A key aspect of the Medicinal Cannabis Scheme is the setting of minimum quality standards for medicinal cannabis products and ingredients. Suppliers of any medicinal cannabis products prescribed by a medical practitioner must provide evidence that they are of a consistent and reliable quality.
The quality standards apply when the Medicinal Cannabis Scheme takes effect on 1 April 2020.
All medicinal cannabis products supplied in New Zealand after 1 April 2020 must meet the minimum quality standards set in the regulations.
Any products imported before 1 April 2020 under a Licence to Import Controlled Drugs or a licence under the Medicines Act 1981 (eg, a Licence to Wholesale) will have a six month transitional period under the regulations ( Products must be assessed by the Medicinal Cannabis Agency by 1 October 2020).
- The Misuse of Drugs (Medicinal Cannabis) Regulations 2019 sets the minimum quality standard for medicinal cannabis products and ingredients
- Dried cannabis and pharmaceutical dosage products (eg, tablets and capsules) can be manufactured and supplied under the medicinal cannabis scheme
- Some products are controlled drugs and others are prescription medicines only, depending on the proportion of substances present in the product. The minimum quality standard applies to both classifications.
The table below lists the licenses required to supply medicinal cannabis products, the products and ingredients required to the meet the minimum standard and the classification that the license falls under. Product assessment fees can be found under the Medicinal cannabis licensing regime.
|Licence||Items that must meet minimum quality standard||Classification|
|Medicinal Cannabis Licence with a supply activity||
(Misuse of Drugs Act 1975)
|Licence under the Medicines Act 1981||
(Medicines Act 1981)
Licences for supply of cannabis-based products
A medicinal cannabis product or ingredient that is a controlled drug and meets the minimum quality standard based on evidence provided to the Medicinal Cannabis Agency can be named on a Medicinal Cannabis Licence that authorises supply.
CBD products that meet the minimum quality standard based on evidence provided to the regulator can be named on a licence issued under the Medicines Act 1981.
Items that must meet minimum quality standard
The minimum quality standard applies to the following medicinal cannabis products and ingredients:
Cannabis starting material
Starting material is fresh or dried cannabis used in or for a medicinal cannabis product. However, the minimum quality standard only applies if the starting material is intended to be exported.
A cannabis-based ingredient is extracted from cannabis and intended to be used in or for a dosage product. The minimum quality standard applies to both imported cannabis-based ingredients and domestically manufactured cannabis-based ingredients.
Medicinal cannabis products
A medicinal cannabis product is the finished product intended to be prescribed to a patient for a therapeutic purpose.
Medicinal cannabis products include:
- dried products
- dosage products.
A dried product is dried cannabis (eg, cannabis flowers) and a dosage product is a product that contains one or more cannabis-based ingredients and is in a pharmaceutical dosage form (such as a tablet, capsule or an oral liquid).
Medicinal cannabis products must not contain any prescription medicine or controlled drug other than cannabis or cannabis-based ingredient(s). The minimum quality standard applies to both imported medicinal cannabis products and domestically manufactured medicinal cannabis products.
CBD (cannabidiol) products
CBD Products are defined in section 2A of the Misuse of Drugs Act 1975. A CBD product must comply with the standard for a cannabis-based ingredient and a dosage product under the Medicinal Cannabis Regulations 2019.
A CBD Product can be a dosage product but cannot be a dried product. This is because a dried product is cannabis, which is a controlled drug. CBD products are not controlled drugs. The minimum quality standard applies to both imported CBD products and domestically manufactured CBD products.
Items that do not need to meet the quality standard
A cannabis-based ingredient or medicinal cannabis product does not need to meet the minimum quality standard if:
- it is supplied to a medical practitioner for a clinical trial
- it is a medicine that has been consented (approved) or provisionally consented for distribution by Medsafe
- it is prescribed, supplied or administered by a medical practitioner who has been granted Ministerial approval to prescribe the product
- it is imported or supplied by a pharmacy on behalf of a medical practitioner who has been granted Ministerial approval to prescribe the product.
Medicinal cannabis fall under two classifications, Prescription medicines only and Controlled drugs. The minimum quality standard applies to all cannabis-based medicines regardless of which classification they fall under.
Prescription medicines only
CBD products are prescription medicines under the Medicines Act 1981 and are not controlled drugs. The minimum quality standard set in the Misuse of Drugs (Medicinal Cannabis) Regulations 2019 applies to CBD products through section 4(A) of the Medicines Regulations 1984. Read more about CBD products and their definitions.
Medicinal cannabis products and ingredients are prescription medicines and controlled drugs when they are cannabis (eg, dried product) or contain specified substances such as delta-9-tetrahydrocanabinol (THC) above a certain quantity. Specified substances are defined in section 2A of the Misuse of Drugs Act 1975.
Requirements of the minimum quality standard
The requirements in Part one of the Medicinal Cannabis Regulations 2019 can be broadly put into three categories:
- requirements for testing with maximum limits
- other requirements
- testing and test methods.
Requirements for testing with maximum limits
The minimum quality standard sets the requirements for testing and the maximum limits (eg, limits of microbial contamination) that medicinal cannabis products and ingredients must comply with prior to import, export or supply in New Zealand. Methods used to test medicinal cannabis products and ingredients are taken from the European Pharmacopoeia which are referenced by chapter in the regulations.
Products and ingredients must comply with the maximum limit requirements and use the test methods specified in regulation 7 to assess the following quality aspects:
- microbial contamination
- heavy metals
- pesticides (imported products)
- pesticides (New Zealand products)
- absence of aflatoxins
- ochratoxin A
- foreign matter
- loss on drying
- total ash
- residual solvents.
The regulations include restrictions to control any contamination or adulteration of medicinal cannabis products. The restrictions set in the Medicinal Cannabis Regulations 2019 require that:
- products and ingredients must not be adulterated
- active ingredients and cannabinoids contained in a medicinal cannabis product must be extracted only from cannabis
- decontamination treatment of products and ingredients must not adversely affect the quality of the item or use or contain ethylene oxide
- smoking is a prohibited form of administration of products
- sterile dosage forms are prohibited
- products and ingredients must not have been treated with a pesticide unless the pesticide is a trade name product registered under the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997 for use on cannabis.
Other requirements set in the minimum quality standard
The minimum quality standard sets other requirements important to maintain the quality of the product. The requirements ensure that the product contains the correct ingredients, is consistent through its shelf life, is packaged and labelled appropriately and does not contain any ingredients that could pose a risk of harm.
For the purposes of the regulations, the active ingredients in cannabis-based ingredients and medicinal cannabis products are each of the following:
- delta-9-tetrahydrocannabinol (THC) and its corresponding acid, delta-9-tetrahydrocannabinolic acid (THCA)
- cannabidiol (CBD) and its corresponding acid, cannabidiolic acid (CBDA)
- any other ingredient derived from cannabis and whose stated content is at least 1.0 percent of the ingredient or product by weight or volume.
Identification of active ingredients
Any cannabis-based ingredient and medicinal cannabis product (including dried product) must identify active ingredients using chromatographic and/or spectroscopic methods. This includes THC, THCA, CBD, CBDA and any other ingredient derived from cannabis and at least 1.0 percent of the ingredient or product by weight or volume.
Assay limits for active ingredients
Each active ingredient in the ingredient or product must be assayed using chromatographic or spectroscopic methods and shown to be within the assay limits.
- For a dried product, each active ingredient must assay at no less than 80 percent of its stated content and no more than 120 percent of its stated content.
- For a cannabis-based ingredient or dosage product, each active ingredient must assay at no less than 90 percent of its stated content and no more than 110 percent of its stated content.
Shelf life and storage conditions
A cannabis-based ingredient or medicinal cannabis product must remain compliant with the requirements of the minimum quality standard relating to the following aspects during the entirety of its shelf life:
- microbiological contamination
- loss on drying
- assay limits for active ingredients
- form and dosage form.
Stability testing must be done on the ingredient or product in accordance with the ICH Q1A (R2) Guideline on Stability Testing of New Drug Substances and Products to determine its shelf life and recommended storage conditions.
Identification of cannabis
Any starting material for export and dried product must be identified as cannabis using microscopic and macroscopic examination.
Container material of a cannabis-based ingredient or medicinal cannabis products must comply with chapters 3.1 and 3.2 of the European Pharmacopoeia. This means that only the container materials in those chapters may be used for these items.
Medicinal cannabis products (dried products and dosage products) must meet the same requirements for packaging and labelling as other medicines in New Zealand, according to Part 4 of the Medicines Regulations 1984, with the following additional requirements:
- the active ingredient definition in the Medicinal Cannabis Regulations applies in the Medicines Regulations for these products
- the directions for use and dosing instructions are not required on the label
- the full labelling requirements in Part 4 of the Medicines Regulations 1984 apply to medicinal cannabis products, despite being unapproved medicines
- the principal display panel of the product’s label must contain the words ‘MEDICINAL CANNABIS PRODUCT’.
Dosage form requires that dosage products must be in a pharmaceutical dosage form as outlined in the European Pharmacopoeia. The monographs for dosage forms set out characteristics and relevant tests for particular dosage forms (eg, a tablet or capsule). A dosage product should behave in a manner appropriate to how it is intended to be taken or administered. Dosage form requirements do not apply to dried product.
Excipients and other ingredients
Excipients and other ingredients can only be used in a dosage product as outlined in the European Pharmacopoeia. Excipients are the non-active ingredients of a product. Any ingredient derived from an animal must not be contaminated with any transmissible spongiform encephalopathy (TSE).
Testing and test methods
Testing undertaken by laboratories or manufacturers must be certified as compliant with Good Manufacturing Practice (GMP). Any testing undertaken in another country must be undertaken by a laboratory or manufacturer that is certified by an Authority the Director-General of Health recognises as a certifier of compliance with GMP (eg, the Therapeutic Goods Administration (TGA), Australia). Please refer to the Medsafe website for GMP guidance.
Laboratories and manufacturers must use the test methods published in the European Pharmacopoeia (Edition 10.0) as referenced in the regulations.
Regulation 9 requires some test methods to be validated. Test methods should be validated according to ICH guideline Q2(R1) Validation of Analytical Procedures: Test and Methodology at each testing site intended for routine quality control of starting material for export, cannabis-based ingredient and medicinal cannabis product.
To meet the minimum quality standard, results must be submitted from tests performed on a representative sample of at least three pilot scale batches of cannabis-based ingredient and medicinal cannabis product. A pilot scale batch must be at least 10 percent of the size of a production scale batch (eg, if a full production scale batch is 10,000 tablets, a pilot scale batch is 1,000 tablets. Therefore three batches of at least 1,000 tablets must be sampled and tested to provide evidence that the product meets the minimum quality standard.).
Tests are to be performed on a representative sample of each consignment of starting material for export. A licence to export controlled drugs is issued on a per-consignment basis under the Misuse of Drugs Regulations 1977. This means that every time you want to export starting material, the consignment must be tested and evidence provided to the Medicinal Cannabis Agency that the consignment meets the minimum quality standard.
The minimum quality standard for each item (starting material for export, cannabis-based ingredient and medicinal cannabis product) must be met at the release of the ingredient/product from the producer/manufacturer and throughout the entirety of its shelf-life.
Further guidance on meeting the minimum quality standards and providing evidence to the Medicinal Cannabis Agency,will be available in February 2020.