New Zealand’s regulator Medsafe has reclassified low-dose CBD from a prescription-only to a restricted medicine, paving the way for it to become available over the counter in pharmacies.

The move brings Medsafe into line with Australia’s Therapeutic Goods Administration (TGA), which down scheduled the medicine in December 2020.

While no CBD products are currently approved in New Zealand, from today, any low-dose CBD product which becomes approved in the future can be supplied by registered pharmacists to patients aged over 18. As in Australia, the maxiumum dose for over-the-counter sales has been set at 150mg per day.

Medsafe said: “No products in this category are available in Australia either at this stage. In general, [they] would be used to treat minor ailments.”

The regulator added the decision followed “careful consideration of the risk-benefit profile of low-dose CBD” including consultation with healthcare professionals, industry, and the public.

“Those in the CBD industry have also previously signalled that a change in classification may allow more opportunities for research into the clinical efficacy and safety of CBD,” it said. “Subsequently, this could create greater opportunities for the approval of low-dose CBD medicines.”

Until now, the main route for supplying CBD in New Zealand was as an unapproved medicine that met the minimum quality standards of the Misuse of Drugs (Medicinal Cannabis) Regulations, meaning it could only be accessed via a prescription from a doctor.

Medsafe added: “This classification change will mean that if, in the future, a CBD product is shown to have a positive risk-benefit balance in terms of safety and efficacy, and is approved by Medsafe as meeting both national and international standards, it can be supplied at a pharmacy following consultation between the patient and pharmacist.”

The move was welcomed by the New Zealand Medicinal Cannabis Council (NZMCC).

NZMCC executive director Sally King

Executive director Sally King said: “It took considerable effort from the council to secure this decision, and we welcome the news that low-dose CBD has been reclassified.

“We believe low-dose CBD can be very competently dispensed via a pharmacist and that such a pathway will be a significant benefit for New Zealand patients in terms of access and affordability.”

However, King acknowledged there was some way to go before CBD is available via that route.

“The medicines approval requirement is, of course, a very high threshold which we are yet to meet and that is our next challenge,” she said.

“CBD classification continues to be problematic all over the globe. We are hoping that sense will prevail with regulators and that safe, high-quality CBD medicine will be much more widely accessible.”

Australia is still waiting for its first low-dose CBD product to be registered as a schedule 3 (over-the-counter) medicine, almost three years after it was down scheduled by the TGA.

Prior to launching Cannabiz, Martin was co-founder and CEO of Asia-Pac’s leading B2B media and marketing information brand Mumbrella, overseeing its sale to Diversified Communications in 2017. A journalist...

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