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CMEC Meeting 30, 26 October 2001

Complementary Medicines Evaluation Committee

26 October 2001

Extracted ratified minutes

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CMEC Meeting 30 extracted ratified minutes (pdf,155kb)

Public recommendation summary

This summary has been posted immediately after the CMEC meeting to give quick advice of the recommendations made by CMEC to the TGA. This summary does not represent the decisions of TGA. Reasons underlying these recommendations will be available after Members ratify the Minutes at the next CMEC meeting.

Item 2 Minutes of CMEC's 29th meeting

Recommendation 30.1

CMEC confirms that the draft Minutes of its previous meeting (CMEC 29, 17 September 2001), as amended, are a true and accurate record of that previous meeting.

Item 4 Appropriate regulation of herbal substances

Recommendation 30.2

CMEC recommends to the TGA that a Working Party be established to further develop the stakeholder consultation paper Review of the regulation of herbal substances to include consideration of the issue of standardisation of herbal substances.

Item 5.1.1 Consideration of a new definition for 'homoeopathic preparation'

Recommendation 30.3

CMEC recommends to the TGA that the definition of 'homoeopathic preparation' included in Regulation 2 of the Therapeutic Goods Regulations be modified in order to more clearly encompass the principles of homoeopathy.

Item 5.2.1 Consideration of a new definition of 'homoeopathic proving'

Recommendation 30.4

CMEC recommends to the TGA that a definition of 'homoeopathic proving' which it had developed be included in the glossary for the Guidelines for levels and kinds of evidence to support indications and claims.

Item 6.1 Activated charcoal

Recommendation 30.5

CMEC recommends to the TGA that activated charcoal is suitable for use as an active ingredient in listable therapeutic goods, subject to labelling advice that this substance may interact with other medicines, and that the user should consult with a health professional if taking it at the same time as another medicine.

Recommendation 30.6

CMEC recommends that the TGA further investigate whether this substance was suitable for use by children, and return the item to CMEC for further consideration.

Item 6.2 Potassium chloride

Recommendation 30.7

CMEC recommends to the TGA that potassium chloride is not suitable for use as an active ingredient in listable therapeutic goods, as the safety associated with its use in these goods could not be established on the evidence provided to the Committee.

Item 6.3 Sodium sulfate

Recommendation 30.8

CMEC recommends to the TGA that sodium sulfate is suitable for use as an active ingredient in listable therapeutic goods, subject to the following condition:

  1. where the substance was not to be used as a laxative, products containing this substance should carry a label statement indicating that the substance may have a laxative effect.

Item 7 Magnolia officinalis

Recommendation 30.9

CMEC recommends to the TGA that Magnolia officinalis retain its status as suitable for use as an active ingredient in listable therapeutic goods.

Item 10.2 Review of the regulation of head lice treatments in Australia

Recommendation 30.10

CMEC endorsed the consultation paper A review of the regulation of head lice treatments in Australia.

Item 10.3 Folic acid preparations and TGA standards

Recommendation 30.11

CMEC recommends to the TGA that a dissolution standard be mandatory for folate supplement preparations, in tablet form, of a strength of 100 micrograms or more per dosage unit.

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