Medsafe Rule of 2 Verification Pathway
= Faster access to medicines
The proposed Verification Pathway aims to accelerate market access for certain medicines by enabling Medsafe approval within 30 days, provided they’ve already been approved in two recognised overseas jurisdictions.
- Recognised countries are expected to include Australia, USA, Canada, UK, EU, Singapore, and Switzerland.
- The dossier must closely match that approved overseas.
- For generics and biosimilars, the overseas reference product must be
identical to one approved for NZ. - Full eligibility and process requirements will be set out in secondary legislation.
This initiative is part of the Medicines Amendment Bill, now open for public consultation until 19 May 2025.
The Bill also proposes expanded prescriber access to unapproved medicines in NZ.
WANT TO KNOW MORE?
For more information and updates on the eligibility and procedural details, stay tuned for the secondary legislation as the regulatory framework evolves.
