Regulatory Situation of Herbal Medicines - A Worldwide Review
(1998; 49 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentACKNOWLEDGEMENTS
View the documentFOREWORD
Open this folder and view contentsI. INTRODUCTION
Close this folderII. REGULATORY SITUATION
Open this folder and view contentsAfrica
Open this folder and view contentsThe Americas
Open this folder and view contentsEastern Mediterranean
Open this folder and view contentsEurope
Open this folder and view contentsSouth East Asia
Close this folderWestern Pacific
View the documentAustralia
View the documentChina
View the documentHong Kong
View the documentMacao
View the documentFiji
View the documentJapan
View the documentMalaysia
View the documentMongolia
View the documentNew Zealand
View the documentPhilippines
View the documentRepublic of Korea
View the documentSingapore
View the documentViet Nam
View the documentIII. CONCLUSION
View the documentIV. REFERENCES
 

New Zealand

In New Zealand, herbal medicines are dealt with in two ways according to the Medicines Act of 1981. On the one hand, any herbal remedy may be manufactured and sold if requested for the expressed purpose of treating a particular person. This remedy must not contain a scheduled medicine and must be supplied under a designation that specifies the plant and the process of manufacture of the remedy, without any other name and without any written recommendation as to the use of the remedy. In these cases, no licensing and no assessment is required.

On the other hand, for any herbal medicine not covered by the above-mentioned conditions, marketing approval is required. The assessment of herbal medicines is carried out in the same way as for proprietary medicines by the Therapeutics Assessment and Utilization Section of the Department of Health. The application includes control of active ingredients and excipients, method of manufacture, control tests of the finished product, labelling, stability etc.

The efficacy of herbal medicines is not evaluated critically. Often there are hardly any clinical data for efficacy, since most of these remedies are prescribed on a patient basis. Supporting evidence for efficacy may include references in standard books, unless this information has been superseded by more recent research data. Indication claims are restricted to self-limiting conditions. In some cases, where there is concern about safety, toxicity data have to be provided; if not, a withdrawal from the market may be the consequence [139].

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