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TGC meeting 27, 9 June 2005

Therapeutic Goods Committee

9 June 2005

Meeting report

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TGC 27th meeting (9 June 2005) report (pdf,58kb)

Summary of key resolutions

Note: This summary has been prepared to provide advice of the Resolutions made by the Therapeutic Goods Committee at its 27th Meeting held on 9 June 2005. 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 26th meeting of the TGC

The Therapeutic Goods Committee RATIFIES the Minutes of the 26th Meeting of the Therapeutic Goods Committee held on 24 November 2004, as a true and accurate record of that Meeting.

Adoption of British Pharmacopoeia 2004

The Therapeutic Goods Committee NOTES:

  • its recommendation made out-of-session in April 2005 (RESOLUTION NO. OOS2005/01) that the British Pharmacopoeia 2004 be adopted in Australia on 1 July 2005 for the purposes of the edition of the British Pharmacopoeia defined under the Therapeutic Goods Act 1989; and
  • that an order giving effect to this was signed by the Delegate of the Minister for Health and Ageing on 19 May 2005 and duly registered on the Federal Register of Legislative Instruments.

Consequential consideration of TGO 70 Standards for export only medicine

The Therapeutic Goods Committee RECOMMENDS that:

  1. Therapeutic Goods Order No.70A Amendment to Therapeutic Goods Order No. 70 - Standards for Export Only Medicine be revoked; and
  2. Therapeutic Goods Order No. 70 Standards for Export Only Medicines be amended to update the references to all four Pharmacopoeias included in it as follows:
    1. European Pharmacopoeia 4th Edition be amended to European Pharmacopoeia 5th edition;
    2. United States Pharmacopeia 26th edition be amended to United States Pharmacopeia 28th edition;
    3. British Pharmacopoeia 2002 be amended to British Pharmacopoeia 2004; and
    4. Japanese Pharmacopoeia 14th edition be amended to Japanese Pharmacopoeia 14th edition including Supplement 1.

Child-resistant packaging requirements for products containing iron oxides

The Therapeutic Goods Committee:

  1. CLARIFIES the entry for iron oxides included in the First Schedule of Therapeutic Goods Order No. 65 Child-Resistant Packaging for Therapeutic Goods (TGO 65), in that the calculation of elemental iron content should exclude iron oxides, when these are present as an excipient in:
    • divided preparations containing 10 mg or less of total iron oxides per dosage unit; or
    • undivided preparations containing 1 per cent or less of total iron oxides,
    for the purposes of determining whether a requirement for child-resistant packaging exists under TGO 65; and
  2. RECOMMENDS that this clarification be drawn to the attention of the Joint Interim Expert Advisory Committee on Standards for consideration in the context of requirements for child-resistant packaging under joint regulatory arrangements.

Standards for fresh blood components

The Therapeutic Goods Committee RECOMMENDS:

  1. the adoption of the 11th edition of the Council of Europe Guide for the preparation, use and quality assurance of blood components as the standard in Australia for blood components including red cells, white cells, platelets and plasma for transfusion;
  2. that reference to tropical areas under the heading "Tropical Diseases" on page 39 of the 11th edition of the Council of Europe Guide for the preparation, use and quality assurance of blood components should not be taken to include areas within Australia; and
  3. that, in relation to blood components, the Therapeutic Goods Administration negotiate a strategy with the Australian Red Cross Blood Service for managing donors and donations from tropical Australia during any outbreaks of tropical diseases.

The Therapeutic Goods Committee RECOMMENDS that blood and blood components must not be manufactured from blood donors who:

  • have lived in the United Kingdom for a cumulative period of six months or more between 1 January 1980 and 31 December 1996; or
  • have had a transfusion of blood or blood products in the United Kingdom from 1980 onwards.

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