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CMEC Meeting 39, 11 April 2003

Complementary Medicines Evaluation Committee

11 April 2003

Extracted ratified minutes

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CMEC Meeting 39 extracted ratified minutes (pdf,257kb)

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 38th meeting

Recommendation 39.1

CMEC confirms that the draft Minutes of its previous meeting (CMEC 38, 29 November 2002), as amended, are a true and accurate record of that previous meeting.

Item 5.1 Azadirachta indica (neem)

Recommendation 39.2

CMEC rescinds a previous recommendation (recommendation 27.7) in regard to the suitability of cold-pressed neem (Azadirachta indica) seed oil for use in listable medicines.

Recommendation 39.3

CMEC recommends that cold-pressed neem seed oil be permitted for use in listable medicines consistent with the decision of the National Drugs and Poisons Scheduling Committee (Decision 2002/36-15) in relation to Azadirachta indica (neem) or its extracts, or its derivatives, as follows:

  • at concentrations up to 1 % for topical application; and
  • at concentrations greater than 1 % for topical application when in a container fitted with a child resistant closure and labelled with the statements:
    • "Not to be taken";
    • "Keep out of the reach of children"; and
    • "Do not use if pregnant or likely to become pregnant."

Item 6.1 Calcium sodium caseinate

Recommendation 39.4

CMEC recommends to the TGA that calcium sodium caseinate is suitable for use as an ingredient in listable medicines, subject to the provision of a label statement indicating that products containing calcium sodium caseinate contain cow's milk protein (or words to that effect).

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