An East Tamaki company has gained New Zealand’s first licence to manufacture cannabis medicines.
The medicinal cannabis company has been issued with the industry’s first GMP (Good Manufacturing Practice) Licence to Manufacture Medicines by Medsafe.
This allows Helius to be the first to manufacture locally-made medicines for New Zealand patients.
“This is our most significant milestone yet,” Carmen Doran, chief executive of Helius, said.
“Helius can move forward to manufacturing high-quality, affordable Kiwi-made medicinal cannabis products.”
Through an international recognition scheme, MedSafe’s latest approval also meets European standards, known as EU-GMP, opening future export possibilities for the privately-owned Kiwi company.
Doran said the journey’s been exhaustive, but “rightly so, we’re making medicine”.
Having raised $48 million in capital since 2018, Helius has invested significantly in its 8800 sqm indoor cannabis cultivation and manufacturing complex.
“We’ve been pushing hard to build the facilities, procedures and systems that will ensure quality,” chief quality officer Bruce Wallace said.
“That is what the GMP is about – controlling all the factors that could influence the quality of our processes.”
Wallace says the GMP Licence certification covers a wide scope from facility design to the training of people.
Medsafe assessed and approved Helius’s manufacturing, packaging, labelling, testing, storage and distribution process.
The GMP audits will ensure that its high standards are maintained.
Each new manufacturing process type will trigger a new audit.
Helius acknowledged recent commentary that the country’s medicinal cannabis regulations are too hard and it’s taking too long for locally-made products to be approved.
“We totally get it,” Doran said. “There’s no time to rest until New Zealand patients have more treatment options.”
He said they are motivated and committed to improving their patients’ quality of life.
“It’s been a tremendous effort,” she said. “We’re all incredibly proud.”