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First Published:  14 February 2013
Revised:  19 June 2015

Introductory Regulatory Guidance

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

Is my product a medicine?
What do I need to do to sell my medicine in New Zealand?
Frequently asked questions

Is My Product A Medicine?

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

If your product is not a medicine, it may be a:

View further guidance on how to decide if your product is a medicine.

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, an application needs to be submitted to Medsafe.

In order to submit an application you will need to think about all of the following factors:

View the Guideline on the Regulation of Therapeutic Products in New Zealand for further guidance on submitting an application to Medsafe.

For information on what happens after you have submitted your application view Medsafe's Evaluation and Approval Process.


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