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CMEC Meeting 30, 26 October 2001
Complementary Medicines Evaluation Committee
Extracted ratified minutes
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.
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.
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.
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.
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.
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.
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.
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.
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:
- 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.
CMEC recommends to the TGA that Magnolia officinalis retain its status as suitable for use as an active ingredient in listable therapeutic goods.
CMEC endorsed the consultation paper A review of the regulation of head lice treatments in Australia.
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.
|CMEC 30 extracted ratified minutes (pdf)||155KB|