New Zealand's Ministry of Health has announced further information about the country's Medicinal Cannabis Scheme, which was enacted on 1 April 2020.
The Medicinal Cannabis Scheme has now come into effect following the commencement of the Misuse of Drugs (Medicinal Cannabis) Regulations 2019. The purpose of the Scheme is to improve access to quality medicinal cannabis products for patients. New Zealand Gazette notices in relation to Sativex™ and medical vaporisers have also come into force.
Information for healthcare professionals
Currently, only cannabidiol (CBD) products and Sativex™ may be prescribed to patients without approval from the Minister of Health.
The range of medicinal cannabis products available for patients will increase over time, as local medicinal cannabis producers, like Helius, enter the market. For a product to be brought into the Scheme, a licensed supplier must apply to the Medicinal Cannabis Agency for a product assessment to establish the product meets the medicinal cannabis minimum quality standard.
The Medicinal Cannabis Agency’s website will be updated periodically as additional medicinal cannabis products are brought into the Scheme.
The imported product, Sativex™, is a cannabis-based medicine that is classified as a controlled drug. While Sativex™ was consented as a medicine from 19 November 2010 as Sativex Oral Spray, case-by-case approval from the Minister of Health has been required for all new prescriptions.
From 1 April 2020, registered medical practitioners no longer need Ministerial approval to prescribe Sativex™ for patients under their care, where this is within their scope of practice. When a prescription has been issued, Sativex™ can be dispensed to the patient by a registered pharmacist, or by a registered medical practitioner if the patient is in their care.
Medicinal cannabis products may not be prescribed in a form designed for smoking. However, it is possible that products suitable for administration by medical vaporiser will be brought within the Scheme over time.
From 1 April 2020, medical vaporisers that have been approved as medical devices by an overseas regulator can be imported and sold in New Zealand. Other vaporiser devices, and utensils with prohibited features, continue to be prohibited.
You can read more about medical vaporisers here, on the Helius website.
Information for industry
The Medicinal Cannabis Agency has now published the key guidance material and forms and is ready to accept medicinal cannabis licence applications. Further guidance material will be published over coming weeks.
Agency staff are working from home due to the COVID-19 lockdown, which means they are unable to answer phone calls and will not be in the office to receive hard copy applications. They will be assessing licence applications during the lockdown, but their assessments may take a little longer than if they were all in the office.
If the COVID-19 lockdown continues for an extended period, Agency staff also won't be able to carry out location inspections. If this is the case, we will review our plans for carrying out location inspections as part of the assessment process.
You can find a range of further information on the Agency’s website, including background on the Scheme, guidance documents and licence application forms.