The information provided in this article is for general informational purposes only. While we endeavour to provide accurate and up-to-date information, there may be instances where information is outdated or incorrect. The contents of this article should not be taken as legal advice nor should it be relied upon in making any business, legal or other decisions. We encourage readers to consult with a qualified legal or professional advisor to obtain proper advice based on your unique circumstances. Cannavigia disclaims any liability for any loss or damage arising out of or in any manner connected with the use of or reliance on the information provided in this article. Note that Cannabis regulations in Australia are evolving rapidly; always consult the ODC and TGA for updates.
Yes, medicinal cannabis has been legal at the federal level in Australia since 2016. This legislation opened the door for patients to access cannabis-based treatments under the guidance of healthcare professionals and with proper regulatory approvals.
Australia is quickly becoming one of the fastest-growing legal cannabis markets in the Asia-Pacific region. In 2024, the industry generated more than AU$3.73 billion, with a projected growth rate of 3.22 percent annually. Market analysts expect the industry to reach around AU$4.53 billion by 2029, driven by growing demand for medicinal cannabis, advancements in research, and the increasing popularity of hemp-based products.
As Australia’s cannabis industry continues to grow, so does the complexity of its regulatory landscape. From cultivation to distribution, compliance and traceability are now essential pillars for any business operating in this space. In this comprehensive guide, we simplify the process of obtaining a cannabis license in Australia, breaking down the necessary requirements and associated costs. We also provide a step-by-step roadmap to navigate the complex regulatory system. We express our gratitude to the Australian Government for their support and assistance in providing the necessary information for this guide, their cooperation has been instrumental in bringing this comprehensive report to life.
Cannabis was first introduced to Australia in the 1780s, when the First Fleet brought hemp seeds to the new colony. These seeds were intended for industrial use, primarily in the production of rope, sails, and textiles. Sir Joseph Banks, a prominent botanist and advisor to the British Crown, specifically requested the seeds as part of a broader effort to establish a hemp-based economy in the colonies. Throughout the 1800s, cannabis was widely used for both medicinal and recreational purposes, and hemp farming was actively supported by early governments as a practical and profitable agricultural endeavor. During that time, a cannabis cigarrete known as Cigares de Joy was widely used within this period for asthma, bronchitis, hay fever and flu.
However, by the 1920s, Australia began to follow international trends that associated cannabis with crime and social decline especially by countries who were signatories to the Geneva Convention. In 1926, the federal government banned the import and export of cannabis. Two years later, Victoria became the first state to criminalize its possession and use, quickly followed by other jurisdictions thus, beginning the era of prohibition.
In 1938 a newspaper called Smith’s Weekly published a Reefer Madness-style piece about how this drug from Mexico (cannabis) makes people go mad and cause victims to behave like sex maniacs. Influenced by global drug control efforts and the Reefer Madness era, the country began implementing restrictive cannabis laws. Even though it caused huge waves, it still did not change the majority of peoples’ minds about the drug. Usage continued but for a small elect group of people.
During the 1950s and 60s, cannabis use in Australia was relatively limited, especially when compared to the widespread consumption of legal substances like tobacco and alcohol. In 1964, authorities in New South Wales discovered hundreds of acres of wild hemp, which led to a major eradication campaign. At the same time, a group of surfers and hippies known as the Weed Raiders moved into the region to take advantage of the natural cannabis growth. Meanwhile, American soldiers on leave from the Vietnam War, who visited Australia for rest and recreation, helped popularise cannabis use within local communities.
By the 1990s and early 2000s, cannabis had become the most commonly used illicit drug in the country with over 39% of those surveyed in 1998 attesting to using cannabis.
This gradual shift in public and political sentiment led to a wave of meaningful regulatory reforms that led to the legalization of medical cannabis in 2016. In 2017, the Therapeutic Goods Administration (TGA) took a major step by reclassifying THC as a Schedule 8 controlled substance and CBD as a Schedule 4 substance. This change made it possible for healthcare professionals to legally prescribe medicinal cannabis through tightly regulated access pathways, including the Special Access Scheme and the Authorised Prescriber Scheme. It was a pivotal moment in Australia’s cannabis policy, especially for patients suffering from chronic conditions and those with limited treatment options.
In the same 2017, Food Standards Australia New Zealand (FSANZ) approved the sale and consumption of low-THC hemp foods, clearing the way for products like hemp seeds, oils, and protein powders to be legally marketed for human consumption. This decision helped further normalize cannabis-related products and expanded the market for hemp-based nutrition and wellness.
The most notable legal reform came in 2020, when the Australian Capital Territory (ACT) became the first jurisdiction in Australia to legalize the personal use and cultivation of cannabis. Adults in the ACT can now legally possess up to 50 grams of dried cannabis and grow up to two plants per person, with a maximum of four plants per household.
The 2022 National Drug Strategy Household Survey reported that support for legalizing recreational cannabis had nearly doubled in just six years. Between 2023 and 2025, medicinal cannabis remained legally available under medical supervision, and several states and territories began actively exploring broader legal reforms.
Australia operates as a federation comprising six states and two self-governing territories, each with its own constitution, parliament, and legal framework. This structure means that while federal law sets overarching standards, each state and territory retains the authority to legislate on a wide range of matters including drug policy.
As a result, a substance like cannabis can be legal under state or territory law but remain illegal at the federal level. This can create legal grey areas and inconsistencies across jurisdictions.
The key distinction between states and territories lies in the source of their legislative power. States derive their authority from their own constitutions, which explicitly define the powers of their parliaments. In contrast, territories do not have constitutions; their law-making powers are delegated by the federal government. These structural differences have contributed to a patchwork of cannabis laws across the country. For example, personal cannabis use is legal in the Australian Capital Territory (ACT) but remains decriminalised or illegal in other parts of the country, depending on the local laws.
Cannabis regulation in Australia operates under a strict federal framework designed to ensure controlled access for medicinal and scientific purposes. The cornerstone of this legal structure is the Narcotic Drugs Act 1967, which was amended in 2016 to allow for the legal cultivation, production, and manufacture of medicinal cannabis.
Under the Narcotic Drugs Amendment Act 2016 Section 8E, the legislation was expanded to explicitly allow:
On 17 February 2017, the Office of Drug Control (ODC) issued the very first Cannabis Research Licence under the medicinal cannabis provisions of the Narcotic Drugs Act 1967. This historic licence was granted to Cannoperations Pty Ltd, a wholly owned subsidiary of the Australian company Cann Group Limited, marking the official beginning of legal medicinal cannabis research in the country.
The licence authorised Cannoperations to legally cultivate medicinal cannabis and conduct research into its potential therapeutic uses. This includes both internal research focused on optimising cultivation methods and strain development, as well as supporting broader scientific efforts aimed at developing effective medicinal cannabis products.
Since then, a comprehensive licensing and permit scheme has been established under the Narcotic Drugs Act to regulate:
These activities are strictly permitted for medicinal or scientific purposes, and any manufacture must be conducted under licence for a permitted supply chain.
Additionally, a separate but related licensing framework governs the manufacture of other narcotic drugs, ensuring rigorous control and compliance across all facets of the regulated drug sector.
As of 8th December 2025, over 300 licences have been issued by the ODC, reflecting the industry's growth and the Australian Government’s commitment to a secure, transparent, and research-driven medicinal cannabis sector.
These activities can only be undertaken for approved medicinal or scientific purposes, and any manufacture of cannabis medicines must be for a permitted supply.
A separate scheme under the same act governs the manufacture of other narcotic drugs, ensuring tight control over all aspects of the supply chain.
The ODC oversees the regulation of medicinal cannabis under the Narcotic Drugs Act 1967. The ODC operates on a cost recovery basis, meaning fees are structured to recoup the costs associated with regulating the medicinal cannabis industry. As of 1 July 2025, the following fees and charges apply:
Note that these fees are subject to annual reviews and may be adjusted to reflect changes in regulatory costs. Additionally, licence holders should consider other compliance-related expenses, such as security measures, record-keeping, and reporting obligations.
For detailed information on the application process, fee structures, and compliance requirements, refer to the ODC's official resources.
Medicinal cannabis products must be registered with the Therapeutic Goods Administration (TGA) and entered into the Australian Register of Therapeutic Goods (ARTG) unless specifically exempt. In addition to federal approval, certain state and territory health departments may impose further conditions or require local authorisations before products can be prescribed or dispensed.
Regulatory compliance is enforced by authorised inspectors under the Regulatory Powers (Standard Provisions) Act 2014. These inspectors have monitoring, inspection, and enforcement powers to ensure that all activities align with the legal and ethical standards outlined in the Narcotic Drugs Act and related regulations.
The ODC continues to provide oversight, issue licenses, and guide applicants through the complex application process to ensure transparency and safety across the industry.
Securing a licence to cultivate, produce, or manufacture medicinal cannabis in Australia is a rigorous, multi-step process governed by the Narcotic Drugs Act 1967 and administered by the Office of Drug Control (ODC) within the Department of Health and Aged Care.
There are three main types of cannabis-related licences issued under the medicinal cannabis licensing scheme:
Each licence type may require an accompanying permit to specify the details of the authorised activities (e.g., location, quantity, and timeframe).
Licensing Requirements and Step-by-Step Application Process
To apply for a license, applicants must demonstrate they are fit and proper persons, have adequate security measures, and maintain compliance readiness. In Australia, being a "fit and proper person" means applicants must demonstrate good character, financial integrity, and a clean criminal record to ensure they can responsibly operate within the highly regulated medicinal cannabis industry. The process involves several detailed steps:
Once a licence is approved, a permit must be obtained to authorise the specific activities, volumes, and locations involved. Ongoing inspections by authorised officers are required to maintain your licence and permits.
Obtaining a licence in Australia’s tightly regulated medical cannabis landscape is only a tip of the iceberg. To remain operational and in good standing with the ODC, licence holders must adhere to strict ongoing compliance obligations. These include maintaining high standards in security, documentation, product integrity, and consumer safety and this is where Cannavigia’s cultivation and manufacturing solutions comes into play. Failure to comply can lead to enforcement actions, including suspension or cancellation of licences.
Australian cannabis licence holders are subject to regular audits and inspections conducted by authorised officers under the Regulatory Powers (Standard Provisions) Act 2014. Maintaining audit readiness requires detailed record-keeping, real-time batch tracking, and transparent operational workflows.
Cannavigia provides a centralised compliance management system that supports:
These features help ensure businesses are fully prepared for unannounced audits and meet the stringent documentation requirements enforced by the ODC.
Medicinal cannabis products in Australia must comply with the Therapeutic Goods Act 1989 and related TGA guidelines. This includes strict rules around:
Cannavigia integrates quality assurance modules that streamline product testing, manage lab results, and generate compliant labelling based on live data. It also ensures that any marketing materials remain within legal advertising parameters, significantly reducing legal risk.
Non-compliance with federal and state regulations can have severe consequences, including:
By centralising compliance operations and offering end-to-end traceability, Cannavigia empowers cannabis companies in Australia to proactively manage risks and build lasting trust with regulators, partners, and patients.
Since the legalization of medicinal cannabis in 2016, the Australian market has seen exponential growth. In 2024, sales were projected to reach approximately $1 billion, a substantial increase from $234 million in 2022. The number of medicinal cannabis units sold in the first half of 2024 reached 2.87 million, up from 1.68 million in the last half of 2023. This surge is attributed to factors such as greater public awareness, an increase in prescribing health professionals, and the rise of telehealth services.
The Australian cannabis market is projected to reach AU$4.53 billion by 2029, reflecting a steady compound annual growth rate of 3.22%. This growth is primarily driven by the legalization of medicinal cannabis in 2016 and the rising number of patients accessing treatments through approved medical pathways.
Domestically, demand for medicinal cannabis in Australia continues to surge, largely driven by prescriptions for conditions such as chronic pain, anxiety, and other persistent health issues. The Authorised Prescriber Scheme has become the primary access pathway, offering patients a more streamlined and regulated route to obtain therapeutic cannabis products.
According to the Penington Institute, the medicinal cannabis market is experiencing rapid growth. In the first half of 2024 alone, Australians spent approximately $402 million on medicinal cannabis, underscoring the increasing reliance on cannabis-based treatments as part of mainstream healthcare.
On the international front, Australia has established itself as a reputable exporter of high-quality medicinal cannabis products. The Office of Drug Control (ODC) oversees the export regulations, ensuring compliance with international standards. In 2023, the Medicinal Cannabis Industry Australia (MCIA) was awarded a $250,000 grant to develop a strategic export roadmap, aiming to position Australia as a leading global supplier.
What are the current cannabis laws in Australia?
Cannabis remains illegal for recreational use in most Australian states and territories. It is against the law to possess, cultivate, or sell cannabis for non-medical purposes under federal legislation and in the majority of jurisdictions. However, the Australian Capital Territory (ACT) is the exception, where adults can legally possess up to 50 grams of dried cannabis and grow up to two plants for personal use.
On the other hand, medicinal cannabis is legal nationwide when prescribed by an authorized medical practitioner. Patients can access medicinal cannabis products through schemes such as the Special Access Scheme (SAS) or the Authorised Prescriber Scheme, under the regulation of the Therapeutic Goods Administration (TGA).
What is medicinal cannabis?
Medicinal cannabis refers to pharmaceutical-grade cannabis products prescribed by a licensed medical professional to treat specific health conditions such as chronic pain, anxiety, epilepsy, and multiple sclerosis. These products contain controlled levels of cannabinoids like THC and CBD and must comply with Australia's strict regulatory standards set by the Office of Drug Control (ODC) and TGA.
What are some common names for cannabis in Australia?
In Australia, cannabis is known by a variety of slang terms. Commonly used names include:
Weed, pot, grass, dope, joints, mull, hydro, yarndi, ganja, bud, and green. These terms may vary across regions and cultural communities, but they all refer to the same plant—Cannabis sativa or Cannabis indica.
How common is cannabis use in Australia?
According to the Australian Institute of Health and Welfare (AIHW) and the Cannabis in Australia 2022 Report, 37% of Australians aged 14 and over or roughly 7.6 million people have used cannabis at least once in their lifetime. Cannabis remains the most widely used illicit drug in Australia, despite growing interest in legal medical applications.
How many students in Australia use cannabis?
Data from the Australian School Students' Alcohol and Drugs Survey shows that 36.4% of students aged 12–17 reported having used cannabis at least once. This statistic highlights the importance of continued education, harm reduction, and early intervention strategies in schools and youth-focused programs.
