Approved and unapproved medicines

New Zealand’s medicinal cannabis framework separates medicines into two legal categories: those that have been formally assessed and approved under the Medicinal Cannabis Scheme, and those that have not. The distinction determines whether a medicine can be prescribed, dispensed and legally possessed.

Approved and unapproved medicines: What Medsafe approval actually means

Medsafe, the New Zealand regulator within the Ministry of Health, 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 items that meet GMP (Good Manufacturing Practice) standards and are notified to the Ministry of Health.

An approved medicine is one that has been assessed by Medsafe and listed on the New Zealand Formulary. An unapproved medicine is any preparation that has not gone through this route. As of the scheme’s commencement on 1 April 2020, only items 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 preparations.

A common misconception is that “legal medicinal cannabis” means a patient can legally smoke raw plant material. That is wrong. The legal medicine is a manufactured pharmaceutical that meets GMP standards. 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 preparations 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 items. (Ministry of Health, 2020)

The regulator is Medsafe. Within it, the Medicinal Cannabis Agency (MCA) issues licences and manages the scheme. Approval is separate from quality: every preparation must be GMP-certified, and the MCA maintains a public list of “approved” items that meet the quality standard. “Approved” does not mean a preparation 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. 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 preparations that meet GMP standards, administered by the MCA. Legal access is via a prescription from a medical practitioner, and the items must be manufactured to pharmaceutical standards. Raw flower, while available, is prescribed and dispensed through a pharmacy, not a dispensary.

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

Driving and impairment: read this first

THC impairs driving. It is illegal to drive while impaired by any drug, including prescribed medicinal cannabis. A positive roadside saliva test for THC can result in prosecution even if you hold a valid prescription. New Zealand has a zero-tolerance approach for the presence of certain drugs in drivers. Discuss this risk with your prescriber before starting treatment and agree on a plan for when you will not drive after dosing.

How to get a prescription: step-by-step

1. Book an appointment with a New Zealand-registered medical practitioner. Any doctor can prescribe; no specialist referral is required, but the doctor must be willing to take responsibility for the prescription.
2. At the appointment, the prescriber must complete an informed consent process: discuss the evidence, risks, side effects and legal boundaries, and document this conversation in your notes.
3. The prescription must be for a “named patient” and specify the exact preparation, dose and administration route. Nurse practitioners cannot prescribe medicinal cannabis unless they hold a special authorisation under the Misuse of Drugs Act.
4. Leave the appointment with a clear treatment plan that includes review dates and criteria for stopping. Take the prescription to a pharmacy. The item will be dispensed there, not at a dispensary.

What “unapproved” means in practice

Most medicinal cannabis preparations prescribed in New Zealand are unapproved medicines. This does not mean they are illegal or substandard. It means they have not been assessed by Medsafe for efficacy in a specific condition. Instead, they are prescribed under the “named patient” provisions of the Medicines Act 1981. The prescriber takes responsibility for the decision, relying on the mandatory GMP certification and the MCA’s listing of the preparation as meeting quality standards. If you are offered a preparation that is not on the MCA’s public list of approved items, ask the prescriber to confirm its GMP status and legal basis for prescription before you accept it.