Dietary Supplements

Published: August 2010

Questions and answers on requesting confirmation of GMP status for the manufacture of a dietary supplement containing folic acid with a daily dose of more than 300 mcg

August 2010

If different companies or sites are used for manufacturing the bulk product and packing the product into the finished product presentation, do you need GMP certification for both the manufacturing sites and the packing sites?

Yes. Packing of the bulk product into the finished product packaging is considered to be a manufacturing step and is relevant to the finished product quality. Packing must therefore be conducted in accordance with the Code of GMP.

If I have product that is manufactured at more than one site, can I request confirmation of GMP status for all manufacturers on one form?

A separate application form is required for each manufacturer. It is helpful if the applications are submitted together and a note included that the submissions relate to multiple manufacturing sites for one product.

Do you require originals, certified copies or photocopies of manufacturing licences and GMP certificates?

Certified copies of GMP compliance documents are preferred however photocopies will be accepted at this time.

If I have several products from one manufacturer can I supply one set of GMP certificates / licences?

Separate photocopies should be supplied for each product. If a certified copy has already been supplied, a photocopy could be supplied with subsequent applications and reference made back to the product that the certified copy was supplied for.

How much detail is required on the finished product specification?

The finished product specification supplied should be the specification used to test the product and release batches onto the market. The specification must meet the requirements of Chapter 4 of the New Zealand Code of GMP (Adobe PDF document 279KB) and particularly section 4.13.

What are the requirements for labelling my dietary supplement?

A dietary supplement intended for sale in New Zealand must meet the labelling requirements for dietary supplements defined in the Dietary Supplement Regulations. For example: the labelling must include the words "dietary supplement".

Does the confirmation of GMP status mean my folic acid supplement complies with the Dietary Supplement Regulations?

No. This process only assesses GMP compliance as required by Regulation 3(1). As the supplier, you are responsible for ensuring your product complies with all other requirements of the dietary supplement legislation.


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