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Information for Industry

Revised: 2 September 2015

Guideline on the Regulation of Therapeutic Products in New Zealand

The Guideline on the Regulation of Therapeutic Products in New Zealand (GRTPNZ) replaces the previous guidelines referred to as the New Zealand Regulatory Guidelines for Medicines (NZRGM Parts A, B, C and D).
The GRTPNZ is under construction.

The GRTPNZ is comprised of 11 parts which reflect the regulatory process administered by Medsafe.

Part 2 of the GRTPNZ is intended to describe the process for new and changed medicine applications including data requirements and is under development.

Completion of Part 2 has been delayed by the commencement of a series of harmonisation activities with the Australian Therapeutic Goods Agency in preparation of a joint regulatory scheme. Therefore the current information relating to new and changed medicine applications is derived from Parts B, C and D of the previous NZRGM plus Part 2a of the GRTPNZ which relates specifically to OTC medicine applications.

The GRPTNZ is expected to undergo further revision as a result of the harmonisation projects underway. It is anticipated that completion of the harmonisation activities will culminate in common guidelines for therapeutic products by July 2017.

Current Guidelines for the regulation of therapeutic products in New Zealand (GRTPNZ)

New Zealand Medicines and Medical Devices Recall Code (PDF 426 KB,49 pages)


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