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NZ Medicinal Cannabis Scheme Launch FAQ’s
Our Medicinal Cannabis Scheme FAQ’s provide both patients and prescribers with answers to commonly asked questions about the scheme.
What will change on the 1st of April 2020 when the Medicinal Cannabis Scheme is launched in NZ?
As of the 1st April 2020, the newly formed Ministry of Health Medicinal Cannabis Agency (“Agency”) will begin processing commercial license applications from medicinal cannabis companies such as Cannasouth.
Health Care Practitioners (“HCP”), e.g. Doctor, General Practitioner, Nurse Practitioner, will also be able to prescribe medicinal cannabis products, including those which contain THC, which previously could only be prescribed by Specialist consultants.
When will New Zealand-produced Medicinal Cannabis products be available?
New Zealand-manufactured GMP compliant quality medicinal cannabis products (“products”) will become available after they have been granted a commercial Medicinal Cannabis Licence from the Agency. Licence applicants are required to undergo a rigorous product assessment process by the Medicinal Cannabis Agency to assure compliance to the Medicinal Cannabis Scheme (“Scheme”).
Due to the current Covid-19 pandemic and the deployment of MOH resources into priority projects to support these efforts, the time frame for acceptance of applications is unknown. Additionally, across the sector we anticipate a significant number of applications will be submitted to the Agency and as such, we expect there will be delays due to the potential backlog of applications.
When will Cannasouth have products available for patients?
Delivering GMP compliant quality medicinal cannabis products to the market for patients is a key objective for Cannasouth. To ensure the highest quality of our finished products, Cannasouth has adopted a vertical integration business strategy, which entails Cannasouth’s involvement during the entire process, from cultivation through to manufacture of finished products. Cannasouth is researching and developing new drug delivery system technologies to facilitate improved efficacy and ease of use for patients.
Under the new Scheme, Cannasouth will be applying for various licences in order to produce its own, and register new medicinal cannabis products. In order to enable rapid patient access to compliant quality medicinal cannabis products , the company is investigating several parallel pathways, one of which includes importing New Zealand compliant white label medicinal cannabis products and Active Pharmaceutical Ingredients (“APIs”) while local manufacturing operations are being established.
What are ‘white label’ products?
White label products are sold by retailers with their own branding and logo but the products themselves are manufactured by a third party.
What is Cannasouth’s view of product compliance to the NZ minimum product quality standard?
Because patient safety is Cannasouth’s highest priority, we support the Medicinal Cannabis Agency’s approach where all NZ medicinal cannabis products are required to comply with the minimum quality standard set forth under the Medicinal Cannabis Scheme. Compliance to the minimum quality standard provides the highest possible level of assurance that our products are safe.
Additionally, product compliance positions the New Zealand medicinal cannabis sector with a unique competitive advantage in global markets, as the NZ standard is one of the highest quality standards in the world.
How do I find out more about Cannasouth’s products?
Section 29 of the Medicines Act, 1981 (“Act”) permits the sale or supply to medical practitioners of medicines that have not been approved, i.e. unapproved medicines. Given that medicinal cannabis products are subject to the Medicinal Cannabis Scheme and do not undergo approval under the Act, they are categorized as “unapproved” medicines. Additionally, section 29 imposes restrictions around advertising of unapproved products; therefore, Cannasouth is not permitted to advertise or market unapproved medicines. The Company is however permitted to provide information to medical professionals if they directly engage and request product information from us.
How do I access medicinal cannabis from the 1st of April?
You will need a prescription from your Health Care Practitioner (“HCP”), e.g. Doctor, General Practitioner, Nurse Practitioner, in order to access medicinal cannabis products. The launch of the Medicinal Cannabis Scheme means that HCPs will be able prescribe medicinal cannabis products which contain THC, which was previously only prescribed by Specialist consultants. Medicinal cannabis products will be available from pharmacies like all other prescription medicines.
What do the Ministry of Health minimum quality standards mean for medicinal cannabis products currently available?
Products that are currently available as of the 1st of April 2020 will remain available for the next 6 months. After that point all products will be required to meet the New Zealand GMP minimum quality standards.
Click here for MoH regulatory information
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