New Zealand Products

The type of application you make depends on the type of product you have. Some products need to have Ministerial Consent and undergo a full evaluation by the New Zealand regulator (Medsafe), while others fall within the Dietary Supplement classification and can be self-assessed. Knowing the difference can save you a lot of time and money.

We can advise you on which application pathway will apply to your product, what information you’ll need to provide, and give you an assessment of your likely success. We can also help you prepare the right responses when an agency asks technical questions or requests more information. Or we can take care of the whole process for you.

At Archer Emery & Associates, we can help you by:

• Providing ad hoc advice verbally and/or in writing on any regulatory issues related to existing or proposed non-prescription medicines
• Determining if an application is required and, if so, determining the application category and data requirements
• Checking whether your manufacturers hold certifications acceptable to Medsafe and cover all the required steps
• Reviewing quality, safety and efficacy documentation for suitability for submission to Medsafe and preparing gap analyses
• Advising you on gaps in your data package and ways to fill them
• Assisting with product development as needed
• Advising on labelling requirements and reviewing labelling
• Preparing Product Data Sheets and Consumer Medicine Information (CMI) documents if necessary
• Conducting literature reviews and preparing reports in CTD format
• Preparing applications for non-prescription medicines and supporting documentation in the required format for submission to Medsafe
• Liaising with the Medsafe and you throughout the evaluation process.