Cannabis Legalization in New Zealand
On December 11, 2018, the New Zealand Parliament passed the Misuse of Drugs (Medicinal Cannabis) Amendment Bill which proposed to improve access to medicinal cannabis for New Zealanders suffering from terminal illness. The bill also permits companies to manufacture medical cannabis products for domestic and international markets and removes cannabidiol as a controlled drug, establishing it as a prescription medicine. Regulations to enable a Medicinal Cannabis Scheme were passed on the 18 December 2019 and came into effect on April 1, 2020.
New Zealand Cannabis Business Licenses
There are five types of licences relating to the supply of medicinal cannabis products available:
A cultivation license authorizes:
- Cultivation of cannabis for use in medicinal cannabis products.
- Cultivation and supply of seeds or plants to another cultivator or a medicinal cannabis license holder.
- Cultivation of starting material for export by a licensed supplier.
- Performing research involving cultivation.
Additional requirements:
- For importing seeds, application for a controlled drug import license is needed for each consignment of seeds. The imported seeds must meet the specifications of MPI Import Health Standard HIS 155.02.05.
- Up to 20 plants and 50 seeds can be declared at a time when bringing varieties of cannabis already established in New Zealand into the Medicinal Cannabis Scheme. Each declaration has a fee of $747.50.
(application fee $5,462.50; license renewal fee $3,392.50)
A seed supply license authorizes:
- Importing cannabis seeds under an import license.
- Exporting cannabis seeds under an export license.
- Purchasing cannabis seeds from a licensed cultivator.
- Supplying seeds to medicinal cannabis license holders with the “cultivation” specific license.
Additional requirements:
- For importing seeds, application for a controlled drug import license is needed for each consignment of seeds. The imported seeds must meet the specifications of MPI Import Health Standard HIS 155.02.05.
(application fee $747.50; license renewal fee: $747.50)
A manufacture license authorizes:
- Processing dried cannabis.
- Extracting a cannabis-based ingredient.
- Manufacturing a medicinal cannabis product.
- Developing test methods.
- Performing laboratory testing.
- Engaging in product development of medicinal cannabis products.
Additional requirements:
- Need to hold a License to Manufacture Medicines issued under the Medicines Act 1981.
- If planned activities are limited to re-packing products that have been manufactured by a GMP-compliant facility and meet the medicinal cannabis minimum quality standard, a License to Pack Medicines is needed instead of a License to Manufacture Medicines.
- To obtain these licenses, compliance with the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods (The Code of GMP) needs to be shown.
- Further information about GMP, the GMP audit process and responsibilities of Medicines Act license holders can be found here.
- Medsafe provides guidance on manufacturing medicines and the regulation of therapeutic products in New Zealand.
- Any products that are for patient use must meet the medicinal cannabis minimum quality standard.
- For conducting tests on medicinal cannabis products to determine whether they meet the medicinal cannabis minimum quality standards, the facility will need to be certified under the Code of GMP for critical tests. For non-critical tests, the ISO (International Organization for Standardization) certification is sufficient.
- For testing products only for regulatory purposes and not for developing medicinal cannabis products, testing activities can be performed under a License to Deal in Controlled Drugs. A medicinal cannabis license is not required.
(application fee $3,105.00; license renewal fee: $2,645.00)
A supply license authorizes supplying or exporting starting material, cannabis-based ingredients or medicinal cannabis products.
Additional requirements:
- Be familiar with the New Zealand Medicines and Medical Devices Recall Code.
- The Medicinal Cannabis Agency expects those holding a supply license to have:
- Procedures to manage complaints and recalls.
- Procedures for effective batch release and tracking of distributed stock.
- A plan of response to questions from media, consumers, healthcare professionals and other interested parties.
- Procedures to advise the Medicinal Cannabis Agency of emerging problems such as recalls, withdrawals or the suspension of market authorization in other jurisdictions.
- Apply to the Medicinal Cannabis Agency for a product assessment before supply of any medicinal cannabis products intended for use by patients, cannabis-based ingredients or shipment of starting material for export. Fees for new medicinal cannabis product assessment can be found here.
- For exporting, a license to export a controlled drug must be obtained for each consignment. An import license must also be obtained from the importing country.
- For exporting a cannabis ‘starting material’ for extemporaneous compounding (for example, in magistral or officinal preparations), minimum quality standard has to be met. GMP requirements also have to be met and a License to Manufacture Medicines or a License to Pack Medicines is required.
(application fee $6,382.50; license renewal fee $5,992.50)
A research license authorizes supplying or administering a medicinal cannabis product that is not a CBD product to a person who is a research subject in a clinical trial. Additional requirements:
- Approval under section 30 of the Medicines Act 1981 is needed to conduct clinical trials on humans.
- For importing starting material, cannabis-based ingredients or medicinal cannabis products, an application for an import license for each consignment is necessary.
Only the fees for initial check and Medicinal Cannabis License are applicable.
Information taken from the Ministry of Health of New Zealand. All fees are in New Zealand dollars and include GST. All application fees are non-refundable, even if the application is declined.
Activity fees are charged per location. If applicants plan to perform the same activity at two different locations, they will need to pay two activity fees. All applicants must first pay a fee for an initial check and obtain a Medicinal Cannabis License. Applicants must apply for at least one activity that will be specified on their Medicinal Cannabis License in the initial application. They can then add another activity at any time after the Medicinal Cannabis Agency has issued a license.
Initial check:
- New application fee: $345.00
- Annual renewal fee: $345.00
Medicinal Cannabis License:
- New application fee: $2,587.50
- Annual renewal fee: $2,587.50
In 2020, there were 20 companies licensed to grow cannabis for research purposes, and in 2023 the number of cannabis companies increased to 37 nationwide. According to the Medicinal Cannabis Agency, there were 42 license holders as of June 2024.
In July 2024, the New Zealand government amended the Misuse of Drugs Regulations, stating that operators exporting medical cannabis now only have to meet the quality standards in the countries they are exporting to.
Cannabis Delivery Service in New Zealand
The Medicinal Cannabis Scheme does not provide for home delivery of medical cannabis.
New Zealand Cannabis Taxes
Only the usual sales tax applies to medicinal cannabis. There is no excise tax applied to medicinal cannabis.
New Zealand Licensing Process
Before you apply:
- Decide what kind of business you want to establish.
- Ensure that you have a suitable location for your business.
- Have proper security arrangements in place.
- Read the guide from the Ministry of Health of New Zealand about applying for a Medicinal Cannabis License.
- Ensure that you are eligible to hold a license.
- If the license applicant is an entity, there must be 1 or more individuals nominated to be a ‘responsible person’: someone who is authorized to control the activity or activities for which the license was obtained and to communicate with the Medicinal Cannabis Agency on behalf of the entity.
- Check if you need any additional licenses: for example, a license to manufacture medicines. Fees for these licenses are additional to the fees for a medicinal cannabis license.
- Develop a cannabis business plan to estimate the start-up expenses and potential profitability.
The application and review process will follow the timeline below:
Application submission: For an electronic submission, the application form along with the supporting documents must be scanned and emailed to medicinalcannabis@health.govt.nz. Alternatively, copies of the application form and supporting documents can be posted to the address indicated in the guide.
Initial check of application: The initial check ensures that the application is complete and that all relevant documents are included. The invoice for the initial check must be paid in order for it to commence.
Full assessment of application: The Medicinal Cannabis Agency will perform an evaluation of the application to make sure that it meets the regulatory requirements. During the assessment of the application, the Medicinal Cannabis Agency may ask for additional information or explanation of the information provided. The fee for the Medicinal Cannabis License and for each activity that the license will cover should be paid before the full assessment of the application can begin.
Inspection of the location: Inspections must be scheduled at least one month in advance. They are performed to ensure that proper security arrangements are in place.
Issue of a Medicinal Cannabis License: If the Agency approves the application, the license to perform the relevant activities at the specified locations is issued for up to one year.
The application for renewal of a license should be made no earlier than 90 days and no later than 30 days before the expiry of the license.
The application must provide information in a form and manner as prescribed by the Director-General (the chief executive of the responsible department) which may include, but is not limited to the following:
- The name, address, and contact details of the applicant or in the case of a body corporate or partnership, the name of every director or partner and the “name, address, and contact details of each person nominated to be a responsible person”.
- The 1 or more types of licensed activities to be added to the license.
- “A declaration from each person nominated to be a responsible person that they are eligible under regulation 31.”
- Information about locations to be used for the licensed activities for which the license is sought.
- The details of adequate arrangements for physical and procedural security as well as the security of staff members at the locations that are to be used for the licensed activities.
- The details of standard operating procedures for each activity.
- The location where the records of the activities will be kept.
- Adequate additional information to enable the Director-General to assess the eligibility of the applicant to hold a license for the activity. Additional information specified for each activity can be found here.
In case the license application is declined, the applicant can apply to the Director-General of Health for a review of the decision. The application for a review must be received by no later than 14 days after the day that the Agency gave notice of their decision to the applicant. The reviewer will conduct the review “in line with regulation 41 of the Misuse of Drugs (Medicinal Cannabis) Regulations 2019”.
What is next:
- Every license holder and every responsible person must comply with all conditions imposed on the license holder by the regulations and ensure that every employee, agent and contractor complies with the regulations as well.
- Any starting material intended for export, a cannabis-based ingredient or a medicinal cannabis product should meet the minimum quality standard with the exceptions mentioned here. The requirements for meeting the minimum quality standard include:
- Requirements for testing with maximum limits
- Other quality requirements
- Testing and validation of testing method
- Any testing or validation of testing method required for meeting the minimum quality standard should be carried out by a GMP-certified manufacturer or laboratory.
- Stability testing must be done on any cannabis-based ingredient or medicinal cannabis product in accordance with the ICH Q1A Guideline to determine its shelf life and recommended storage conditions.
- Any starting material intended for export or a dried product must be positively identified as cannabis by use of both macroscopic and microscopic examination.
- The active ingredients in a cannabis-based ingredient or a medicinal cannabis product must be positively identified by use of chromatographic or spectroscopic methods.
- A container made of a material that complies with chapters 3.1 and 3.2 of the European Pharmacopoeia must be used for packing a cannabis-based ingredient or a medicinal cannabis product.
- Only a pesticide which is a trade name product that is registered under the Agricultural Compounds and Veterinary Medicines Act 1997 for use on cannabis can be applied.
- An authorized person should be allowed to inspect a location specified in the license at any reasonable time.
- The Director-General can take samples of cannabis and cannabis products at any time to examine or test them.
- The applicant shall establish any standard operating procedures required by the regulations, including security; recordkeeping; employee qualifications, supervision, and training; quality assurance; adverse event reporting and recall; waste disposal and sanitation; transportation of medicinal cannabis; inventory management, including storage and labeling of medicinal cannabis; cash management and anti-fraud procedures; and preventing unlawful diversion of medicinal cannabis.
New Zealand Cannabis Market Infographics
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