Australia: Medicinal Cannabis - Access and Distribution


In February 2016, amendments to the Narcotic Drugs Act 1967 (Cth) (ND Act) and the Therapeutic Goods Act 1989 (Cth) (TG Act) provided for a new legislative framework for accessing medicinal cannabis in Australia. The complexity of the framework, however, means that it can be difficult to navigate. We take a look at the new framework as it applies to patients and medical practitioners seeking access to medicinal cannabis.

This is the second article in our two part series on the regulatory framework surrounding medicinal cannabis in Australia. Our first article can be accessed here: Medicinal cannabis - cultivation, production, and manufacture.


  1. Cannabis: (marijuana) the plant of the genus Cannabis.
  2. Medicinal Cannabis: cannabis products prescribed to relieve the symptoms of a medical condition.
  3. Cannabinoids: the components contained within the cannabis plant that produce pharmacological effects.
  4. Cannabidiol: (CBD) a non-psychoactive cannabinoid that has appears to have positive effects on patients.
  5. Tetrahydrocannabinol: (THC) the principal psychoactive cannabinoid of cannabis.
  6. Industrial Cannabis: (Hemp) cannabis with a THC level of no more than 1%, primarily used for its fibre and oil.
  7. Cultivation: growing the cannabis plant.
  8. Production: harvesting the cannabis plant.
  9. Manufacture: the extracting of active ingredients from the cannabis plant, and creating medicine in its dosage form.

The key cannabinoids used in medicinal cannabis are THC and CBD. They have shown positive effects on patients suffering from a wide range of illnesses.


Australia is a signatory to the United Nations' Single Convention on Narcotic Drugs (1961) (Convention), an international treaty to prohibit production and supply of narcotic drugs except for specific purposes such as medical treatment and research.

The ND Act enables Australia to meet its obligations under the Convention, particularly to ensure that domestic supply of narcotic drugs do not exceed domestic medicinal and scientific demand.


The TG Act is a federal law administered by the Therapeutic Goods Administration (TGA), part of the Commonwealth Department of Health. The ND Act is also a federal law and is administered by the Office of Drugs Control (ODC), a new body established under the new framework within the Commonwealth Department of Health.

Access to and distribution of medicinal cannabis products is a joint responsibility between the Federal Government (through the TGA and the ODC) and the states. Patients must obtain both the relevant federal and state approvals.


The TGA is responsible for the Poisons Standard in which, until recently, cannabis and its related compounds were listed within Schedule 9 - Prohibited Substances. On November 1 2016, in line with the new legislation, cannabis was relisted under Schedule 8 - Controlled Substances. CBD was listed as a separate substance to cannabis for the first time, and placed in Schedule 4 - Uncontrolled but Prescribed Drugs.

Products which contain substances in Schedule 4 or 8 of the Poisons Standard must be registered on the TGA's Australian Register of Therapeutic Goods (ARTG) to be considered a "registered good". Registered goods are assessed for safety, quality and efficacy. Goods that are not registered on the ARTG cannot be subsidised by the Federal Government.

The ARTG listing process is onerous, costly, and slow to comply with. Further, medicinal cannabis derived from natural cannabis (rather than synthetic) consists of a series of complex compounds which operate together when administered to patients. For this reason, neither this series of compounds nor the entire plant can be registered on the ARTG. So most medicinal cannabis drugs, as unregistered goods, are not subsidised by the Federal Government, and patients must pay full market price for the drugs.


Unregistered goods, including medicinal cannabis, are not assessed for efficacy by the TGA and, unless they are forbidden by state or territory law, are supplied through:

  • the Special Access Scheme
  • the Authorised Prescribers Scheme, or
  • clinical trials

Special Access Scheme (SAS)

The SAS provides a pathway for the import or supply of medicinal cannabis for a single patient, on a case-by-case basis. Patients are grouped into two categories under the scheme:

  1. Category A: terminally ill patients, or
  2. Category B: all other

Category A patients currently cannot gain federal approval for access to medicinal cannabis through the SAS.

Authorised Prescribers Scheme (APS)

A medical practitioner may be granted authority by the TGA to become an "Authorised Prescriber" of medicinal cannabis to specific patients with a particular medical condition.

To be an authorised prescriber, the medical practitioner must:

  • have the training and expertise appropriate for the condition being treated and the proposed use of the product
  • be able to best determine the needs of the patient
  • be able to monitor the outcome of therapy

Once a medical practitioner becomes an authorised prescriber they do not need to notify the TGA when they are prescribing the medicinal cannabis. However, they must report to the TGA the number of patients treated on a six monthly basis.

Clinical trials

Federal approval can also be gained through clinical trials. A trial must have an Australian sponsor which may be an individual, a body or organisation, or a company. The TGA deals directly with the sponsor on all matters relating to the trial.


As different states have different legislation, a patient's access to medicinal cannabis will depend on where they live. This article focuses on the Queensland legislation.

Until recently, under the Health (Drugs and Poisons) Regulation 1996 (Qld), cannabis was a prohibited substance in Queensland.

On 1 March 2017, changes to the Public Health (Medicinal Cannabis) Act 2016 (Qld) (PHMC Act) commenced, creating a new regulatory framework to allow medicinal cannabis to be prescribed and dispensed to patients in Queensland while also preventing unauthorised use of these products. The new PHMC Act defines medicinal cannabis as a good not listed on the ARTG. Any cannabis used outside of the regulatory framework will be illegal.

There are now two pathways for a patient in Queensland to receive state approval for treatment with medicinal cannabis:

  1. Patient-Class Prescriber
  2. Single-Patient Prescriber

Patient-Class Prescriber

Under the patient-class prescriber pathway, a certain class of specialist doctors may be granted an as-of-right authority to prescribe specific medicinal cannabis products for patients suffering a specific range of conditions, without the need for any additional chief executive approval. The patient classes which can currently access this pathway include multiple sclerosis induced spasticity, drug-resistant epilepsy, chemotherapy induced nausea, and terminally ill patients.

To become a patient-class prescriber, a doctor must be within the class of specialists listed in the regulation. They must also inform Queensland Health each time that they prescribe, supply, or administer medicinal cannabis.

Single-Patient Prescriber

The single-patient prescriber pathway allows a medical practitioner, who believes their patient may benefit from treatment with medicinal cannabis, to apply to Queensland Health for approval to prescribe a medicinal cannabis product for the patient.

In contrast to the patient-class prescriber scheme, under the single-patient prescriber pathway, medicinal cannabis approvals, dispensing approvals or clinical trial approvals all involve case-by-case application, consideration, approval and review processes.


To support both the single-patient prescriber and patient-class prescriber frameworks, the ODC grants dispensing approvals to approved pharmacists to dispense medicinal cannabis under strict conditions.

In February 2017, the Federal Government announced changes to Schedule 5A of the Therapeutic Goods Regulations 1990 to allow companies to apply for approval to import medicinal cannabis products into Australia for sale to patients with the necessary federal and state approvals. This amendment is explained further in our February 2017 article Medicinal cannabis access made easier for approved patients.


The recent legislative changes do make it possible to access medicinal cannabis in Australia. However, the system is not without faults. These are largely generated by the incompatibility of medicinal cannabis with the current narcotics legislative framework, particularly in regard to the following characteristics:

  • the process is slow, costly, and difficult, particularly for patients requiring urgent access to medicinal cannabis
  • the drugs are also not available to terminally ill patients, who arguably are most in need
  • the requirement for both state and federal approval adds unnecessary complexity to the accessing process
  • most medicinal cannabis drugs are not subject to government subsidies
Jon Meadmore
Corporate advisory
Colin Biggers & Paisley

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

Melanie Williamson
Harriette Watson
Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at and we will use commercially reasonable efforts to determine and correct the problem promptly.