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Wednesday, Sep 28, 2022
Mugglehead Magazine
Alternative investment news based in Vancouver, B.C.


Australia wants medical cannabis importers to follow GMP standards

Currently, Australian producers must comply with GMP standards but there isn’t the same requirement for foreign firms

Sydney Opera House in Australia at night
Photo by Diliff via Wikimedia Commons

Companies importing cannabis into Australia could face stricter rules, if proposed regulatory changes from the federal government are approved.

The country is in the process of gathering feedback on changes to the manufacturing, labelling and packaging of medical cannabis. Notably, Australia wants imported medical cannabis products to comply with Good Manufacturing Practice (GMP) standards to “level the playing field for domestic suppliers and importers,” according to the Therapeutic Goods Administration.

The TGA’s update on Tuesday said the reforms remain on track for March 2022, and that the government is in the process of drafting amendments and determining a transition period for the new rules.

The revisions would require imported medical cannabis to be manufactured on sites with GMP standards. The companies importing the goods must have evidence of compliance for each batch, but there won’t be a formal clearance process.

Since the proposal to the medical cannabis program impacts other members of the World Trade Organization, a consultation is underway for members to submit feedback.

“This measure provides greater certainty on the quality and safety of products available to Australian patients. It extends broadly the same standards to offshore manufacturers currently required of Australian manufacturers,” reads the WTO document.

“For the avoidance of doubt, the TGA will not be requiring sponsors of offshore manufacturers to comply with a unique Australian manufacturing standard. Sponsors will be able to rely on a manufacturer’s adherence to an internationally accepted GMP standard (of a type acceptable to the TGA) that may be specific to that manufacturer’s country.”

Comments will be accepted until Feb. 20.

Read more: Tilray launches new medical products and training program in Australia

Read more: Australia switches to single licence for medical cannabis companies

Under current laws, Australian producers must adhere to GMP standards, but there isn’t the same requirement for foreign firms.

The TGA — the branch of the health agency that regulates therapeutic goods — considers most medical cannabis products “unapproved products.” Medical cannabis is imported into Australia under the Special Access Scheme/Authorised Prescriber Scheme (SAS/AP).

Since Australia started its medical cannabis program, there has been a “significant” increase in the supply and use of medical cannabis products, according to the WTO document. A review of the regulations and a consultation were held because of that, and the TGA subsequently developed the reforms.

Labelling and packaging requirements — intended to improve the presentation for patients and prescribers — include children-resistant packaging, labelling that better identifies active ingredients and clarity on microbiological testing requirements.


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