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

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:

Type of application

If your product is a medicine, you will need to submit a New Medicine Application together with supporting data. If your product is a related product, you will need to submit a New Related Product Application together with supporting data.

Forms

You will need to submit a New Medicine or Related Product Application Form. Medsafe has developed guidance on how to complete this form. View documents 14 to 22 in the list of Forms for further guidance.

[See reference 10: Forms & Templates]

Supporting data

Information required in your application includes data demonstrating the safety, efficacy and quality of the ingredients and of your final product. Efficacy is a technical term used to describe how well a medicine works.

You will need to show the safety and efficacy of your product in the treatment of humans. Evidence will need to be provided from clinical trials or by providing robust, scientific peer reviewed literature. Medsafe cannot accept evidence of traditional use or testimonials to support your efficacy claims. Data to show the quality of your product during its shelf-life will also need to be submitted. Supporting data can range in size from a few hundred pages to a few hundred boxes, depending on the type of your application.

View Part 2 of the Guideline on the Regulation of Therapeutic Products in New Zealand for

further guidance on supporting data. [See reference 10]

Good manufacturing practice (GMP)

Your product will need to be made in a facility that complies with good manufacturing practice. Good manufacturing practice describes the systems, manufacturers of medicines are required to have in place to ensure products are consistently safe, effective and of acceptable quality. The requirements are described in a code of practice called the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of

Therapeutic Goods. [See reference 12]

If your product is not made in New Zealand, you will also need to think about the requirements for commercial importation. The New Zealand Customs Service is able to advise you on this. [Link: https://www.customs.govt.nz/business/ ]

Sponsor responsibilities

The sponsor is the person or company legally responsible for placing the product on the market in New Zealand.

As sponsor you must have a physical address in New Zealand.

For further guidance on sponsor responsibilities, view:

• regulation 50 of the Medicines Regulations 1984

• sections 17, 21, 29, 41, 42 and 57 of the Medicines Act 1981 [See Reference 13]