Medicinal cannabis in New Zealand: an overview
New Zealand established a formal regulatory framework for medicinal cannabis with the Medicinal Cannabis Scheme, which came into effect in April 2020 and was developed by the Ministry of Health. Prior to this scheme, patients could access cannabis-based products only through the Misuse of Drugs Act 1975 ministerial exception pathway, which involved individual ministerial approval.
The Medicinal Cannabis Scheme introduced a more streamlined and scalable system, creating licensing and quality standards for the cultivation, manufacture, and supply of medicinal cannabis products in New Zealand. Medicinal cannabis products in New Zealand are classified as prescription medicines and can only be obtained with a valid prescription from a registered medical practitioner. The Ministry of Health and Medsafe — the New Zealand medicines and medical devices safety authority — each play regulatory roles within this framework.
The Medicinal Cannabis Scheme
The Medicinal Cannabis Scheme is administered by the Ministry of Health. It sets out licensing requirements for businesses that cultivate, manufacture, or supply medicinal cannabis in New Zealand, and establishes the Minimum Quality Standard (MQS) that products must meet to be prescribed and supplied in the country.
The MQS covers aspects of product quality including cannabinoid content accuracy, microbiological safety, and labelling requirements. Products that meet the MQS can be imported into or manufactured in New Zealand for prescription use. The Ministry of Health maintains a list of medicinal cannabis products that have been assessed as meeting the MQS, which prescribers and pharmacists can reference.
Patients cannot purchase medicinal cannabis products directly without a prescription, regardless of whether those products meet the MQS.
How patients access medicinal cannabis
In New Zealand, a patient who wishes to access medicinal cannabis must be under the care of a registered medical practitioner who determines that medicinal cannabis is appropriate for that patient's specific medical situation. The practitioner writes a prescription, which can be dispensed by a pharmacy that is set up to handle Schedule 4 medicines or, where applicable, controlled drugs.
Medicinal cannabis in New Zealand is classified under Schedule 4 of the Misuse of Drugs Regulations 2008 when it meets the approved product criteria, and under Class C controlled drug status for THC-containing products. Prescribers are responsible for assessing patient suitability, discussing realistic expectations, explaining how to use any device required for administration, and monitoring the patient's response.
Patients should discuss any questions about medicinal cannabis access with their GP or specialist.
Medsafe and medical device regulation
Medsafe is the regulatory authority for medicines and medical devices in New Zealand. For therapeutic cannabis products, Medsafe's medicines team oversees product quality and prescription medicine classification. For devices used in administering medicinal cannabis — such as vaporisers intended for dried flower — Medsafe's medical device team is the relevant regulatory body.
New Zealand's medical device regulatory framework does not require pre-market approval for most devices in the way that the TGA's ARTG process does in Australia, but devices must still comply with applicable safety standards and are subject to regulatory oversight through the WAND notification system. Healthcare professionals and patients in New Zealand can check device regulatory status through Medsafe.
WAND registration and what it means
WAND — the Web Assisted Notification of Devices — is New Zealand's system for notifying medical devices to Medsafe. Suppliers are required to notify Medsafe of medical devices they supply in New Zealand through WAND. WAND registration does not constitute formal pre-market approval in the same way as the Australian ARTG process, but it provides a regulatory record and places the supplier under post-market surveillance obligations.
Devices listed in WAND can be looked up by healthcare professionals, pharmacists, and patients to verify that a device has been notified to Medsafe and that the supplier has accepted regulatory responsibilities in New Zealand. The Grenco Medical Elite II Vaporiser is Medsafe WAND registered, meaning it has been notified to Medsafe for supply in New Zealand.
The role of the vaporisation device
When a patient is prescribed dried medicinal cannabis flower for inhalation in New Zealand, a suitable vaporisation device is required. The device and the cannabis product are regulated separately — the cannabis product under the Medicinal Cannabis Scheme and Medsafe, and the device under Medsafe's medical device framework.
Using a device that has been notified to Medsafe and meets applicable safety standards provides a level of assurance that a consumer vaporiser not notified to Medsafe cannot offer. In New Zealand, the Grenco Medical Elite II is available through Veridion Group, the authorised New Zealand distributor.
As with all medicinal cannabis device use, patients should follow the Instructions for Use provided with the device and the guidance of their prescribing healthcare practitioner.