Australia’s Department of Health, preparing to overhaul its medical cannabis regulations, is poised to require that all products imported into the country’s small but growing market be produced in accordance with Good Manufacturing Practice (GMP).
The move would effectively shut out non-GMP-compliant manufacturers operating overseas by bringing production rules governing imported medical cannabis products into line with those produced domestically.
The proposed rules, which also cover labeling and packaging, are currently before the World Trade Organization (WTO), where member countries have until late February to submit comments.
One of the most meaningful changes involves imported medical cannabis products, which currently don’t have to adhere to the same strict quality production requirements as locally made ones.
The government currently requires Australian medical cannabis manufacturers to comply with Good Manufacturing Practice (GMP) standards. However, a similar requirement does not apply to products imported into Australia.
That has led to charges of unfair competition favoring internationally produced medical marijuana.
Imported medicinal cannabis products will be required to be manufactured on sites with “acceptable” GMP standards, according to the proposed rules.
The companies importing the goods, known as sponsors, will have to maintain evidence to show compliance for each batch of medical cannabis products they import.
The Therapeutic Goods Administration (TGA), which oversees access to unapproved medical cannabis treatments in Australia via the Special Access Scheme, said it will provide “clear guidance” on the GMP practices and evidence that will be required.
The government has pledged an unspecified “reasonable” transition period so companies can adapt to the new requirements.
“For the avoidance of doubt, the TGA will not be requiring sponsors of offshore manufacturers to comply with a unique Australian manufacturing standard,” the TGA said in the WTO notice.
“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.”
The new rules will also require child-resistant packaging, plus:
- Labeling that better identifies active ingredients.
- Clarity on microbiological testing requirements.
“The objectives of the package of reforms are to provide assistance to patients and medicinal practitioners to identify equivalent products within the large range of products available,” according to the WTO document.
“This will be achieved by requiring more information on product labels.”
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Australia is one of the fastest growing federally regulated medical marijuana markets in the world.
But, at an estimated 200 million Australian dollars ($152 million) in sales last year, the country still lags behind Canada, which topped global sales in 2021 with an estimated 484 million Canadian dollars ($390 million) in sales of unapproved medical marijuana.
However, Canadian spending on medical cannabis fell to a five-year low in the first half of 2021.
Since 2018, there have been roughly 208,263 approvals for the drug under Australia’s Special Access Scheme Category B pathway.
Approvals by year were:
- 122,565 in 2021.
- 57,714 in 2020.
- 25,160 in 2019.
- 2,559 in 2018.
International companies are keen to capitalize on the growing market.
This week, New York-based producer Tilray Brands expanded its medical cannabis product offering in Australia.
The company also launched a medical cannabis educational platform for health-care professionals.
“As medical cannabis demand increases worldwide, we remain committed to providing (health-care) professionals and patients with safe and reliable access to the highest-quality medical cannabis products,” Denise Faltischek, head of international and chief strategy officer, said in a statement.
Matt Lamers can be reached at email@example.com.