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CMEC Meeting 64, 14 December 2007

Complementary Medicines Evaluation Committee

14 December 2007

Extracted ratified minutes

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CMEC Meeting 64 extracted ratified minutes (pdf,135kb)

Public recommendation summary

This summary is posted shortly after the CMEC meeting to give quick notification of certain recommendations made by CMEC to the TGA. The TGA is yet to consider these recommendations and so this summary does not represent final decisions of TGA and should not be taken as such.

Reasons underlying these recommendations will be available after ratification of the Minutes at the next CMEC meeting. Other recommendations may be made at CMEC meetings but, because they concern confidential matters, or matters requiring further consideration by the TGA, they are not available for public disclosure.

Item 2 Confirmation of Draft Minutes of CMEC 63 (12 October 2007)

Recommendation 64.1

CMEC confirms that the draft Minutes of its previous meeting (CMEC 63, 12 October 2007), as amended, are a true and accurate record of that meeting.

Item 5.1 'Arabinogalactan' derived from Larix occidentalis or Larix larcinia

Recommendation 64.2

CMEC recommends to the TGA that 'arabinogalactan' derived from Larix occidentalis or Larix larcinia, and being of "high-grade" purity (polysaccharide content ≥85%), is suitable as an ingredient in Listed therapeutic products, subject to a maximum daily dose limit of 15 g, and resolution of outstanding composition issues.

Item 5.2 Piperine (of Piper nigrum or Piper longum)

Recommendation 64.3

CMEC recommends to the TGA that a maximum daily dose limit of 10 mg be adopted for piperine when present as a component in herbal preparations for use in Listed medicines.

Item 7.1.2 Review of Convolvulus arvensis

Recommendation 64.4

CMEC recommends to the TGA that Convolvulus arvensis is not suitable for use as an ingredient in Listed medicines.

Item 7.1.3 Review of Periploca sepium

Recommendation 64.5

CMEC recommends to the TGA that Periploca sepium is not suitable for use as an ingredient in Listed medicines.

Item 7.1.4 Review of Pinellia ternata

Recommendation 64.6.1

CMEC recommends to the TGA that untreated raw tuber of Pinellia ternata is not suitable for use in Listed medicines.

Recommendation 64.6.2

CMEC recommends to the TGA that traditional preparations of the tuber of Pinellia ternata remain suitable for use in Listed medicines.

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