Medicinal Cannabis Agency - Minimum quality standard

The aim of the medicinal cannabis minimum quality standard is to ensure the consistency and quality of the products that medical practitioners prescribe to their patients.

The medicinal cannabis minimum quality standard is set out in the Misuse of Drugs (Medicinal Cannabis) Regulations 2019 and further explained in Guideline on the Regulation of Medicinal Cannabis in New Zealand Part 3: Guidance for Medicinal Cannabis Product application.

The aim of the medicinal cannabis minimum quality standard is to ensure the consistency and quality of the products that medical practitioners prescribe to their patients.

All suppliers of cannabis-based ingredients, starting material for export and medicinal cannabis products (including CBD products) must provide evidence to the Medicinal Cannabis Agency that their products meet the minimum standard before they can be supplied.

Definitions

Starting material is fresh or dried cannabis that is intended to be used in, or for, a medicinal cannabis product

A cannabis-based ingredient is extracted from cannabis and intended to be used in or for a dosage product.

A medicinal cannabis product is the finished product intended for therapeutic use. This includes material intended for compounding. It must not contain any prescription medicine or controlled drug other than cannabis or cannabis-based ingredients.

Medicinal cannabis products include:

  • dried products – for example, dried cannabis flowers
  • dosage products – products that contain one or more cannabis-based ingredients and are in a pharmaceutical dosage form such as a tablet, capsule or an oral liquid.

A CBD product is a dosage product or a cannabis-based ingredient that contains cannabidiol but little-to-no tetrahydrocannabinols (THC) or other specified substances. See detailed definition.

Application of the minimum quality standard

The following table sets out which items are required to meet the minimum quality standard.

Type Import For domestic supply For export
Starting material Not required Not required Required
Cannabis-based ingredients (including CBD products) Required Required Required
Medicinal cannabis products (including CBD products) Required Required Required

Exemptions

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 under a medicinal cannabis licence with a ‘research’ activity. Read more.
  • it has consent or provisional consent for distribution under the Medicines Act 1981 (ie, it is an approved medicine such as SativexTM or has provisional approval)
  • it is a CBD product prescribed, supplied or administered by a medical practitioner to a named patient
  • it is a controlled drug and is prescribed, supplied or administered by a medical practitioner who has been granted Ministerial approval to prescribe the product to a named patient under their care
  • it is imported or supplied by a pharmacy on behalf of a medical practitioner who has prescribed the product to a named patient under their care.

Requirements of the minimum quality standard

Part 1 of the Misuse of Drugs (Medicinal Cannabis) Regulations 2019 sets out the minimum quality standard for medicinal cannabis products. There are three broad categories of requirements for meeting the minimum quality standard:

  • requirements for testing with maximum limits
  • other quality requirements
  • testing and validation of testing method.

Requirements for testing with maximum limits

The minimum quality standard sets testing requirements and maximum limits (eg, limits for microbial contamination) that medicinal cannabis products and ingredients must comply with prior to import, export or supply in New Zealand.

The testing requirements and maximum limits are based on the European Pharmacopoeia (10th edition), which provides quality standards for medicines and their components. Medicinal cannabis must be tested for:

  • microbial contamination
  • heavy metals
  • pesticides[1]
  • absence of aflatoxins
  • ochratoxin A
  • foreign matter
  • loss on drying
  • total ash
  • residual solvents.

[1] Regulation 7(2) sets out a list of pesticides that domestic starting material for export (SME), cannabis-based ingredients (CBI) and medicinal cannabis products, must be tested for. Currently this list has some pesticides that cannot be tested for in New Zealand for crude oils only.

Due to the limitations in testing for crude oils in New Zealand, the Agency requires any applications for CBI, not tested to the complete list of pesticides, to include a justification as to why they have not been completely tested. The justification should include confirmation that these untested pesticides are not used in the cultivation of the cannabis used to manufacture the CBI.

Other quality requirements

The minimum quality standard sets other requirements that are important for the quality of the medicinal cannabis product. These ensure 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 high risk of harm.

Active ingredients

For the purposes of the minimum quality standard, the active ingredients in cannabis-based ingredients and medicinal cannabis products are:

  • 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 one percent of the ingredient or product by weight or volume.

Active ingredients must be identified and assayed using chromatographic and/or spectroscopic methods and shown to be within the specified 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

Stability testing must be carried out on cannabis-based ingredients and medicinal cannabis products 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. 

For the entirety of its shelf life, the ingredient or product must remain compliant with the minimum quality standard requirements for:

  • microbiological contamination
  • loss on drying
  • assay limits for active ingredients
  • form and dosage form.

Suppliers may only have data to support a short shelf life because long-term stability data is not yet available for their product. In these instances, there are two options when applying for a product assessment. Note that all applications still need to pass the completeness check to be accepted for assessment.

Option 1: Submit a new product (NP) application with a shelf life that is supported by the stability data available at the time of submission. When data supporting a longer shelf life becomes available, apply for a Changed Medicinal Cannabis Product (CMCP).

For example, a supplier can submit six months of stability data with the application and propose a shelf life of six months. If all the data has been satisfactorily reviewed, the product can be verified as meeting the minimum quality standard. When further data is available, for example, 12 months or 24 months of stability data, the supplier may submit a CMCP application with the data that supports the longer shelf life.

Option 2: Submit a new product (NP) application for a product with the available stability data and a longer proposed shelf life. The full stability data supporting the proposed shelf life must be provided when requested by the Agency. The product will not be verified as meeting the minimum quality standard until the Agency has received the full stability data that adequately supports the proposed product shelf life.

For example, companies can provide six months of stability data with a proposed shelf life of nine months. Any further information that is required for the Agency to verify the product meets the quality standard, such as the additional stability data supporting a longer shelf life, will be requested after the initial assessment.

Identification

Any starting material for export and dried product must be identified as cannabis using microscopic and macroscopic examination.

Container material

The container material for a cannabis-based ingredient or medicinal cannabis product must be one of the materials set out in chapters 3.1 and 3.2 of the European Pharmacopoeia (10th edition).

Labelling

Medicinal cannabis products must meet the packaging and labelling requirements for medicines set out in Part 4 of the Medicines Regulations 1984, with the following variations:

  • the definition of ‘active ingredient’ in the Misuse of Drugs (Medicinal Cannabis) Regulations 2019 applies for these products
  • 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
  • the principal display panel of the product’s label must contain the words ‘MEDICINAL CANNABIS PRODUCT’.

In addition for Non-CBD products:

In the upper part of the principal display panel, printed in conspicuous block capital letters, the words “CONTROLLED DRUG”, followed immediately by the appropriate designation specified in subclause (2):

  • Class B1 for extracts
  • Class C1 for dried product.

Dosage form

Medicinal cannabis products (including CBD products) that are dosage products must be in a pharmaceutical dosage form for which there is a monograph in the European Pharmacopoeia (10th edition). The product must comply with the requirements of the monograph and must not be in a sterile dosage form such as eye drops.

Dosage form requirements do not apply to dried product.

Excipients and other ingredients

Excipients are the non-active ingredients used to help formulate a product. They must comply with the European Pharmacopoeia (10th edition) requirements.

Dosage products must also not contain any ingredient derived from an animal that is contaminated with any transmissible spongiform encephalopathy (TSE).

Restrictions to control contamination, adulteration and form

The minimum quality standard includes restrictions to control any contamination or adulteration and the form of medicinal cannabis products. These require that:

  • active ingredients and cannabinoids within a medicinal cannabis product must be extracted only from cannabis
  • products and ingredients must not be adulterated
  • decontamination treatment of products and ingredients must not adversely affect quality, and must not use or contain ethylene oxide
  • products must not be in a form intended for smoking
  • products must not be in a sterile dosage forms (eg, eye drops)
  • products and ingredients must not have been treated with a pesticide unless the pesticide is a tradename product registered under the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997 for use on cannabis. See the Pesticide active ingredients section below for exceptions.

Pesticide active ingredients that the Agency has no objection to for use in the cultivation of medicinal cannabis 

The Medicinal Cannabis Agency (the Agency) is aware that some growers wish to use pesticides on their crops and the Regulations currently do not allow this. While this issue is explored further, we propose an interim solution of allowing certain pesticide active ingredients to be used on medicinal cannabis crops.

Licence holders must still comply with all other requirements of the Regulations, including Regulation 7, which specifies pesticides that must be tested for and their limits. 

Read more about Pesticide active ingredients.

Testing and validation of testing method

Testing facilities

Testing laboratories or manufacturers testing medicinal cannabis or products must be certified as compliant with the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods (the Code of GMP).

Where testing is undertaken outside New Zealand and evidence of GMP-certification is provided, the laboratory or manufacturer must be certified by an authority recognised by Medsafe as listed in Part 4 of the Guideline on the Therapeutic Products in New Zealand.

See the Medsafe website for further information about GMP

ISO/IEC 17025:2017 accreditation

Medicinal cannabis products and cannabis-based ingredients are required to be manufactured by a manufacturer certified as compliant with the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods (the Code of GMP).

ISO/IEC 17025:2017 accreditation is recognised as appropriate for laboratories testing starting material for export. It is also recognised as appropriate for laboratories testing cannabis-based ingredients and medicinal cannabis products for tests not considered critical.

Tests that measure variables considered critical must be performed by a GMP-certified laboratory or manufacturer. Other testing required by the regulations may be performed at GMP or ISO/IEC 17025:2017 accredited laboratories (Table 1).

Where testing is undertaken outside New Zealand and evidence of GMP-certification is provided, the laboratory or manufacturer must be certified by an authority recognised by Medsafe as listed in Part 4 of the Guideline on the Therapeutic Products in New Zealand.

ISO accreditation will only be accepted for accredited domestic and international laboratories who are signatories of the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Agreement.

See the Medsafe website for further information about GMP

See the IANZ website for further information about ISO/IEC 17025:2017.

Table 1. GMP and ISO/IEC 17025:2017 appropriate tests

Critical Tests - GMP

Other tests - GMP or ISO/IEC

Assay limits for active ingredient

Microbiological contamination

Form and dosage form

Identification of cannabis

 

Identification of active ingredients

 

Heavy metals

 

Pesticides (imported products)

 

Pesticides (domestic products)

 

Absence of aflatoxins

 

Ochratoxin A

 

Foreign matter

 

Total ash

 

Residual solvents

 

Loss on drying

Tests not considered critical do not require evidence of method validation to be submitted to the Agency if the testing laboratory uses the applicable European Pharmacopeia method. An exception to this is in the case of identification for active ingredients. For the identification test for active ingredients, performed by an ISO/IEC 17025:2017 accredited laboratory, the Agency will require method validation in line with ICH Q2 (R1) guidance.

Test methods

Laboratories and manufacturers must use the test methods published in the European Pharmacopoeia (10th edition) and referenced in the Misuse of Drugs (Medicinal Cannabis) Regulations 2019.

Regulation 9 requires some test methods to be validated. Test methods for the routine quality control of starting material, cannabis-based ingredients and medicinal cannabis product must be validated by a GMP-certified manufacturer or laboratory.

Batch sampling

To verify that a cannabis-based ingredient or a medicinal cannabis product meets the minimum quality standard, results must be submitted from tests performed on a representative sample of at least three pilot-scale batches.

A pilot-scale batch must be at least 10 percent of the size of a production-scale batch. For example, where a production-scale batch is 10,000 tablets, three batches of at least 1,000 tablets must be sampled and tested to provide evidence the product meets the minimum quality standard.

To verify that starting material for export meets the minimum quality standard, a representative sample of each consignment must be tested.

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