Industry lead regulatory model

Tuesday, March 25th 2008

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25th March.
Regular readers of this newsletter will know that the NZ Health Trust has been working for some time now to coordinate a sensible, risk based regulatory system to fill the void created by the demise of the Therapeutic Products Bill.

An extensive consultation process has been carried out with industry and interest groups around New Zealand and the draft model now created has received near unanimous support. This system is designed to provide a "safe harbour" for natural products that meet 4 simple tests;

1. Does the product comply with the definition of a natural and traditional health product?
2. Does the product manufacturer and distributor have an accepted Risk Management Program or Good Manufacturing Practice system in place?
3. Is the required evidence held for any health claims made?
4. Has the product been lodged on the central web based registry?

If the answer to those 4 questions are yes then the product is exempt from both Medicines and Food laws.

Because manufacturers are able to choose from a long list of approved GMP's, they are able to pick the one most appropriate for their product and for the markets they sell into. As an example this means you don't need to comply with Aussie rules if you only sell into Asia.

The model is now reaching a stage where we have been able to have initial discussions with MP's and feedback to date has shown there is strong interest in the work that has been done. So far, however, the Minister of health has refused to meet with the Trust to progress this important initiative.

Copied from NZ Health Trust Newsletter No 45
www.nzhealthtrust.co.nz

If you need help or advice, you are welcome to email our naturopathic team with your health question.

Disclaimer: The health information presented here has been written for the New Zealand health consumer. It is of a general nature and is only intended to provide a summary of the subjects covered. The information is not intended to be comprehensive or to provide medical advice to you. While all care has been taken to ensure the accuracy of the information, no responsibility or liability is accepted, and no person should act in reliance on any statement contained in the information provided. All health ailments should be treated by a qualified health professional.

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