TGC meeting 34, 13 May 2009

Meeting report

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TGC 34th meeting (13 May 2009) meeting report (pdf,116kb)

Summary of key resolutions

Note: This summary has been prepared to provide advice of the Resolutions made by the Therapeutic Goods Committee at its 34th Meeting held on 13 May 2009. It should not be assumed that recommendations made by the TGC to the TGA represent the decisions of the TGA. Reasons underlying the TGC Resolutions will be available in the form of an edited Report following ratification of the Minutes by the Committee.

Minutes of the 33rd meeting of the Therapeutic Goods Committee

The Therapeutic Goods Committee (TGC) NOTES that:

1. The Minutes of the 33rd Meeting of the TGC held on 15-16 October 2008 were ratified out-of-session in December 2008 as a true and accurate record of that Meeting; and
2. The documents Summary of Key Resolutions and Information For Stakeholders - Report On Meeting were published on the TGA website in October and December 2008 respectively,

in accordance with usual practice.

Subcommittee reports - Subcommittee on Packaging Requirements for Therapeutic Goods for Human Use

The Therapeutic Goods Committee (TGC) NOTES:

1. That the first meeting of the TGC's Subcommittee on Packaging Requirements for Therapeutic Goods for Human Use was held on Friday 7 November 2008 and the second Meeting was held on Friday 20 March 2009;
2. The outline of the document A Guideline on Improving the Performance of Non-Reclosable Packaging for Medicines as a Barrier to Children developed by the Subcommittee and that further work on this document is to be undertaken;
3. The Subcommittee has considered comments from stakeholders on the adequacy of the technical content of the document Code of Practice for the Tamper-Evident Packaging of Therapeutic Goods (TEP Code of Practice) and will be preparing a revised document for stakeholder consultation; and
4. That the Subcommittee will undertake further work to develop an effective order which will transfer container requirements for therapeutic goods from the Standard for the Uniform Scheduling of Drugs and Poisons to the control of the Therapeutic Goods Administration.

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Status report on adoption of multiple pharmacopoeias as default standards

The Therapeutic Goods Committee:

1. NOTES that amendments to the Therapeutic Goods Act 1989 to adopt the British Pharmacopoeia, the European Pharmacopoeia and United States Pharmacopeia-National Formulary as default standards for medicines and other therapeutic goods that are not medical devices are under consideration by the Australian Parliament; and
2. SUPPORTS the publication of information for stakeholders on the implementation of the additional default standards legislation.

Adoption of British Pharmacopoeia 2009

The Therapeutic Goods Committee NOTES:

1. Its recommendation made out-of-session in March 2009 that the British Pharmacopoeia 2009 should be specified in an order made under the definition of 'British Pharmacopoeia' at subsection 3(1) of the Therapeutic Goods Act 1989 (the Act) as the edition of that standard in force with effect 1 June 2009; and
2. That an order giving effect to this amendment to the edition of the British Pharmacopoeia in effect under the Act has been made by the Delegate of the Minister for Health and Ageing, and duly registered on the Federal Register of Legislative Instruments.

Standards and labelling requirements for homeopathic and anthroposophic medicines

The Therapeutic Goods Committee (TGC) NOTES that:

1. The Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 introduced into the House of Representatives on 19 March 2009 includes proposed changes to the Therapeutic Goods Act 1989 (the Act) relating to the regulation of homoeopathic and anthroposophic medicines;
2. These changes to the Act are planned to commence on 1 July 2011 and will be supported by amendments to the Therapeutic Goods Regulations 1990 and various Orders;
3. The proposed Regulations for homoeopathic and anthroposophic medicines, as presented to stakeholders in the Therapeutic Goods Administration (TGA) September 2008 consultation paper Regulation of Homoeopathic and Anthroposophic Medicines in Australia, are currently undergoing further development;
4. Changes to Therapeutic Goods Order No. 69 General Requirements for Labels for Medicines relating to labelling requirements for homoeopathic and anthroposophic medicines are likely to be necessary; and
5. Appropriate stakeholder consultation regarding the proposed changes will be undertaken by the TGA prior to their consideration by the TGC.

Medicine labelling - Labelling of transdermal patches

The Therapeutic Goods Committee RECOMMENDS that:

1. For safety reasons, transdermal patches should have markings which will make each patch uniquely identifiable after application to a patient;
2. The Therapeutic Goods Administration (TGA) consult with stakeholders on the proposal that Therapeutic Goods Order No. 69 General requirements for labels for medicines be amended to require that transdermal patches be labelled with:
   1. a code or other markings that are unique to the product and its strength; or
   2. the product name, and where there is more than one strength of that product, an indicator of the strength; or
   3. the name of the active ingredient together with a statement of the quantity of active ingredient released in a stated time.
3. A transition period of two years be allowed for those transdermal patches which currently have inadequate or no identification markings for compliance with this requirement; and
4. The TGA inform the publishers of the reference document MIMS of the intent to require markings on transdermal patches and request that the publication include photographs or diagrams of transdermal patches to assist in their identification.

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Medicine labelling - Inclusion of bar codes on medicine labels

The Therapeutic Goods Committee RECOMMENDS that:

1. Stakeholders should be consulted on the proposal that Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO 69) should be amended to require that the labels of medicines include a machine readable code such as a bar code; and
2. The proposal to be consulted on should include the following elements:
   1. The machine readable code must encode the Global Trade Item Number (GTIN) for the medicine as allocated under the GS1 System;
   2. The machine readable code must identify different product variants and, as a minimum, differentiate between different strengths, pack sizes and dose forms;
   3. Inclusion of additional information such as batch and expiry details should not be prevented;
   4. The format of the machine readable code should not be specified, but sponsors of medicines be permitted to select the format best suited to their particular product and the regulatory environment;
   5. The machine readable code must appear on the primary pack of the medicine; and
   6. A transition period of three years should be permitted for compliance.

Medicine labelling - Units of potency

The Therapeutic Goods Committee:

1. SUPPORTS amendment of Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO 69) to require that, where potency units are used on labels as a measure of activity, the potency must be expressed in terms of International Units (IU) as established by the World Health Organization; and
2. RECOMMENDS that the Therapeutic Goods Administration consult with stakeholders on an amendment to TGO 69 that would have this effect.

Medicine labelling - Declaration of excipients

The Therapeutic Goods Committee:

1. NOTES that proposals relating to the declaration of additional excipients on medicine labels have undergone stakeholder consultation on a number of occasions since 2005;
2. NOTES that providing information on excipients in medicines that have potential to cause allergic or other severe adverse effects in sensitive individuals is important for consumer safety;
3. RECOMMENDS that the First Schedule to Therapeutic Goods Order No. 69 General requirements for labels for medicines should be amended to:
   1. Include new entries for:
      • crustacean and crustacean products, to be applicable to products for any route of administration;
      • egg and egg products, to be applicable to products for any route of administration;
      • fish and fish products, to be applicable to products for any route of administration;
      • milk and milk products, applicable to products for any route of administration;
      • potassium salts above the threshold of 1 mmol (39 mg) elemental potassium per dose, to be applicable to products for oral administration and declared on the label in terms of the milligram amount of elemental potassium per dose;
      • sesame seed and sesame seed products, to be applicable to products for any route of administration;
      • soya beans & soya bean products, to be applicable to products for any route of administration but excluding:
        • fully refined soybean oil and fat;
        • natural mixed tocopherols, natural D-alpha tocopherol, natural alpha tocopherol acetate, and natural D-alpha tocopherol succinate from soybean sources;
        • vegetable oils derived phytosterols and phytosterol esters from soybean sources; and
        • plant stanol ester produced from vegetable oil sterols from soybean sources; and
      • tree nuts & tree nut products, to be applicable to products for any route of administration.
   2. Clarify that the existing entry for peanuts and peanut products includes Arachis hypogaea and Arachis (peanut) oil; and
   3. Amend the existing entry for sodium salts to require that the statement of sodium content refer to the milligram amount of elemental sodium per dose.
4. RECOMMENDS that stakeholders be advised of the proposed amendments and consulted on a proposed transition period of two years for the changes to labels to be implemented; and
5. RECOMMENDS that the proposed warning statements relating to the potential for bee pollen, propolis and royal jelly to cause severe allergic reactions be included in the document Required Advisory Statements for Medicine Labels and that the required warning statements apply equally to listed and registered medicines irrespective of whether the substance is present as active ingredient or an excipient.

Medicine labelling - Prominence of active ingredient names

The Therapeutic Goods Committee:

1. NOTES that proposals for an increase in the font size used for active ingredient names on medicine labels have undergone stakeholder consultation on a number of occasions since 2005;
2. AGREES that clear display on medicine labels of active ingredient names is important in ensuring the quality use of medicines and for consumer safety;
3. RECOMMENDS that Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO 69) be amended to require that:
   1. For prescription medicines, the name(s) of active ingredient(s) appearing on the main label must be:
      • written in a font size at least half that used for the product name but, in any case, in a letter height that is not less than 2 millimetres; and
      • positioned immediately beneath, and left aligned with, the product name;
   2. For registered non-prescription medicines, including registered complementary medicines, the name(s) of active ingredient(s) appearing on the main label must be:
      • written in a font size at least half that used for the product name but, in any case, in a letter height that is not less than 2 millimetres; and
      • positioned immediately beneath, and left aligned with, the product name;
   3. For prescription medicines and registered non-prescription medicines, including registered complementary medicines, where the names of active ingredients are shifted to a side, or rear, panel or label, as permitted by subclauses 3(3)(a) and 3(3)(b) of TGO 69, then the names of the active ingredients must be displayed in a letter height that is not less than 2 millimetres.
4. NOTES that no significant safety concerns relating to the display of active ingredient names on the labels of listed medicines have been brought to the Committee's attention, and therefore no change to current requirements for the display of active ingredient names on those medicines is proposed at this time.
5. RECOMMENDS a transition period of three years for the changes to labels of prescription medicines and registered non-prescription, including registered complementary medicines, to be implemented.
6. RECOMMENDS that stakeholders be advised of the proposed amendments.

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