New Zealand's medicines regulator Medsafe has shifted low-dose CBD from prescription-only status to a restricted medicine, a change that would allow it to be sold over the counter at pharmacies.
The decision aligns Medsafe with Australia's Therapeutic Goods Administration (TGA), which down scheduled the medicine in December 2020.
No CBD products have yet received approval in New Zealand, but from today, any low-dose CBD product that gains future approval may be dispensed by registered pharmacists to patients aged 18 and over. The daily maximum dose for over-the-counter sales has been set at 150mg, consistent with Australia's approach.
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 said the decision came after "careful consideration of the risk-benefit profile of low-dose CBD" and included input from healthcare professionals, industry stakeholders, and members of 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."
Prior to this change, the primary pathway for accessing CBD in New Zealand was through an unapproved medicine meeting the minimum quality standards under the Misuse of Drugs (Medicinal Cannabis) Regulations, which required a doctor's prescription.
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 New Zealand Medicinal Cannabis Council (NZMCC) responded positively to the announcement.
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.”
King did, however, caution that pharmacy availability remains some distance away.
“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, nearly three years after the TGA completed its own down scheduling.
