New and revised guidance and forms for verified medicinal cannabis products have been published.
Revisions have been made to provide up-to-date guidance to allow for changes to verified medicinal cannabis products, and to provide a specific form for starting material for export applications.
Part 2: Information for New Zealand Manufacturers and Packers
Part 2: Information for New Zealand Manufacturers and Packers has been revised to provide up-to-date guidance on the starting point of GMP and process validation requirements.
Part 3 Guidance for a New Medicinal Cannabis Product application
A new application form for a new medicinal cannabis product Type 3. Starting Material for Export (SME) has been introduced. This form is a revised version of the New Medicinal Cannabis Product (NMCP) application form. It is specific to Type 3: Starting Material for Export applications.
The NMCP application Part 3 Guidance has been revised to provide direction on the requirements and completion of an SME application form. The revision details how to apply for verification against the minimum quality standard for a lot of starting material for export. A lot can be exported in several consignments over a period of six-months.
The Part 3 guidance has also been revised to recognise that ISO/IEC 17025:2017 accreditation is acceptable for laboratories conducting non-critical testing of medicinal cannabis products and starting material for export.
In addition, clarification has been provided on stability data requirements for cannabis-based ingredient applications.
Part 5: Guidance for a Changed Medicinal Cannabis Product
Regulation 47 requires prior approval of changes to verified products before implementation.
A new form has been published, the CMCP application form. This form allows licence holders to apply for assessment of changes prior to implementation of these changes.
The new guidance, Part 5: Guidance for a Changed Medicinal Cannabis Product Application details the fees and documentation required for the assessment of the change.
You can find all of these files on the Medicinal Cannabis Scheme guideline and forms section.
If you have any further questions, please email the Medicinal Cannabis Agency at: medicinal_cannabis@health.
Medicinal cannabis products that meet the minimum quality standard
The Misuse of Drugs (Medicinal Cannabis) Regulations 2019 (the Regulations) set the minimum quality standard that medicinal cannabis products and ingredients must meet before they can be supplied in New Zealand. Importers, manufacturers, and suppliers must apply for assessment and provide evidence to the Medicinal Cannabis Agency to verify that their products meet the minimum quality standard.
ANTG Mariposa and ANTG Rocky have been verified as meeting the minimum quality standard.
More information on the products can be found on the Ministry of Health website.
