Medicines

Regulatory Guidance

Guidance in determining whether a product is a therapeutic product, and if so, whether it is medicine, a medical device or a related product.

How to seek approval for medicines.

Processing Times for New Medicine Applications (NMAs) and Changed Medicine Notifications (CMNs)

Medsafe's policy related to particular types of medicine and application

Medsafe's processing times for applications.

An overview of the regulation of dietary supplements in New Zealand.

Guidance for individuals and businesses operating as natural health practitioners in New Zealand.

A list of clinical trial sites for which self-certification has been lodged with Medsafe.