Legal access to medicinal cannabis products is increasing. Medical cannabis customers can purchase certain medicinal cannabis products with a low dose of cannabidiol over-the-counter at pharmacies without a prescription. For the first time, subject to certain conditions, companies in Australia can legally cultivate, manufacture, import or supply medicinal cannabis products by obtaining a licence to do so. Despite this, the regulatory framework is challenging to navigate. This complexity is due to the novelty of the situation and the constantly evolving regulation. This article outlines five key steps you need to consider before starting a medicinal cannabis company in Australia.
1. Become a Sponsor
In the context of the Therapeutic Goods Act 1989 (Cth), a Sponsor is a company that exports, imports or manufactures therapeutic goods for supply in Australia. To import or supply medicinal cannabis in Australia, you must be a Sponsor. Likewise, you may be required to apply to have your product included on the Australian Register of Therapeutic Goods (ARTG). A Sponsor may be an individual or a company.
If you are setting up a company to supply medicinal cannabis in Australia, you must first incorporate a company. However, suppose your company, business or trading names make explicit or implicit references to medicinal cannabis. In that case, you may be in breach of the Therapeutic Goods Act 1989 (Cth) advertising requirements for medicinal cannabis products.
As Sponsors have numerous responsibilities and obligations under the law, it is strongly recommended that any Sponsor works closely with a regulatory affairs consultant to ensure compliance with applicable laws and regulations.
2. Decide Whether to Import or Manufacture the Medicinal Cannabis
Import
If you wish to import medicinal cannabis (which your Australian company will sell), you will need to find an appropriate overseas supplier. The supplier you choose and the product itself must meet specific Therapeutic Goods Administration (TGA) standards. Where the product is a starting material (i.e. in a form that cannot be supplied to a patient), the product does not need to be registered on the ARTG.
This supplier will have to meet the following TGA manufacturing standards:
- evidence of acceptable Good Manufacturing Practices (GMP) in the form of a GMP clearance. This clearance is necessary for each of the overseas manufacturing sites before the goods can be registered;
- the country where the product’s manufacture occurs has active oversight of medicinal cannabis products and holds them to its manufacturing standards; and
- the product is supplied to patients in the country of its manufacture and is not manufactured solely for export to other markets.
Canada, Germany, the Netherlands, Switzerland, and Israel are countries that currently meet the above standards.
The product must also meet the following TGA standards:
- TGO 100 – the medicinal cannabis products must be free from contamination with specified microorganisms;
- the products must be free from contamination with other microorganisms that might be objectionable in the dosage form; and
- TGO 93 – the product to be imported must meet certain minimum quality requirements.
To import products into Australia, you will also need to apply for a licence and a permit to import from the Australian Government Office of Drug Control (ODC).
Manufacture
If you wish to manufacture medicinal cannabis locally, you must apply for a licence and permit through the ODC. You must also obtain GMP clearance or certification from the TGA. Depending on where you intend to manufacture the products, you may also need to apply for corresponding licences and permits from your local State or Territory government.
Continue reading this article below the form3. ARTG Registration
The Therapeutic Goods Act 1989 (Cth) provides that a sponsor must not import, export, manufacture or supply therapeutic goods unless those goods are listed or registered on the ARTG, or are subject to an exemption.
To supply low-dose CBD in Australia, your product must first be registered on the ARTG. To register your medicinal cannabis product on the ARTG, you will need to make an application to the TGA. This application consists of:
- submission and assessment of data that supports the quality, safety and efficacy of the product for its intended use;
- valid GMP evidence;
- completed forms; and
- payment of fees.
4. Unapproved Medicine Access Pathway
You may also be able to import and supply some unapproved or unregistered medicinal cannabis products in Australia through the unapproved medicine access pathways. To import and supply unapproved medicinal cannabis in Australia, you will need to make sure that the product meets all the relevant TGA manufacturing standards, such as TGO 93. Likewise, you must also submit a declaration form to the TGA. In this form, you will state that the product you wish to import or supply meets certain minimum requirements.
For example, currently, there are three restricted ‘pathways’ for accessing unapproved or unregistered medicinal cannabis products in Australia:
- The Authorised Prescribed Scheme (AP): authorised medical practitioners can supply medicinal cannabis to a particular class of patients;
- The Special Access Scheme B (SAS B): certain health practitioners can access and supply medicinal cannabis to a single patient; or
- Clinical Trial: this involves submitting a Clinical Trial Notification (CTN) to notify the TGA of your intention to conduct a clinical trial of your particular medical cannabis product. Your notification will then go through the Clinical Trial Approval (CTA) process.
Each pathway has different requirements. Therefore, you must read the application form carefully. Consider contacting a lawyer or a regulatory affairs consultant to assist you with the application.
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5. Apply for Necessary State or Territory Licences
In addition to the national regime above, the State or Territory you will be operating out of may also have local laws regulating your medicinal cannabis company. You will need to make sure you comply with both. For example, read about these below:
- Queensland;
- New South Wales;
- Australian Capital Territory;
- Victoria;
- Tasmania;
- Northern Territory;
- Western Australia; or
- South Australia.
Key Takeaways
Access to medicinal cannabis in Australia is still relatively new. The regulatory framework for medicinal cannabis businesses, sponsors, suppliers and manufacturers is complex, and it is important that where you are operating in the space, you are aware of the various laws and regulations applicable to you. It requires a consideration of both Commonwealth and State or Territory laws.
If you have any questions about starting a medicinal cannabis company in Australia, our experienced compliance lawyers can assist you as part of our LegalVision membership. For a low monthly fee, you will have unlimited access to lawyers to answer your questions and draft and review your documents. Call us today on 1300 544 755 or visit our membership page.
Frequently Asked Questions
What is a Sponsor in the context of medicinal cannabis in Australia?
A Sponsor is a company or individual that exports, imports, or manufactures therapeutic goods for supply in Australia, as defined by the Therapeutic Goods Act 1989 (Cth). Sponsors have specific responsibilities and must comply with applicable laws and regulations.
Do I need to incorporate a company to become a Sponsor?
Yes, you must incorporate a company if you plan to supply medicinal cannabis in Australia. Additionally, be cautious about using company names that explicitly or implicitly reference medicinal cannabis to avoid breaching advertising requirements under the Therapeutic Goods Act 1989 (Cth).
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