An introduction to Australia's cannabis industry, its regulatory framework, principal participants and ongoing development.
Australia's cannabis industry has undergone significant changes since the introduction of a national framework for medicinal cannabis cultivation and production in 2016.
What was once a highly restricted sector has developed into an industry involving licensed cultivators, manufacturers, importers, wholesalers, healthcare practitioners, pharmacies, researchers and regulatory authorities.
Despite this development, cannabis remains subject to strict legal controls in Australia. Understanding the distinction between medicinal, scientific, industrial hemp and non-medical cannabis activities is essential to understanding the industry.
The Narcotic Drugs Amendment Act 2016 established a Commonwealth framework for the cultivation and production of cannabis for medicinal and scientific purposes.
This was a significant milestone in the development of Australia's regulated medicinal cannabis industry.
The framework operates alongside existing therapeutic goods legislation, state and territory medicines laws and Australia's international drug control obligations.
Several government bodies have responsibilities relating to medicinal cannabis.
Office of Drug Control (ODC)
The ODC administers Commonwealth licensing and permit requirements for medicinal cannabis cultivation, production and relevant manufacturing activities, as well as controls relating to the import and export of regulated substances.
Therapeutic Goods Administration (TGA)
The TGA regulates therapeutic goods in Australia, including requirements relating to medicinal cannabis products, quality standards, prescribing access pathways and advertising.
State and territory authorities
State and territory governments administer additional requirements relating to controlled medicines, including aspects of prescribing, dispensing, possession and professional practice.
Businesses operating across Australia must understand both Commonwealth and applicable state or territory requirements.
Medicinal cannabis is regulated as a therapeutic good when supplied for medical purposes.
Some medicinal cannabis products are included in the Australian Register of Therapeutic Goods (ARTG). However, many products supplied in Australia are unapproved therapeutic goods, meaning they have not undergone the TGA's full assessment for registration.
Access to unapproved medicinal cannabis products may be arranged by eligible healthcare practitioners through regulatory pathways such as the Special Access Scheme and Authorised Prescriber Scheme.
Clinical decisions about prescription medicines require an individual assessment by an appropriately qualified healthcare professional.
Cannabis contains numerous naturally occurring chemical compounds, including cannabinoids and terpenes.
Two of the most widely researched cannabinoids are tetrahydrocannabinol (THC) and cannabidiol (CBD).
Cannabis-based medicinal products may be manufactured in several formulations, including:
Oral oils and solutions
Capsules and other oral dosage forms
Dried plant material
Oromucosal preparations
Other pharmaceutical formulations
Different formulations have different characteristics, regulatory requirements and considerations relating to the