The term medicinal cannabis products encompasses several types of products that may be prescribed to treat various medical conditions.
Medicinal cannabis products, excluding cannabidiol (CBD) products, are Class B1 controlled drugs and Ministerial approval is required before most can be prescribed, supplied or administered, in accordance with regulation 22 of the Misuse of Drugs Regulations 1977.
On this page:
- Ministerial approval
- Categories of medicinal cannabis products
- Guidelines to assess applications
Ministerial approval is required before most medicinal cannabis products can be prescribed, supplied or administered, in accordance with regulation 22 of the Misuse of Drugs Regulations 1977. Ministerial approval is delegated to the Ministry of Health.
Ministerial approval is not needed to prescribe:
- Sativex for spasticity related to MS. More information can be found on the Medsafe website
- Cannabidiol (CBD) products
The Ministry defines four categories of medicinal cannabis products:
- Pharmaceutical grade medicinal cannabis products that have consent for distribution in New Zealand
- Pharmaceutical grade medicinal cannabis products that do not have consent for distribution in New Zealand
- Non-pharmaceutical grade medicinal cannabis products
- CBD Products
The guidelines to assess applications for Ministerial approval to prescribe, supply or administer these products are listed below. There are separate application forms for each category.
External consultation on the guidelines used to assess applications to prescribe cannabis-based products took place in May 2016. Download the document below:
- External Consultation on Guidelines to Assess Applications for Ministerial Approval to Prescribe Cannabis-based Products (PDF, 97 KB)
- External Consultation on Guidelines to Assess Applications for Ministerial Approval to Prescribe Cannabis-based Products (Word, 205 KB)
If you require further information as to the appropriate form to use for an application for Ministerial approval to prescribe a cannabis-based product please email: firstname.lastname@example.org.
1. Pharmaceutical grade medicinal cannabis products that have consent for distribution in New Zealand
More information on Sativex and the application process to prescribe Sativex for multiple sclerosis or other conditions can be found on the Medsafe website.
2. Pharmaceutical grade medicinal cannabis products that do not have consent for distribution in New Zealand
The following matters are taken into account when assessing applications for Ministerial approval to prescribe pharmaceutical grade medicinal cannabis products without consent for distribution in New Zealand, regulated by Regulation 22 of the Misuse of Drugs Regulations 1977:
- application from an appropriate specialist
- a manufacturer has demonstrated a commitment to the development of the product as a pharmaceutical or
- the product has been prepared pharmaceutically and the characteristics and formulation are clearly described and defined
- the product has completed animal studies demonstrating proof of concept and potential clinical benefit
- the product is undergoing an appropriately designed Phase II clinical study or
- the product has completed clinical trials and is marketed overseas but is not approved for distribution in New Zealand
- the product is available for use
- the following are met where relevant:
- evidence that there will be close follow up of patient by a prescriber
- evidence that a wide range of conventional treatments have been trialled and symptoms are still poorly controlled
- condition is an approved condition for use or
- condition is one for which there is some evidence of efficacy, preferably in clinical trials
- Ministry clinicians assess application is appropriate
- no history of abuse or diversion of controlled drugs
- the patient has no known contraindication to the use of the product
- initial approvals usually for 12 months
- baseline clinical indicators generally required and evidence of improvement before a new approval is given.
Please download, fill in and email application form to: email@example.com
The following matters are taken into account when assessing applications for Ministerial approval to prescribe non-pharmaceutical grade medicinal cannabis products regulated by Regulation 22 of the Misuse of Drugs Regulations 1977:
- severe or life-threatening condition
- evidence that reasonably applicable conventional treatments have been trialled and the symptoms are still poorly controlled
- 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 account has been taken of any evidence of potential benefit and weighed against known adverse effects
- application from a specialist appropriate to the medical condition being treated or the Chief Medical Officer of a District Health Board
- applicant or specialist prescriber has sought adequate peer review eg, 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
- provision of a Certificate of Analysis, preferably from an accredited laboratory, so that the concentration of the active ingredient(s) is known
- patient or guardian has provided informed consent.
Products that are not pharmaceutical will not be approved for use in clinical trials.
The guidelines to assess applications to prescribe a non-pharmaceutical grade medicinal cannabis products are more rigorous than the guidelines to prescribe pharmaceutical grade products with or without consent for distribution in New Zealand. This reflects the lack of authoritative quality and safety data and the lack of robust efficacy data for these products.
The use of a non-pharmaceutical grade product will not contribute meaningful data to the pool of scientific research on the safety and efficacy of medicinal cannabis products in the condition being treated. This is due to the inability to replicate the results (due to variation in the strength and composition of the product) and the inability to generalise results from a single patient to a broad patient group.
Please download, fill in and email application form to firstname.lastname@example.org.
A CBD product means a product that—
- contains cannabidiol; and
- does not contain a specified substance; or
- contains specified substances in an amount that is no more than 2% of the sum of the amount of cannabidiol and the amount of specified substances in the product; and
- does not contain any other controlled drug; and
- does not contain a psychoactive substance (as defined in section 9 of the Psychoactive Substances Act 2013)
A specified substance means a substance that—
- naturally occurs in cannabis; and
- a tetrahydrocannabinol; or
- an isomer, ester, or ether of a tetrahydrocannabinol; or
- an ester or ether of an isomer of a tetrahydrocannabinol; or
- a salt of any substance described in subparagraphs (i) to (iii); or
- a substance that has a structure substantially similar to that of any substance described in subparagraphs (i) to (iv); and
- for substances listed in paragraph (b)(ii) to (v), is capable of inducing more than a minor psychoactive effect, by any means, in a person.
In other words, a specified substance is a substance found naturally in cannabis that is a tetrahydrocannabinol or a psychoactive related substance. The words “is capable of inducing more than a minor psychoactive effect, by any means” includes a chemical that can be altered by a simple conversion technique (such as heating) to produce a chemical that has a more than a minor psychoactive effect, such as tetrahydrocannabinolic acids, which can be converted to tetrahydrocannabinols themselves by a simple conversion technique (eg, THCA converts to THC by heating and therefore would be a specified substance).
To determine whether a product meets the definition of a CBD product, you will need to calculate the percentage of specified substances (x) as a percentage of the total CBD (y) and specified substances content (z) using the following equation:
x = z ÷ (y + z) x 100
If x equals 2 or less (without rounding), and does not contain any other controlled drugs or psychoactive substances (as defined in the Psychoactive Substances Act) the product meets the definition of a CBD product. The following diagrams explains:
Other medicinal cannabis products
Products that contain CBD but do not meet the definition of a CBD product because the levels of THCs or related psychoactive substances are too high, are still available on prescription but are also controlled drugs. Ministry of Health approval is required to prescribe, supply or administer these controlled drugs for a medical purpose. Any medical practitioner holding an appropriate licence to import controlled drugs may import these products for supply to a known patient or patients, once Ministry approval has been obtained. Persons or companies holding the appropriate licences to import and deal in controlled drugs are also allowed to import these products and supply them to medical practitioners or pharmacies for known patients. Patients may not import these products. For further information on bringing controlled drugs (eg medicinal cannabis products) into New Zealand refer to Bringing medicines into New Zealand.
Medicinal cannabis products that do not meet the definition of a CBD product are categorised as follows:
Pharmaceutical grade products that have consent for distribution in New Zealand. Consent for distribution means that the product has been determined by Medsafe to meet acceptable safety and efficacy requirements for distribution in New Zealand. The only product meeting this criterion currently is Sativex for the treatment of multiple sclerosis. It may also be prescribed for some other medical conditions at the prescriber’s discretion.
Pharmaceutical grade products that do not have consent for distribution in New Zealand, for example a product that has been manufactured by a pharmaceutical company overseas.
Non-pharmaceutical grade products, that is products that are not manufactured to internationally recognised pharmaceutical manufacturing standards. They may, or may not, have been intended to be used as medicines.