Medicinal Cannabis Scheme guideline and forms

Key Changes to the Scheme July 2024 

This document intends to help current or potential licence holders understand the key changes to the Misuse of Drugs (Medicinal Cannabis) Regulations 2019 and provides guidance on how to comply with the new requirements.

Licensing Scheme Overview

This document provides an overview of the Medicinal Cannabis Scheme’s regulatory and licensing regime and outlines the types of medicinal cannabis licences that can be issued along with the purpose of each licence activity.

Information for New Zealand Manufacturers and Packers

This document provides prospective manufacturers and packers of medicinal cannabis products with relevant information about:

• the Licence to Manufacture Medicines and the Licence to Pack Medicines under the Medicines Act 1981
• how to comply with the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods.

Guidance for a New Medicinal Cannabis Product Application

This document outlines how to make an application for a new medicinal cannabis product.

Guidance for Applicants for a Medicinal Cannabis Licence

This document provides guidance on applying for a Medicinal Cannabis Licence under the Misuse of Drugs Act 1975 (the Act) and the Misuse of Drugs (Medicinal Cannabis) Regulations 2019 (the Regulations).

While we have made every effort here to explain the scope of the information that you need to provide in your application, it is your responsibility to understand your obligations under the Act and Regulations and provide true and accurate information in your application.

Please send all correspondence about your application to [email protected]

Guidance for a Changed Medicinal Cannabis Product Application

This document outlines the application and evidence requirements for approval from the Medicinal Cannabis Agency to make a planned change to a medicinal cannabis product or cannabis-based ingredient listed on a current licence.

Pesticide use on medicinal cannabis crops

This document provides an overview of the permitted pesticides which may be used on medicinal cannabis crops.

Forms

Form A: Application for a Medicinal Cannabis Licence

Form D: Declaration of illicit seed and plants

Form LA: Application to Amend a Medicinal Cannabis Licence

Form DP: Application to Change the Directors or Partners

Form R: Application to renew a Medical Cannabis Licence

NP Application Form: Application for assessment of a New Medicinal Cannabis Product

CP Application Form: Application for an assessment of a Changed Medicinal Cannabis Product