Medicinal cannabis products: overview of regulation

31 October 2016

This information about medicinal cannabis is for patients, health professionals, cultivators, manufacturers and researchers.

The Australian Government is working towards facilitating access to medicinal cannabis products for patients with a medical condition for which there is evidence to support its use.

Access to medicinal cannabis is highly regulated and is also affected by regulations of the state or territory that you live in.

Facilitating access to medicinal cannabis

On 1 November 2016, medicinal cannabis becomes a controlled drug in the Poisons Standard. As a result of this change, medicinal cannabis can be prescribed under the provisions of a controlled drug (Schedule 8) of the Poisons Standard. However, whether medicinal cannabis can be prescribed in a particular jurisdiction depends on whether the state or territory has adopted the change.

Check the website of your state or territory health department to find out whether medicinal cannabis products are allowed in your state or territory.

Multiple laws and regulators

The state and territory governments and the Australian Government Department of Health all play a part in regulating medicinal cannabis in Australia.

State and territory health departments have a role through medicine scheduling and particular requirements on how controlled drugs, including medicinal cannabis, may be authorised for use by specified patient groups in their jurisdiction.

The Australian Government Department of Health regulates medicinal cannabis products through:

How the legislative requirements work together

The following table provides an overview of how the legislative requirements work together.

Process step Therapeutic Goods Act (TGA) Narcotic Drugs Act (ODC) States and territories involved?

Patient need

Medical authorisation

Access - see footnote 1

OR

  • No
  • Yes
Import (if obtaining from overseas) Import
  • Responsibility of the sponsor
  • Yes
Distribution

PATIENT
with medical authorsation

  • No
  • Responsibility of the licensee
  • Yes
Manufacture of medicine in its dosage form Local cultivation and supply - see footnote 2
  • Licensable
  • Licences and permits
  • Yes
Manufacture of active ingredient
  • Licensable
  • Yes
Harvest (termed 'production' in the Narcotic Drugs Act)
  • No
  • Licences and permits
  • No
Cultivation
  • No
  • No
  1. These access arrangements apply unless an appropriate medicinal cannabis product is on the ARTG and available.
  2. Access requirements still apply.

Access

Medicinal cannabis is a controlled substance that is regulated to prevent diversion and illicit use. For this reason, demand and supply are linked in the regulatory process. For permits to be issued to Australian manufacturers, there needs to be communication between health professionals obtaining access for patients and medicinal cannabis manufacturers.

Patient need

Patients will only be able to access medicinal cannabis if they:

  • live in a state or territory where it is not a prohibited substance
  • obtain a prescription from an appropriate medical practitioner, who obtains permission from:
    • the state or territory
    • the TGA
    for you to obtain a specific medicinal cannabis product.

Medical authorisation

Access to medicinal cannabis is available through:

If you wish to prescribe medicinal cannabis to a patient, you will need to apply to the TGA through one of these schemes.

Make sure that medicinal cannabis is not a prohibited substance in your state or territory.

For more information see Access to medicinal cannabis.

Import

Importers require:

Local cultivation and supply

Cultivation and harvest (production)

If you want to become involved in the cultivation and production (harvest) of medicinal cannabis, you are required to hold a cultivation and production licence and permit(s) under the Narcotic Drugs Act. It is also possible to hold separate cultivation and production licences under the Narcotic Drugs Act. You are not required to hold any licences under the Therapeutic Goods Act if you are carrying out only these steps.

Manufacture

If you are (or want to be) a medicine manufacturer in Australia and you want to become involved in the manufacture of medicinal cannabis, you are required to comply with each of the applicable legislative frameworks:

Applications for ODC and TGA licences to manufacture

The application processes for the ODC manufacture licence for medicinal cannabis and the TGA licence to manufacture therapeutic goods are separate because they are based on different legislation:

  • An ODC manufacture licence manages security, prevention of diversion and control on stock levels, which are obligations on Australia under the Single Convention on Narcotic Drugs 1961.
  • A TGA manufacturing licence ensures, through the application of Good Manufacturing Practice, that the medicinal cannabis products will be of appropriate quality.

As a result, the applicable requirements are different. To be granted both licences, the applicant needs to meet both sets of requirements.

Distribution of Australian product

As a controlled drug, the distribution of medicinal cannabis is regulated by the states and territories.

Research

Research (laboratory and nonclinical)

If you want to conduct laboratory or nonclinical research using medicinal cannabis that does not involve administration to humans, then the medicinal cannabis can be supplied directly to you from a cultivator/producer. (It does not have to come from a manufacturer.) However, in order for the cultivator to obtain a licence and permit to supply you with cannabis, they will need to be able to clearly explain to ODC the purpose of the research and the controls that will be in place to prevent illicit use or diversion. These controls will still be required in the conduct of the laboratory or nonclinical research.

You still need to ensure that you have the appropriate permission from your state or territory.

You are not required to hold any licences under the Therapeutic Goods Act unless you are developing a therapeutic good.

Clinical trials

The Therapeutic Goods Act and state and territory legislation apply to clinical trials of medicinal cannabis.

If you wish to conduct a clinical trial using medicinal cannabis:

  • Make sure that medicinal cannabis is not a prohibited substance in your state or territory
  • Obtain approval from a Human Research Ethical Committee
  • Notify the TGA (clinical trial notification scheme) or apply for approval (clinical trial exemption scheme). See Clinical trials at a glance.

If medicinal cannabis for clinical trials comes from an Australian manufacturer, the manufacturer will need to establish a formal relationship with you so that all of the relevant permits can be granted to the manufacturer, producer and cultivator.

Export

Export of medicinal cannabis is currently not permitted under the Narcotic Drugs Act unless the product is on the Australian Register of Therapeutic Goods (ARTG). Export of other medicinal cannabis products may only be considered by Government when this is consistent with our international obligations under the United Nations Single Convention on Narcotic Drugs 1961.

Related guidance

We have prepared a Medicinal cannabis factsheet (pdf,342kb).

The following guidance on medicinal cannabis as a therapeutic good is available:

The following guidance on medicinal cannabis as a controlled substance is available:

Version history

Version history
Version Description of change Author Effective date
V1.0 Original publication Regulatory guidance team October 2016