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CMEC Meeting 21, 6-7 July 2000

Complementary Medicines Evaluation Committee

6 June 2000

Extracted ratified minutes

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CMEC Meeting 21 extracted ratified minutes (pdf,127kb)

Public recommendation summary

Item 3 Report of the Working Party on Substantiation of Claims

Recommendation 21.1

CMEC endorses the work in progress on the amended document Guidelines for levels and kinds of evidence to support claims for therapeutic goods.

Item 5.2.1 St John's Wort

Recommendation 21.2

CMEC confirms its previous advice to the TGA that all medicines containing St John's Wort (Hypericum perforatum) and intended for oral use must carry the following label warning:

'St John's Wort affects the way some prescription medicines work. Consult your doctor.'

However CMEC considers that homoeopathic preparations of St John's Wort, other than mother tinctures, should not be required to carry the above warning.

Item 6.2 Arginine

Recommendation 21.3

CMEC recommends to the TGA that L-, DL- and D-arginine are not suitable for use as active ingredients in listable therapeutic goods.

Item 6.3 Palm tocotrienols

Recommendation 21.4

CMEC recommends to the TGA that the substance 'tocotrienols complex - palm-derived' is suitable for use as an active ingredient in listable therapeutic goods, without any substance-specific restrictions.

Item 10.1. Compositional guidelines - chemical

Recommendation 21.6

Members endorsed the content of the document Format for draft compositional guidelines for chemical substances and noted that it will be released for stakeholder comment.

Item 10.3. Naming of homoeopathic products

Recommendation 21.7

CMEC recommends to the TGA that for all homoeopathic medicines, whether registered, listed or exempt from inclusion in the Australian Register of Therapeutic Goods, both the name of the goods and the name of the active ingredients present in them, should be qualified with the prefix 'homoeopathic' to differentiate them from their non-homoeopathic counterparts.

Item 10.9 Colloidal anhydrous silica and silicon dioxide - clarification of the intent of a CMEC recommendation

Recommendation 21.8

CMEC recommends to the TGA that the existing restriction on the use of colloidal anhydrous silica and silicon dioxide, that they not be presented in a powdered dosage form when used as active ingredients in listable therapeutic goods, be removed. CMEC further recommends that colloidal anhydrous silica and silicon dioxide should not be permitted for use in listable goods, as either active or excipient ingredients, when the intended route of administration of these goods is by inhalation.

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