What's the current regulatory environment, and how do you get your medicinal cannabis license for cultivation in Australia?
Marijuana is as popular as ever in Australia. However, access to medical cannabis remains an arduous process for patients. Enrollment in Australia’s medical marijuana program is growing yearly. As Australians increasingly engage with medical cannabis, interest in Australian cannabis cultivation is growing.
While the regulation of medical marijuana in Australia is rigorous, it is harmonized with Canada's legal standards. Canadians looking to import cannabis to Australia have a clearly defined legal pathway to do so. It also paves the road for collaboration with cannabis cultivation solutions.
Qualifying for Australian Medical Marijuana
In Australia, medicinal cannabis is not considered first-line therapy for any symptom or illness. One must meet the required criteria and must have attempted other treatments before trying medical marijuana. There are exceptions to this, notably for palliative care. Other qualifying conditions include:
- Chemotherapy-induced nausea and vomiting
- Chronic pain
- Multiple sclerosis
Australia also restricts access to medical cannabis for patients who have risk factors and contraindications. “Cannabis products containing THC are generally not appropriate for patients who:
- Have a previous psychotic or concurrent active mood or anxiety disorder;
- Are pregnant, planning on becoming pregnant, or breastfeeding; and/or
- Have unstable cardiovascular disease.”
Australian Marijuana Regulation
The Australian Department of Health sets out highly structured guidances and prescribing guidelines . The Department of Health’s Therapeutic Goods Administration (TGA) oversees the use and prescribing of medical marijuana and governs its regulation.
“The TGA is responsible for ensuring that therapeutic goods available for supply in Australia are safe and fit for their intended purpose. The TGA administers the Therapeutic Goods Act 1989 which establishes the regulatory framework for all medicines in Australia.
The Act provides a number of processes that provide access to unapproved therapeutic goods. For medicinal cannabis products, these include access through:
While there are additional legal requirements that must be met before medicinal cannabis products can be imported and supplied through these schemes, they do provide a pathway for access to these medicines.
Access to medicinal cannabis products (2020, June 2).
Quality Standards for Australian Medicinal Cannabis
The TGA explains that there are many standards and regulations that apply to medicinal cannabis products, including Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017 and Therapeutic Goods (Microbiological Standards for Medicines)(TGO 100) Order 2018 , along with the Poison Standards
Australian medical cannabis manufacturers are required to obtain a licence to manufacture medicinal cannabis products (sometimes referred to as GMP licence), except in cases where they are exempted in Schedule 7 or Schedule 8 of the Therapeutic Goods Regulations 1990. Specifically, these manufacturing requirements apply to Australian medical cannabis products that are on the Australian Register of Therapeutic Goods (ARTG) and unapproved products lists.
Australian GMP for Medicinal Cannabis
The applicable Australian standard for manufacturing medical marijuana products is the Code of GMP. For which the TGA has also published specific guidance on GMP compliance for the manufacture of medicinal cannabis products that applies to unapproved cannabis products supplied under 'approved access' provisions.
The Australian GMP for medical cannabis is similar to the GPP cannabis requirements of Health Canada, the US GMP for pharmaceuticals, or to EU GMP for botanical drugs. This is notable because the TGA uses internationally harmonized manufacturing standards. They want to allow manufacturers to operate in an international environment when it comes to medicine, including cannabis.
Importation and Export of Cannabis to Australia
Those seeking to import cannabis to Australia need to have evidence of acceptable GMP in the form of a GMP clearance in their country that is equivalent to the Australian GMP standard. Oversees cannabis producers can apply to obtain Australian GMP clearances.
Australia has another pathway for importing cannabis from Canada, Germany, the Netherlands, Switzerland, and Israel. Their regulations note that these specific countries have equivalent manufacturing regulation standards for cannabis products that are not on the Australian Register of Therapeutic Goods (ARTG).
When it comes to exporting and importing cannabis to Australia, the Australian sponsor must ensure that the oversees company also complies with Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017 and Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018.
The Legality of Marijuana in Australia
Whether you are looking to become a cannabis cultivator in Australia, or are interested in importing cannabis materials, it is important to understand how marijuana is and isn’t legal in Australia. Cannabis is only legal with a prescription and when grown in accordance to strict laws.
Federally , cannabis is a Schedule 8 Controlled Drug with a prescription or a Schedule 9 Prohibited Substance without prescription in Australia. Each state/territory has its own variations and laws about how people can access and produce controlled drugs and prohibited substances.
“...State and Territory Governments classify the vast majority of medicines and poisons in accordance with the Poisons Standard (also known as the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP)) to achieve a uniform national approach to the scheduling of substances and uniform labelling and packaging requirements.” Contacts for State/Territory medicines & poisons regulation units Scheduling medicines & poisons 18 February 2020.
Cannabinoid Scheduling in Australia
Cannabis and cannabinoids are scheduled two ways in Australia: Schedule 8 Controlled Drugs include Cannabis (including seeds, extracts, resins and the plant or any part of the plant) and tetrahydrocannabinol (when extracted from cannabis) when prepared or packed for human therapeutic use (may also be considered Schedule 9 Prohibited Substance).
Schedule 4 Prescription Only Medicines include cannabidiol (CBD) when the cannabinoids component in the preparation for therapeutic use contains at least 98% cannabidiol and 2% or less of other cannabinoids found in cannabis.
“In mammals the median lethal dose of THC has been estimated to be >800mg/kg. CBD appears to be of very low toxicity. Doses of 1000mg/kg CBD appear to have been tolerated safely in humans.” - Australian Government Department of Health; Therapeutic Goods Administration, overseeing body of the use and prescribing of medical marijuana.
Canadian Cannabis in Australia
With excitement in Canada, as the Trade Commission offers support to companies looking to expand internationally, Australia could be a good partner. With Canadian GPP regulations being favorable to Australian regulators, existing practices, products, and services could feasibly be expanded to Australia. One thing is certain: cannabis-oriented Canadians are interested in supporting the Australian industry, and Australia seems to offer a pathway to make it happen.
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