The following sections provide relevant information about the Medicinal Cannabis Scheme for doctors, pharmacists and other health professionals involved in the provision of quality medicinal cannabis products for therapeutic use by patients.
On this page:
- Patients must have a prescription
- CBD products
- Other medicinal cannabis products
- Products approved under the Medicines Act 1981
- Unapproved medicinal cannabis products
- Minimum quality standards
- Ministerial approvals
- Prescriptions issued prior to 1 April 2020
A patient must have a prescription from a doctor registered to practice in New Zealand before they can be supplied any medicinal cannabis product, including any cannabidiol (CBD) product.
Prescriptions for medicinal cannabis products:
- should specify the brand and prohibit any generic substitutions
- must not be for a product in a form intended for smoking
- must not be for a product meeting the definition of ‘food’ under the Food Act 2014
- must not be for a product in a sterile dosage form (eg, eye drops).
- prescriptions for CBD products, must be for no more than a three-month supply
- prescriptions for other medicinal cannabis products, including Sativex, must be handwritten on a controlled drug prescription form and be for no more than a one-month supply.
Sativex™ is a cannabis-based product 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 for off-label use of Sativex™.
From 1 April 2020, registered medical practitioners no longer need Ministerial approval to prescribe Sativex™ for off-label use 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.
CBD products are not classified as controlled drugs under the Misuse of Drugs Act 1975.
To be considered a CBD product under Section 2A of the Act, the product may contain only trace amounts of tetrahydrocannabinol (THC) and certain other related substances, and cannot contain any other controlled drugs or psychoactive substances. See a detailed definition of CBD.
Pharmacists may import or procure CBD products that meet the Medicinal cannabis minimum quality standard. They may also import or procure CBD products that do not meet the minimum quality standard when a doctor has issued a prescription to a named patient.
A medicinal cannabis product that contains THC or other psychoactive substances extracted from cannabis is a controlled drug under the Misuse of Drugs Act 1975. These products may be in a pharmaceutical dosage form, or as dried flower intended for vaporisation.
SativexTM is currently the only medicinal cannabis product ‘approved’ for distribution under the Medicines Act 1981. Approved medicines have been assessed for safety and efficacy for their approved indications, in addition to quality.
Medical practitioners can prescribe SativexTM without Ministerial approval for any on-label or off-label indications within their scope of practice, where there is a clinical need.
A doctor may not prescribe a medicinal cannabis product that is not an ‘approved’ medicine unless:
- the Medicinal Cannabis Agency has verified the product meets the Medicinal cannabis minimum quality standard, or
- approval for a named patient has been granted by the Minister of Health following an application from a relevant medical specialist or the Chief Medical Officer of a District Health Board.
Pharmacists may import or procure ‘unapproved’ medicinal cannabis products when either of these exceptions applies. A licence to import a controlled drug will be required for each consignment. More information is available on the CBD products page.
Medical practitioners should ensure they are familiar with the requirements of the Medicines Act and the Medsafe guidance on the Use of Unapproved Medicines and Unapproved Use of Medicines.
On 1 April 2020 the Ministry of Health began accepting applications from medicinal cannabis product suppliers for product assessments. The purpose of an assessment is to establish whether the product meets the Medicinal cannabis minimum quality standard.
The minimum quality standards have been designed to provide doctors with confidence in the quality and consistency of any medicinal cannabis products they prescribe to their patients. The standards do not include an assessment of the safety or efficacy of the product.
Medicinal cannabis products that meet the minimum quality standard, or are approved can be viewed on products that meet the minimum quality standard.
The Medicinal Cannabis Agency will consider the following matters when assessing applications for Ministerial approval to prescribe ‘unapproved’ medicinal cannabis products that have not been verified to meet the minimum quality standards:
- Does the patient have a severe or life-threatening condition?
- Is there evidence that reasonably applicable conventional treatments have been trialled and the symptoms are still poorly controlled?
- Is there evidence that the risk/ benefit of the product has been adequately considered by qualified clinical specialists – that is, the risk of treatment with an unproven product is less than the risk of non-treatment and any evidence of potential benefit has been considered and weighed against known adverse effects?
- Is the application from a specialist appropriate to the medical condition being treated or the Chief Medical Officer of a District Health Board?
- Has the applicant or specialist prescriber sought adequate peer review? For example, Hospital Ethics Committee approval, Drug or Therapeutics Committee review, review by other specialists in the condition being treated and/or specialist colleagues involved in the treatment of the patient?
- Has the applicant provided a Certificate of Analysis, preferably from an accredited laboratory, so that the concentration of the active ingredient(s) is known?
- Has the patient or guardian provided informed consent?
The Medicinal Cannabis Scheme came into effect on 1 April 2020. Patients who were prescribed CBD products or ‘unapproved’ medicinal cannabis products prior to this date may continue to access these products until 30 September 2021 without further approval beyond a prescription.
However, where the prescription was issued following Ministerial approval, this approval must not have lapsed. The prescriber may reapply to the Minister to continue prescribing for their patient if required.
This transitional period will allow affected suppliers to arrange for their products to be assessed by the Medicinal Cannabis Agency to verify they meet the medicinal cannabis minimum quality standard.
The Misuse of Drugs Prohibition of Utensils) Notice 2020 sets out that a vaporiser can be imported and sold only if it has been approved as a medical device by an overseas regulator. This ensures the vaporiser will be a safe method for administering medicinal cannabis.
Other vaporiser devices, and utensils with prohibited features, continue to be prohibited from New Zealand.
If you are uncertain whether a specific vaporiser has been approved as a medical device, please contact [email protected].