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]
Healthcare & Pharmaceutical Landscape of NZ
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