The countdown for imported medicinal cannabis to meet Good Manufacturing Practice quality standards will begin this month, the Therapeutic Goods Administration (TGA) has said, but the length of the transition period is still unknown.
The regulator confirmed to Cannabiz last night that reforms to TGO 93 governing imported product will be in place by March 31.
Meanwhile, reforms relating to extemporaneous compounding, whereby pharmacists and other medical practitioners are required to seek TGA approval under the Special Access Scheme prior to compounding, are already in place. After a two-month transition period, the rules will be enforced from April 29.
The TGA said the imported product transition period, designed to give importers and overseas manufacturers time to upgrade their processes, is still under discussion “with key stakeholder groups”.
In reality, the March 31 date will mean little in terms of the quality of product being shipped to Australia other than to act as the start of the transition period.
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 regulator added that updated guidance on the GMP practices and evidence required will be provided on the TGA website, while a public webinar will be held in early April. Details have yet to be confirmed.
Significantly, the onus will be on sponsors to ensure the new quality standards are being met, with overseas manufacturers not required to be TGA-accredited. Instead, importers will need to produce evidence, when requested, that products are compliant.
Medicinal Cannabis Industry Australia has previously warned about the prospect of companies “dumping” non-GMP product in Australia before the end of the transition period.
It is also thought the new rules will see several companies no longer import medicinal cannabis, while some overseas manufacturers will decline to upgrade their processes to meet the GMP requirements and no longer send product to Australia.
The disparity between local and imported products has long been a source of tension, with local manufacturers and other companies using GMP facilities insisting they are being held to higher standards and being competitively disadvantaged as a result.
A review and consultation process – potential reform to medicinal cannabis manufacturing, labelling and packing requirement – began in December 2020 with almost 50 submissions lodged with the TGA.