Proposed extension of the abbreviated procedure for new medicine applications and section 24(5)(a) notifications

Overview

This consultation is aimed at pharmaceutical companies seeking to submit  abbreviated applications to Medsafe for regulatory approval of new medicine products or changed medicine notifications.

Medsafe is seeking your feedback on changes to these guidelines:

• Guideline on the Regulation of Therapeutic Products in New Zealand: New Medicine Applications
• Guideline on the Regulation of Therapeutic Products in New Zealand: Changed Medicine Notifications and Non-Notifiable Changes

Updates are proposed to:

• Allow for New Medicine Applications based on a parent product (line extensions) to be submitted using the Abbreviated Evaluation Procedure;
• Introduce an Abbreviated Evaluation Procedure for Changed Medicine Notifications referred under Section 24(5)(a); and
• Revise other parts of the New Medicine Application guideline regarding application types, data protection, applications based on a parent product, provisional consent and priority review, to provide more options and greater clarity for applicants.

Important: This consultation is specific to extension of the existing abbreviated process. The anticipated verification process (enabled by the Medicines Amendment Act 2025) will be the subject of a separate consultation that will begin early in 2026.

The proposals in this consultation do not apply to over-the-counter (OTC) medicines, as overseas evaluation reports are generally not available for these types of medicine products. Medsafe is working separately with companies of OTC medicines to identify opportunities for greater harmonisation and guidance development.

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.

All comments will be carefully considered and changes may be made as a result of the comments received.

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