6. Registration Processes

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Dietary Supplements
New Zealand

This section provides information on any product notification or registration and manufacturing site registration processes.

6.1 Product Notification

N/A

6.2 Product Registration

No, there is currently no pre-approval process for dietary supplements in New Zealand before they are put on the market. It is the responsibility of the sponsor to ensure that dietary supplement products are manufactured to an acceptable quality, labeled appropriately, meet the quality guidelines, and comply with regulations such as the Dietary Supplement Regulations 1985 [1], the Food Act 2014 [2], the Animal Products Act 1999 [3] (if applicable) and any other relevant measures.

6.3 Other Notes or Requirements

N/A

6.4 Manufacturing Site Registration

Only for dietary supplements containing folic acid (500 mcg/day) as outlined in Section 3.1 “Dietary supplements containing folic acid”.

6.4.1 Standard/Rules for Manufacturing Site

In principle, dietary supplements fall under the Food Act 2014 [2] and therefore should be manufactured, packed, and sold in a manner that complies with the Act and the Food Regulations 2015 [4].

Most businesses handling dietary supplements whether manufacturing, packaging, or selling will need to register their business either under a National Programme or with a Food Control plan. Information on the requirements is available on the MPI website [5] which includes tools to help businesses assess which program is the most suitable. Step-by-step guides to registering a National Programme or Food Control Plan can be found on the relevant pages in [6].

Businesses operating under a Food Control Plan need to register their plan each year, using either an industry template or a custom-designed plan. They also need to have a suitable person (e.g. from the local Council or a registered verifier) to verify that they are following the plan. In some cases, the verification can be done remotely if the company does not export products and has previously been verified. There are other conditions as detailed in [7] for remote verification. Businesses operating under a National Program [8] must register the business (usually with the local Council or the MPI if they operate across many council jurisdictions), meet the food safety standards, keep relevant records, and be verified as described above.

Note that the above requirement applies to local food businesses including manufacturers and not overseas manufacturers.

6.4.2 Other Notes or Requirements for Manufacturing Site Registration

N/A