Approved and unapproved medicines

New Zealand’s medicinal cannabis framework separates products into two legal categories: those that have been formally assessed and approved under the Medicinal Cannabis Scheme, and those that have not. The distinction is not cosmetic, it determines whether a product can be prescribed, dispensed, and legally possessed in New Zealand. This page explains how Medsafe approval works, what “unapproved” means in practice, and the exact steps a prescriber and patient must follow under the Misuse of Drugs Act.

What Medsafe approval actually means

Medsafe is the New Zealand regulator within the Ministry of Health that assesses medicines for quality, safety, and efficacy. Under the Misuse of Drugs Act 1975, all medicines containing THC or CBD must be approved before they can be legally prescribed, dispensed, or imported for patient use. The Medicinal Cannabis Scheme, established under the Misuse of Drugs (Medicinal Cannabis) Regulations 2019, creates a legal pathway for products that meet GMP (Good Manufacturing Practice) standards and are notified to the Ministry of Health.

The key distinction: an approved medicine is one that has been assessed by Medsafe and listed on the New Zealand Formulary. An unapproved medicine is any product that has not gone through this route. As of the scheme’s commencement on 1 April 2020, only products that meet GMP standards and are approved by the Ministry of Health can be prescribed, dispensed, or imported for medicinal use. The Medicinal Cannabis Agency (MCA), part of Medsafe, manages the scheme and maintains a public list of approved products.

A common misconception is that “legal medicinal cannabis” means a patient can legally smoke raw plant material. That is wrong. The legal product is a manufactured pharmaceutical that meets GMP standards, and the raw flower, while available, is prescribed and dispensed through a pharmacy, not a dispensary. The scheme legalises access via a prescription from a medical practitioner, not a general licence to use cannabis.

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Medicinal cannabis in New Zealand

Medicinal cannabis in New Zealand is a regulated pharmaceutical pathway under the Misuse of Drugs Act 1975 (as amended by the Misuse of Drugs (Medicinal Cannabis) Amendment Act 2018). It is not a general licence to use cannabis. The scheme legalises access via a prescription from a medical practitioner, and products must meet GMP standards and be approved by the Ministry of Health. The thing newcomers most often get wrong is that “legal medicinal cannabis” does not mean a patient can legally smoke raw plant material or buy unregulated products; the legal product is a manufactured pharmaceutical, and the raw flower, while available, is prescribed and dispensed through a pharmacy, not a dispensary. (Ministry of Health, 2020)

The regulator is Medsafe, and within it, the Medicinal Cannabis Agency (MCA) issues licences and manages the scheme. Product approval is separate from product quality: every product must be GMP-certified, and the MCA maintains a public list of “approved products” that meet the quality standard. A product being “approved” does not mean it has been shown to work for a given condition; it means it meets the quality and manufacturing standards to be prescribed.

The Misuse of Drugs (Medicinal Cannabis) Amendment Act 2018 came into force on 1 November 2018, creating a legal pathway for patients to access medicinal cannabis products. The Medicinal Cannabis Scheme was then established under the Misuse of Drugs Regulations 2019, effective 1 April 2020. The scheme allows medical practitioners to prescribe cannabis products that meet GMP standards, and it is administered by the Medicinal Cannabis Agency (MCA), a unit within Medsafe. The key point: legal access is via a prescription from a medical practitioner, and the products must be manufactured to pharmaceutical standards. The raw flower, while available, is prescribed and dispensed through a pharmacy, not a dispensary.

Medsafe approval: Products must be approved by Medsafe under the scheme. There are two routes: fully consent-holder products (with a Medsafe product approval) and unapproved medicines. As of 2024, most medicinal cannabis products are unapproved medicines, prescribed under the “named patient” provisions of the Medicines Act 1981, with the prescriber taking responsibility. The Medicinal Cannabis Agency (MCA), part of Medsafe, issues licences for cultivation, manufacture, supply, and import/export under the Misuse of Drugs Act. GMP certification is mandatory for all products.

PRESCRIPTION REQUIREMENTS: - A medical practitioner registered in New Zealand must issue the prescription. Nurse practitioners cannot prescribe medicinal cannabis unless they hold a special authorisation under the Misuse of Drugs Act. - The prescriber must complete an informed consent process: discuss the evidence, risks, side effects, and legal boundaries, and document this conversation in the patient’s notes. - The prescription must be for a “named patient” and specify the exact product, dose, and administration route. - No specialist referral is required; any doctor can prescribe, but they must be willing to take responsibility. - The patient must be given a clear treatment plan, including review dates and criteria for stopping.