Access to medicinal cannabis products

21 March 2018

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.

Patient access to medicinal cannabis in Australia

The Australian Government is facilitating access to medicinal cannabis products to appropriate patients for medical conditions where there is evidence to support its use. To achieve this, a number of legislative and regulatory changes have been implemented at the Commonwealth level through the Department of Health, comprising of the Therapeutic Goods Administration (TGA) and the Office of Drug Control (ODC).

Medicinal cannabis products are regulated as medicines in Australia and are therefore subject to legal requirements. Generally, medicines imported into, supplied in, and exported from Australia must be entered in the Australian Register of Therapeutic Goods (ARTG), which is administered by the TGA. Medicinal cannabis products not on the ARTG can be supplied through alternative pathways until more clinical evidence is gathered through clinical trials to support its registration. These alternative pathways make reference to Special Access Scheme (SAS) and Authorised Prescriber (AP).

Cultivation, production and manufacturing of medicinal cannabis in Australia

On the 30 October 2016, legislation came into effect to allow legal cultivation, production and manufacturing of medicinal cannabis products in Australia. The legislative changes forecasted an increase availability of medicinal cannabis products available to suitable patients. The ODC administers this scheme and works in collaboration with therapeutic goods legislation and state and territory legislation. The ODC is responsible for the regulation of domestic cultivation and harvest, as well as other aspects of manufacture of medicinal cannabis, under the Narcotics Drug Act 1967.

For more information surrounding the legislation and regulation applicable to medicinal cannabis products, please visit the 'Medicinal cannabis products: overview of regulation' web page.

Please note

Cannabis remains a highly regulated drug in Australia and the use and supply of cannabis for non-medicinal purposes (for example, recreational use) is illegal in Australia, in accordance with applicable Commonwealth, state and territory laws.

Role of the TGA

Administers the Therapeutics Good 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 Therapeutics Good 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.

Provides quality standard measures

The TGA is responsible for governing regulatory standards for medicinal cannabis products in Australia. Medicinal cannabis products accessed through AP, SAS or clinical trial pathways attain the same quality standards as applicable to any other experimental or emerging medicine. Quality controls are implemented through standards such as the Therapeutic Goods Order No. 93 - Standard for Medicinal Cannabis (TGO93). TGO93 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 TGO93 guidance document.

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

Scheduling is a national classification system that controls how medicines and poisons are made available to the public. Medicines and poisons are classified into schedules according to the level of regulatory control that is required to protect public health and safety.

In some jurisdictions, the scheduling of medicinal cannabis products will determine the requirements under the state or territory drugs and poisons legislation.

The scheduling of medicinal cannabis products predominantly containing cannabidiol is dependent on the concentration of other cannabinoids found in cannabis that are in the product.

Medical practitioners seeking to access cannabidiol products in Schedule 4 (S4) Prescription Only Medicine of the Poisons Standard should liaise with the supplier of the product to ensure that the maximum limits applied to all other cannabinoids (taking into account variability within and between batches) allow it to remain within that schedule.

The addition of an entry in Appendix D of the Poisons Standard as part of the recent scheduling decision means that medical practitioners may require approval by their state/territory health department before they can prescribe medicinal cannabis products in that jurisdiction. The legislation between each state and territory may be different and a medical practitioner should ensure they meet the applicable prescribing requirements before applying to or notifying the TGA.

Cannabis and tetrahydrocannabinols

Under certain circumstances, cannabis (including seeds, extracts, resins and the plant or any part of the plant) and tetrahydrocannabinols (when extracted from cannabis) when prepared or packed for human therapeutic use, are 'Controlled Drugs' under Schedule 8 (S8) of the Poisons Standard.

Access in the particular state/territory will need to be confirmed with the state/territory.

Cannabidiol

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 preparations for therapeutic use contain 2% or less of other cannabinoids found in cannabis.

Other substances

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.

For further information regarding the 2016 scheduling decision, please refer to Final decision on scheduling of cannabis and tetrahydrocannabinols: Frequently asked questions.

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 (a doctor) with appropriate qualifications and/or expertise for the medical condition requiring treatment. Approval or authorisation is granted on a case-by-case basis.

Australian registered medical practitioners who wish to apply to access medicinal cannabis products for their patient/s are required to:

  • Gain informed consent from the patient in relation to the proposed use of the unapproved product. The doctor and patient, patient's parents or guardian accept responsibility for any adverse consequence of therapy.
  • Notify/apply on a patient's behalf for approval/authorisation to supply these products through the available Commonwealth access schemes [i.e. Special Access Scheme (SAS) or Authorised Prescriber (AP)].
  • Ensure State/Territory requirements are satisfied.
  • Obtain an import license/ permit to import the product through the Office of Drug Control. Please note this may not be applicable if a product is currently being held in Australia.
  • Monitor patient outcome and report any suspected adverse drug reactions.

For answers to frequently asked questions relating to accessing medicinal cannabis products see the consumer section of our 'Access to medicinal cannabis products: questions and answers' web page.

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.

For answers to frequently asked questions relating to accessing medicinal cannabis products see the consumer section of our 'Access to medicinal cannabis products: questions and answers' web page.

If you have any other questions about medicinal cannabis products, talk to your doctor.

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.

If you are an Australian registered medical practitioner wanting to access medicinal cannabis products for your patient(s) through the above schemes, you may need to do or arrange the following:

  • determine your state/territory legislative requirements
  • make an application or notification under the SAS or the Authorised Prescriber Scheme
  • apply for a licence and permission to import, if necessary
  • comply with conditions of approval/authorisation and ongoing regulatory requirements.

For further information regarding these processes, including a step-by-step resource for doctors and information as to what to include in an application to the TGA please see our 'Access to medicinal cannabis products: steps to using access schemes' web page.

The Office of Drug Control website has published a list of Sponsors who have been authorised to import medicinal cannabis stock into Australia for supply only through SAS B approvals or AP authorisation. Please note that inclusion on this list does not guarantee stock availability or automatic approval for patient access by the TGA or the States and Territories.

The TGA has developed educational materials in consultation with the States and Territories for doctors to support them in determining whether prescribing medicinal cannabis is appropriate and beneficial for their patients. These guidance documents will be updated iteratively when new evidence emerges and are available on the medicinal cannabis - guidance documents web page.

For answers to frequently asked questions relating to accessing medicinal cannabis products see the health professional section of our 'Access to medicinal cannabis products: questions and answers' web page.

Review of clinical evidence for medicinal cannabis and cannabis products

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.

The purpose of this review was to provide a shared point of reference on the current evidence on the use of medicinal cannabis products for particular conditions/indications for individual clinicians and government departments, as well as the wider public.

While the outcomes of the work help inform decision making, decisions on patient access to particular cannabis products for particular patients or patients groups under the care of a particular medical practitioner will still be made on an individual basis by state and territory government health departments and the Commonwealth through the Therapeutic Goods Administration.

Further information and the guidance documents themselves are available on the medicinal cannabis - guidance documents web page.

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.

The Act outlines the legal responsibilities of the sponsor of unapproved medicinal cannabis products, as follows:

  • Ensure compliance with all applicable standards - there are a number of Therapeutic Goods Orders that apply to medicinal cannabis products. Civil and criminal penalties may apply where these requirements are not met. Non-compliance with a standard is also grounds for recalling a medicine from the market.
  • The sponsor importing the medicinal cannabis product is not legally able to supply the product until the product has received all of the relevant approvals, authorisation or exemption. Supplying a product without the relevant approval, authorisation or exemption would amount to unlawful supply. Civil and criminal penalties may apply in such circumstances.

Product quality standards

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 Order No. 93 (Standard for Medicinal Cannabis) (TGO 93) and Therapeutics Goods Order No. 77 (Microbiological standards for medicines) (TGO77).

TGO 93

Applies to:

  • approved and unapproved medicinal cannabis products
  • imported and Australian manufactured medicinal cannabis products
  • medicinal cannabis products supplied in Australia or exported from Australia.

The TGA has published a guidance document that provides a plain English explanation of various requirements of TGO 93 and their application to assist sponsors in complying with their regulatory obligations.

The TGA has developed a declaration form that must be completed for unapproved medicinal cannabis products to declare that the product(s) conform to TGO 93. This should be completed by the medicinal cannabis product manufacturer.

The reason for requesting that the medicinal cannabis product manufacturer complete the declaration form is that the person importing or supplying the unapproved medicinal cannabis product(s) in Australia may not be the commercial sponsor of the good (e.g., a medical practitioner). The highly technical nature of TGO 93 means that this person may not be in a position to declare that the product conforms to the standard. The manufacturer of the medicinal cannabis product that has responsibility for quality control testing of the finished product is best placed to declare that the medicinal cannabis product conforms to this standard.

The manufacturer of the medicinal cannabis product(s) is required to submit the completed form to the person applying to access the medicinal cannabis product(s) through the available access pathways.

For unapproved medicinal cannabis products to be accessed via:

  • SAS and Authorised Prescriber: The form is submitted to the medical practitioner. The medical practitioner is required to submit this form as supportive documentation to the TGA with their notification or application, unless the sponsor has already submitted the form to the TGA on the doctors behalf.
  • Clinical Trials - CTN/CTX: The form is submitted to the clinical trial sponsor. The Australian clinical trial sponsor should complete the section at the end of the form to include the name of the medicinal cannabis product(s) used in the clinical trial as well as the TGA clinical trial application number and protocol number. The clinical trial sponsor is then required to submit this form as supportive documentation to the TGA with their application or notification, as applicable. In the case of a CTN involving the use of a medicinal cannabis product, the clinical trial sponsor should submit this form via email to clinical.trials@health.gov.au. In the case of a CTX involving the use of a medicinal cannabis product, the clinical trial sponsor should submit this form as part of the CTX application made to the TGA.

Please note that although the cannabis plant used in the manufacture of the medicinal cannabis product must meet the requirements of Schedule 1 of TGO 93, 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.

TGO77

TGO 77 specifies the minimum microbiological requirements with which a medicine must comply throughout its shelf life. Medicinal cannabis (a non-sterile medicine) must comply with the relevant acceptance criteria of the British Pharmacopoeia, the European Pharmacopoeia or the United States Pharmacopoeia-National Formulary when tested by the nominated test methods. Determination of the absence of objectionable organisms is the responsibility of the sponsor and requires access to a competent microbiology group.

Manufacturing standards

Australian Manufacturers

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 (e.g. 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.

Overseas manufacturers

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 TGO77.

Reporting requirements

Import and supply

Reporting requirements for the import and supply of unapproved therapeutic goods may apply to both the sponsor of the goods and the person to whom approval has been granted (the medical practitioner or pharmacist).

The responsibilities of the sponsor supplying therapeutic goods under the SAS or the Authorised Prescriber Scheme are set out in Schedule 5A item 1 of the Therapeutic Goods Regulations 1990.

The sponsor is required to submit a report to the TGA every six months with the following information:

  • The total number of unapproved therapeutic goods supplied by the sponsor during the 6 month period.
  • The number of times these therapeutic goods have been supplied to medical practitioners under the available schemes.
  • Quantity supplied at each transaction.

This report is to be submitted twice a year at the end of June and December (i.e. 30/06 and 31/12).

Adverse events

In relation to the supply of therapeutic goods under the SAS or the Authorised Prescriber Scheme, the sponsor has a role in monitoring the use of their products continually and to record the safety of the medicine and the balance of its benefit and risk.

Ideally, the use of an unapproved therapeutic good should be the subject of treatment protocols issued by the sponsor, with clear requirements for the treating medical practitioner to report any adverse outcomes to the sponsor.

Sponsors of therapeutic goods supplied under the SAS or the Authorised Prescriber Scheme are also required to communicate rapidly to the TGA information that has an important bearing on the benefit-risk assessment of the product, particularly if it may lead to changes to the usage under the schemes.

Sponsors are required to report adverse events within the timeframes outlined in the guidelines Access to unapproved therapeutic goods via the Special Access Scheme and Access to unapproved therapeutic goods: Authorised prescribers, respectively.

For more information on how to report adverse events, please see the 'How to submit an adverse event report'.

Further information

Further information on the various access requirements for medicinal cannabis is available from: