The Medicines Amendment Act came into force on 19 November 2025.
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The Medicines Amendment Act 2025 amends the Medicines Act 1981 to improve access to medicines. It does this by:
- introducing a streamlined verification pathway for medicines approval in New Zealand, and
- updating prescribing settings to enable wider prescribing of unapproved medicines in appropriate circumstances.
The Act also:
- updates details of the membership and terms of the Medicines Classification Committee in the Medicines Act.
- enables new medicines not yet approved by Medsafe to be advertised at medical conferences in New Zealand.
- removes a restriction that prevents prescribers from holding a financial interest in a pharmacy.
Further information on the verification pathway
The Act sets out requirements and rule-making powers for medicines to be considered through the verification pathway. The next step to establish secondary legislation to set the operational rules and fees for the pathway. Consultation on the fees and rules will be undertaken early in 2026.
Prescribing settings
The Act expands prescribing settings so that unapproved medicines can be prescribed where they are necessary.
An unapproved medicine is one that has not been evaluated by medicines regulator Medsafe to establish its safety, quality and efficacy.
If a medicine is unapproved in New Zealand, it does not necessarily mean it is unsafe. Unapproved medicines can be available overseas that would be acceptable in New Zealand, but the companies have not applied for approval.
Prior to the Medicines Amendment Act 2025, under the Medicines Act 1981, only doctors could prescribe an unapproved medicine for the treatment of a specific patient.
The Medicines Amendment Act expands the settings so that:
- all authorised prescribers will be able to prescribe unapproved medicines when there is a shortage of an approved medicine, but only when the unapproved alternative is funded by Pharmac, and
- nurse practitioners and pharmacist prescribers will be able to prescribe unapproved medicines for reasons other than a supply shortage, just as doctors can now.
All prescribers will continue to be limited to prescribing medicines within their scope of practice and in their profession’s specified list, as they are now.
