The Medicines Amendment Act 2025, which came into force on 19 November 2025, introduced a verification pathway under which medicines can be approved for distribution in New Zealand if they have been approved by two recognised overseas regulatory authorities. The verification pathway is an additional pathway option for companies, on top of the two pathways Medsafe already has.
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Verification pathway details set out in the Act
The Act sets out requirements that medicine applications must meet to be considered through the verification pathway.
The Act provides that for a medicine to be considered for the verification pathway, it must have full marketing authorisation granted by two or more recognised authorities. The medicine to be supplied in New Zealand must be identical in all material respects to the medicine authorised, with allowance for minor differences.
It also provides that the Director-General of Health must be satisfied that the medicine:
- has not been rejected, withdrawn, or is pending deferral by a recognised regulatory authority for quality, safety or efficacy reasons
- has not been subject to any regulatory action that may result, or has resulted in, a suspension or revocation of the market authorisation by any recognised regulatory authorities
- does not need an independent assessment by Medsafe to contextualise the benefit-risk profile due to local disease epidemiology, public health considerations or New Zealand specific health risks
- meets the requirements for consent by verification set out in the rules
The proposed rules ensure the pathway is both quick and robust.
Verification pathway Rules
Due to the technical nature of the details of the pathway, the Act provides for the operational policies of the pathway to be set out in secondary legislation (rules) made by the Minister of Health. Consultation on the verification pathway Rules took place between 16 February and 10 April 2026.
The Medicines (Consent by Verification) Rules 2026 were made on 20 May 2026 and come into force on 3 July 2026.
