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TGC meeting 32, 29 April 2008

Therapeutic Goods Committee

29 April 2008

Meeting report

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TGC 32nd meeting (29 April 2008) meeting report (pdf,150kb)

Summary of key resolutions

Note: This summary has been prepared to provide advice of the Resolutions made by the Therapeutic Goods Committee at its 32nd Meeting held on 29 April 2008. 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 31st meeting of the TGC

The Therapeutic Goods Committee notes that:

  • The minutes of the 31st meeting of the Therapeutic Goods Committee held on 29 November 2007 were ratified out-of-session as a true and accurate record of that meeting; and
  • The documents Summary of key resolutions and information for stakeholders - report on meeting have been published on the tga website.

Subcommittee reports - Subcommittee on Biologicals

The Therapeutic Goods Committee (TGC) notes:

  • Nominations for membership of the subcommittee on biologicals are being sought by the Therapeutic Goods Administration in accordance with the recommendation made by the TGC at its previous meeting; and
  • A meeting of the subcommittee will be held as soon as feasible following appointment of members.

Subcommittee reports - Subcommittee on packaging requirements for therapeutic goods

The Therapeutic Goods Committee (TGC) notes:

  • Nominations for membership of the subcommittee on packaging requirements for therapeutic goods for human use were sought in accordance with the recommendation made by the TGC at its previous meeting;
  • Nominations were considered out-of-session and members have been appointed; and
  • It is anticipated that the first meeting of the subcommittee will be held mid-year.

Therapeutic Goods Order No. 77 Microbiological standards for medicines and draft guidance document - report on stakeholder consultation and consideration of matters raised by stakeholders

The Therapeutic Goods Committee:

  1. Notes that:
    • Stakeholder consultation on draft Therapeutic Goods Order No 77 - Microbiological standard for medicines and its draft companion guidance document has been undertaken;
    • Stakeholders were generally supportive of the proposed new Therapeutic Goods Order and the guidance document although a small number of issues were raised for further consideration by the committee; and
    • The committee has now considered the issues raised by stakeholders through the consultation process.
  2. Recommends that:
    • Therapeutic Goods Order No 77 - Microbiological standard for medicines (TGO 77), amended in accordance with the discussion of the committee and following finalisation of any drafting matters, be adopted as an order made under Section 10 of the Therapeutic Goods Act 1989;
    • The end of the transition period for full compliance of medicines with TGO 77 should be 1 January 2010; and
    • The draft guidance document guidance on Therapeutic Goods Order No. 77 Microbiological standards for medicines should be amended for consistency with TGO 77, and in accordance with the discussion of the committee, and be published on the TGA website as soon as possible following entry of TGO 77 onto the Federal Register of Legislative Instruments.

Therapeutic Goods Order No. 78 - General requirements for tablets and capsules and draft guidance document - report on stakeholder consultation and consideration of matters raised by stakeholders

The Therapeutic Goods Committee:

  1. Notes that:
    • Stakeholder consultation on draft Therapeutic Goods Order No 78 - General requirements for tablets and capsules and its draft companion guidance document has been undertaken;
    • Stakeholders were generally supportive of the proposed new Therapeutic Goods Order and the guidance document although a small number of issues were raised for further consideration by the committee; and
    • The committee has now considered the issues raised by stakeholders through the consultation process.
  2. Recommends that:
    • Therapeutic Goods Order No 78 - General requirements for tablets and capsules (TGO 78), amended in accordance with the discussion of the committee and following finalisation of any drafting matters, be adopted as an order made under Section 10 of the Therapeutic Goods Act 1989 to supersede Therapeutic Goods Order No. 56 General standard for tablets, pills and capsules;
    • The transition period for full compliance of medicines with TGO 78 should be 2 years, calculated from date of entry of TGO 78 onto the Federal Register of Legislative Instruments (FRLI); and
    • The draft guidance document guidance on Therapeutic Goods Order No. 78 General requirements for tablets and capsules should be amended for consistency with TGO 78, and in accordance with the discussion of the committee, and be published on the TGA website as soon as possible following entry of TGO 78 onto the FRLI.

Therapeutic Goods Order No. 80 - Child-resistant packaging requirements for medicines and draft guidance document - report on stakeholder consultation and consideration of matters raised by stakeholders

The Therapeutic Goods Committee:

  1. Notes that:
    • Stakeholder consultation on draft Therapeutic Goods Order No. 80 Child-resistant packaging requirements for medicines and its draft companion guidance document has been undertaken;
    • Stakeholders were generally supportive of the proposed new Therapeutic Goods Order and the guidance document although a small number of issues were raised for further consideration by the committee; and
    • The committee has now considered the issues raised by stakeholders through the consultation process.
  2. Confirms that the intention of TGO 80 is to specify packaging requirements applying to medicines when released by a sponsor for supply.
  3. Recommends that:
    • Therapeutic Goods Order No. 80 Child-resistant packaging requirements for medicines (TGO 80), amended in accordance with the discussion of the committee and following finalisation of any drafting matters, be adopted as an order made under Section 10 of the Therapeutic Goods Act 1989 to supersede Therapeutic Goods Order No. 65 Child-resistant packaging for therapeutic goods;
    • The transition period for full compliance of medicines with TGO 80 should be 3 years, calculated from date of entry of TGO 80 onto the Federal Register of Legislative Instruments (FRLI); and
    • The draft guidance document guidance on Therapeutic Goods Order No. 80 Child-resistant packaging requirements for medicines should be amended for consistency with TGO 80, and in accordance with the discussion of the committee, and be published on the TGA website as soon as possible following entry of TGO 80 onto the FRLI.
  4. Further recommends that:
    • As a consequence of the importance of child-resistant packaging in reducing the incidence and severity of accidental poisoning of children with medicines, the Therapeutic Goods Administration (TGA) encourage the pharmacy profession to develop a professional practice standard relating to the safe packaging of medicines by pharmacists when the quantitiy to be dispensed does not allow supply of the original pack; and
    • In view of the increased range of medicines requiring child-resistant packaging following adoption of TGO 80 as a standard, the pharmacy profession be invited to provide feedback to the TGA on the impact of this on specific patient groups (as evidenced by requests for dispensed medicines to be repackaged from the sponsor's original pack).

Therapeutic Goods Order No. 79 - General requirements for the labelling of medicines and draft guidance document - report on stakeholder consultation and consideration of matters raised by stakeholders

The Therapeutic Goods Committee (TGC):

  1. Notes that:
    • Stakeholder consultation on draft Therapeutic Goods Order No. 79 General requirements for the labelling of medicines and its draft companion guidance document has concluded;
    • A large volume of responses has been received from stakeholders; and
    • The responses to the consultation were varied and raised a number of significant matters concerning the usefulness and practicality of the proposed initiatives for medicine labelling.
  2. Requests that, in order to assist the tgc in its consideration of the matters raised by stakeholders, the Therapeutic Goods Administration gather additional relevant information and present this to the next meeting of the committee.

Adoption of British Pharmacopoeia 2008

The Therapeutic Goods Committee notes:

  • Its recommendation made out-of-session in February 2008 (Resolution No. OOS2008/01) that the British Pharmacopoeia 2008 be adopted in Australia on 1 July 2008 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 9 April 2008 and duly registered on the Federal Register of Legislative Instruments.

Expansion of the default standard to include pharmacopoeias other than the British Pharmacopoeia

The Therapeutic Goods Committee:

  1. Notes stakeholder consultation undertaken previously supported the adoption, by the proposed Australia New Zealand Therapeutic Products Authority, of multiple pharmacopoeias as default standards for medicines;
  2. Considers that further consultation in an Australia-only context would be unlikely to reverse this support;
  3. Recommends that:
    • The Therapeutic Goods Administration progress changes to legislation to adopt the British Pharmacopoeia, the European Pharmacopoeia and United States Pharmacopoeia-national formulary as equal default standards for medicines and other therapeutic goods that are not medical devices; and
    • The definitions of the British Pharmacopoeia, European Pharmacopoeia and United States Pharmacopoeia-national formulary in the amended Therapeutic Goods Act 1989 include a statement that the current edition is defined by the effective date specified by the British Pharmacopoeia Commission, the Council of Europe or the United States Pharmacopoeial Convention Inc respectively.

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