The Medicines Amendment Act 2025 received Royal assent on 18 November 2025, coming into force immediately. The Medicines Amendment Act's overarching aim is to improve patient access to medicines, and it achieves this by making a number of specific but important changes to prescribing and approval processes under New Zealand's aging medicines legislation, the Medicines Act 1981.
Key changes include:
- Introducing the "Rule of Two" verification pathway, which provides a streamlined process for medicines to be approved for distribution in New Zealand if they have already been fully approved in two other recognised overseas jurisdictions
- Allowing nurse practitioners and pharmacist prescribers to prescribe unapproved medicines to patients under section 29, an authority that was previously limited to medical practitioners
- Enabling authorised prescribers to prescribe unapproved medicines that are listed by Pharmac as a 'funded alternative' where an approved medicine is in short supply
- Repealing the restrictions on authorised prescribers owning an interest in a pharmacy
- Introducing an exception to the total prohibition on advertising of unapproved medicines, which will allow them to be advertised at medical conferences subject to certain administrative requirements being met.
The new verification pathway is the headline change introduced by the Medicines Amendment Act, and aims to increase the speed at which new medicines are approved in New Zealand. For now, the approved overseas jurisdictions are Australia, the United States, Canada, the United Kingdom, the European Union, Singapore and Switzerland. This new pathway (which includes confidentiality protections for five years from when the application is received), and the ability to advertise new medicines at medical conferences, will be of particular interest to overseas manufacturers and sponsors seeking to expand their offerings in New Zealand. The change may also align New Zealand more closely with international markets, and make it easier for sponsors to include New Zealand in global launch strategies.
The other amendments are not just technical, and the easing of a number of long-standing restrictions in the Medicines Act could create new opportunities for businesses in the sector. The expanded prescribing rights for nurse practitioners and pharmacist prescribers are intended to support better access to medicines and continuity of care for patients (particularly in aged care and rural settings) but may have a wider impact on provider processes for prescribing unapproved medicines. The removal of the restrictions on prescribers holding an interest in pharmacies might create the potential for more integrated end-to-end business models within health provider groups, with potential positive impacts for both patient outcomes and the efficiency of commercial operations.
It remains to be seen how these amendments will be reflected in practice, and to what extent this will impact on patient access to medicines. Much of the Medicines Act is still significantly outdated, and wider changes are expected following the Government's announcement in October that a new Medical Products Bill is continuing to take shape (see our previous update), and is expected to be introduced early in the new year. If you have any questions, please contact one of our health team.
Co-authored by Ciara O'Neill (Summer Clerk).
