Rua Bioscience Gains GMP Certification

PO Box 1387, Gisborne 4040, Aotearoa New Zealand | 0800 RUABIO | www.ruabio.com



FOR PUBLIC RELEASE
NZX Limited
Wellington

Tuesday, September 28, 2021

Rua Bioscience receives licence to manufacture (GMP), produces first product;
on track to deliver revenue

Rua Bioscience (NZX:RUA), New Zealand’s first Māori founded NZX-listed company, has received
Good Manufacturing Practice (GMP) certification from Medsafe, enabling the company to start
the manufacture its first medicinal cannabis product, a cannabinoid (CBD) oil.

GMP certification is the global standard for all pharmaceuticals and certifies that Rua can
manufacture a product that is consistently safe and of acceptable quality. GMP is a pre-requisite
for both domestic and export sales.

Rua Bioscience CEO, Rob Mitchell, says it is a significant milestone for the Tairāwhiti-based
pharmaceutical company.

“Gaining certification just 12 months after commissioning our facilities and listing on the NZX is a
massive achievement, and a testament to the great work being done here in Tairāwhiti by a
highly-experienced, talented and tenacious team,” he says.

“Put simply, GMP certification means we've moved a long way down the path to being allowed to
manufacture products. The next stage is to submit a New Medicinal Cannabis Product
Application to the Medicinal Cannabis Agency who will undertake an assessment against the
Minimum Quality Standards.

"While it is unclear how long the application review process will take, we anticipate being able to
supply product for the domestic market by early 2022. Manufacturing will take place at our
purpose-built facility in Gisborne and the compounded CBD oil will be available in New Zealand
as a prescription only medicine.

“Achieving GMP certification means many of the common processes that will be required for the
production of dried cannabis flower have also been reviewed. Rua Bioscience has a New Zealand
exclusive contract for supply to intended for German pharmaceutical distribution partner, Nimbus
Health, so we will be able to start fulfilling those orders as soon as dried flower products have
been through similar approval processes,” he says.

Rua’s certification comes after a series of challenging external delays. Chief Operations Officer,
Paul Naske views the process as an invaluable learning opportunity that will ultimately hold the
company in good stead as further products are brought to market.

“While the process has been challenging at times, we were always confident in our people,
processes and of a positive outcome.

“It’s important to remember that, at this point, the New Zealand industry is heavily reliant on
overseas laboratories for critical pieces of the GMP puzzle. But this is temporary – as the industry
develops, so too will New Zealand-based ancillary services, which will streamline industry
practice,” he says.

MARKET ANNOUNCEMENT

PO Box 1387, Gisborne 4040, Aotearoa New Zealand | 0800 RUABIO | www.ruabio.com
Since the implementation of the Medicinal Cannabis Scheme, Rua has focused on meeting the
heightened global demand for medicinal cannabis products through the establishment of world
class cultivation and manufacturing capabilities in Tairawhiti.

Data released by the Ministry of Health under the Official Information Act shows that the number
of packs of medicinal cannabis prescribed and supplied in New Zealand is growing at an average
rate of 250 per cent annually. The number of packs supplied in New Zealand in the year to 30
June 2021 was over 31,000; compared to just 2,000 in 2018. This growth is in spite of patients’
ability to access medicinal cannabis being constrained by a lack of available products, limited
prescriber understanding of the clinical benefits of medicinal cannabis and the absence of
government subsidies. According to a study published in the British Journal of General Practice,
CBD oils are commonly prescribed in New Zealand for pain, epilepsy and anxiety
1
.

Meanwhile the German market remains the largest single market for GMP (pharmaceutical) grade
cannabis globally. German clinicians can prescribe medicinal cannabis for a variety of conditions
and a great number of these prescriptions are paid for (reimbursed) by Statutory Health Insurers.
In the year ending 30 June 2021, 313,500 prescriptions for medicinal cannabis products were
reimbursed for German patients, valued at NZ$298m (€177m). These reimbursed sales are
complemented by a substantial private-paying market that has an estimated additional value of
NZ$169m (€100m).

"Achieving GMP certification is the penultimate step towards achieving Rua Bioscience's vision of
delivering medicines to patients. We couldn't be more excited to be delivering on that vision" said
Mr Mitchell.

ENDS

Contact:
Kerry Donovan
Communications Manager
Kerry.donovan@ruabio.com



About Rua Bioscience
Rua Bioscience (RUA:NZX) is a vertically integrated New Zealand pharmaceutical company, and a
pioneer in the New Zealand medicinal cannabis sector. Established in 2017 to support economic
development in Te Tairāwhiti, Rua holds licences to cultivate and manufacture medicinal
cannabis products, has two commercial-scale facilities and holds an exclusive contract with
German distributer Nimbus Health to supply dried flower. Rua’s knowledge of the global market
and expertise in cannabis plant chemistry and analytics, cultivation optimisation, plant processing
and pharmaceutical manufacturing supports its strategy to identify long-term value opportunities
in agritech and pharmaceuticals. www.ruabio.com



1
Gulbransen, G., Xu, W., & Arroll, B. (2020). Cannabidiol prescription in clinical practice: an audit
on the first 400 patients in New Zealand. BJGP open, 4(1), bjgpopen20X101010.
https://doi.org/10.3399/bjgpopen20X101010