescribe medicinal cannabis products in your state/territory.

The approval time is generally under 5 working days once all the relevant information required by the TGA to assess the application is provided by your medical practitioner.

There can be many reasons why you may not be able to access an unapproved medicinal cannabis product, even after your doctor has notified the TGA or received TGA approval/authorisation to supply it to you. While submitting a notification or application to the TGA is necessary, there are other factors that can affect availability and supply, such as:

  • securing a legal supply of the product: 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 should 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.
  • receiving the necessary approvals to prescribe the medicinal cannabis product under state/territory legislation: Your doctor must be approved by their state/territory health department before they can prescribe medicinal cannabis products in their state/territory.

Yes, the TGA has established quality standards for medicinal cannabis products that companies that import, manufacture and supply medicinal cannabis products in Australia are required to meet.

However, if prescribing under SAS Category A, it is the responsibility of the importing doctor or pharmacist to demonstrate the products meet those standards.

Personal import of medicinal cannabis products is subject to tight 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 for prescribing an unapproved product rests with the prescriber. The prescriber and patient, patient's parents or guardian accept responsibility for any adverse consequence of therapy. You have the right to decline to prescribe an unapproved product if you believe there is either insufficient clinical justification to support the use of the product.

The Act provides a number of mechanisms to enable access to unapproved therapeutic goods. For medicinal cannabis products these include:

  • access for individual patients through either:
    • Authorised Prescriber Scheme
    • Special Access Scheme (Category A or B)
      • Category A patients are defined as 'persons who are 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'.
      • Category B patients are all patients that do not fit the Category A definition. A doctor can choose to use Category B, even where the patient meets the Category A definition.
  • access as part of a clinical trial.
No. The TGA will accept each notification and evaluate each application received under the Special Access Scheme or the Authorised Prescriber Scheme for access to a specific medicinal cannabis product. This will be the basis of the supporting evidence submitted and any other information that may be known to the Delegate of the Secretary.
No. The TGA will accept each notification and evaluate each application received under the Special Access Scheme or the Authorised Prescriber Scheme requesting access to a specific medicinal cannabis product on the basis of the supporting evidence submitted.
No. Both TGA and state and territory requirements must be met before prescribing a medicinal cannabis product.
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.

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 is expected of a pharmaceutical grade product.
No. The manufacturer should complete this form and submit it to the TGA directly or to you, the medical practitioner, for you to submit to the ODC as part of an import application with a SASA notification or to the TGA as supporting documentation for your SASB or AP application.
Yes. The completed declaration form along with any attachments must be submitted with and will be considered as part of the SAS notification/application or Authorised Prescriber application. The form will serve as evidence that the product intending to be supplied by the medical practitioner to their patient(s) meets the high standard of quality expected of a pharmaceutical grade product.
No.

A sponsor is under no obligation to supply an unapproved product merely because it has been notified to, approved or authorised under the Special Access Scheme or the Authorised Prescriber 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 Australian Register of Therapeutic Goods (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 Australian Register of Therapeutic Goods (ARTG) are considered unregistered therapeutic goods and therefore 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 Special Access Scheme or the Authorised Prescriber Scheme respectively.

Yes. There are various standards that apply to medicinal cannabis products, including Therapeutic Goods Order No. 93 (Standard for Medicinal Cannabis).

The TGA has published a guidance document that provides a plain English explanation on how to apply the requirements set out in Therapeutic Goods Order No. 93 (Standard for Medicinal Cannabis), 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 (GMP) 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 Standard for Medicinal Cannabis (TGO 93). 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 form is submitted to the TGA via email to . 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. For each product covered in the declaration, please provide a representative Certificate of Analysis (CoA) and specifications for the raw material and finished product for our records.

Please note that a new form along with a representative CoA and specifications for the raw material and finished product 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 (e.g., 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 webpage.