Medical Marijuana In New Zealand (Regulations & Guidelines For Producers)

Learn the latest updates on medical marijuana regulations in New Zealand

Are you curious about the guidelines for growing medical marijuana in New Zealand? Cannabis in New Zealand has been evolving rapidly, and the regulations around medical marijuana are changing as well.

Looking to learn about growing medical cannabis in New Zealand and how to stay compliant with local regulations? Consider GrowerIQ’s cannabis production software that can help you with just that.

Medical Marijuana Laws In New Zealand

In 2018, New Zealand passed a law to legalize medical marijuana under the Misuse of Drugs (Medicinal Cannabis) Amendment Bill Act. This legislation assigned the oversight of medical marijuana in New Zealand to the country’s Medical cannabis agency, which set regulations concerning how patients can access:

• Cannabis
• What products are available
• What formulations are legal or illegal.

Challenges in Accessing Medicinal Cannabis in New Zealand

The Misuse of Drugs Act Amendment legalized medicinal cannabis, New Zealand’s medical marijuana program has been criticized as among the strictest worldwide, making it very challenging for people to access effective medicine. 

Only recently, in 2021, the first New Zealand-made CBD medicines became available to patients. Only a few cannabis-based medicines are government-approved; before 2021, they had to be imported overseas.

Regulations on CBD Products and Government Approval

Cannabidiol (CBD) products that meet the legal definition of containing less than 2% of trace THC are the only products doctors can prescribe without government approval, except in rare medical cases. The government has also approved Sativex, but it must be ordered overseas.

Industrial Hemp Regulations and Restrictions on Cannabis Products

According to the Misuse of Drugs (Industrial Hemp) Regulations of 2006, industrial hemp is also allowed in New Zealand as long as it has less than 0.35% THC and is produced by a licensed producer. 

Outside New Zealand’s restrictive laws, all cannabis products besides CBD and Sativex are considered Class B1 controlled substances. Only those with terminal illnesses or seeking to treat multiple sclerosis spasticity can receive treatment with these medicines.

Legal Consequences for Cannabis-Related Activities

The possession, cultivation, sale, production, or substance use of Class B illicit drugs — including marijuana — can be punished by increasingly harsh penalties. Cultivation and trafficking charges can result in a lifetime prison sentence as a maximum penalty.

Public Opinion and Future of Cannabis Legalization in New Zealand

New Zealanders’ future with cannabis legalization and cannabis law reform remains uncertain. Voters did not pass a 2020 cannabis referendum determining whether to legalize its recreational use. And yet, in the same year as the 2020 referendum, a New Zealand study reported that 80% of survey participants favored medicinal use, and 26.8% supported recreational cannabis use.

Can You Grow Marjuana In New Zealand?

It is illegal for New Zealanders to cultivate cannabis for personal use, even if the person in question holds a prescription for medical marijuana. The cultivation of cannabis can be punished by up to seven years imprisonment, while possessing cannabis seeds can yield up to one year of prison time and a $500 fine.

Licensing Requirements for Cannabis Cultivation in New Zealand

Cannabis can only be cultivated by licensed producers as approved by the Medical Cannabis Agency. Those who want to work in the industry need to hold a medicinal cannabis license or work for a person or company that holds a license. The license will specify the types of activities that a license holder may carry out, such as commercial cultivation of cannabis or manufacture or supply of medicinal cannabis products.

Challenges Faced by Cannabis Growers

Cannabis growers face challenges in managing reporting, documentation, and compliance requirements due to the:

• Complexity of regulatory frameworks
• Evolving legal standards
• The need for accurate record-keeping in a highly regulated industry

GrowerIQ: A Solution for Cannabis Producers

GrowerIQ provides cannabis growers a comprehensive solution for managing compliance and quality throughout the seed-to-sale process. Uncomplicate Your Hemp Production with our:

• Seed-to-Sale Tracking
• Quality Management
• Cultivation Planning

Related Reading

• Industrial Hemp in New Zealand

How To Get A Licence To Produce Medicinal Marijuana In New Zealand

Licensing Types

Cultivation

If you plan to cultivate cannabis for medicinal purposes or supply seeds, plants, or plant material, you will need a cultivation activity specified in your license. This is a fundamental activity for cannabis farmers and producers.

Seed Supply

A seed supply activity may be more appropriate for individuals who function solely as seed merchants. This activity does not permit the cultivation or supply of cannabis plants or plant material.

Research

If you wish to supply or administer non-CBD medicinal cannabis products to research subjects in clinical trials or studies, you must hold a license with a research activity. Your products should comply with good manufacturing practice standards.

Possession for Manufacture

Those processing dried cannabis, extracting cannabis-based ingredients, manufacturing medicinal cannabis products, or performing related activities require a possession for manufacture activity specified on their license.

Supply

Individuals intending to supply or export starting material, cannabis-based ingredients, or medicinal cannabis products require a supply activity specified on their license.

To apply for a license, you must secure a suitable location, and the Medicinal Cannabis Agency will assess your application. Location inspections are conducted to ensure adequate security measures are in place. Depending on your business activities, you may also need other licenses.

Eligibility Requirements

To be eligible for a medicinal cannabis license, individuals and entities must meet certain criteria. These include:

• Being 18 or older
• Residing in New Zealand
• Having the expertise and resources to comply with regulations
• Meeting specific legal criteria

Medical Marijuana Minimum Quality Standard and Guidelines in New Zealand

The medicinal cannabis minimum quality standard is an essential aspect of the regulations surrounding medical marijuana in New Zealand. This standard is established in the Misuse of Drugs (Medicinal Cannabis) Regulations 2019 and further detailed in the Guideline on the regulation of medicinal cannabis in New Zealand

Guidance for a New Medicinal Cannabis Product Application

The primary objective of the medicinal cannabis minimum quality standard is to ensure that the products prescribed by medical practitioners to their patients are consistent and of high quality. To adhere to this standard, all suppliers of cannabis-based ingredients and medicinal cannabis products, including CBD products, must provide evidence to the Medicinal Cannabis Agency that their offerings meet this minimum quality standard before being permitted for distribution within New Zealand.

Minimum Quality Standard Assessments in Cannabis Production

The minimum quality standard assessments can encompass various evaluations, ranging from:

• Product assessments to supply starting materials
• Cannabis-based ingredients
• Medicinal cannabis products for export

For those engaging in export activities, a license to export a controlled drug for each consignment is mandatory. Import licenses from the importing countries are also required.

Exemptions to the Minimum Quality Standard for Cannabis Products

Certain exemptions exist where a cannabis-based ingredient or medicinal cannabis product does not need to meet the minimum quality standard. Products intended for clinical trials or studies under a medicinal cannabis license with a research activity are exempt products:

• Prescribed
• Supplied
• Administered by a medical practitioner under specific circumstances 

Are exempt from meeting the standard. The medicinal cannabis minimum quality standard plays a crucial role in ensuring the consistency and quality of medical marijuana products in New Zealand, providing a framework for maintaining high standards in the industry.

Related Reading

• Growing Medicinal Marijuana in New Zealand
• Cannabis Cultivation Compliance in New Zealand

Testing And Validation Of Testing Method

The medicinal cannabis minimum quality standard in New Zealand is determined by law. All suppliers must submit this validation to the Medicinal Cannabis Agency to provide evidence that cannabis-based ingredients, starting materials for export, and medicinal cannabis products meet the minimum standard. The testing requirements and maximum limits are based on the European Pharmacopoeia, which establishes quality standards for medicines and their components in New Zealand.

Microbial Contamination

To meet the minimum standard, medicinal cannabis must be tested for microbial contamination, ensuring a safe product for consumption. This includes testing for harmful microorganisms such as:

• Bacteria
• Molds
• Yeasts

Heavy Metals

Another essential aspect of testing is ensuring that medicinal cannabis products are free from heavy metals. High levels of heavy metals can pose serious health risks to consumers like:

• Lead
• Arsenic
• Mercury 

Pesticides

Testing for pesticides is crucial to ensuring that medicinal cannabis products are safe for consumption. Residue from pesticides used during cultivation can be harmful if ingested by patients, emphasizing the importance of this testing requirement.

Absence of Aflatoxins and Ochratoxin A

Aflatoxins and ochratoxin A are toxic substances produced by certain molds that can contaminate cannabis products. Testing for the absence of these toxins is vital to ensuring the safety and quality of medicinal cannabis products.

Foreign Matter, Loss on Drying, Total Ash, Residual Solvents

Additional qualities tested include:

• Foreign matter
• Loss on drying
• Total ash
• Residual solvents

Ensuring that medicinal cannabis products meet specific criteria for these qualities helps guarantee their safety and effectiveness for patients.

Quality Standard Compliance

Medicinal cannabis products must meet various other quality standards, including:

• Active ingredients
• Shelf life
• Storage conditions
• Container material
• Labeling
• Identification
• Dosage form
• Excipients
• Restrictions to control contamination

Laboratory Accreditation

Testing laboratories in New Zealand must comply with New Zealand GMP, and ISO/IEC 17025:2017 accreditation is recognized as appropriate for laboratories testing starting export material. This accreditation ensures testing facilities adhere to strict quality standards to provide accurate and reliable results for medicinal cannabis products.

Regulations On Importing And Exporting Medical Marijuana In New Zealand

Importing and exporting medical marijuana in New Zealand is subject to strict regulations. Medicinal cannabis license holders must also obtain a controlled drug import or export license if they intend to import or export cannabis seed, starting material, a cannabis-based ingredient, or a medicinal cannabis product. 

Medicines Control issues licenses to import or export controlled drugs, with a fee of $194.22 per license. A separate import or export license is required for each consignment, with potential delays if discrepancies are found in the application process. Cannabis nursery stock, including:

•  Plants
• Cuttings
• Rootstock
• Tissue for propagation
• Tissue culture

It cannot be imported until the Ministry for Primary Industries publishes a plant import health standard for cannabis plants. 

Requirements for Exporting Controlled Drugs from New Zealand

For exports from New Zealand, the destination country must provide a license to import controlled drugs before a permit to export controlled drugs can be issued. Ensuring that the consignment is described consistently across all licenses is crucial to avoid complications in the import or export process.

Medical Marijuana Product Assessments and Record-Keeping

In New Zealand, before producing or supplying any cannabis-based ingredient or medicinal cannabis product, producers must apply to the Medicinal Cannabis Agency for a product assessment. 

Assessment and Compliance for Medicinal Cannabis Products in New Zealand

This assessment is crucial as it verifies whether the products meet the minimum quality standard required in New Zealand. Once the assessment is completed and the product meets the standard, it will be added to the producer’s license, allowing them to supply the product within the country. 

Regulations for Export-Only Medicinal Cannabis Products and Cannabis-Based Ingredients

For export-only medicinal cannabis products and cannabis-based ingredients, there is a provision that allows these products to be listed on a medicinal cannabis license without the need for verification if they are manufactured in compliance with Good Manufacturing Practice (GMP) by a GMP-certified manufacturer and the importing country is willing to accept such products.

Record Keeping Requirements

The recordkeeping requirements in New Zealand are extensive, and you must adhere to GMP regulations. Even if you are only growing cannabis flowers, you will need to keep meticulous records and start adhering to GMP regulations in the drying stage, when risks to product safety and quality begin.

While some countries delay implementing GMP until after the buds are dried and cured, New Zealand is much more strict and requires its cannabis cultivators to behave like pharmaceutical producers. This requires having:

• Defined manufacturing batch number system
• Developed specifications for the raw materials, finished product, and primary packaging components
• Established the manufacturing process and written standard operating procedures
• Established the control points and critical parameters for the process
• Finalized batch manufacturing and packing records
• Amount/quantity of plants cultivates
• Amounts/quantities of mother plants, seeds, and clones (and failed plants/seeds)
• Plant destruction records
• Sales and distribution records
• Cannabis inventory
• Seed-to-sale tracking

The Importance of Digital Record-Keeping in Cannabis Cultivation

New Zealand does allow for the use of paper records, but with the strict requirements of their regulations, paper records are likely to become a liability. Their loss of destruction could result in significant losses in productivity. The solution is thus having software that is capable of seed-to-sale tracking and logging cultivation activities. Numerical data such as:

• Plant weight
• Handling of high-level quality management functions like CAPA and deviation reporting
• Record retention
• Quality control inspections

GrowerIQ’s seed-to-sale and quality management software can help you with all your cannabis-related operations, including compliance.

Importance of Digital Tools and Software

New Zealand allows the use of paper records, but due to the strict requirements of its regulations, paper records can become a liability, leading to potential productivity losses. Using software capable of seed-to-sale tracking and logging cultivation activities is essential for cannabis producers in New Zealand to stay compliant. 

Digital tools can help maintain numerical data such as plant weight and handle high-level quality management functions like:

• Corrective and Preventive Actions (CAPA)
• Deviation reporting
• Record retention
• Quality control inspections

GrowerIQ’s seed-to-sale and quality management software is an example of a tool that can assist cannabis producers in New Zealand with all their cannabis-related operations, including compliance with the country’s stringent regulations.

Uncomplicate Your Cannabis Production Today With GrowerIQ!

Cannabis growers in New Zealand face numerous challenges in managing reporting, documentation, and compliance requirements due to the:

• Complexity of regulatory frameworks
• Evolving legal standards
• The need for accurate record-keeping in a highly regulated industry

At GrowerIQ, our software offers a comprehensive solution for managing cultivation operations, ensuring compliance, optimizing quality, enhancing efficiency throughout the seed-to-sale process, and simplifying the production process overall.

Seed-to-Sale Tracking

Our software provides cannabis growers with an efficient seed-to-sale tracking system that allows for the seamless monitoring of every step in the cultivation process. With GrowerIQ, you can easily track the movement of plants, materials, and products, ensuring compliance with regulatory standards and maintaining accurate records for all transactions.

Quality Management

Quality is crucial in the cannabis cultivation process, and our software offers a range of functionalities to assist growers in optimizing the quality of their products. From monitoring environmental conditions to analyzing plant health, GrowerIQ provides growers with the tools they need to enhance the quality of their cannabis products and ensure customer satisfaction.

Cultivation Planning

Efficient cultivation planning is essential for maximizing yields and ensuring a smooth production process. With GrowerIQ, cannabis growers can:

• Create detailed cultivation plans
• Track progress
• Adjust as needed to optimize their operations
• Achieve the best possible results

Compliance Assistance

Compliance is a top priority for cannabis growers, and our software simplifies meeting regulatory requirements and maintaining accurate records. GrowerIQ helps growers navigate the complexities of compliance by providing tools that ensure adherence to legal standards and streamline reporting processes.