Department of Health

Medicinal cannabis regulatory framework

Key messages

  • A framework of Commonwealth and state legislation regulates medicinal cannabis cultivation, manufacture and supply in Victoria, and Australia.

The medicinal cannabis regulatory framework in Victoria is shaped by both State and Commonwealth legislation, as well as international conventions to which Australia is a signatory, such as the United Nations' Single Convention on Narcotic Drugs 1961.

Commonwealth legislation

Commonwealth legislation restricts the cultivation, manufacture, supply and use of narcotic drugs in accordance with international obligations in these areas. It also ensures that therapeutic goods sold in Australia meet suitable standards of safety, quality and efficacy, and places restrictions on the importation of controlled medicines.

Commonwealth legislation and standards regulating medicinal cannabis in Australia include:

The Narcotic Drugs Act 1967

  • Administered by the Commonwealth Office of Drug Control (ODC).
  • Provides the Commonwealth government with powers to meet international obligations relating to the regulation of drug manufacture.
  • The Narcotic Drugs Amendment Bill 2016 amended the Narcotic Drugs Act 1967 to allow for the cultivation and manufacture of cannabis for medicinal and related scientific purposes in Australia.
  • Establishes a comprehensive national licensing and permit scheme to regulate the cultivation, production and manufacture of cannabis in Australia for medicinal and scientific purposes.

The Therapeutic Goods Act 1989

  • Administered by the Commonwealth Therapeutic Goods Administration (TGA)
  • Provides a regulatory framework to ensure therapeutic goods supplied in Australia (such as medicinal cannabis) meet acceptable standards of quality and safety.
  • Sets out how to apply for a medicine to be approved and registered in the Australian Register for Therapeutic Goods (ARTG) in order to be legally supplied in Australia.
  • Provides a number of mechanisms to enable access to unapproved therapeutic goods, including the Special Access Scheme and Authorised Prescriber Scheme.
  • The TGA have also compiled Therapeutic Goods Order. No. 93, defining the quality requirements required by all unapproved medicinal cannabis products available in Australia.

The Australian Poisons Standard (SUSMP)

  • The Poisons Standard is a Commonwealth legislative instrument consisting of decisions that classify different medicines and poisons into 'Schedules'.
  • The regulatory measures that apply to different substances in Victoria and other states depend on how they are scheduled in the Poisons Standard.
  • Medicinal cannabis products are currently listed as either Schedule 4 or Schedule 8 substances in the Poisons Standard, depending on cannabinoid content.
  • Schedule 4 medicinal cannabis products are those in which cannibidiol (CBD) makes up at least 98% of the total cannabinoid content, with any other cannabinoids (e.g. THC) accounting for no more than 2% of total cannabinoids.
  • All other medicinal cannabis products are classified as Schedule 8 substances.

The Customs Act 1901

  • Prohibits the personal importation of cannabis and cannabis based products.
  • However, cannabis and cannabis based products can be imported on a patient's behalf by a specified medical practitioner if they are licenced under the Customs Act to do so.
  • The Customs Act also has a travellers exemption, allowing a person (or their carer) to enter Australia with up to 3 months' supply of a prescribed therapeutic good -- including medicinal cannabis products supplied overseas.

Victorian legislation

Victorian legislation imposes additional restrictions on controlled substances (including scheduled medicines) to minimise the harm their misuse poses to the community.

The regulatory measures that apply to different drugs and medicines in Victoria depends on how they are scheduled in the Australian Poisons Standard (the SUSMP). The Victorian legislative controls for scheduled substances vary according to their risk and are set out in the below legislation.

The Drugs, Poisons and Controlled Substances Act 1981

  • Administered by the Victorian Department of Health and Human Services
  • Prohibits and regulates the possession and use of medicines and poisons in Victoria.
  • Regulates the possession and supply of scheduled substances through licences and permits issued by the department.
  • In most circumstances, registered health practitioners are required to gain a Treatment Permit from the department before prescribing a Schedule 8 medicine (including for Schedule 8 medicinal cannabis products).
    • The purpose of these permits is to prevent unsanctioned concurrent prescribing ('prescription shopping') and to minimise the risk of addiction or abuse of controlled substances.
  • Manufacturers and wholesalers are also required to have an authorisation (such as a licence and a permit) to obtain, possess, sell or supply medicinal cannabis in Victoria. Visit the Business and Industry page to learn more.
  • The act also regulates the possession and supply of scheduled synthetic medicinal cannabinoids.

The Drugs, Poisons and Controlled Substances Amendment (Real-time Prescription Monitoring) Act 2017 and regulations.

  • Prescribe matters required for the implementation the government's SafeScript initiative. This includes which medicines are monitored in SafeScript, Victoria's real-time prescription monitoring software.
  • From April 2020, it will be mandatory for doctors and pharmacists to check SafeScript when writing or dispensing a prescription for schedule 8 medicines and certain schedule 4 medicines, including some medicinal cannabis products.

Growing cannabis for personal use and the recreational use of cannabis is illegal in Victoria.

Reviewed 02 December 2021


Contact details

Office of Medicinal Cannabis Department of Health

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