This page was previously titled Medicinal cannabis. More information about this change can be found in the Changes to terminology around applications for cannabis-based products media release.
On this page:
- Cannabis-based products
- Guidelines to assess applications
The term cannabis-based products encompasses several types of products containing extracts of the cannabis plant that may be used to treat various medical conditions.
Cannabis-based products are Class B1 controlled drugs and Ministerial approval is required before these can be prescribed, supplied or administered, in accordance with regulation 22 of the Misuse of Drugs Regulations 1977.
Please note that the Government does not support the use of unprocessed or partially processed cannabis leaf or flower preparations for medicinal use.
There are three types of cannabis-based products that may be considered for Ministerial approval:
- 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 as a non-consented product for some other medical conditions.
- 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.
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.
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.
More information on Sativex® and the application process to prescribe Sativex® for multiple sclerosis or “non-consented conditions” can be found on the Medsafe website(medsafe.govt.nz)
The requirement for Ministerial approval for Sativex® was delegated to the Ministry of Health some years ago.
2. Pharmaceutical grade cannabis-based 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 cannabis-based 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 if for non-approved use
- 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 6 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 cannabis-based 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 grade or not pharmaceutically prepared will not be approved for use in clinical trials.
The guidelines to assess applications to prescribe a non-pharmaceutical grade cannabis-based product 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 cannabis-based 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