Verification Pathway for New Medicine Applications

Overview

This consultation is primarily aimed at pharmaceutical companies seeking to submit applications to Medsafe for new medicines for consent by verification. Consent by verification is the application pathway that enables expedited approval of medicines in New Zealand. This relies on assessment and approval by two recognised overseas regulatory authorities. The verification approval process was enabled by the Medicines Amendment Act 2025, and is described in section 22A to 22F of the Medicines Act 1981.

Medsafe is seeking your feedback on both the rules and guideline for this pathway.

Rules are secondary legislation. Guidelines provide guidance on legislative requirements, including their interpretation, and outline administrative processes.

Where consultation questions relate to the rules, please also read and consider both the rule and the corresponding section(s) of the guideline when providing feedback.

The recognised regulatory authorities are:

• European Medicines Agency (centralised procedure only)
• Therapeutic Goods Administration (Australia)
• Health Canada
• United States Food and Drug Administration
• Medicines and Healthcare products Regulatory Agency (UK)
• Health Sciences Authority (Singapore)
• Swiss Agency for Therapeutic Products (Swissmedic)

To assist in the analysis of submissions, Medsafe will only accept submissions made through this consultation website. However, the full consultation documents are attached below and can be viewed online, downloaded, and/or printed. Please do not generate responses solely using AI.

Please ensure that comments are specific to each question being asked. There is a final question at the end of the document, 'do you have any further comments?' which is an opportunity to comment on items not raised as a specific question.

All comments will be carefully considered and changes may be made to the rules and/or the guideline as a result of the comments received.

To take part in this consultation, click on the online survey link below.