The health regulator has issued a stark warning to the industry that no-one in the supply chain will be immune from sanctions should non-compliant product be found to be circulating in the market post July 1.
Jenny Burnett, manufacturing quality branch head at the Therapeutic Goods Administration (TGA), made clear there will be penalties “for anybody” who handles product that does not meet TGO 93 regulations.
Under the regulations, which come into force in less than four months’ time, all medicinal cannabis products released for sale after July 1 must meet Good Manufacturing Practice quality standards.
While the industry is still grappling with the changes – with many still unsure how they will apply in certain scenarios – the TGA told the ACannabis conference in Melbourne that punishments will apply “across the board”, and not just to 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.”
During a panel discussion at the conference, Burnett stressed the new rules did not mean product would become compliant if non-GMP material was imported into Australia and simply packaged in a GMP site on-shore.
Such an assertion “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.”
Meanwhile, time has long-since run out for companies who need to have overseas manufacturing sites inspected and accredited by the TGA before July.
Burnett said it is taking 12 to 18 months for the regulator to conduct inspections, a time frame she made no apology for.
During Covid, the TGA was working in some “incredibly difficult” conditions, she said, where border closures curtailed 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.”
