The Therapeutic Goods Administration has confirmed that imported medicinal cannabis products will need to comply with Good Manufacturing Practice standards beginning this month, though the duration of the transition period for companies to adjust remains unconfirmed.
The regulator has confirmed that reforms to TGO 93, which governs imported medicinal cannabis, will take effect as of March 31.
Separately, requirements for extemporaneous compounding—whereby pharmacists and medical practitioners must obtain TGA approval through the Special Access Scheme before preparing compounded products—are already in effect. These rules will become mandatory on April 29, following a two-month adjustment period.
The TGA stated that the transition period for imported products, intended to allow importers and overseas manufacturers time to adjust their operations to the new requirements, remains under discussion with industry stakeholder groups.
In practical terms, the March 31 date holds minimal relevance for the quality of products reaching Australia; it is essentially when the transition period commences.
A TGA spokesperson said: "The new obligations – including the GMP requirements – will only apply to goods released for supply after the end of the transition period.
"Overseas manufacturers and importers will therefore not be required to do anything in the interim. However, the purpose of the transition period is to allow them to adjust their business practices to the changes, if necessary."
The TGA will provide updated guidance on the website describing GMP practices and required documentation, along with a public webinar in early April, though specific details are still to be announced.
Sponsors will be responsible for verifying compliance with the new standards, as overseas manufacturers will not be obligated to obtain TGA accreditation. Instead, importers must furnish documentation, upon request, demonstrating that products meet the required standards.
Medicinal Cannabis Industry Australia has previously cautioned that companies might "dump" non-compliant products into the Australian market before the transition period concludes.
The new regulations are expected to lead some importers to withdraw from medicinal cannabis imports, with overseas manufacturers choosing not to invest in upgrading their operations to comply with GMP standards, which will result in fewer shipments to Australia.
A long-standing divide exists between domestic and imported products, with Australian manufacturers in GMP facilities arguing they face stricter requirements and competitive disadvantages.
The TGA initiated a consultation and review process—addressing potential changes to manufacturing, labelling, and packaging standards for medicinal cannabis—in December 2020, which generated nearly 50 submissions.
