Australia's medicines regulator has issued a firm warning to the medicinal cannabis industry that everyone involved in the supply chain faces penalties if non-compliant products are found circulating in the market after July 1.
Jenny Burnett, manufacturing quality branch head at the Therapeutic Goods Administration (TGA), made clear that sanctions will apply "for anybody" who handles product that does not meet TGO 93 regulations.
The regulations, which take effect in under four months, require all medicinal cannabis products released for sale after July 1 to comply with Good Manufacturing Practice quality standards.
With many in the industry still working through how the new rules apply in specific situations, the TGA told attendees at the ACannabis conference in Melbourne that penalties will fall "across the board" — extending well beyond product sponsors.
Burnett also told delegates that the TGA is putting in place "post-implementation reviews and compliance activities".
"Under the Therapeutic Goods Act, there are penalties for anybody who supplies. So importers, exporters, anybody who supplies product that doesn't comply with the standard," she said. "Anybody."
"It's not just the sponsor. It's the wholesaler, it's the pharmacist, it's anybody who passes those goods on. So it applies across the board.
"It's a really important point. It's not just the sponsor's legal responsibility. So anybody who's touched it, anybody in that supply chain."
In a panel discussion at the conference, Burnett also clarified that products would not become compliant simply because non-GMP material imported into Australia was packaged at a licensed GMP facility on-shore.
Such a suggestion "makes my blood boil", she said.
"I'm sorry, GMP licensed manufacturers out there will know that it's more than just throwing it into a package. It's your site, it's the training, it's your staff, it's the release for supply from that final step in manufacturing," Burnett said.
She told the audience that the manufacturing division will work closely with TGA laboratories which have conducted previous testing campaigns to address specific problems raised with the regulator about medicinal cannabis.
"We will similarly be doing that as necessary as part of our compliance activities [post July 1]," Burnett said.
"If you're manufacturing in Australia, every step of manufacture has to be in a GMP licensed site. If you're doing it overseas, you have to do it the same way.
"That's exactly what we're doing this for, to level the playing field that everyone is talking about."
For companies that still need overseas manufacturing sites inspected and accredited by the TGA before July, the window has effectively closed.
Burnett said the regulator is currently taking 12 to 18 months to complete inspections, a timeframe she offered no apology for.
During Covid, the TGA was operating under "incredibly difficult" conditions, she said, with border closures severely limiting travel.
"The TGA kept up inspections as much as we possibly could," she said. "But we've got a backlog and while medicinal cannabis is a really important product for many, many patients in Australia, I'm sorry – in fact I'm not going to apologise – our focus has been on covid vaccines, covid treatments and other critical medicines.
"We have said that if you put in a request for an inspection… please flag it so we can look at it and be aware of it and progress it as swiftly as we can. But it's going into a queue and realistically it's going to take 12 to 18 months."
