Australia is considering reforms that have the potential to transform the country’s cannabis sector.
The Department of Health, through the Therapeutic Goods Administration (TGA), is seeking comments on a review of the regulatory processes for the manufacturing, labeling and packaging of medical marijuana products, the agency announced this week.
Australia is considering, among other things:
- Introducing equivalent Good Manufacturing Practice (GMP) requirements for imported medicinal cannabis products.
- Introducing labeling requirements for imported cannabis.
- Requiring child-resistant packaging.
- Reviewing compounding for medicinal cannabis products.
“The overall objective is to provide greater assurance for medical practitioners and patients regarding the quality and safety of medicinal cannabis products that are imported and supplied in Australia,” the TGA statement said in a statement.
Submissions will be received until Jan. 29, 2021.
Industry consultant Rhys Cohen said the potential GMP reforms are badly needed.
“Right now, locally made products must be made to GMP standards, while imported products do not,” he told Marijuana Business Daily.
“Fixing that will benefit Australian patients as well as our industry, although it is likely that many products on the market today will be pulled as a result.”
Cohen welcomed the move to review compounding.
“Compounding is meant to provide ad-hoc, custom preparations for specific patients,” he said.
“But there are concerns it is actually being used to routinely manufacture large volumes of generic products while avoiding the costs of actually becoming a licensed, quality-assured manufacturer.”
Local industry publication Cannabiz first reported in October that the Department of Health was looking at a requirement that imported products be manufactured according to GMP standards.
Some Australian businesses have said the inconsistent GMP rules have created “an uneven playing field,” Cannabiz reported.
Any move by Australia to impose a GMP-certification requirement for imports could be costly for some Canadian growers.
Australia was the top destination for Canada’s exports of medical cannabis oil products last year – with roughly 3,700 liters (977 gallons) shipped there in 2019.
The international market for medical cannabis imports is growing fast but remains very small and competitive.
A consultation paper titled “Potential reforms to medicinal cannabis manufacturing, labelling and packaging requirements” is available for download here.
More information on the TGA consultation can be found here.
Matt Lamers is Marijuana Business Daily’s international editor, based near Toronto. He can be reached at [email protected].