Medicinal Cannabis Scheme guideline and forms

Part 1: Licensing Scheme Overview

• Part 1 will be available soon

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.

Part 2: Information for New Zealand Manufacturers and Packers

• Part 2: Information for New Zealand Manufacturers and Packers Version 2.0 (Word, 322 KB)
• Part 2: Information for New Zealand Manufacturers and Packers Version 2.0 (PDF, 313 KB)

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.

Part 3: Guidance for a New Medicinal Cannabis Product Application

• Part 3: Guidance for a New Medicinal Cannabis Product Application Edition 2  (Word, 339 KB)
• Part 3: Guidance for a New Medicinal Cannabis Product Application Edition 2 (PDF, 549 KB)

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

Part 4: Guidance for Applicants for a Medicinal Cannabis Licence

• Part 4: Guidance for Applicants for a Medicinal Cannabis Licence (Word, 363 KB)
• Part 4: Guidance for Applicants for a Medicinal Cannabis Licence (PDF, 535 KB)

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]

Part 5: Guidance for a Changed Medicinal Cannabis Product Application

• Part 5 Guidance for a Changed Medicinal Cannabis Product Application (Word, 324 KB)
• Part 5 Guidance for a Changed Medicinal Cannabis Product Application (PDF, 400 KB

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.

Forms

Form A: Application for a Medicinal Cannabis Licence

• Section A: Applicant details and declaration (Word, 272 KB)
• Section B: Cultivation activity (Word, 47 KB)
• Section C: Nursery activity (Word, 39 KB)
• Section D: Research activity (Word, 42 KB)
• Section E: Possession for manufacture activity (Word, 46 KB)
• Section F: Supply activity (Word, 39 KB)

Form D: Declaration of illicit seed and plants

• Form D: Declaration of illicit seed and plants (Word, 258 KB)

Form LA: Application to Amend a Medicinal Cannabis Licence

• Form LA: Application to Amend a Medicinal Cannabis Licence (Word, 282 KB)

Form R: Application to renew a Medical Cannabis Licence

• Section RA: Applicant details and declaration (Word, 359 KB)
• Section RB: Cultivation activity (Word, 40 KB)
• Section RC: Nursery activity (Word, 34 KB)
• Section RD: Research activity (Word, 32 KB)
• Section RE: Possession for manufacture activity (Word, 35 KB)
• Section RF: Supply activity (Word, 35 KB)

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

• NMCP application form: Application for assessment of a New Medicinal Cannabis Product (Word, 268 KB)

SM Application Form: Application for the assessment of a New Medicinal Cannabis Product: Type 3 Starting Material for Export

• SM application form (Word, 277 KB)

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

• CP application form (Word, 274 KB)