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TGC meeting 26, 24 November 2004

Therapeutic Goods Committee

24 November 2004

Meeting report

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TGC 26th meeting (24 November 2004) report (pdf,64kb)

Summary of key resolutions

Note: This summary has been prepared to provide advice of the Resolutions made by the Therapeutic Goods Committee at its 26th Meeting held on 24 November 2004. 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 25th meeting of the TGC

The Therapeutic Goods Committee RATIFIES the Minutes of the 25th Meeting of the Therapeutic Goods Committee, held on 7 September 2004, as a true and accurate record of that Meeting.

Subcommittee on Blood and Tissues

The Therapeutic Goods Committee:

  • DISBANDS its Subcommittee on Blood and Tissues established in August 2003 to consider standards for haematopoietic stem cells harvested from placental cord blood, and haematopoietic stem cells harvested from sources other than placental cord blood, and provide a draft Therapeutic Goods Order for consideration by the Therapeutic Goods Committee; and
  • RECORDS a vote of thanks to Members of the Subcommittee for their efforts and consideration of this matter.

Subcommittee on Child-Resistant Packaging

The Therapeutic Goods Committee:

  • RECOMMENDS that the matters identified in Resolution No. 24/03 relating to standards for child-resistant packaging be referred to the proposed Joint Interim Expert Advisory Committee on Standards, as standards for such packaging must be resolved in the context of the trans-Tasman therapeutic products agency; and
  • DECIDES not to proceed with the establishment of a Subcommittee on Child-Resistant Packaging as previously recommended in Resolution No. 24/03 of May 2004.

British Pharmacopoeia 2004

The Therapeutic Goods Committee RECOMMENDS consideration of the consultation responses on adoption of the British Pharmacopoeia 2004 occur out-of-session, following close of the consultation period on 13 December 2004, with a view to adoption of the British Pharmacopoeia 2004 as the edition of that document defined under the Therapeutic Goods Act 1989.

Australian Code of GMP for Medicinal Products - update of Annex I

The Therapeutic Goods Committee RECOMMENDS the adoption of the November 2004 edition of the Australian Code of Good Manufacturing Practice for Medicinal Products as a Manufacturing Principle.

Therapeutic Goods Order No. 34 Standard for Diagnostic Goods of Human Origin

The Therapeutic Goods Committee NOTES that, following consultation by the Therapeutic Goods Administration on a proposal to revise Therapeutic Goods Order No. 34 (TGO 34) Standard for Diagnostic Goods of Human Origin, TGO 34 is to remain the applicable standard for diagnostic goods of human origin until the end of the transition period for the introduction of the new regulatory framework for in vitro diagnostic medical devices (IVDs).

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Review of the Code of Good Wholesaling Practice for Therapeutic Goods for Human Use

The Therapeutic Goods Committee RECOMMENDS that, subject to minor amendment, the draft document Australian Code of Good Wholesaling Practice for Therapeutic Goods for Human Use (November 2004 revision) be released for appropriate stakeholder consultation.

Review of Therapeutic Goods Orders

  1. The Therapeutic Goods Committee RECOMMENDS that:
    • TGO 9 Standard for B. abortus. Rose-Bengal Antigen;
    • TGO 10 Standard for B. abortus. Milk Ring Test Antigen;
    • TGO 12 Standard for Sterility of Intramammary Injections;
    • TGO 21 General Standard for Live Avian Viral Vaccines;
    • TGO 25 Standard for Hydrocortisone Acetate Eye Ointment and Ear Ointment; and
    • TGO 30 Standards Adopted from the British Pharmacopoeia (Veterinary) 1985, the British Pharmacopoeia (Veterinary ) 1977 and the British Veterinary Codex 1965, supplement 1970,
    should continue in the revocation process, as previously recommended.
  2. The Therapeutic Goods Committee CONSIDERS that:
    • TGO 29 Standard for Ethanol;
    • TGO 44 Revocation;
    • TGO 46 Revocation; and
    • TGO 60 Revocation of Therapeutic Goods Order No. 14 - "General Standards for Metered Dose Aerosols for inhalation",
    are only relevant under the current therapeutic goods legislation and should not require consideration by the proposed Joint Interim Expert Advisory Committee on Standards.
  3. The Therapeutic Goods Committee NOTES that:
    • TGO 69 General requirements for labels for medicines; and
    • TGO 69A Amendment to Therapeutic Goods Order No. 69 - General requirements for labels for medicines,
    are already under consideration in the trans-Tasman context by the Joint Expert Committee on Trans Tasman Labelling Requirements for Medicines.
  4. The Therapeutic Goods Committee NOTES that the following Therapeutic Goods Orders for medical devices are not relevant to the Therapeutic Goods Administration's new regulatory system for medical devices. These Orders need to be retained only until 4 October 2007, which marks the end of the transition period for the new regulatory system for medical devices:
    • TGO 28 Standard for Contraceptive Devices - Diaphragms;
    • TGO 34 Standard for Diagnostic Goods of Human Origin;
    • TGO 37 General Requirements for Labels for Therapeutic Devices;
    • TGO 41 Single-use Syringes for the Injection of 100 Units per millilitre Insulin (U-100);
    • TGO 49 General Standard for Sutures;
    • TGO 52 Gloves for General Medical and Dental Use;
    • TGO 53 Single-use Sterile Surgical Rubber Gloves;
    • TGO 59 Polymer Urethral Catheters for General Medical Use;
    • TGO 61A Replacement of TGO 61: Contraceptive Devices - Rubber Condoms;
    • TGO 67 Standard for Dental Material;
    • TGO 67A Amendment to Therapeutic Goods Order No. 67A - Standard for Dental Materials; and
    • TGO 68 Standard for Plasticized Polyvinyl Chloride (PVC) Blood Bags.
  5. The Therapeutic Goods Committee RECOMMENDS that the following Therapeutic Goods Orders should be reviewed in the trans-Tasman context by the proposed Joint Interim Expert Advisory Committee on Standards:
    • TGO 8 Standards Adopted from the British Pharmaceutical Codex 1973;
    • TGO 20 Child Resistant Containers (superseded by TGO 65, current only for transition period);
    • TGO 33 Amendment of Schedules to Therapeutic goods Order No. 20 Child Resistant Containers (superseded by TGO 65, current only for transition period);
    • TGO 45 Amendments of the Schedule to Therapeutic Goods Order No.8 - Standards adopted from the British Pharmaceutical Codex 1973;
    • TGO 47 Barium Lime;
    • TGO 50 General Standard for Pyrogen and Endotoxin Content of Therapeutic Goods;
    • TGO 54 Standard for Disinfectants and Sterilants;
    • TGO 54A Amendment to the Standard for Disinfectants and Sterilants;
    • TGO 54B Amendment to the Standard for Disinfectants and Sterilants;
    • TGO 56 General standard for tablets, pills and capsules;
    • TGO 63 Standard for Sterile Therapeutic Goods;
    • TGO 64 Standard for Tampons - Menstrual;
    • TGO 64A Amendment to TGO 64: Standard for Tampons - Menstrual;
    • TGO 65 Child-resistant packaging;
    • TGO 70 Standards for Export Only Medicines;
    • TGO 70A Amendment to TGO 70 Standards for Export Only Medicines;
    • TGO 71 Tamper-Evident Packaging of Therapeutic Goods (not yet gazetted); and
    • TGO 72 Standards for Blood Components.
    Of these Therapeutic Goods Orders, the Therapeutic Goods Committee NOTES that:
    • TGO 56, TGO 65 and TGO 71 should be given high priority for review;
    • TGO 50 and TGO 63 may no longer be relevant and hence may not be needed;
    • TGO 54/54A/54B and TGO 64, whilst needing review, are outside the scope of the trans-Tasman regulatory framework and are likely to be Australia-only requirements.
  6. The Therapeutic Goods Committee REQUESTS that the Joint Interim Expert Advisory Committee on Standards provide advice to the Therapeutic Goods Committee on the outcome of its consideration of these Therapeutic Goods Orders.

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