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Import of cannabis into Australia is a crucial part of the country's medical cannabis industry, as it allows patients to access a wider range of products than is currently available through domestic production. While there are several licensed producers of medical cannabis in Australia, they are not yet able to meet the demand for medical cannabis products. This gap is an opportunity for importers to capitalize on. Learn how.
The import of medical cannabis into Australia is subject to strict regulations and oversight by the Therapeutic Goods Administration (TGA). Companies that wish to import medical cannabis into Australia must hold an import license issued by the Office of Drug Control (ODC), and the products must be approved by the TGA before they can be distributed to patients.
Currently, the majority of medical cannabis products imported into Australia come from Canada, with companies such as Aurora Cannabis, Canopy Growth, and Tilray among the major suppliers. Other countries, such as Israel, Lesotho, and Portugal, also export medical cannabis products to Australia.
The import of medical cannabis products into Australia has increased rapidly in recent years, with imports of cannabis products increasing from 1,139 kilograms in 2018 to 9,710 kilograms in 2022. This growth is expected to continue as demand for medical cannabis products in Australia grows.
While the import of medical cannabis into Australia has been crucial in allowing patients to access a wider range of products, it is also subject to some limitations. For example, the cost of imported medical cannabis products can be significantly higher than domestically produced products, which can be a barrier for some patients. Additionally, some patients may prefer locally produced products, which are subject to stricter quality control and regulatory oversight.
In Australia, cannabis is classified as a Schedule 8 drug, which means that it is subject to strict regulations. Medical cannabis can only be prescribed by a registered medical practitioner, and it must be obtained from a licensed producer. The medical cannabis industry in Australia is heavily regulated, with strict requirements for cultivation, manufacturing, and distribution.
There are currently several licensed producers of medical cannabis in Australia. These companies have invested heavily in research and development, as well as in the construction of facilities for cultivation and manufacturing.
Medical cannabis in Australia has been legal since 2016, but the industry is still in its early stages. The legalisation of medicinal cannabis has been welcomed by many patients and healthcare professionals as an additional treatment option for conditions where conventional treatments have been ineffective.
In Australia, cannabis is classified as a Schedule 8 drug, which means that it is subject to strict regulations. Medical cannabis can only be prescribed by a registered medical practitioner, and it must be obtained from a licensed producer. The medical cannabis industry in Australia is heavily regulated, with strict requirements for cultivation, manufacturing, and distribution.
The size of the legal cannabis market in Australia was estimated at USD 66.0 million in 2022, and from 2023 to 2030, it is anticipated to increase at a CAGR of 29.6%. The public’s growing understanding of the advantages of weed consumption for health is fueling the market’s expansion. The market in Australia is anticipated to expand as cannabis use becomes increasingly legal, primarily for medicinal reasons. The expansion of legalization, the rising patient population, increased government support, and the presence of domestic and international players in the market are some additional key drivers of the development.
The Australian medical cannabis industry is expected to grow rapidly in the coming years, with estimates suggesting that the market could be worth up to AUD $1.2 billion by 2025. However, there are still significant barriers to growth, including regulatory hurdles, high costs of production, and limited access to capital.
Despite these challenges, the medical cannabis industry in Australia is gaining momentum, with increasing numbers of patients accessing medical cannabis products and ongoing research into the potential therapeutic benefits of cannabis. As the industry continues to mature, it is likely that we will see more investment, more research, and more patients benefitting from medical cannabis.
Unless they are exempt from being entered in the ARTG or are otherwise the topic of an approval or authority under the Therapeutic Goods Act 1989, therapeutic goods in Australia must be registered in the Australian Register of Therapeutic Goods (ARTG) before they can be supplied. (TG Act).
The regulatory requirements for importing, producing, and supplying finished medicinal cannabis goods that are not listed in the ARTG are outlined in this guidance for Australia. Because the TGA has deemed these goods “unapproved,” it cannot vouch for their effectiveness, safety, or quality.
The importer must include information on the products they plan to import, as well as the quantities of each product, with their application for a license.
Importers should confirm that the pertinent exporter already possesses the necessary license or approval prior to submitting an import application. To apply for export clearance of medicinal cannabis products to Australia, the exporter must have a license or approval from their own government.
Sponsors may only distribute unapproved cannabis-based medicines through a designated route for unregistered therapeutic goods. In certain situations, sponsors are allowed to use a third party’s distribution services or to store their goods in the third party’s warehouse. Wholesale distribution of unapproved medical cannabis goods is prohibited.
As with any other ARTG registered medication, medicinal cannabis products that have been entered in the registry and are as a result authorized by the TGA may be sold and distributed through wholesale supply.
Starting materials are not finished medical cannabis products; instead, finished products are those that can be given to a patient.
Exempt commodities are raw materials used to make therapeutic products. This means that unless they are pre-packaged for supply for other therapeutic purposes or are formulated as a dosage form, they are not needed to be entered in the ARTG. Therefore, as long as they are not in a form that can be administered to a patient, the TG Act permits the importation, manufacture, supply, or export of starting materials (including active pharmaceutical ingredients), without those products being entered in the ARTG.
In order to lawfully import, export, manufacture or supply finished medicinal cannabis products, those products must be registered or listed on the ARTG unless an exception applies; such as an exemption, approval or authority under the TG Act.
Note: The import into or export from Australia of medicinal cannabis products as starting material or finished goods must comply with the requirements set out in the Customs (Prohibited Imports) Regulations 1956. The cultivation and production of cannabis starting materials in Australia (prior to export or manufacture under a TGA GMP licence) must comply with the requirements set out in the Narcotic Drugs Act 1967.
Under the Therapeutic Goods Regulations of 1990 (TG Regulations), finished medicinal cannabis products that are imported or made in Australia are exempt from the requirement to be entered in the ARTG as long as they are kept under the sponsor’s direct control until they are supplied through one of the recognized distribution channels for unregistered medicines.
The Authorised Prescriber Scheme, the Special Access Scheme B, or a clinical trial notice or approval are those routes.
The ARTG exemption is subject to the following circumstances in addition to the requirements of “direct control” and supply through an authorized pathway:
The ARTG exemption does not apply and the importation or manufacture of the finished medicinal cannabis products will be illegal if they are imported, made, or supplied in violation of the aforementioned conditions and requirements.
However, if the product is supplied to the patient or healthcare professional in accordance with the pertinent approval, authority, or exemption given under the authorized pathway, it will still be legal.
Sponsors who illegally import, produce, or sell finished medical cannabis products may face civil and criminal penalties.
Note 1: For the purposes of the TG Act, the sponsor of the goods will typically be the entity that is primarily in charge of the export, import, or domestic manufacture of the goods (or who arranges for another party to carry out those activities). This is demonstrated in the current situation by licenses and permits given by the Office of Drug Control for import or manufacturing.
Note 2: Regulation 47B of the Therapeutic Goods Regulations 1990 outlines the sponsor’s record-keeping responsibilities with regard to the origin and supply of goods. These regulations are intended to facilitate quick communication with the approval holder in the event of a product recall or defect as well as the reporting of adverse events.
In Australia, it is against the law to distribute unlicensed medical cannabis goods through wholesale agreements. Even if the supply is made to or by a wholesaler who is authorized by state or territorial law, this is still the situation. If a sponsor supplies a therapeutic product to a third party without the necessary permission, exemption, or authority, they are in violation of the law and may be subject to civil penalties as well.
The TG Act further stipulates that, unless the goods are registered or listed, it is illegal for someone who is not the sponsor of an unapproved therapeutic good to give that therapeutic good to “another person who is not the ultimate consumer of the goods” (including through wholesale).
Although finished medicinal cannabis products kept under the direct control of the sponsor until provided via an authorized pathway are covered by an ARTG exemption (as mentioned above), the exemption does not cover wholesale agreements. This is due to the fact that in wholesale agreements, the goods are typically sold to a middleman or third party, which means they are no longer directly under the sponsor’s control.
The supply of the goods is not covered by the ARTG exemption because the sponsor no longer has direct control over them before supply. The Narcotic Drugs Act of 1967, the Customs (Prohibited Imports) Regulations of 1956, and state and territory laws may all be affected by this.
If the sponsor retains ownership and direct control of the products until they are supplied, they may employ third parties to help them with distribution. In a distribution agreement, a third party typically offers the sponsor services related to the products (such as warehousing, courier, or brokering services), but the sponsor usually retains ownership and control of the products, unlike in a wholesale agreement.
As mentioned, in Australia medical cannabis is legal and can be prescribed by a doctor for specific medical conditions. While the specific cannabis strains used for medical purposes in Australia may vary, some strains are more commonly used for their therapeutic properties. These strains often have higher levels of CBD, the non-psychoactive compound in cannabis, and lower levels of THC, the psychoactive compound.
Some popular medical cannabis strains include Blue Dream, White Widow, and Charlotte’s Web, which are known for their anti-inflammatory, anti-anxiety, and pain-relieving effects. Other strains such as Jack Herer and Gorilla Glue #4 may also be used for medical purposes, as they are known for their calming and mood-enhancing effects. And are consider one of the best weed strains in Australia. It’s important to discuss the use of medical cannabis with a doctor and to obtain it from a reputable source.
‘WeGROW’ has both its cultivation and processing facilities based 1,600 meters above sea-level in the mountains of Lesotho, where clean air and peaceful environment ensure the growth of high quality cannabis plants according to strict EU-GMP Principles for cultivation, extraction and the processing of cannabis for the medicinal and pharmaceutical markets by exporting medical cannabis to Germany and other global cannabis markets.
The 60,000 square meter cannabis facility in Lesotho has 30,000 square meter of production space in a unique hybrid greenhouse environment and employs >100 members of the surrounding communities.
The greenhouse is built to harness the power of the sun and improve the quality of the cannabis flower. The unique greenhouse design utilizes the power of the sun to increase terpenes and resin development throughout the life cycle of the plant. This unique growing technique, paired with innovative processing techniques, allows for a finely cured and polished product that consumer across Germany enjoy.
WeGROW’s products are reliable because each variety contains a consistent amount of cannabinoids and terpenes. They are also free of contaminants such as microbes, pesticides and heavy metals. These qualities make WeGROW cannabis products reliable and safe for patients, while ensuring distributors a safe route to import cannabis from Africa.
WeGROW is producing at highest quality in a facility that sets the gold standard for the cannabis industry. Our greenhouses are powered by sunlight to provide optimal growing conditions.
Compassionate pricing is a game-changer that not only subscribes to our values of accessibility for all, but makes us highly competitive as a supplier to international markets.
As the leading Cannabis company in Lesotho we have developed a unique genetic portfolio of 13 stable high demanded medical grade strains backed with years of successful reputation import medical cannabis to Germany. These strains are highly THC concentrated and specially adopted for chronicle pain syndromes.
Pricing: Medical cannabis is still far too unaccessible and expensive, especially for out-of-pocket patients. Yet high quality cannabis can be grown very cheaply in many parts of the world like in Africa. We are bringing it to Germany. We guarantee highest quality through our production process and pass on the price advantages to patients through low production costs and high volumes.
Branding: WeGROW operates as a trusted long-term production partner offering white or private label services for the importer to build their brand in the markets they operate.
Market Fit: WeGROW fullfils the strict German and European quality standards for medicinal cannabis. As a result, patients receive cannabis flowers as high-quality medicinal products that meet all regulatory requirements according to the EU-GMP standard.
Logistics: Sending cannabis around the world is not that easy. In close coordination with WeGROW’s processing partners, they coordinate the obtaining of import and export permits and advise them on all issues that may arise – from the correct transport packaging to the choice of the logistics company. Once arrived in Germany, the cannabis gets prepared for production into a medicinal product in a highly secured and climatically standardised storage facilities.
Processing: The essential manufacturing steps for cannabis medicinal products take place in an EU GMP (Good Manufacturing Practice) certified production facility in Germany. Every single flower is processed and inspected. We do not use ionising radiation at all, which helps to protect the terpenes and active substances in the plant.
Quality: Protocols of controls and laboratory analyses at various points along the production process ensure the reliable pharmaceutical quality of the end product. Patients can thus concentrate fully on their therapy and do not have to worry about the quality of the medicines.
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In Short: Yes! It is possible to import medicinal cannabis for personal use if you have a valid prescription from an Australian-registered medical practitioner and have received approval from the Therapeutic Goods Administration (TGA).
To import medicinal cannabis, you will need to submit an application to the TGA through their Special Access Scheme (SAS). This involves providing relevant documentation, such as your prescription and details of the product you wish to import.
The TGA permits the import of various types of medicinal cannabis products, including oils, capsules, tinctures, and flower. However, the specific requirements and restrictions vary depending on the product and its intended use.
No, you can only import medicinal cannabis products from countries that have legalized and regulated their use. Additionally, the TGA has a list of approved overseas manufacturers that you can source your products from.
The cost of importing medicinal cannabis varies depending on several factors, including the type of product, quantity, and shipping fees. Additionally, you may need to factor in the cost of any customs clearance fees and taxes that apply. It is recommended to seek advice from your chosen supplier and a customs broker to determine the full cost of importing medicinal cannabis into Australia.
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