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Access to medicinal cannabis products
This information is for consumers, health professionals, sponsors and manufacturers who are involved in providing appropriate patients with access to medicinal cannabis products as an unapproved drug through the Special Access Scheme (SAS) or Authorised Prescriber Scheme.
The term 'medicinal cannabis products' covers a range of cannabis preparations intended for therapeutic use, including pharmaceutical cannabis preparations, such as oils, tinctures and other extracts.
Role of the TGA
Administers the Therapeutic Goods Act 1989
The TGA is responsible for ensuring that therapeutic goods available for supply in Australia are safe and fit for their intended purpose. The TGA administers the Therapeutic Goods Act 1989 (the Act), which establishes the regulatory framework for all medicines in Australia.
The Act provides a number of mechanisms to enable access to unapproved therapeutic goods. For medicinal cannabis products these include access through:
While there are additional legal requirements that must be met before medicinal cannabis products can be imported and supplied through these schemes, they do provide a pathway for access to these medicines to appropriate patients.
Administers the SAS
Overview of medicinal cannabis and the SAS
The TGA has a responsibility to encourage the use of medicines that are included in the Australian Register of Therapeutic Goods (ARTG), as these products have been evaluated to ensure they meet strict standards of safety, quality and effectiveness.
For this reason, it is expected that medical practitioners (prescribers) will have considered all clinically appropriate treatment options that are included in the ARTG before applying to access an unapproved medicinal cannabis product under the SAS.
Where products in the ARTG are found to not be clinically suitable, the SAS provides a pathway for prescribers to access unapproved products for individual patients on a case-by-case basis. It is important to note that the TGA does not vouch for the quality, safety and effectiveness of unapproved products accessed through SAS and the prescriber and patient (via informed consent) accept responsibility for any adverse consequences of treatment.
It is the responsibility of the prescriber making the application to specify for which indication they are intending to use the unapproved medicinal cannabis product.
To date, the TGA has approved SAS applications including, but not limited to, the following indications:
- chemotherapy-induced nausea and vomiting
- refractory paediatric epilepsy
- palliative care indications
- cancer pain
- neuropathic pain
- spasticity from neurological conditions
- anorexia and wasting associated with chronic illness (such as cancer).
The above list is provided as an overview and does not guarantee TGA approval for applications specifying these indications. SAS Category B applications are individually considered by the TGA based on the information provided with the application. A number of applications for indications other than those listed above have also been approved. Health professionals wishing to obtain further information about how to make a SAS application for a medicinal cannabis product should refer below.
SAS Category B approval statistics
Up to 31 August 2020, the TGA has approved over 61,000 SAS Category B applications for unapproved medicinal cannabis products.
A breakdown of the number of SAS Category B approvals by month for the previous 12 months is also provided below:
|Month||Number of SAS Category B approvals|
- These figures represent the number of SAS Category B approvals only.
- The total number of approvals is provided since 1992 when TGA received the first known medicinal cannabis SAS application. However, the large majority of approvals have occurred since 2016.
- These figures are correct at the time of publishing, however are subject to change in order to reflect updates due to subsequent application cancellations, withdrawals and amendments.
- Approval numbers do not equal the actual number of patients receiving these medicines under the SAS. This is due to the possibility of repeat applications for the same patient. It is also possible that an individual patient may be associated with separate approvals for multiple products. SAS applications contain de-identified information and it is not possible for the TGA to accurately calculate patient numbers.
- Approval under the SAS does not necessarily mean the patient has accessed or continues to access treatment. Following approval, the actual supply of medicinal cannabis is a matter for the medical practitioner and their patient.
- Australian patients may also be accessing unapproved medicinal cannabis products outside the SAS via the Authorised Prescriber scheme or in a clinical trial and these will not be captured in the SAS figures provided above. As of 31 August 2020 there are 103 Authorised Prescribers.
- Sativex (nabiximols), an approved medicinal cannabis product included in the ARTG, is also available in Australia and its use is not included in these statistics.
SAS online system
As of 30 July 2018 an online system was introduced to enable the lodgement of SAS applications and notifications through an online system. The TGA has been working in collaboration with the State and Territory Health Departments to streamline the application processes pertaining to the prescription of and subsequent access to unapproved medicinal cannabis products in Australia.
The SAS online system includes functionality that will now allow prescribers in certain States and Territories to submit an application to both the Commonwealth and the relevant State/Territory Health Department simultaneously. Prior to the introduction of this system, prescribers of unapproved medicinal cannabis products were required to complete and separately submit paper forms to the TGA and relevant State Health Department.
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.
Provides quality standard measures
The TGA is responsible for governing regulatory standards for medicinal cannabis products in Australia. Quality controls are implemented through standards such as the Therapeutic Goods -(Standard for Medicinal Cannabis) (TGO 93) Order 2017. TGO 93 provides appropriate regulatory controls to ensure that the quality of the medicinal cannabis and ingredients used in the manufacture is of an acceptable standard and safe for it consumer. For more information please review the Conforming with the TGO93 web page.
Plays a vital role in the scheduling of medicines
The TGA also plays a vital role in the scheduling of medicines in Australia. The Schedules are published in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) and may be adopted by state and territory jurisdictions to take legal effect.
On the 1st of November 2016, amendments were made to the scheduling of medicinal cannabis products. This involved Schedule 9 (S9) Prohibited Substances being down regulated to Schedule 8 (S8) Controlled Drug for certain medicinal cannabis products. The scheduling changes remain a decision for individual states/territories to include in their legislation for medicinal cannabis.
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) when prepared or packed for human therapeutic use, are 'Controlled Drugs' under Schedule 8 (S8) of the Poisons Standard.
Access will need to be confirmed with the relevant State/Territory noting that laws differ between jurisdictions. For State and Territory contact information please see: Access to medicinal cannabis products: using access schemes.
Cannabidiol (CBD) is one of the cannabinoids which may be extracted as a therapeutic good from cannabis. From 1 June 2015, cannabidiol has been included under Schedule 4 (S4) 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.
Nabiximols, nabilone and dronabinol are listed as Controlled Drugs in S8 of the Poisons Standard. S8 substances also require a prescription from an Australian-registered medical practitioner to obtain and possess within Australia.
Information for consumers
Individual consumers cannot apply to obtain approval to import and access unapproved medicinal cannabis products. Access can only be arranged through an Australian registered medical practitioner with appropriate qualifications and/or expertise for the medical condition requiring treatment. Approval or authorisation is granted on a case-by-case basis.
For further information about medicinal cannabis regulation and access in Australia please see the consumer information brochure.
If you have any other questions about medicinal cannabis products, please talk to your doctor for advice.
Information for health professionals
Australian registered medical practitioners who would like to access unapproved medicinal cannabis products for the treatment of appropriate patients outside of clinical trials may choose to do so through the SAS or the Authorised Prescriber Scheme.
For further information regarding these processes, including a step-by-step resource for medical practitioners and information as to what to include in an application to the TGA please see our 'Access to medicinal cannabis products: using access schemes' web page.
The Office of Drug Control website has published a list of manufacturers and suppliers of medicinal cannabis products. This may assist prescribers with medicinal cannabis product selection. Note that the Australian Government cannot guarantee availability or supply by any manufacturer or importer listed on the website.
Clinical justification requirements for SAS Category B applications
When applying to access an unapproved medicinal cannabis product on behalf of a patient under the SAS Category B pathway, prescribers must provide a clinical justification. The justification should include the seriousness of the patient's condition, consideration for the use of medicines that are included in the ARTG and the potential risks and benefits of using the proposed unapproved medicine.
The clinical justification may be succinct and should summarise:
- An outline of the patient's symptoms and/or diagnosis
- Details of relevant past treatments and procedures trialled or considered, including reasons why therapeutic goods currently included in the ARTG may not be the most appropriate treatment for the individual patient in the particular circumstance
- An appraisal of the expected clinical benefits versus the potential risks of the proposed treatment
There are no restrictions on the medical conditions for which a prescriber may apply via the SAS to access an unapproved medicinal cannabis product for their patient, provided the prescriber has the appropriate knowledge on the condition being treated and on the medicinal cannabis product they wish to prescribe.
Supporting evidence may be requested by the TGA for some novel indications.
In some instances, evidence of specialist support from a practitioner with appropriate expertise may also be requested.
Clinical evidence, guidelines and resources for health professionals
The Commonwealth Department of Health, together with the NSW, Victorian and Queensland State Governments commissioned a multi-centre team of clinicians, experimental pharmacologists and other scientists at the University of New South Wales, University of Queensland and University of Sydney to review the current clinical evidence for medicinal cannabis in a range of conditions.
Further information and the guidance documents themselves are available on the medicinal cannabis - guidance documents web page.
Other available resources include:
- The NSW Cannabis Medicines Prescribing Guidance published by the Australian Centre for Cannabinoid Clinical and Research Excellence (ACRE). This guidance provides interim information to assist medical practitioners in their decision-making around prescribing and managing the use of cannabis medicines. Guidance has been developed for anorexia/cachexia in advanced cancer, chemotherapy-induced nausea and vomiting, nausea in palliative care, dementia, non-cancer pain and spasticity.
- The United Kingdom National Institute for Health and Care Excellence (NICE) guideline on Cannabis-based medicinal products. This guideline covers prescribing of medicinal cannabis for patients with intractable nausea and vomiting, chronic pain, spasticity and severe treatment-resistant epilepsy. The guideline also includes an evidence review and tools and resources to help put the guidance into practice.
- The Royal Australian College of General Practitioners (RACGP) medicinal cannabis webinars. These webinars look at the use and prescribing of medicinal cannabis in general practice.
- NPS MedicineWise has developed a series of medicinal cannabis resources for prescribers and pharmacists.
Clinical trials on medicinal cannabis substances, extracts and products
The following Excel files provide information from the Australian New Zealand Clinical Trials Registry (ANZCTR) for relevant trials notified between 1 January 2015 and 30 November 2019 using the search terms THC, CBD and cannabinoid/s. Only trials that explore potential therapeutic uses of medicinal cannabis substances or products are shown in the files.
- THC clinical trials (xlsx,144kb)
- CBD clinical trials (xlsx,177kb)
- cannabinoid clinical trials (xlsx,178kb)
The ANZCTR is an online register of clinical trials being undertaken in Australia, New Zealand and elsewhere. Note that some trials undertaken in Australia may be registered with registries other than the ANZCTR. Trials from all Primary Registries of the World Health Organization International Clinical Trials Registry Platform can be searched at: International Clinical Trials Registry Platform.
All details of trials registered on the ANZCTR are made publicly available. Registration is voluntary, but if a registrant chooses to register a trial, certain fields are mandatory. Responsibility for registration lies with the sponsor defined as 'an individual, company or institution or organisation which takes responsibility for the initiation, management and/or financing of a clinical trial'. It is the sponsor's responsibility to ensure that the information submitted is accurate and up-to-date.
The registry records a trial's objectives, main design features, sample size and recruitment status, treatments under investigation, outcomes being assessed, principal investigator and contact person.
Information for sponsors and manufacturers of medicinal cannabis products
The person or company in Australia who provides the unapproved medicinal cannabis product to the treating medical practitioner or pharmacist is considered the sponsor of that product in Australia. In cases where the medicinal cannabis product is sourced from overseas, the sponsor may also be the importer of the medicine.
General information for sponsors is available through the Role of the sponsor web page.
Product quality standards for medicinal cannabis
Sponsors of medicinal cannabis products must ensure that their products comply with all applicable quality standards. There are various standards that may apply to medicinal cannabis products, including Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017 and Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018.
Manufacturing standards for medicinal cannabis
Under the Therapeutic Goods Act 1989 Australian medicines manufacturers are required to obtain a licence to manufacture medicinal cannabis products (sometimes referred to as GMP licence) unless exempted in Schedule 7 or Schedule 8 of the Therapeutic Goods Regulations 1990. This requirement applies to products that are on the ARTG and unapproved products that may be accessed through the available pathways (Authorised prescriber, special access scheme, clinical trials) for medicinal cannabis products. The applicable standard for medicines manufacture is the Code of GMP. We have published specific guidance on GMP compliance for the manufacture of medicinal cannabis products that applies to unapproved products supplied under 'approved access' provisions.
Products registered on the ARTG
The TGA uses internationally harmonised manufacturing standards to allow manufacturers to operate in an international environment. For medicinal cannabis products intended to be registered on the ARTG that involve an overseas manufacturer, evidence of acceptable GMP in the form of a GMP clearance will be required for each of the overseas manufacturing sites before the goods can be registered. A GMP clearance is only issued if robust evidence is provided to demonstrate that the medicinal cannabis product has been manufactured in accordance with the Code of GMP (or an equivalent manufacturing standard). For more information on how to obtain a GMP clearance please see GMP clearance for overseas manufacturers.
Products not on the ARTG
For medicinal cannabis products intended to be supplied through the available unapproved medicine access pathways that involve an overseas manufacturer, the medicinal cannabis product must be manufactured in accordance with an acceptable manufacturing standard.
TGA provides the following guiding principles to sponsors to assist them in determining what would typically constitute an acceptable manufacturing standard for medicinal products supplied through unapproved access scheme:
- The country in which manufacture of the product occurs has active oversight of medicinal cannabis products and holds them to its own manufacturing standards.
- The product is supplied to patients in the country of its manufacture; and is not manufactured solely for export to other markets.
The countries that demonstrate compliance the above principles currently include Canada, Germany, the Netherlands, Switzerland and Israel.
Sponsors of medicinal cannabis products must ensure compliance with all other applicable manufacturing standards in addition to TGO93 and TGO100.
Further information on the various access requirements for medicinal cannabis is available from:
- Access to medicinal cannabis products: using access schemes
- Conforming with TGO 100
- Conforming with the TGO93
- Medicinal cannabis: importation and the traveller's exemption
- Special Access Scheme (SAS)
- Authorised prescribers
- Access to medicinal cannabis products: Frequently Asked Questions (FAQs)
- Import and export of controlled substances
- Final decision on scheduling of cannabis and tetrahydrocannabinol
- Office of Drug Control