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:
- What is a medicinal cannabis product?
- Medicinal cannabis minimum quality standard
- Prescribing medicinal cannabis
- Unverified medicinal cannabis products
- Dispensing medicinal cannabis
- Importing unverified medicinal cannabis products
- Where to find more information
A medicinal cannabis product is a prescription medicine which is either dried cannabis or a pharmaceutical dosage form containing one or more ingredients extracted from the Cannabis plant. All medicinal cannabis products are subject to the requirements of the Medicinal Cannabis Scheme and must meet the minimum quality standard. Except for Sativex™, all medicinal cannabis products are unapproved medicines. There are two broad categories of medicinal cannabis products which are detailed below.
All cannabidiol (CBD) products are prescription medicines. A CBD 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 a CBD product.
Any medicinal cannabis product which is not a CBD product is a Class B1 controlled drug. These may contain any level of cannabinoids and include all dried flower products.
Across both categories, medicinal cannabis products do not include:
- medicines which contain ingredients that are not derived from the Cannabis plant
- sterile dosage forms such as eye drops
- any product intended for smoking
- any product meeting the definition of a ‘food’ under the Food Act 2014.
All medicinal cannabis products distributed in New Zealand must meet the medicinal cannabis minimum quality standards (MQS). The MQS 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.
A medicinal cannabis product must be prescribed by a doctor registered to practice in New Zealand. Any medicinal cannabis product that has either been verified against the MQS or approved as a medicine can be prescribed without specialist recommendation or Ministerial approval.
Medicinal cannabis products that meet the MQS, or are approved medicines are listed here.
Prescriptions must meet the legal requirements and must specify:
- the product brand and composition of active ingredients (eg, tetrahydrocannabinol and cannabidiol)
- directions for use, including the prescribed dose and route of administration, including where appropriate, the device by which the product is to be administered.
No medicinal cannabis products are approved as medicines. It is recommended to prescribe by brand to ensure your patient receives the same medicine at each point of dispensing, and in line with the requirements for prescribing an unapproved medicine.
- prescriptions for CBD products must be for no more than a three-month supply
- prescriptions for controlled drug products (including Sativex™) must be either handwritten on a controlled drug prescription form or be on a personally signed barcoded prescription issued from the NZePS system, for no more than one month’s supply.
Quality-verified products or approved medicines should be trialled before unverified products are prescribed. Unverified products have no assurance of quality or of the specified active cannabinoid content on the product label.
A doctor may not prescribe a medicinal cannabis product that has not been verified as meeting the minimum quality standard unless 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.
Please contact the Medicinal Cannabis Agency for more information ([email protected]).
Medical practitioners should ensure they are familiar with the requirements of the Medicines Act 1981 and the Medsafe guidance on the Use of Unapproved Medicines and Unapproved Use of Medicines.
Medicinal cannabis products must be dispensed in the same manner as other prescription medicines and controlled drugs.
Prescriptions for medicinal cannabis products:
- must satisfy all legal requirements
- must include an approval number showing Ministerial approval has been granted to prescribe a controlled drug product if the product is not listed here
- must be for no more than three-months supply in the case of a CBD product
- must be for no more than one-month supply in the case of a controlled drug product.
Brand substitution cannot take place without the prescriber’s explicit authorisation. As all medicinal cannabis products (except Sativex™) are unapproved medicines, the prescriber has to be satisfied that the brand of medicine prescribed is appropriate for their patient (including having informed consent). Without verification against the MQS or medicines approval, there is no assurance that any two brands contain the same active ingredient(s).
Unverified products may only be imported into New Zealand by a registered doctor, or pharmacist pursuant to a prescription, in an amount required for a named patient.
A licence to import a controlled drug is required for each consignment where the unverified medicinal cannabis product is not a CBD product. Expectations of future prescriptions is not a reasonable excuse to import unverified medicinal cannabis products.
The administration of some medicinal cannabis products requires a vaporiser. Vaporisers can be purchased from the NZ supplier, or imported directly. 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 provide a safe method for administering medicinal cannabis. Other vaporiser devices, and utensils with prohibited features, continue to be prohibited from importation into New Zealand.
Medical devices, including vaporisers, must be notified to WAND by the importer, manufacturer or supplier. Please see the Medsafe guidance for more information.
If you are uncertain whether a specific vaporiser has been approved as a medical device, please contact [email protected].
The Ministry is currently producing primer resources on medicinal cannabis for healthcare professionals. These are expected to be available during the second half of 2021.
Clinical guidance has been produced by the Therapeutic Goods Administration (TGA) in Australia and Health Canada. While not specific to any product, this information may be useful for those wanting to prescribe medicinal cannabis to their patients:
- TGA Medicinal cannabis – guidance documents
- Health Canada Information for Health Care Professionals: Cannabis and the cannabinoids
Health professionals are also reminded of their obligations and responsibilities when using unapproved medicines.