Revised: 16 January 2025

Information for Industry

Current Guidelines on the Regulation of Therapeutic Products in New Zealand

Overview of therapeutic product regulation


Regulatory requirements for medicines and related products


Regulatory requirements for medical devices


  • Regulatory requirements for medical devices.

(Under construction please refer to the guidance for medical devices for current guidance)

Manufacturing


Labelling


Bioequivalence


Advertising


Pharmacovigilance


(effective from 1 July 2024)

Safety alerts, complaints and recalls


  • Therapeutic product safety alerts, complaints and recalls.

(Under construction please refer to the uniform recall procedure (PDF 469 KB, 49 pages))

Information for prescribers and consumers


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