New Zealand became one of the first countries to grant regulatory approval for a named prescriber to administer psilocybin in therapy — under Section 29 of the Medicines Act.
New Zealand's Medsafe approval allows individual psychiatrists to prescribe, supply, and administer psilocybin to named patients with treatment-resistant depression — lawfully, outside a formal clinical trial.
Before June 2025, no one could legally prescribe psilocybin in New Zealand outside a research setting. The first approval changed that. It does not make psilocybin legal in general. It creates a narrow medical pathway for qualified specialists.
Psilocybin stays a Class A controlled drug under the Misuse of Drugs Act 1975. Approved prescribers operate under a specific ministerial exemption, not a broad reclassification. Anyone else who supplies or uses psilocybin remains subject to criminal penalties.
New Zealand is one of a small group of countries — alongside Australia, Canada, and Switzerland — that now permit psilocybin use in a supervised clinical setting. The NZ scheme is the youngest and most restricted of these. It is significant because New Zealand moved faster than the UK or most of Europe, and did so without a dedicated legislative act — using existing controlled-drug regulations instead.
As of mid-2026, Medsafe is processing additional applications. The number of approved prescribers is small but growing. This page tracks the current state of access for New Zealand patients and clinicians.
Two separate legal instruments give New Zealand prescribers the ability to use psilocybin in a clinical setting: Regulation 22 of the Misuse of Drugs Regulations 1977 (for the controlled-drug layer) and Section 29 of the Medicines Act 1981 (for the unapproved-medicine layer).
Regulation 22 governs controlled drugs that require ministerial approval before a clinician can prescribe them. Psilocybin falls into this category because it is a Class A substance. A prescriber must apply to the Minister of Health — in practice, through Medsafe — and show clinical justification for each intended use. Approvals under Reg 22 name a specific prescriber and a specific patient or defined patient group. They are not transferable.
Section 29 of the Medicines Act 1981 covers unapproved medicines — products that have not gone through Medsafe's standard marketing approval process. It allows a licensed prescriber to supply an unapproved medicine to a named patient under their care. Because no psilocybin product is Medsafe-approved in New Zealand, every prescription also needs to satisfy Section 29 as well as Reg 22. A prescriber who holds Reg 22 approval can use Section 29 to then source and supply the compound.
Professor Cameron Lacey, a Christchurch-based psychiatrist and clinical academic, received the first Medsafe approval to prescribe psilocybin in New Zealand on 19 June 2025.
The announcement came alongside a separate Medsafe decision to make melatonin available over the counter — both were part of a package of access changes announced by the government that month. Professor Lacey's approval covers patients he has personally assessed and diagnosed with treatment-resistant depression. The approval is his alone.
In media interviews following the approval, Professor Lacey said he hoped the pathway would be widened quickly so more patients could benefit. He described the process of applying as "complex but achievable" for psychiatrists who already have clinical experience with psychedelic research.
The approval lets Professor Lacey prescribe, supply, and administer psilocybin. That last word — administer — is important. It means he can be physically present during dosing sessions, not just write a prescription and send the patient home. Psilocybin sessions under this scheme happen in a clinical setting, with the prescriber or a supervised team present throughout the experience.
Medsafe approvals for psilocybin are currently limited to patients with treatment-resistant depression — meaning people who have not improved after at least two adequate courses of antidepressant treatment.
There is no published minimum number of failed treatments written into Regulation 22 itself. The clinical threshold is set by the prescriber's treatment proposal, which Medsafe reviews. In practice, applications have followed the definition used by most clinical trials: at least two antidepressants at adequate dose and duration, without sufficient response.
Patients must also pass a clinical screen. Prescribers are required to assess for contraindications including:
These criteria mirror those used in the COMPASS Pathways and Imperial College London clinical trials that underpinned Medsafe's decision to open the pathway. New Zealand does not yet have a domestic clinical trial dataset of its own.
A psychiatrist who wants to prescribe psilocybin must submit a formal application to Medsafe under Regulation 22 of the Misuse of Drugs Regulations 1977. Medsafe published detailed guidance on the application process in July 2025.
The application must include:
The peer-review requirement is the most distinctive step. Before Medsafe considers an application, another qualified clinician must assess the treatment proposal. This is not a formal ethics committee review (as required in Australia), but it functions similarly — it screens out applications that lack adequate clinical rationale.
See the guide to becoming a psychedelic therapist for training routes that build the experience base Medsafe expects.
Australia's TGA Authorised Prescriber scheme and New Zealand's Regulation 22 pathway both allow psilocybin use outside a clinical trial, but they work in structurally different ways. The Australian scheme is broader; the New Zealand scheme is narrower and more case-by-case.
| Feature | New Zealand (Reg 22) | Australia (TGA Authorised Prescriber) |
|---|---|---|
| Effective date | June 2025 (first approval) | 1 July 2023 |
| Approval body | Medsafe / Minister of Health | TGA + Human Research Ethics Committee |
| Who can prescribe | Psychiatrists approved individually by Medsafe | Psychiatrists approved as a class by TGA/HREC |
| Ethical review required | Peer review of treatment protocol | Full HREC approval required |
| Approved conditions | Treatment-resistant depression | Treatment-resistant depression; PTSD (MDMA) |
| Number of approved prescribers (mid-2026) | Small and growing | Several dozen across Australia |
| Classification of psilocybin | Class A controlled drug (unapproved medicine) | Schedule 8 controlled medicine |
| Prescriber reporting obligations | Ongoing reporting to Medsafe | Ongoing reporting to TGA |
When New Zealand fits: if you are a New Zealand resident with treatment-resistant depression, the domestic pathway avoids travel to Australia. When Australia fits better: if you need faster access to a more established program with more active prescribers. For Australia's full scheme, see the Australia psychedelic rescheduling guide.
One non-obvious difference: New Zealand's scheme does not currently include MDMA for PTSD. Australia moved on both psilocybin and MDMA at the same time. New Zealand's December 2025 Ministry of Health briefing noted MDMA for PTSD as a future consideration, but no approval timeline has been set.
The Medicines Amendment Act 2025 modernised New Zealand's broader framework for unapproved medicines, and it improves the infrastructure around psilocybin — but it does not replace the Regulation 22 requirement.
The Act introduced two significant changes. First, a new verification pathway allows Medsafe to approve a medicine if two recognised overseas regulators have already approved the same product. This could eventually apply to a psilocybin product if the FDA or EMA grants one a marketing approval — a step that has not happened yet.
Second, the Act expanded prescribing rights so that nurse practitioners and pharmacist prescribers can now supply unapproved medicines, not just doctors. For psilocybin specifically, this does not yet change who can prescribe, because Regulation 22 approvals are currently issued only to psychiatrists.
The Act is best understood as building a faster pathway for the future — one that could make psilocybin access simpler if and when an approved product reaches market. For today's patients, the route remains Regulation 22. For the global regulatory picture, see our psychedelic legalization tracker.
Psilocybin is a Class A controlled drug and is illegal for general use in New Zealand. However, since June 2025, Medsafe can grant individual psychiatrists approval to prescribe psilocybin for treatment-resistant depression under Regulation 22 of the Misuse of Drugs Regulations 1977. Only approved prescribers may lawfully supply or administer it outside a clinical trial.
A psychiatrist applies to Medsafe under Regulation 22 of the Misuse of Drugs Regulations 1977. The application must include a peer-reviewed treatment proposal and evidence of clinical experience. If approved, the psychiatrist can prescribe psilocybin to named patients with treatment-resistant depression. Each approval is specific to the prescriber — not a class of prescribers.
Professor Cameron Lacey, a Christchurch-based psychiatrist, was the first person approved by Medsafe to prescribe psilocybin in New Zealand. His approval was granted on 19 June 2025 for treating patients with treatment-resistant depression outside a formal clinical trial.
Australia's TGA Authorised Prescriber scheme allows any eligible psychiatrist approved by a human research ethics committee to prescribe psilocybin as a class, and multiple prescribers have been approved since July 2023. New Zealand's scheme approves prescribers one at a time under Regulation 22, making it narrower and more case-by-case. Both restrict use to treatment-resistant depression and require on-site administration under clinical supervision.
The initial Medsafe approvals are limited to treatment-resistant depression — patients who have not responded to at least two adequate antidepressant treatments. Prescribers must carry out detailed clinical assessments and screen for contraindications such as a personal or family history of psychosis, active suicidal ideation, and relevant drug interactions.
Yes, in a limited way. Patients with treatment-resistant depression can be referred to an approved prescriber. As of mid-2026, only a small number of psychiatrists hold Medsafe approval, so access depends on being seen by one of those clinicians. Medsafe published guidance in July 2025 to help more psychiatrists apply, and the number of approved prescribers is expected to grow.
The Act expanded the broader unapproved-medicines framework and created a new verification pathway for overseas-approved products, but it does not remove the Regulation 22 requirement for psilocybin. Because psilocybin is also a Class A controlled drug — not just an unapproved medicine — individual prescriber approval from Medsafe is still required.
New Zealand, Australia, Canada, Switzerland, and others are each moving at their own pace. The legalization tracker maps the current state of approved access across every active jurisdiction — updated as new prescriber approvals, rescheduling decisions, and legislation come through.
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