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CMEC Meeting 49, 10 December 2004

Complementary Medicines Evaluation Committee

10 December 2004

Extracted ratified minutes

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CMEC Meeting 49 extracted ratified minutes (pdf,118kb)

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 48th meeting

Recommendation 49.1

CMEC confirms that the draft Minutes of its previous meeting (CMEC 48, 15 October 2004), as amended, are a true and accurate record of that previous meeting.

4.1 Working Party on Herbal Medicine Issues - Draft stakeholder consultation paper: Regulation of herbal substances in a joint Australian/New Zealand therapeutic products agency

Recommendation 49.2

CMEC endorses the TGA draft consultation paper: Regulation of herbal substances in a joint Australian/New Zealand therapeutic products agency, as amended, and recommends that it be made available for stakeholder comment.

Item 5.3 Action arising from previous meetings - Asarone

Recommendation 49.5

CMEC notes the report: Final position paper on the use of herbal medicinal products containing asarone prepared by the European Agency for the Evaluation of Medicinal products (EMEA) in December 2003 and recommends to the TGA, that no regulatory action is required since the herbs of concern identified in the report are not supplied in medicines included in the Australian Register of Therapeutic Goods.

Item 10 Matters referred from within TGA

Item 10.2 Matters referred from within TGA - Draft stakeholder consultation paper: Proposed regulatory definitions for complementary medicines and homoeopathic medicines in a joint Australian/New Zealand therapeutic products agency

Recommendation 49.6

CMEC endorses the TGA draft consultation paper: Proposed regulatory definitions for complementary medicines and homoeopathic medicines in a joint Australian/New Zealand therapeutic products agency, as amended, and recommends that it be made available for stakeholder comment.

Item 10.3 Matters referred from within TGA - Proposed stakeholder consultation paper: Regulation of homoeopathic and related medicines in a joint Australian/New Zealand therapeutic products agency

Recommendation 49.7

CMEC endorses the TGA draft consultation paper: Regulation of homoeopathic and related medicines in a joint Australian/New Zealand therapeutic products agency, as amended, and recommends that it be made available for stakeholder comment.

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