Published: 14 February 2013
Revised: 27 May 2024

Medicines

Introductory Regulatory Guidance

The information below provides a starting point if you plan to market a product in New Zealand that may have a therapeutic benefit.

Is My Product A Medicine?

The first thing you need to do is work out if your product is a medicine.

Refer to the Medsafe guidance in:

• Overview of therapeutic product regulation, available for download from the Guidelines on the Regulation of Therapeutic Products in New Zealand (GRTPNZ) webpage
• the Categorisation of Products webpage.

You can also seek advice from independent regulatory consultants.

What do I need to do to sell my medicine in New Zealand?

Medicines and related products need consent from the Minister of Health before being sold in New Zealand. As part of this process, you will need to submit an application to Medsafe with supporting data demonstrating evidence of safety, efficacy and quality, including evidence of manufacture under Good Manufacturing Practice.

For more information, refer to Overview of regulatory processes for new and changed medicines, available for download from the GRTPNZ webpage.