Access to medicinal cannabis products

3 October 2017

This guidance is for consumers, health professionals, sponsors and maufacturers 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.

The Australian Government is facilitating access to medicinal cannabis products to appropriate patients for medical conditions where there is evidence to support its use. However, to fully achieve this, a number of legislative and regulatory changes have been implemented at the Commonwealth level. Additionally, the rules relating to medicinal cannabis products may vary between states and territories and could affect access in those jurisdictions.

Commonwealth Department of Health regulates medicinal cannabis products through the Therapeutic Goods Administration (TGA) and the Office of Drug Control (ODC).

Medicinal cannabis products are regulated as medicines in Australia. 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. However, there are other mechanisms for access to medicines that are not registered on the ARTG. Medicinal cannabis products supplied in Australia will use these alternative supply pathways while evidence to support registration is gathered through clinical trials.

Legislation came into effect on 30 October 2016 to allow legal cultivation, production and manufacturing of medicinal cannabis products in Australia. This scheme is administered by the ODC. This legislation is designed to make available medicinal cannabis products and works together with the therapeutic goods legislation and state and territory legislation to make medicinal cannabis products available to certain patients.

For further information about legislation and regulation that applies to medicinal cannabis products see our '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

We administer 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:

These mechanisms maintain the same standards for medicinal cannabis products that apply to any other experimental or emerging medicine.

We also play a role in the scheduling of medicines. However, the states and territories have the authority to decide if they want to adopt a scheduling change for a medicine in their relevant legislation.

Down scheduling of medicinal cannabis products from Schedule 9 (S9) Prohibited Substances to Schedule 8 (S8) Controlled Drug in certain circumstances came into effect on 1 November 2016. It is a matter for the states and territories to implement this scheduling decision into the relevant law in their jurisdictions to reduce the number of restrictions placed on their manufacture, supply, possession and use, to facilitate access to appropriate patients.

The 1 November 2016 version of the Poisons Standard provides more detail on the scheduling requirements and the Explanatory Memorandum has further explanation.

The TGA is responsible for the regulation of the quality aspects of medicinal cannabis products.

TheTherapeutic Goods Order No. 93 - Standard for Medicinal Cannabis (TGO 93) has been developed by the TGA, after consultation with stakeholders, to provide appropriate regulatory controls to ensure that the quality of the medicinal cannabis products and ingredients used in the manufacture of medicinal cannabis products is acceptable.

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.

Accessing medicinal cannabis products

We administer the following schemes that allow eligible medical practitioners to apply for the importation and supply of medicinal cannabis products that are not registered on the ARTG:

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.

We also allow access for the purposes of clinical trials, which may be conducted to develop an evidence base to support safety and efficacy of medicines. For further information see our 'Clinical trials at a glance' web page.

Information for consumers

Individual consumers cannot apply to us to obtain approval to import and access unapproved medicinal cannabis products.

Such 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. This doctor can notify/apply on the patient's behalf for approval to import and supply these products through the Special Access Scheme (SAS Category A or B). Alternatively, the doctor can apply to us to become an Authorised Prescriber. Approval or authorisation is granted on a case-by-case basis.

This doctor must also apply and obtain approval under the applicable state or territory laws to prescribe a medicinal cannabis product to a particular patient,, where relevant. Please note that the rules relating to medicinal cannabis products may vary between states and territories and could affect whether or not you can be prescribed those medicines in that jurisdiction.

Additionally, if both state and TGA requirements are satisfied, the doctor (or pharmacist/hospital on the doctor's behalf) wishing to import the product may then need to obtain import permits from the ODC, unless the product is already being held in Australia. The Office of Drug Control website gives 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.

We are developing educational materials in consultation with the states and territories for doctors to support them in determining whether prescribing medicinal cannabis is appropriate and beneficial. These educational materials will be available towards the end of 2017.

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 want 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.

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 have 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 is 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 will 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.

A series of reviews of the evidence around the potential use of medicinal cannabis products in the following conditions is near completion:

  • Paediatric and adult epilepsies
  • Multiple sclerosis
  • Nausea and vomiting, resulting from chemotherapy and HIV/AIDS therapy
  • Various types of pain
  • Palliative care

In this work, the researchers conducted a systematic 'review of reviews' of previously published systematic reviews, and synthesised the findings of the individual studies as well as the conclusions of the reviews.

Evidence came from review of the following databases - Medline, Embase, PsycINFO, and EBM Reviews. Searches were limited to studies published from 1980 to late 2016 - early 2017. Reviews in these databases were screened for quality, and required that reviews conduct a comprehensive search of the literature, and described the characteristics of the individual studies inclusion.

Multiple databases were searched using specific search terms and the search strategy guided by a specialist Librarian. The review protocols were each registered to Prospero, an international prospective register of systematic reviews supported by the UK National Institute for Health Research. In the systematic reviews, priority was given to randomised controlled trials conducted since 1980, but the reviewers also included observational studies, e.g. case reports, retrospective chart reviews, self-report surveys.

Two reviewers independently examined titles and abstracts for relevance, using Covidence Software which improves healthcare evidence synthesis by improving the efficiency and experience of creating and maintaining databases for reviews and integrates tools for assessing risk of bias in articles. Relevant articles were obtained in full, and independently assessed by two reviewers for suitability for inclusion and if excluded from the analysis, reasons for exclusion were documented in Covidence. The Cochrane Risk of Bias tool was used to assess studies. The GRADE approach to evaluating the quality of empirical studies was also used./p>

It is anticipated that these reviews will be published in late 2017 - early 2018.

The linked documents are bibliographies of the major studies used in developing the five reviews. For each study, they include the

  • Abstract (summary) of the study, as prepared by the original researchers who carried out the study
  • Publication details (authors names, date, details of the particular medical journal)
  • Type of study performed (e.g. Randomised Controlled Trial, Case controlled, Open label observational, self-reported etc.)
  • Grade of evidence

Bibliographies

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).

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 . 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.

Manufacturing standards

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.

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.

Medicinal cannabis products supplied through unapproved access schemes

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 applicable manufacturing standards in addition to Therapeutic Goods Order No. 93 - Standard for Medicinal Cannabis (TGO 93).

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 us every six months listing the therapeutic goods supplied to medical practitioners under the SAS or the Authorised Prescriber Scheme.

The report by the sponsor must list each of the unapproved therapeutic goods supplied by the sponsor during the period to which the report relates; and state the number of times these therapeutic goods have been supplied to medical practitioners, and the quantity supplied.

Therefore the sponsor should submit a report twice yearly (for example, at the end of June and December) detailing the number of times the therapeutic goods have been supplied and the quantity supplied.

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'.

Supporting documentation to be provided by medical practitioners

A notification or application to access unapproved medicinal cannabis products can be made under the SAS or an application can be made under the Authorised Prescriber Scheme by a medical practitioner.

Medical practitioners are required to complete the relevant form and provide supportive information for Special Access Scheme Category B or Authorised Prescriber in relation to the product to allow us to assess if the import and/or supply of the medicinal cannabis product is appropriate.

Further information can be found under 'Evidence to accompany an application or notification to access medicinal cannabis products' in Step 2 of the 'Access to medicinal cannabis products: steps to using access schemes' web page.

For answers to frequently asked questions relating accessing medicinal cannabis products, see the sponsors and manufacturers of medicinal cannabis products section of 'Access to medicinal cannabis products: questions and answers'.

Further information

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