July 13, 2020

Medical Cannabis Licensing in Australia

Medical Cannabis

Medical Cannabis

Recent market predictions show that Australia’s medical cannabis market is expected to reach US$146.4 billion by the year 2025. And the existing 1,000 registered patients receiving medicinal cannabis is set to reach 400,000 by 2028. In the coming years, the Australian cannabis industry aims to address the global shortage for pharmaceutical-grade medicinal cannabis.

With these recent clinical discoveries and business innovations related to medicinal cannabis, it’s expected that the number of medical Cannabis licensing applications will grow. More and more entrepreneurs are planning to tap this new market. If you’ve also considered starting a cannabis production or cultivation business, here are some insights to help you get started.

Who are the governing and authorising bodies for license applications?

Cannabis remains an illicit product in Australia, although license is granted to those who’ve passed the permit schemes and requirements. Authorisation comes from the Office of Drug Control. And as a medicine, production of cannabis products is closely monitored by the Therapeutic Goods Administration. These two agencies are part of Australia’s Department of Health, forming the Health Products Regulation Group.

As with other countries that produce cannabis products, Australian companies have international obligations to the United Nations Convention on the cultivation and production of this medicinal plant. This agreement seeks to prevent storage and hoarding of these products. The regulations also ensure that there would be no diversion in the production of medical cannabis to narcotic material.

What are the requirements to apply for a medical cannabis license?

Would you like to cultivate cannabis plants? Are you planning to manufacture cannabis products? Or do you want to do both – cultivation and production – in your own site? Whichever is your purpose, there are different requirements required to get the permits and license you need.

For those planning to manufacture products, these requirements are needed:

  1. Office of Drug Control or ODC license and permit
  2. Territory or State permission documents
  3. TGA approved GMP license, especially those products intended for human use

If you’re planning to cultivate cannabis plants, you must to talk to the authorising bodies about the following:

  1. Type of cannabis plants that are allowed for cultivation
  2. Production quantity
  3. Cultivation process, excluding the harvest
  4. Production timeframes
  5. Your partners who’ll receive and process the cannabis plants, which can either be a researcher or manufacturer

The filing of these requirements is a rigorous process as the Australian government has always been careful about medicines and their usage. In fact, applicants need to be interviewed and required to go through criminal background investigation. They must not have any issues on dishonesty, fraud, drug-related cases, or any serious offence in the past 10 years. Stakeholders involved in the cultivation and production must also have their own respective licenses.

What are the services you might need for the application?

Licensing applications might take a long time to push through. With the series of interviews and assessments applicants need to go through, it helps to find a group of consultants to expedite the process. When looking for a cannabis licensing consultancy firm, see if you can avail of the following services:

  1. Floor and site plans
  2. Compliance interpretation
  3. SES and local government engagement
  4. Narrative application content
  5. Pertinent business documents filing and processing
  6. Procedures for site-specific standard operations
  7. Plan and assessment for risk management
  8. Detailed security plan
  9. Local service providers
  10. Import and export options

Experts know the methods that are low risk and cost-efficient for you to achieve compliance permits faster. They’ll also help you prepare the GMP, TGA documentation, and security clearance, which are important in highlighting your site’s suitability for cannabis cultivation. In the same way, they’ll also identify which areas of your existing plans, methods, and site that need improvement. With their expertise, you’re also guaranteed of a smooth application process, increasing your likelihood of approval even at first submission.

Australia is indeed posed as one of the world’s leading players of pharmaceutical-grade cannabis products as shown in the growing cannabis-related researches and innovation. This leads local entrepreneurs and even those from other countries to look forward to tap into this new market. As a way to keep this under strict control, the Australian government has also imposed strict guidelines for the cultivation and manufacture of medicinal cannabis. Hence, the license application and assessment becomes ever more rigorous. The cannabis licensing process might be challenging. But with the help of experts, you’ll see your site in full operation in no time, and it will all be worth it.

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