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Information for Industry

Revised: 25 September 2014

Guideline on the Regulation of Therapeutic Products in New Zealand

The Guideline on the Regulation of Therapeutic Products in New Zealand (GRTPNZ) was intended to replace the New Zealand Regulatory Guidelines for Medicines (NZRGM Parts A, B, C and D).
The GRTPNZ is under construction.

Development 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. The harmonisation projects are expected to cumulate in common guidelines for therapeutic products by July 2017.

In response to requests from sponsors, Medsafe has undertaken a revision of Parts A, B, and C of the NZRGM to incorporate policy statements and recent outcomes of consultation and remove obsolete information. This is an interim measure to address immediate concerns with the currency of the NZRGM while the GRTPNZ is under construction.

Changes to Part A consist of:

Changes to Part B consist of the following additions:

Changes to Part C consist of the following additions:

There have also been minor editorial changes to improve readability.

Current Regulatory Guidelines (NZRGM and GRTPNZ)

 

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