New Zealand Regulating Natural Health Products and Medical Devices

Dec 1, 2022

The Therapeutic Products Bill was introduced to New Zealand Parliament on 30 November 2022. It is intended to replace the current Medicines Act 1981 & Dietary Supplements Regulations 1985. The aim of the Bill is to regulate medicines, medical devices and natural health products.

The Bill will regulate how products are manufactured, tested, imported, promoted, supplied and exported. A Therapeutic Products Regulator will be established  with a range of compliance & enforcement powers. It is intended that medical devices & natural health products that were lawfully being supplied in New Zealand before the bill commences will have a transitional period of 2 to 5 years to seek a market authorisation.

A very large amount of secondary legislation will need to be made before the bill comes into force.  The backstop commencement date of 1 September 2026 is to allow adequate time for the secondary legislation to be developed, including allowing time for consultation.

New Zealand are following the TGA regulations that are applicable in Australia. You can find the Bill here