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Legal access to medicinal cannabis products is increasing. For example, from 1 February 2021, 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 manufacture, import or supply medicinal cannabis without a prescription from a doctor or other authorised health practitioner. Despite this, the regulatory framework is somewhat hard to navigate. This complexity is due to the novelty of the situation and the constantly evolving regulation. This article outlines five steps you need to take before starting a medicinal cannabis company in Australia.

Note: Low-dose cannabidiol (CBD) products have a maximum dose of CBD limited to 150 mg per day. 

Step 1: Become a Sponsor 

In the context of the TGA, a sponsor is a company which 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 must 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.

Note that it is a criminal offence for a non-sponsor to supply medicinal cannabis products in Australia.

Step 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. Also, you must ensure the supplier you choose and the product itself meets specific TGA standards.

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 own 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.

The TGA currently acknowledges Canada, Germany, the Netherlands, Switzerland, and Israel as meeting 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 to import from the Australian Government Office of Drug Control.

Manufacture

If you wish to manufacture medicinal cannabis locally, you will need to apply for a licence and permit through the Australian Government Office of Drug Control. Your product must also meet the relevant TGA standards before you can register it on the ARTG. 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.

Step 3: 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. For instance, 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.

Step 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:

Each pathway has different requirements. Therefore, it is essential you read the application form carefully. Consider contacting a lawyer to assist you with the application.

Step 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:

Key Takeaways

Access to medicinal cannabis in Australia is still relatively new. The regulatory framework of getting approved as a medicinal cannabis supplier is complex and involves multiple steps. It requires considering both Commonwealth and State or Territory laws. If you have any questions regarding your business or getting your medicinal cannabis company set up, contact LegalVision’s business lawyers on 1300 544 755 or fill out the form on this page.

Frequently Asked Questions

Is supplying or manufacturing medicinal cannabis legal in Australia?

Yes. The Narcotic Drugs Amendment Act 2016 (Cth) allows Australian companies, subject to certain conditions, to legally manufacture, import or supply medicinal cannabis.

What should I know if I want to import medical cannabis?

If you wish to import medical cannabis (which your Australian company will sell), you will need to find an appropriate overseas supplier. You must ensure the supplier you choose and the product itself meets specific TGA standards. In order to supply a low-dose CBD product in Australia, you will need to register the product on the Australian Register of Therapeutic of Goods.

What should I know if I want to manufacture medical cannabis?

If you wish to manufacture medicinal cannabis locally, you will need to apply for a licence and permit through the Australian Government Office of Drug Control. You may also need to apply for corresponding licences and permits from your local State or Territory government.

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