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How to Start a Medicinal Cannabis Business in Australia

  • December 16, 2021
  • 4 min read
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How to Start a Medicinal Cannabis Business in Australia

As medicinal, recreational and industrial use of cannabis is becoming more and more popular and decriminalized across the globe, many people are considering starting their own company that would provide customers with access to this product. If you live in Australia, you’ll be glad to hear that medicinal cannabis has been legal in the country since 2016, meaning that opening a medicinal cannabis business is an option. However, as is the case with any business, there are certain steps you have to follow to ensure your company isn’t breaking any laws. Here is what you need to do if you want to start a medicinal cannabis business in the Land Down Under.

Become a sponsor

For starters, it’s important for you to understand that in order for you to supply medicinal cannabis in Australia, you need to become a sponsor. If you’re not a sponsor, supplying medicinal cannabis products is a criminal offence. With that in mind, the Therapeutic Goods Administration (TGA) defines a sponsor as an individual or company that imports, exports or produces therapeutic goods for supply in the country. Before applying to become a sponsor as a company, you should first incorporate your business in Australia.

Choose from importing or growing your own cannabis

Once you’re incorporated and a sponsor, it’s time to decide if you will import medicinal cannabis or manufacture it on your own.

If you opt for the first solution, you will have to find a reliable supplier from overseas and ensure their product meets the TGA standards. For example, they will need Good Manufacturing Practices (GMP) clearance. Then, the country where they manufacture the product needs to have oversight and standards when it comes to cannabis products. Lastly, the product also has to be supplied in the country where it’s manufactured and it cannot be solely exported to other markets. Germany, Switzerland, the Netherlands, Canada and Israel currently meet the necessary standards. Moreover, the product must meet TGO 100 and TGO 93 standards as well as be free from contamination. Another thing you cannot overlook is getting an Australian Government Office of Drug Control licence to import medicinal cannabis.

On the other hand, to manufacture your own medicinal cannabis, you will have to get a licence and permit from the Australian Government Office of Drug Control as well as from your local state or territory government. If you’re completely new to this, it’s also vital that you learn how to grow cannabis, which will depend on your climate. You also need a quality supplier for the seeds and all other necessary growing equipment.

Register on the Australian Register of Therapeutic Goods

No matter the path you choose, as a sponsor, you cannot provide therapeutic goods that are not listed or registered on the Australian Register of Therapeutic Goods (ARTG) unless they are subject to exemption. If you want to supply Aussies with low-dose CBD, your need to submit an application to the TGA in order to get your medicinal cannabis products registered on the ARTG. You will need to provide data that shows the quality, safety and efficacy of your product, valid GMP evidence, filled-in forms and payment of fees.

Look into unapproved medicine access pathways

However, you should also know that you might be able to import and supply unregistered medical cannabis through the unapproved medicine access pathways. If your product meets all the necessary TGA standards like TGO 93 and you submit a declaration form, you might still be able to offer your products. There are currently three pathways that you can look further into: The Authorised Prescribed Scheme (AP), The Special Access Scheme B (SAS B), and Clinical Trial. Each has its own requirements so you can consider having an attorney help you with the application.

Obtain all the necessary state or territory licenses

Something else you should do before you start packaging your products is check if you comply with the state or territory laws that regulate the medicinal cannabis industry. As the rules can vary depending on where your business is based, you want to carefully look through all the necessities and consult with a lawyer as well.

While Australia is not yet as liberal as some other countries when it comes to cannabis use, there is still a market there. If you’re thinking about starting a medicinal cannabis business, make sure you do it by the book.

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