Confusion about cannabis legality is rampant among Australians. Everyone is asking the same question: “Is it legal to grow Cannabis in Australia?” This article overviews ODC licence application processes for medicinal cannabis in Australia and discloses the number of medicinal cannabis applications approved to date (June 2019). Approximate reading time: 3 minutes.
The Legality of Growing Cannabis in Australia (ODC Application Link)
Is it legal to grow cannabis for medical use?
The process of gaining pharmaceutical-medicine manufacturing licences can be lengthy and complex.
Filing an Application for Cannabis with the ODC and TGA
Assistance with Cannabis Licence Applications, ODC Guidelines and TGA Criteria
- The process of application submission for growing cannabis is daunting to most start-up businesses aiming to enter the cannabis sector.
- Each country also varies in its requirements for licencing, permits and product quality (GMP) approval processes.
- Many countries have legalised medical marijuana to aim for early entry (avoiding ‘missing out’, but few countries have regulations fully in place.
Volatility in regulatory requirements, hemp or cannabis licencing application systems and related standards is expected to occur.
Key factors leading to licencing uncertainty and strict regulations in Australia and other countries entering the medicinal cannabis market include:
- the size of the medical marijuana market (e.g., no country wants to miss out on GDP/GNP, research cred and medical innovations)
- Governments are not only overseeing the industry, and investing in research and related projects, some are key stakeholders as well as licence authorities and production regulators
- Research data on efficacy/product safety remains sparse; so caution needs to be applied to reduce potential harms and unwanted side effects (or inconsistencies in cannabis medicines)
There are numerous other factors to consider (such as Government involvement and foreign interests in a country’s GDP and GNP, as seen in Thailand).
How do I get a licence? PharmOut cannabis greenhouse designers, clean room engineers and GMP compliance experts are in demand by start-up businesses around the world, including Australia, South Africa and worldwide. They can assist with your entire ODC application approval process; or help you expand your operations in new locations.
Examples of support include site selection, facility architecture, lighting automation and water resource management, validation and systems designs/GMP, reporting software, security installation designs, and other engineering innovations in cannabis cultivation and exportation.
These design components are crucial to meet the stringent TGA criteria (TGO92) and ODC licencing requirements and permits.
Additionally, they have validated GMP employee training and various forms of assistance for application approval processes for medicinal cannabis licences and permits for cultivation and exportation.
Cannabis legalisation history in brief
Australia legalised medicinal cannabis at the federal level on 24th February 2016. The Government indicated they were committed to ensuring Australia was a significant provider of medicinal cannabis, with climate and agricultural conditions making Australia well-suited for crop management and industry-scale production. That noted, growing cannabis crops in Australia requires an extensive licencing approval process and very specific designs including good manufacturing processes (GMP).
- While marijuana (cannabis) is now a legalised drug for medicinal use, confusion abounds in the public sector and amongst patients and GPs.
- Many regulatory policies for production and exportation remain in progress and are subject to changes as the industry evolves.
- Recreational use remains banned although states vary in criminal vs civil legislation surrounding cannabis possession (importation and exportation involve serious repercussions).
- Ongoing debates involve the legalisation of recreational use and sale of cannabis in various states and territories in Australia, including ACT.
Australia is currently defining policies, regulation and licencing guidelines for cannabis cultivation, seed imports and exportation.
These policies include legal sources for importing cannabis seeds.
- The ODC cannabis application approval process is, as noted, complex and costly.
- Overall, cannabis production and possession remains illegal unless you’ve been granted a licence and have proper permits including TGA approval.
- However, state and federal policies about medicinal cannabis sometimes conflict.
Next section: number of applications for medicinal cannabis production currently approved by the Australian ODC and TGA.
Number of Australian Cannabis Licenses Issued by ODC so far
Under 30 cannabis cultivation licenses have been issued by the ODC (Office of Drug Control) so far. However, many start-up businesses are applying to the ODC.
These Office of Drug Control (ODC) application approval numbers for medicinal cannabis are current as of 7th June 2019:
Cannabis Cultivation and Production Licences approved and issued to date: 27
Number of Cannabis Research Licences approved and issued to date: 16
Cannabis Manufacturing Licences granted in Australia: 23
Seed Importation for Pharmaceutical Cannabis and/or Export
Even if you have the required ODC licensing and approval permits, your medicinal cannabis seed sources must be purchased from legal seed suppliers in Australia or overseas.
Approval from ODC must be gained prior to importing seeds or exporting medical cannabinoid products. Cannabis regulations still fall under the Australian Narcotic Drugs Amendment Act (2016) Amendment #C2016A00012 in relation to the Single Convention on Narcotic Drugs (1961).
It is not legal to grow cannabis in Australia without the proper licences and permits. Strict regulations govern seeds and plant stock. Importing stock or exporting cannabis-based products also requires special import and export licences with high-level tracking systems and record-keeping requirements/GMP processes.
States can vary on how they handle minor cannabis possession, however, importing and exporting cannabis is a federal-level criminal offence.
Who is eligible for a licence to grow, produce or export medicinal cannabis products?
The ODC application process for cannabis is lengthy and subjected to extensive checks and applicant scrutiny. Criminal records will be checked. Job seekers in the cannabis industry are expected to be subjected to intensive security checks and police checks before becoming employed in the cannabis sector.
- Pharmaceutical manufacturing processes must meet GMP, TGA’s TGO93 and other validated quality manufacturing regulations.
- Expert consultations for designs, engineering, life cycle validation, approval permits and licence applications are strongly advised.
Only licenced organisations with ODC and TGA approval can grow cannabis legally in Australia. You will need to submit numerous, complex licence and permit applications in order to legally grow cannabis in Australia, even for medicinal purposes or private use.
How much does it cost to apply for a licence to grow medicinal cannabis?
Starting a cannabis production business is costly. It’s not just the licencing fee, but having all of the proper site specifications and architectural designs, validation/GMP and security considerations, as well as other complex engineering and cultivation management systems in place. For expert consultation on ODC application approval processes or ensuring GMP cannabis production for exportation or domestic supplies, contact the medicinal cannabis expert engineers, architects, cannabis horticulturalists and GMP trainers at PharmOut.
Growers, importers, manufacturer, producers and exporters of pharmaceutical-grade cannabis and cannabinoid products will be subject to strict scrutiny from government regulatory authorities. This means that high-level GMP training and monitoring will be required for job seekers in the cannabis industry in Australia.
- Good manufacturing processes and quantity reporting, quality testing, safety, security and other types of manufacturing reporting are going to be the hot topics amongst growers, equipment suppliers, cannabis-industry employees and Government authorities alike.
- The industry will spawn specialised ‘greenhouse’ facility designs with extensive environmental controls and plant health monitoring systems.
- These measures must ensure that plants are free from contamination while achieving standardised production output meeting pharmaceutical-grade criteria and GMP.
Legal Suppliers of Medicinal Cannabis Seeds or Plant Stock in Australia
Where can I legally buy cannabis seeds in Australia?
Without the proper licences and permits, you cannot buy, nor import, cannabis seeds in Australia.
- If you have been granted the required licences and permits, you still need to follow strict governmental protocols, especially if you plan to import seed or plant stock.
- Australia agencies are currently working to attain quality seed stock strains for licenced medicinal cannabis companies and hemp production.
- Click here for information on applying for medicinal cannabis manufacturing licences in Australia.
For information on acquiring seeds or cannabis nursery stock (plants and cuttings), visit the ODC.gov.au website: https://www.odc.gov.au/acquiring-seeds-and-nursery-stock.
When will it be legal to grow Cannabis in Australia?
There is a possibility that Australia might legalise cannabis use for recreational purposes or allow for home-grown cannabis products at some stage in time. States have varied in how they handle drug possession of recreational cannabis or other illegal products, often determined by the quantity of cannabis in possession. Evidence remains sparse so as a harm-prevention strategy, thus far, recreational use is banned and medicinal use is somewhat restricted.
- It is still illegal to grow cannabis in Australia including possessing small amounts, even though medicinal cannabis has been legalised.
- Criminal codes vary and some states are more lenient than others in terms of how they handle small amounts of cannabis possession.
- That noted, recreational cannabis use has been extremely common in Australia for decades.
Innovation in Cannabis Cultivation
Legalisation of medicinal cannabis now allows for MEDICAL APPLICATION RESEARCH and long-term clinical studies.
Due to a lack of data, it remains challenging for doctors and patients to understand dispensing requirements, optimal dosing and reliable, QA tested pharmaceutical-cannabis supply sources for medical purposes.
Differences between countries legalising Cannabis (Medical Marijuana)
Each new country legalising medicinal or recreational cannabis has unique regulatory and licencing requirements, weather conditions and water management issues to contend with as the sector grows.
Cannabis suppliers are in their early stages of production and experts in the field are exploring innovative ways to design and engineer the best processes and procedures for cannabis production.
Innovation is being seen in a number of areas including:
- facility architecture and greenhouse designs
- efficient and safe cannabis production processes (GMP)
- sterility testing, pest control and contamination prevention
- water use/water use impacts of this new agricultural phenomenon
- Security and safety of personnel working with the plants and cannabinoid products
- Security and efficiency of businesses handling the transportation and exportation reporting processes
- GMP SOPs, templates and cannabis industry employee training
How many Australians consumer cannabis for medicinal vs recreational use?
- At this stage, accurate assessments of the percentage of people who use cannabis in Australia for either recreational or medicinal purposes is lacking
- There is only one currently approved drug and that’s for certain types of Epilepsy, but cannabis for Epilepsy is NOT the first line of treatment
- Legality issues likely skew survey responses and related research findings
- However, cannabis use for either medicinal or recreational reasons remains prevalent throughout Australia (regional variances are frequently recorded)
USA Recreational vs Medical Marijuana: In the USA, the estimate is 1/3 cannabis use for medical purposes and 2/3 for recreational purposes; but these use statistics are subject to change and the data may be subjected to numerous research biases. Read more about the market growth statistics and worldwide use of cannabis.
Cannabis Use Statistics (Australia)
Australia has one of the highest cannabis use rates in the world.
- Australia’s population is relatively small at 25 million people, representing only 0.33% of the world’s population.
- Even so, Australia has a high rate of cannabis use, with at least 1 in 3 adults over 22 trying cannabis at least once.
- According to a 2016 Drug Use Survey, 3.1 Million Australians used an illicit drug
- Cannabis use in Australia has remained steady for several decades; use statistics suggest 10.4% to over 12% of the population use cannabis regularly.
Over 1 million people used cannabis in Australia last year, with over 750,000 Australian using cannabis on at least a weekly basis. Daily users: Over 300,000 Australians use cannabis daily, although there is a chance usage is underreported due to the illegal status of cannabis across the states and territories.
Cannabis Use Safety and Harm Policies
- Cannabis use is the illicit drug of choice for many, due to availability, general social acceptability and cost; it was used alone and/or with tobacco, alcohol or other illicit substances
Harm-minimisation drug policies have been the general approach to drug use in Australia. This has led to heated cannabis debates between users, advocates, medical researchers, conservative political parties and public health protection groups. Overall, however, the approach has been harm-minimisation as punishment approaches have not proven highly successful in curbing illicit drug use, especially cannabis.
What leads countries to legalise marijuana?
Countries vary in legalisation policies and punishments. Even severe punishment countries like Thailand have legalised medicinal cannabis in recent years.
Industry experts and law-reform advocates across the world felt cannabis law changes were only a matter of time. With many states in the USA leading commercialization and taxation of the cannabis industry, other countries followed in semi-rapid succession.
Why do governments want to legalise cannabis cultivation? No Government or Country wants to miss out on what’s likely to become the largest, fastest growing industry/pharmaceutical sector ever to spread across the globe.
Cross-Generational Cannabis Use: Baby Boomers and Millennials
Cannabis, in the past, was mostly used by people in their teens and twenties. Cannabis use dropped off when individuals accepted long-term job roles and/or started families in their late 20s or early 30s. However, some cannabis use persists across a lifetime, and frequent cannabis use often leads to smoking addictions and/or increases in daily use rates.
- More baby-boomers are currently governing Australian politics and drug-use policies
- Many drug-policy lawmakers have grown up with marijuana use being prevalent in Australia
- Millennials are also regularly exposed to drug use at music festivals and ‘raves”.
- Over 1 in 3 Australian adults aged 22 and above reported trying cannabis at least once
How do Australians consume Cannabis?
- Many users of cannabis currently either smoke it mixed with tobacco, use specific vaping equipment, or ingest cannabis through food sources.
- Some individuals use extracted products which have varying consistencies, however, some supply sources will not be sanctioned by the ODC nor meet TGA’s production requirements, such as the TGA’s TGO93.
- Standardisation of pharmaceutical cannabis products, including extraction, packaging and exportation processes, is challenging; and requires GMP compliance, regular product content testing, safety testing/quality management, record-keeping and SAE reporting.
Page last updated: July 31, 2019.