Cannabis products manufacturing & export from Australia

Somewhat like in Israel, the decision to legalise cannabis for export boosted the Australian industry financially. By legalising medical marijuana, Australia is hoping to tap into a market projected to be worth $63.5bn by 2024 (according to foreign analysts.)

Legal exports of marijuana products, are pushing the share prices of almost a dozen locally listed cannabis producers to record highs. Regulations such as GAP (Good Agriculture Practices) and GMP (Good Manufacturing Practices) that currently prevent exports of medicinal cannabis products from Australia are being changed. The Australian’s government has high ambitions for the local cannabis industry. According to the Australian government, There will be “more than enough” Cannabis products for Australian and international consumers. Though some people worldwide might not agree with that statement.

The Australian Cannabis market

The first listed cannabis company in Australia was MMJ in January 2015. However, as the industry has emerged, this number has grown significantly and as at the date of this article there are more than 22 cannabis companies listed on the ASX (the Australian stock market exchange or “Australian Securities Exchange”). Though all the companies are based around cannabis, their product offerings and target markets differ. A few companies are targeting nutraceuticals and developing products based on the therapeutical benefits of cannabis. The current size of the Australian medical cannabis market since its legalisation for medical use was approximately 50-100m US Dollars in 2018. Legalisation for cannabis medical use is effective since October 30th, 2016.

The only medicinal cannabis product currently registered is not marketed in Australia. As a result, medicinal cannabis products are currently available only through ‘approved access’ pathways.

GAP, GMP and regulation of Cannabis in Australia

Although Patient access and product manufacturing standards will still be determined in conjunction with State and Territory governments, which might make regulations between states different, much like in the US, giving each state or local government the ability to “pile up” more regulations of their own if they wish to do so, including security, traceability, QMS (Quality Management System), GAP (Good Agriculture Practices), GMP (Good Manufacturing Practices), GLP (Good Laboratory Practices) and GDP (Good Distribution Practices).

There have been more than 12 Australian Cannabis companies that have received a licence to grow or manufacture medicinal cannabis based on the GAP and GMP standards accordingly. The manufacturing, registration and supply of medicinal cannabis products are regulated by the Therapeutic Goods Administration (TGA) who is also in charge of medicinal products. Medicinal products regulations in terms of quality, safety and efficacy of medicines as well as access to medicines that have not been approved for general use.

Medicinal products manufacturers that are willing to distribute their products in Australia, are required to approve these products for general use through entry in the Australian Register of Therapeutic Goods (ARTG). However, the ARTG offer different pathways for medicinal products approval which are not registered on the ARTG:

  • Special Access Scheme (SAS)
  • Authorized prescribers
  • Clinicaltrials (CTN or CTX)

Cannabis products in Australia will be regulatory and classified as prescription medicines, and accordingly would be subject to the Therapeutic Goods Act. As of 5th of July 2017. Currently, there are three main Australian regulatory guidelines related to medicinal cannabis:
Medical cannabis licence- Certification of Cannabis cultivation and supply for human medicinal use based on the Good Agriculture Practices (GAP)

  • Cannabis research licence- Cultivation for scientific research purposes
  • Cannabis manufacturing licence- GMP Certification of Australian Cannabis companies to manufacture cannabis products and to operate other activities such as Cannabis packaging, testing, storage, distribution, possession, control, disposal or destruction etc.

Cannabis products import into Australia

The current legislative framework in Australia also enables the importation of medicinal cannabis with the requirement of an importation permit and licence from the ODC (Office of Drug Control), as well as regulatory approval from the cannabis exporting country.

About Cannabis GxP consultancy

Cannabis GXP is an Israel-based consultancy firm working within the cannabis industry.

We are currently engaged in revolutionizing the world of cannabis and hemp cultivation, production and regulation, and are reaching out to growers and manufacturers across the world who wants to join this amazing ride.

We are proud to stand at the forefront of the GMP standards and regulation fields in Israel and worldwide.

Our team is compelled to spread the message of the importance of cannabis regulation and standardization as the world enters a new era of cannabis legislation.

We aim to position our clients with their best foot forward when it comes to anything and everything cannabis related.

We assist companies and growers with facility design, Quality Assurance, Good Practices (GAP/GMP/GLP/GDP), training, and dealing with local and global regulation. Cannabis GXP strives to assist our clients with the development, manufacture and distribution of pharma-grade cannabis products, with a strong emphasis on safety, efficacy, and professionalism.

Cannabis GXP is a subsidiary company of Bio-Chem Ltd. (2007) – a consultancy company for Pharmaceutical, Medical Devices, Cosmetics, and Supplements, based in Israel.

Some of our esteemed clients: Teva, Tikun Olam, J&J, Weizmann Institute of Science, BOL pharma, Seach, Nuuvera, Gamma-Cert, Cannabillis, Monsanto, Evogene, Collplant, Sigma-Aldrich, and many more.

Our Cannabis consultancy services include:

  • Investigational Cannabis product development and clinical trials
  • Cannabis growing & manufacturing facilities design
  • Cannabis Quality Assurance & Good practices (GxP)
  • Cannabis product manufacturing technology
  • Cannabis product regulation & FDA/EU submission
  • Novel Cannabis APIs and product delivery systems

If you need one or several of our services, we will be more than happy to assist.

Please do not hesitate to contact us for further information.