Getting a US-approved medicine in New Zealand: the legal route, documents and timing

Creator: Reserve Meds
Published: 2026-10-17

A sourced guide for patients, families and doctors in New Zealand, checked against Medsafe rules on 17 October 2026.

Reviewed by the Reserve Meds clinical operations team on 17 October 2026. Sources accessed 17 October 2026.

The short answer

In New Zealand, a medicine without Medsafe consent can still be supplied to a named patient under section 29 of the Medicines Act 1981. A medical practitioner, nurse practitioner or pharmacist prescriber requests it for a known patient, the patient must consent, and the supplier notifies Medsafe after supply. Section 29A covers funded alternatives during shortages.

Regulator: Medsafe, the New Zealand Medicines and Medical Devices Safety Authority.
Main route: Section 29 supply of an unapproved medicine for a named patient.
Who requests: A medical practitioner, nurse practitioner or pharmacist prescriber.
Price: Quote on request.

Who regulates medicines in New Zealand

Medsafe, part of the Ministry of Health, gives consent before a medicine can be sold, supplied, distributed or advertised in New Zealand. Medicines without that consent are called unapproved medicines.^[1]

The legal route for a medicine that is not registered in New Zealand

Sections 29 and 29A of the Medicines Act allow the sale or supply of unapproved medicines. Section 29 permits supply to medical practitioners, nurse practitioners and pharmacist prescribers for a named patient in their care. The patient must be known at the time of supply.^{[2, 1]}

Section 29A lets any authorised prescriber obtain an unapproved medicine that Pharmac funds as an alternative to an approved funded medicine that is in short supply.^[2]

Consent matters. The prescriber must explain what is being prescribed and why, and the patient must agree, under the Code of Health and Disability Services Consumers' Rights. The patient must also be told that information about the supply is kept by the importer and a subset is sent to Medsafe.^[1]

Documents you will usually need

Medsafe's rules put the paperwork on the prescriber and the supplier:^{[2, 1]}

A prescription from a medical practitioner, nurse practitioner or pharmacist prescriber for the named patient
The patient's informed consent, recorded by the prescriber
Supplier records that include the prescriber's and patient's names (kept by the supplier and open to Medsafe audit)
A monthly notification from the supplier to Medsafe giving the trade and generic name, dose form, strength, pack size, month and quantity supplied

Timing, quantities and fees

Section 29 does not need Medsafe approval before supply: the supplier notifies Medsafe after the end of each month in which supply happened. In practice the time it takes depends on the supplier, import logistics and the medicine's storage needs. Some controlled drugs cannot be used for an unapproved use without Ministerial approval.^{[2, 1]}

How a US-approved medicine reaches a patient in New Zealand

First, confirm the medicine is approved in the US. FDA's Drugs@FDA database lists approved prescription medicines and links to the approved label.^[3]

In New Zealand the prescriber asks a supplier or importer to bring the medicine in under section 29 for the named patient. We work with the prescriber and the New Zealand supplier and arrange US supply through our wholesale partner, with the documents the supplier needs for its own records.

Once the local permission is in place, the medicine is bought from the US supply chain, packed for the temperature the label requires, and shipped to the named hospital, clinic or importer with the documents customs will ask for. Cold-chain medicines need a validated shipper and a temperature record for the whole journey.

If the medicine is a cell or gene therapy, the rules are different: these are usually given only at qualified treatment centers chosen by the manufacturer, so the realistic route is often treatment at a center abroad rather than import.^[4]

Practical checks before you start

Ask the treating specialist whether a registered alternative already exists in New Zealand. Most special routes only apply when it does not.
Check whether the medicine is a controlled drug. Controlled medicines need extra permits in almost every country.
Ask the hospital pharmacy whether it has handled this route before and who signs the application.
Keep copies of every document and approval. Customs and the hospital will ask for them again at delivery.

How Reserve Meds helps

Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner. We help families and treating doctors understand the route, prepare the documents the regulator or hospital asks for, arrange supply from the US once approval is in place, and keep everyone updated. We do not diagnose, prescribe or decide what a regulator approves.

We coordinate access to FDA-approved medicines only. Investigational medicines are only available through a manufacturer's expanded-access program requested by the treating physician; we can explain that route, but we do not supply them. Your coordination fee is quoted in writing for your case before you commit. No hidden charges. We give you a written timeline estimate for your case before you commit.

Ask us about a medicine for a patient in New Zealand

Tell us the medicine, your country and a WhatsApp or phone number. We reply within one business day. On WhatsApp we usually reply the same day.

Frequently asked questions

Is a section 29 medicine legal in New Zealand?

Yes. Sections 29 and 29A of the Medicines Act 1981 allow an unapproved medicine to be supplied for a named patient, with the patient's consent and supplier notification to Medsafe.

Who can prescribe an unapproved medicine under section 29?

Medical practitioners, nurse practitioners and pharmacist prescribers. Under section 29A, any authorised prescriber can prescribe a Pharmac-funded alternative during a shortage.

Does Medsafe have to approve each case first?

Not under section 29. The supplier notifies Medsafe after supply, monthly, and keeps records that Medsafe can audit.

Does Reserve Meds apply to the regulator for us?

No. The application is made by the person or institution the rules name, usually the treating doctor or hospital. We help prepare the paperwork, confirm the US approval and arrange supply from the US once permission is granted.

How much does it cost?

Quote on request. The total depends on the medicine, the dose, shipping, import steps and coordination. Your coordination fee is quoted in writing for your case before you commit. No hidden charges.

Sources for these answers: ^{[2, 1]}

Sources

All sources were opened and checked on 17 October 2026. Rules and labels change, so the treating hospital or regulator confirms the current position before anything is filed.

Medsafe New Zealand: Use of Unapproved Medicines and Use of Approved Medicines for an Unapproved Purpose (accessed 17 October 2026)
Medsafe New Zealand: Supplying Unapproved Medicines (revised 8 December 2025) (accessed 17 October 2026)
US FDA: How do I find out if a drug is approved? (accessed 17 October 2026)
US FDA: Approved Cellular and Gene Therapy Products (accessed 17 October 2026)

This page is general information, not medical or legal advice. It does not replace advice from your own doctor or the regulator.