New Zealand has a complex and restricting set of cannabis regulations, but marijuana cultivation is allowed. So, how do you legally grow cannabis on the island?
The medical marijuana industry has come to New Zealand under hefty regulation. While there is always much fanfare for new cannabis markets, you will want to think hard before getting a New Zealand cannabis cultivation license. The small nation treats medical cannabis with the same regulation you would see in the pharmaceutical industry. While the standards and compliance measures are very detailed and clear, they are also very costly to adhere to.
Medical Cannabis Legalization in New Zealand
In October 2020, New Zealanders will get to vote on whether or not to legalize cannabis for personal recreational use. In 2019, their medicinal marijuana laws came into effect through The Misuse of Drugs (Medicinal Cannabis) Regulations 2019. Those regulations control the licensing, production, distribution, and sale of medical cannabis and impose the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods (GMP) to ensure their quality and safety.
New Zealand Cannabis Drug Scheduling
Under the Misuse of Drugs Act of 1975, possession of non-prescribed cannabis is still illegal. It carries a maximum jail sentence of 3 months or a $500 fine. The possession of 28 grams or more may also bring about penalties for intention to supply.
Medical Marijuana Regulation in New Zealand
Medical marijuana regulation in New Zealand is very complex. GMP (Good Manufacturing Practice) regulations are applied to all activities that occur after harvest, and producers must have validated processes that are based on a formal GMP risk assessment. It is advantageous to work with a team that is experienced in pharmaceutical regulation if you plan on starting a cannabis business in New Zealand.
Cannabis businesses will need to create a quality system that governs all of the activities happening within the venture. A security plan, a site master file, and an equipment master file are also a necessity. The New Zealand Medicinal Cannabis Agency oversees all licensing and audits.
New Zealand Cannabis License Options
- Cultivation license
- Nursery license
- Research license
- Manufacturing license
- Supplier license
How to Get a Cannabis License in New Zealand
If you want to become a cannabis cultivator in New Zealand, you will need to fulfil a number of requirements. Like in Canada, you will also need to have a site constructed and ready for operation. You’ll need to start by reading all of the Medical Cannabis Guidelines, especially Parts 2, 3, and 4 which explain the expectations for GMP compliance, non-GMP regulatory compliance, and the detailed requirements for obtaining a license. The Minimum Quality Standard is another regulatory document that must be read and understood.
These examples show how New Zealand cannabis growers must use a GMP risk assessment to provide a rationale for when they begin implementing GMP in their production process. Depending on the specific procedures a company uses, growers will need to take GMP measures after the cannabis is dried.
Images taken from Part 2 of The Medical Cannabis Guidelines.
Cannabis licenses in New Zealand are not overly expensive, but the cost of creating GMP compliant facilities, integrating its processes, and adhering to its policies is can be hefty. New Zealand cannabis license applications can be obtained online.
New Zealand’s Cannabis Recordkeeping Requirements
The recordkeeping requirements in New Zealand are extensive and must adhere to GMP regulations. Even if you are only growing cannabis flower, you will need to keep meticulous records and start GMP adherence 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
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 lost of destruction could result in major losses in productivity. The solution is thus having a software that is capable of seed-to-sale tracking and logging cultivation activities. Numerical data such as plant weight, as well as the handling of high-level quality management functions like CAPA and deviation reporting, record retention, and quality control inspections also need to be retained. GrowerIQ’s seed-to-sale software can help you with all your cannabis-related operations.
GMP Risk Assessments
A risk assessment is a formal process that is used to consider the level of risk when evaluating an establishment’s conformity to the GMP. This includes the nature and extent of the deviation(s) in relation to the type of products being handled and the activities being conducted. Quality Risk Management is a systematic process for the assessment, control, communication, and review of threats to the quality of the medicinal product. It can be applied both proactively and retrospectively.
The Principles of Quality Risk Management
- The evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the patient
- The level of effort, formality and documentation of the Quality Risk Management process is commensurate with the level of risk
- Risk assessment is an important tool that can assist in addressing deviations, corrective actions, complaints, and can help inform HACCP planning. During a risk assessment, an inspector assigns a risk classification to each observation, ranging from 1 for “critical,” to 2 for “major,” to 3 for “other.”
Risk assessments form a very formal procedure based on evidence and observations. One cannot simply base them on their own perspectives. GrowerIQ offers template SOPs for controlled quality management procedures such as risk assessment.
The risk assessment procedure helps you classify risks and use those assessments to justify quality control measures and procedures. All observations that are recorded in a report of risk analysis will require corrective action, regardless of the overall inspection rating attributed to the inspection.
Risk Assessment Classifications
Critical Observation (Risk 1)
Describes a situation that is likely to result in a product that may result in an immediate or latent health risk, or that involves fraud, misrepresentation or falsification of processes, products or data.
Major Observation (Risk 2)
Describes a situation that may result in the production of a drug not consistently meeting its marketing authorization. Some Risk 2 observations may be upgraded to Risk 1, for example in cases where the issue identified is not isolated to one area or system – these are indicated with an arrow (↑).
Other Observation (Risk 3)
Describes a situation that is neither critical nor major, but is a departure from the GMPs. Any Risk 3 observation could be upgraded to Risk 2.
Bearing in mind that risk assessment is just a pre-requisite to creating SOPs and a quality management system, the complexities of New Zealand’s cannabis regulations are evidently not to be taken lightly and are likely to require a dedicated team of professionals with experience both in cannabis and pharmaceutical regulation.
A highly experienced Quality Manager can help guide you through the process of establishing systems that will ensure you qualify for a license. Even with the obtention of a template SOP system, only a Quality Manager that can validate and customize for a business’s need.
Seed-to-Sale Software for New Zealand Cannabis Tracking
If you are looking to start a cannabis company in New Zealand, you will definitely need to have seed-to-sale tracking software in addition to quality management software and an ERP. Luckily, GrowerIQ has all of these features and can keep you GMP and GACP compliant when used properly. GrowerIQ also offers expert support and consulting that can help you create the intricate quality systems and procedures that the New Zealand cannabis program requires.
Find Out More
New Zealand’s marijuana industry is still in its first steps. Legalization of recreational use has yet to occur, but it is likely in the country’s near future. In the meantime, consult with GrowerIQ’s cannabis experts to find out how to hold a stake in New Zealand’s cannabis market and adhere to all its regulations. Our Seed-to-Sale software can facilitate the growing process and help you get a lucrative marijuana venture started. Learn more by filling out the form below!
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