Supplying Medicines and Supplements to New Zealand
A practical guide for buyers worldwide sourcing from New Zealand, and for manufacturers and exporters selling into it.
New Zealand builds on approvals you already hold. A local sponsor applies to Medsafe, and since July 2026 the verification pathway can approve an identical product within 30 working days if two recognised regulators have approved it. Pharmac then decides public funding through its annual tender, where the winner can supply up to 95% of the funded market.
For buyers, New Zealand is a source of medicines and dietary supplements made under a PIC/S GMP system that New Zealand joined in 2013. Medsafe handles requests for a certificate of pharmaceutical product, and exporters of dietary supplements can apply to Medsafe for an export certificate.
New Zealand at a glance
| Regulator | Medsafe, part of the Ministry of Health |
|---|---|
| Who holds the approval | A New Zealand sponsor; an overseas company needs a local subsidiary or an agent with a physical address and a wholesale licence |
| Registration | CTD with a New Zealand Module 1; targets of 150 working days for a full application and 75 for an abbreviated one |
| Fast routes | Abbreviated route on overseas evaluation reports; verification pathway since 3 July 2026, decided within 30 working days |
| Public funding | Pharmac annual tender: principal supply status gives up to 95% of the funded market for about three years |
| Unapproved medicines | Section 29 for a named patient, and section 29A when a funded medicine is short |
How to supply medicines to New Zealand
- Appoint a New Zealand sponsor. The sponsor must be a manufacturer, importer or proprietor living in New Zealand. Agree in writing who owns the dossier. Our Japan, Korea, Australia and New Zealand guide explains the role.
- Choose your route by the approvals you hold. Verification needs full approval from two of the TGA, Health Canada, the EMA (centralised), HSA, Swissmedic, the MHRA and the FDA, each no more than four years old. PMDA and MFDS approvals don't count. FDA-only generics can't use the abbreviated route. Our dossier and registration service can help.
- Line up GMP evidence. Each new site needs a current GMP certificate from a recognised authority, no more than three years old. A TGA GMP clearance is accepted. Without acceptable evidence, Medsafe can audit the site at your cost. Keep your GDP records ready too.
- Bid in the Pharmac tender. Pharmac's annual tender covers hundreds of products. You need Medsafe consent before a tender can be awarded, so register first. Our tender supply service can help you prepare.
Under section 29, unapproved medicines can be supplied to a medical practitioner, nurse practitioner or pharmacist prescriber for a named patient, and section 29A covers unapproved, Pharmac-funded alternatives when a funded medicine is short. Suppliers notify Medsafe each month and keep supply records. See named-patient and special import and government tender supply.
Sourcing from New Zealand
- Originator medicines and comparators. Medicines approved by Medsafe can be bought through the New Zealand sponsor or a licensed wholesaler. Ask for batch certificates and cold-chain records. See our comparator supply service and comparator sourcing guide.
- Contract manufacturing. New Zealand plants work under a PIC/S GMP system, and the New Zealand–EU MRA covers GMP inspections between the two sides. Check each site's licence and scope before you sign. See our CDMO guide and white-label manufacturing.
- Dietary supplements. Supplements made in New Zealand follow the Dietary Supplements Regulations. Exporters can apply to Medsafe for an export certificate for dietary supplements, and the label must carry no therapeutic claims. See our nutraceutical sourcing.
- Export documents. Medsafe handles applications for a certificate of pharmaceutical product. Ask the New Zealand sponsor to apply, and check which certificates your own regulator wants. See our CoPP guide and documentation and quality pack.
Supplements
Dietary supplements are regulated under the Dietary Supplements Regulations 1985, made under the Food Act 2014, and Medsafe administers them. There is no pre-approval, but supplements can't contain prescription, restricted or pharmacy-only medicine ingredients, and they can't have a therapeutic purpose, so keep disease claims off the pack. MPI handles food importer registration and biosecurity rules. We help brands get supplements made under their own label by GMP-certified contract manufacturers: see nutraceutical private label.
What people in New Zealand search for
Semrush data from October 2026 shows that people in New Zealand search most for protein powder (about 12,100 searches a month, plus 8,100 for “protein powder nz”), vitamin D (9,900), and protein and collagen (6,600 each).
Generic names are common in New Zealand medicine searches: omeprazole and prednisone get about 2,900 a month each, atorvastatin, pregabalin and sertraline about 2,400 each, and iron 2,300.
How importers, pharmacies and manufacturers in New Zealand search
Trade searches are low: “private label nz” and “private label products” get about 30 each a month, so direct contact with sponsors and wholesalers matters more than search.
Originator brands searched by name include Wegovy (semaglutide). Brand names are trademarks of their owners and are used only to identify the medicine.
Supplements we can help you make
Often searched medicines include omeprazole, prednisone, atorvastatin and sertraline. Some examples we list:
Documents to ask your supplier for
- A Certificate of a Pharmaceutical Product (CoPP) in WHO format.
- The plant's GMP evidence, such as a WHO-GMP, EU-GMP or PIC/S certificate, plus any inspection by your regulator.
- The registration dossier (CTD or ACTD), with bioequivalence data for generics where required.
- Stability data for hot climates.
- A Certificate of Analysis for every batch.
Not sure a supplier is genuine? Read how to verify a pharmaceutical supplier. For the neighbouring markets, see our Japan, South Korea, Australia and New Zealand import guide.
Sourcing for New Zealand?
Send the product, strength, quantity and the documents your regulator needs. We will match you with GMP-certified manufacturers and suppliers who can serve your market, wherever they are based.
Send your requirement Talk to our team