Rua Bioscience has received the go-ahead from New Zealand’s government to distribute its first cannabis medicine locally.
The company says it has received verification its first medicinal cannabis product – a cannabidiol (CBD) oil formulation – meets the NZ Medicinal Cannabis Agency’s (Medsafe’s) quality standards; which is no mean feat as the bar has been set very high.
Rua states it intends distribution of the product as a prescription-only medicine through GPs and specialists to commence by the end of the first quarter of next year, or early in the second quarter.
The medicine will be manufactured at Rua Bioscience’s facility in Gisborne, which was awarded GMP (Good Manufacturing Practice) certification a few months ago.
“Rua has hit this milestone as a result of the tenacity and hard work of our team, and we’re grateful for the careful stewardship of the Medicinal Cannabis Agency as they take the NZ industry safely into a new frontier of medicine,” said Rua Bioscience Chief Operations Officer Paul Naske.
While Rua’s announcement doesn’t provide specifics on the nature of this product, the NZ Medicinal Cannabis Agency website provides a bit more information.
- Product: RUA CBD100
- Total CBD (CBD+CBDA) 100 mg/mL
- Total THC (THC+THCA) < 0.2 mg/mL
- Pack size: 30ml
- Administration: Oral, supplied with 1mL oral syringe with 0.05 mL volume markings
At the time of publishing, there are just eight medicinal cannabis products that meet the minimum quality standard under NZ’s rather unfortunately named Misuse of Drugs (Medicinal Cannabis) Regulations 2019. Any doctor in New Zealand can prescribe a product listed – a specialist recommendation and Ministerial approval are not required to do so.
So, Rua Bioscience is currently among an elite group and is no doubt eager to get product distributed in order to maximise first-mover advantage.
“Next year will be all about going wider, faster and earlier. We are fully focused on meeting the needs of patients, our community and our investors, who have been steadfast in their support,” said Rua Bioscience Chief Commercial Officer, Dr Andrea Grant.
New Zealand’s minimum quality standard came into full effect on September 30 this year. Regulations provided for a transitional period to enable medicinal cannabis products already imported into the country as at 1 April 2020 to continue to be supplied without a product assessment until that time.