New Zealand Products

Therapeutic products are regulated in New Zealand by Medsafe.  New Zealand is in the process of updating its legislation and the new rules will come into effect soon.  We can help you navigate through both the existing and upcoming New Zealand requirements for therapeutic products.

Find out more about:

OTC medicines

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.

Change Applications

Making changes to products can be a simple process that only requires you to notify Medsafe, or it can be a complex one that requires a full assessment and approval by the agency.

What’s more, sometimes a change in one area can mean changes are also required in another that take time and expertise to resolve.

We can ensure you make the right application for your proposed changes, that it clearly addresses any problems and knock-on possibilities, and that it answers the questions Medsafe are likely to have.

We can either help you to do it yourself, or prepare and lodge your Medsafe change applications on your behalf. Either way, you’ll save time and money.

Dietary Supplements

Dietary supplements In New Zealand are generally products that are vitamins, minerals, probiotics or herbal substances for oral administration.  They do not have to be included in the Medsafe register if they comply with certain formulation and labelling requirements.  If they do not meet the requirements for Dietary Supplements they will be OTC medicines in New Zealand and Ministerial Consent will be needed.

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 dietary supplements
  • Determining if the criteria for supply as a dietary supplement are met, or suggesting changes so that they can be met
  • Advising on labelling requirements and reviewing labelling
  • Liaising with Medsafe and/or TAPS on your behalf as needed

Medical devices and IVDs

Medsafe operates a notification system for medical devices.  These products need to be included on Medsafe’s WAND database.  At present, access to the database is limited to New Zealand residents.

At present, IVDs are not required to be included in the WAND database but are subject to labelling and other requirements.

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

  • Offering advice on how to achieve a WAND notification for the medical devices you would like to supply in New Zealand
  • Assisting in checking that label and any other relevant regulatory requirements are met.

Contact Us

Archer Emery and Associates – the Therapeutic Goods Administration (TGA) Experts. To find out how to enhance your regulatory team and maximize your chances of success – whatever the project. Click here to get in touch >>