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TGC meeting 20, 16 April 2002

Therapeutic Goods Committee

16 April 2002

Meeting report

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TGC 20th meeting (16 April 2002) report (pdf,36kb)

Summary of key resolutions

Note: This summary has been prepared to provide advice of the Resolutions made by the Therapeutic Goods Committee at its 20th Meeting held on 16 April 2002. 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.

Child resistant packaging - progress towards a new therapeutic goods order

The Therapeutic Goods Committee recommends that:

  • The TGA circulate the amended draft Therapeutic Goods Order to the TGC for comment prior to circulation of a final draft to a wide range of stakeholders; and
  • The TGA prepare a final version of Therapeutic Goods Order No. 65 Child-Resistant Packaging for Therapeutic Goods, incorporating comments received after circulation, for consideration at the next Meeting of the TGC.

New good manufacturing practice guide for medicinal products

The Therapeutic Goods Committee recommends that:

  1. The Australian Code of Good Manufacturing Practice for Therapeutic Goods - Medicinal Products (August 1990), the Australian Code of Good Manufacturing Practice for Therapeutic Goods - Medicinal Gases (July 1992) and the Investigational Medicinal Products Code of GMP [as defined in Therapeutic Goods (Manufacturing Principles) Determination No 1 of 1999] be revoked;
  2. The Pharmaceutical Inspection Co-operation Scheme (PIC/S) document Guide to Good Manufacturing Practice for Medicinal Products (Revision 3 dated 15 January 2002) be adopted as a Manufacturing Principle in Australia, with the exception of:
    • Annex 4 (Manufacture of Veterinary Medicinal Products other than Immunologicals),
    • Annex 5 (Manufacture of Immunological Veterinary Medical Products) and
    • Annex 14 (Manufacture of Products Derived from Human Blood or Human Plasma);
  3. A transition period of 12 months apply from the date of gazettal of the PIC/S document as a Manufacturing Principle; and
  4. The TGA and the Industry Associations work together to develop appropriate education programs and information material, for example by:
    • Holding a quarterly liaison meeting between the TGA and Industry Association good manufacturing practice groups leading up to and during the transition period, with the first meeting to be held mid-June 2002, toidentify and resolve issues;
    • Developing a Question and Answer forum on the TGA website; and
    • Conducting regional educational seminars for industry.

Therapeutic Goods Order No. 29 - Review of standards for ethanol

The Therapeutic Goods Committee recommends that Therapeutic Goods Order No. 29 Standards for Ethanol be revoked, with 12-month transition arrangements to apply.

Amendment 1 to British Pharmacopoeia 2001

The Therapeutic Goods Committee:

  1. shall consider, out of session after 30 April 2002, the adoption in Australia of Amendment 1 to British Pharmacopoeia 2001; and
  2. recommends that the TGA consider the logistics of implementation of ongoing revisions to the British Pharmacopoeia.

Review of labelling requirements for medicines

The Therapeutic Goods Committee gives in principle support to the consolidation of all mandatory label requirements, including all mandatory warning statements, into the Labelling Order, with a target effective date of 1 July 2004.

Therapeutic Goods Order No. 66 - Standards for blood components

The Therapeutic Goods Committee recommends the adoption of the Council of Europe document entitled Guide to the preparation, use and quality assurance of blood components, 8th edition dated January 2002, as the Australian standard for fresh blood components as defined in Therapeutic Goods Order No. 66 Standards for Blood Components.

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