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CMEC Meeting 29, 24 September 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 28, 27 July 2001), as amended, are a true and accurate record of that previous meeting.
Item 5.1.2 Adverse reactions for homoeopathic product containing Gelsemium sempervirens and other ingredients
CMEC recommends to the TGA that appropriate regulatory action be taken in regard to products which contain levels of Gelsemium sempervirens in excess of those permitted in listable goods.
Item 6.1 Bovine colostrum extract
CMEC recommends to the TGA that bovine colostrum extract is suitable for use as an active ingredient in listable therapeutic goods, subject to the following conditions:
- a label statement indicating that products containing bovine colostrum extract are not suitable for children under the age of 5 years
- a label statement indicating that products containing bovine colostrum extract contain lactose and cow's milk proteins (or words to that effect).
This recommendation is subject to confirmation by consultant paediatricians of the appropriate age range specified in the first part of the recommendation.
CMEC recommends to the TGA that subject to certain matters being resolved to the satisfaction of the Office of Complementary Medicines, Trametes versicolor is suitable for use as an active ingredient in listable therapeutic goods.
It was re-affirmed that in vitro data must be supported by human data. CMEC recommends that letters to applicants advising that their application for inclusion of a new substance in Schedule 4 of the Therapeutic Goods Regulations should contain advice to the effect that:
- sponsors must hold appropriate evidence to support claims made in relation to Listed goods; and
- any indications or claims included in the application were not evaluated by CMEC or the TGA.
CMEC recommends to the TGA that calcium glucarate is not suitable for use as an active ingredient in listable therapeutic goods, as the safety associated with long-term β-glucuronidase inhibition could not be established on the evidence provided to the Committee.
CMEC made a recommendation to the TGA regarding an application under this agenda item.
CMEC made four recommendations to the TGA regarding applications under this agenda item.
|CMEC 29 Extracted Ratified Minutes (pdf)||113KB|