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. 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 medicinal cannabis 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
  • 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 prescribed, supplied or administered by a medical practitioner who has been granted Ministerial approval to prescribe the product to a named patient
  • it is imported or supplied by a pharmacy on behalf of a medical practitioner who has prescribed the product.

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 for meeting the minimum quality standard requirements:

  • 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 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
  • absence of aflatoxins
  • ochratoxin A
  • foreign matter
  • loss on drying
  • total ash
  • residual solvents.

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 1.0 percent of the ingredient or product by weight or volume.

Active ingredients must be assayed using chromatographic and/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

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.

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 propose a shelf life of 6 months and provide 6 months of stability data. If the Agency is satisfied, the product can be verified as meeting the minimum quality standard. Once further data is available, for example, 12 months or 24 months of stability data, the supplier submits a CMCP application with the data that supports the longer shelf life.

Option 2: Submit a NP application for a product with the available stability data and provide the full stability data when requested by the Agency. However, the product will not be verified as meeting the minimum quality standard until the Agency has received the stability data that adequately supports the proposed product shelf life.

For example, companies can provide 6 months of stability data with a proposed shelf life of 9 months. The NP application would need to pass a completeness check to be accepted for assessment. Any further information that is required for the Agency to verify the product meets the quality standard, such as the additional stability data, 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’.

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 of a product. They can be used in a dosage product and must follow the European Pharmacopoeia (10th edition).

Dosage products must also not contain any ingredient derived from an animal this 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.

Testing and validation of testing method

Testing facilities

All testing undertaken by laboratories or manufacturers 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, 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

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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