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CMEC Meeting 71, 5 March 2009

Complementary Medicines Evaluation Committee

5 March 2009

Extracted ratified minutes

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CMEC Meeting 71 extracted ratified minutes (pdf,136kb)

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 70 (5 December 2008)

Recommendation 71.1

CMEC confirms that the draft Minutes of its previous meeting (CMEC 70, 5 December 2008), as amended, are a true and accurate record of that meeting.

Item 4.2 Glycyrrhiza glabra and Glycyrrhiza uralensis update

Recommendation 71.2

CMEC recommends to the TGA that oral Listed medicines containing the ingredients G. glabra and G. uralensis require the following label advisory statement:

  • "Contains liquorice. People with kidney disease or high blood pressure should seek advice from a healthcare practitioner before consuming this product".*

* NOTE: This recommendation is an amendment of, and supersedes, Recommendation 68.3. Recommendation 71.2 does not include a reference to pregnancy in the label advisory statement.

Recommendation 71.3

CMEC agreed that a cut off dose for glycyrrhizin, below which the label advisory statement does not apply, should be established by the TGA in consultation with industry.

Item 4.3 Selaginella tamariscina update

Recommendation 71.4

CMEC endorses Recommendation 66.6, that preparations of the herb (above ground parts) of Selaginella tamariscina, traditionally prepared as described in the Pharmacopoeia of the Peoples Republic of China, remain suitable for inclusion in Listed medicines.#

# NOTE: This recommendation is a slight amendment of, and supersedes, Recommendation 66.6. Recommendation 71.4 specifies the Pharmacopoeia of the Peoples Republic of China as the reference for the traditional preparation method for preparations of Selaginella tamariscina.

Item 4.4 Pinellia ternata update

Recommendation 71.5

CMEC recommends to the TGA that only those preparations of the tuber of Pinellia ternata, traditionally prepared as described in the Pharmacopoeia of the Peoples Republic of China, remain suitable for inclusion as ingredients in Listed medicines.+

+ NOTE: This recommendation is a slight amendment of, and supersedes, Recommendation 64.6.1. Recommendation 71.5 specifies the Pharmacopoeia of the Peoples Republic of China as the reference for the traditional preparation method for preparations of the tuber of Pinellia ternata.

Item 5.1 Potassium chloride in 'oral rehydration therapy products'

Recommendation 71.6

CMEC recommends to the TGA that potassium chloride (KCL) where consistent with the British Pharmacopoeia monograph for KCL, is suitable for use as an ingredient in Listed therapeutic products used for oral rehydration only, subject to appropriate label requirements.

Recommendation 71.7

CMEC recommends to the TGA that the regulation of all potassium salts should be consistent across the range of potassium salts and should be based on potassium content.

Recommendation 71.8

CMEC recommends to the TGA that the current limit of 600 mg of KCL per dose unit, as a component or an excipient, be reduced to 550 mg per dose unit, consistent with the entry in Schedule 4 of the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP); and that this limit should also be applied to any potassium salt, based on equivalence in terms of potassium content.

Item 7.1 Review of Solidago gigantea and Solidago virgaurea

Recommendation 71.9

CMEC recommends to the TGA that the aerial parts only of Solidago virgaurea and Solidago gigantea remain suitable for use as ingredients in Listed medicines.

Item 10.4 Regulation of vitamin A in products for infants and children

Recommendation 71.10

CMEC recommends to the TGA that the use of vitamin A in Listed therapeutic products intended for infants and children, be subject to life stage specific upper limit (UL), as recommended by the NHMRC.

Recommendation 71.11

CMEC recommends that an appropriate label advisory statement, based on the current statement required for vitamin A products intended for adult use, be developed and implemented by the OCM for products intended for infants and children.

Recommendation 71.12

CMEC recommends to the TGA that additional regulatory measures (e.g. an Order or a a regulatory amendment) be developed and implemented which would permit control of the release limits for vitamin A in liquid products (as is the case for tablets and capsules) intended for infants and children.

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