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CMEC Meeting 24, 1 December 2000
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 23, 13 October 2000), as amended, are a true and accurate record of that previous meeting.
Item 3 Guidelines on levels and kinds of evidence to support claims for therapeutic goods ('Guidelines') and proposed warning statements for coded indications
CMEC recommended the adoption of a series of coded warning statements associated with coded indications used in the Electronic Lodgement Facility.
Important note: The TGA will undertake stakeholder consultation before progressing this matter.
CMEC recommends to the TGA that conjugated linoleic acid 75% is not suitable for use as an active or excipient ingredient in listable therapeutic goods as there is insufficient evidence of its long-term safety for human use, particularly that associated with the trans-10, cis-12 form of linoleic acid.
CMEC recommends to the TGA that calcium lactate gluconate is suitable for use as an active ingredient in listable therapeutic goods.
CMEC recommended a product for registration.
|CMEC 24 Extracted Ratified Minutes (pdf)||91KB|