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TGC meeting 29, 7 September 2006

Therapeutic Goods Committee

7 September 2006

Meeting report

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TGC 29th meeting (7 September 2006) report (pdf,89kb)

Summary of key resolutions

Note: This summary has been prepared to provide advice of the Resolutions made by the Therapeutic Goods Committee at its 29th Meeting held on 7 September 2006. 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 28th Meeting of the TGC

The Therapeutic Goods Committee NOTES that:

  • the Minutes of the 28th Meeting of the Therapeutic Goods Committee held on 24 January 2006, 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 Child-Resistant Packaging

The Therapeutic Goods Committee ACCEPTS the Report of Meeting 4 of its Subcommittee on Child-Resistant Packaging, held on 31 July 2006.

  1. The Therapeutic Goods Committee NOTES that:
    • stakeholder consultation on the document Draft Managing Director's Order Child-Resistant Packaging of Therapeutic Products under a Joint Australia New Zealand Therapeutic Products Agency (draft CRP Order) has concluded and responses have been considered by its Subcommittee on Child-Resistant Packaging;
    • in consideration of the stakeholder responses, the draft CRP Order has been amended by the Subcommittee; and
    • the Subcommittee has made a number of recommendations concerning related matters (labelling of transdermal patches containing opioids or nicotine, development of a best practice guideline concerning standards for non-reclosable packaging, and limits for iron compounds) for consideration by the Therapeutic Goods Administration/Medsafe and/or the Australia New Zealand Therapeutic Products Authority.
  2. The Therapeutic Goods Committee RECOMMENDS that the draft CRP Order be re-titled to refer specifically to medicines, rather than therapeutic products.
  3. The Therapeutic Goods Committee REFERS the draft CRP Order, as further amended by the Therapeutic Goods Committee, to the Joint Interim Expert Advisory Committee on Standards for consideration and finalisation.
  4. The Therapeutic Goods Committee SUPPORTS the recommendations made by its Subcommittee on the following related matters and RECOMMENDS that these also be referred to the Joint Interim Expert Advisory Committee on Standards for consideration:
    • the need for the label of transdermal patches containing opioids or nicotine to include a statement regarding safe disposal after use;
    • the need for development of a best practice guideline on non-reclosable forms of child-resistant packaging; and
    • the need for a watching brief to be maintained on the harmonisation between Australia and New Zealand of scheduling of iron compounds, and possible consequential need for the cut-off limit for requiring child-resistant packaging to be reconsidered.
  5. The Therapeutic Goods Committee REQUESTS that the Therapeutic Goods Administration draft a Supplementary Notes section for the draft CRP Order prior to its referral to the Joint Interim Expert Advisory Committee on Standards.

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Revocation of Therapeutic Goods Orders No. 8 Standards Adopted from the British Pharmaceutical Codex 1973 and No. 45 Amendments of the Schedule to TGO8: "Standards Adopted from the British Pharmaceutical Codex 1973"

The Therapeutic Goods Committee RECOMMENDS the revocation of the following Therapeutic Goods Orders:

  • Therapeutic Goods Order No. 8 Standards adopted from the British Pharmaceutical Codex 1973 (TGO 8); and
  • Therapeutic Goods Order No. 45 Amendments of the Schedule to TGO8: "Standards adopted from the British Pharmaceutical Codex 1973" (TGO 45).

Adoption of British Pharmacopoeia 2005

The Therapeutic Goods Committee NOTES:

  • its recommendation made out-of-session in April 2006 (RESOLUTION NO. OOS 2006/01) that the British Pharmacopoeia 2005 be adopted in Australia on 1 July 2006 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 15 May 2006 and duly registered on the Federal Register of Legislative Instruments.

Consequential Consideration of TGO 70 Standards for Export Only Medicines

The Therapeutic Goods Committee RECOMMENDS that:

  • Therapeutic Goods Order No. 70 Standards for Export Only Medicines (as amended by TGO 70A) be amended to update the reference to all four pharmacopoeias as follows:
    • British Pharmacopoeia 2002 be amended to British Pharmacopoeia 2005;
    • European Pharmacopoeia 4th Edition be amended to European Pharmacopoeia 5th Edition, including Supplements 5.1 to 5.6 inclusive;
    • United States Pharmacopeia 26th Edition be amended to United States Pharmacopeia - National Formulary USP 29 - NF 24; and
    • Japanese Pharmacopoeia 14th Edition be amended to Japanese Pharmacopoeia 14th Edition including Supplement I and Supplement II; and
  • Export medicines should meet standards for quality equivalent to those for the domestic market.

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Therapeutic Goods Order No. 64 Standard for Tampons - Menstrual - submission regarding tampon absorbency test methodology

  1. The Therapeutic Goods Committee NOTES:
    • the submission made by XXXXXXXX seeking amendment to Therapeutic Goods Order No. 64 Standard for Tampons - Menstrual (TGO 64), in order to permit the use of an alternate absorbency test methodology, namely the EDANA/FDA methodology; and
    • the advice provided on this issue by the Therapeutic Goods Administration.
  2. The Therapeutic Goods Committee SUPPORTS the principle that Australia should not apply unique requirements to therapeutic goods except where this can be justified.
  3. The Therapeutic Goods Committee CONSIDERS that:
    • a Therapeutic Goods Order should not permit the use of alternate methodologies that lead to different test results;
    • the use of different test methodologies to determine tampon absorbency can result in different absorbency ratings for the same tampon;
    • use of the EDANA test methodology in place of the methodology specified in the Australia New Zealand Standard AS/NZS 2869:1998 Tampons - Menstrual, which is adopted by TGO 64, without corresponding changes to absorbency classifications, would potentially result in an increase in the weight of fibre in tampons in order to achieve the same stated absorbency, and hence result in an increase in the actual absorbency of tampons in Australia;
    • such an increase in absorbency, without corresponding changes to labelling, would have potential to increase the risk of Toxic Shock Syndrome among users; and
    • there also would be potential for significant consumer confusion associated with the introduction of a second or replacement scheme for absorbency labelling.
  4. The Therapeutic Goods Committee RECOMMENDS that:
    • Standards Australia should be requested to consider amending the test method given in Australia New Zealand Standard AS/NZS 2869:1998 Tampons - Menstrual to take into account the information provided by XXXXXXXX concerning the EDANA test methodology; and
    • Any changes made to the test methodology in the Australia New Zealand Standard should take into account consequences in relation to:
      • the absorbency of the tampon; and
      • labelling requirements for tampons marketed in Australia.

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Proposed Revocation of Therapeutic Goods Order No. 47 Barium Lime

The Therapeutic Goods Committee RECOMMENDS the revocation of Therapeutic Goods Order No. 47 Barium Lime.

Therapeutic Goods Order No. 59 Polymer Urethral Catheters for General Medical Use

  1. The Therapeutic Goods Committee NOTES that:
    • Therapeutic Goods Order No. 59 Polymer Urethral Catheters for General Medical Use (TGO 59) determines that the standards for polymer urethral catheters for general medical use are those specified in Clauses 1 to 10 inclusive and Appendices A and B of the document titled "AS/NZS 2696:1996 Australian/New Zealand Standard, Medical devices - Polymer urethral catheters for general medical use" published by Standards Australia on 5 July 1996; and
    • AS/NZS 2696:1996 was withdrawn by Standards Australia with effect 28 October 2005.
  2. The Therapeutic Goods Committee CONSIDERS that the standards given in AS/NZS 2696:1996, as adopted by TGO 59, remain relevant to the regulation of polymer urethral catheters for general medical use as medical devices.
  3. The Therapeutic Goods Committee RECOMMENDS that:
    • the Therapeutic Goods Administration seek legal advice on whether TGO 59 can refer to a withdrawn Australian Standard and therefore be retained without change until the end of the transition period for the new regulatory system for medical devices in October 2007; and/or
    • explore with Standards Australia the possibility of AS 2696:1996 being re-instated as current until October 2007; and
    • advice on these matters be referred back to the Committee for consideration at its next Meeting.

Therapeutic Goods Order No. 63 Standard for Sterile Therapeutic Goods

The Therapeutic Goods Committee:

  • NOTES that Therapeutic Goods Order No. 63 Standard for Sterile Therapeutic Goods (TGO 63) remains relevant to the regulation of sterile therapeutic devices until 4 October 2007, which marks the end of the transition period for the new regulatory system for medical devices;
  • NOTES that TGO 63 should be retained without amendment until the end of that transition period, as reference to test requirements for sterility specified in Appendix XVI of British Pharmacopoeia 1998, rather than the requirements specified in the current edition of the British Pharmacopoeia, is of little practical consequence in the short term; and
  • RECOMMENDS that Medical Device Standards Order No. 3 be revised to refer to the updated version of the TGA Guidelines for Sterility Testing of Therapeutic Goods (2006) for medical devices that are required to be subjected to end-point sterility testing for conformance with Essential Principle 8.3(3).

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Code of Good Wholesaling Practice for Therapeutic Goods for Human Use - consultation responses

  1. The Therapeutic Goods Committee NOTES that:
    • stakeholder consultation on the draft revision to the Australian Code of Good Wholesaling Practice for Therapeutic Goods for Human Use has been undertaken;
    • stakeholders have identified some parts of the draft Code which would benefit from technical and/or editorial amendment; and
    • some stakeholders have raised policy matters relating to the Code, indicating that further refinement may be needed.
  2. The Therapeutic Goods Committee:
    • AGREES to a number of amendments to the technical aspects of the draft Code that take account of the stakeholder comments, as discussed, as well as editorial changes; and
    • CONSIDERS that, in view of the application of the Code by the States and Territories, those issues raised by stakeholders relating to policy should be referred back to the National Coordinating Committee on Therapeutic Goods (NCCTG) for resolution, and then finalisation of the Code.
  3. The TGC has identified the following matters raised by stakeholders as being matters that require consideration and resolution by the NCCTG:
    • application of the Code to third party logistics providers;
    • scope of the Code in terms of which therapeutic goods it applies to (pharmaceuticals, scheduled medicines, medical devices, IVDs etc), and whether the same requirements are relevant to all;
    • the need for further consideration of, and delineation between, those stated requirements that are mandatory and those that should be advisory only, including the meaning of the terms 'should', 'shall' and 'must';
    • whether the Code is to also cover movement of therapeutic goods from retail level back to wholesaler where goods are returned;
    • the inclusion of provisions for batch traceability to retail level;
    • implementation by States and Territories, including transition from the existing Code; andimplications of the Code to arrangements for the supply of Pharmaceutical Benefit Scheme medicines, and obligations on wholesalers under the 4th Community Pharmacy Agreement and associated Community Service Obligation (CSO) arrangements;
    • application in the context of the proposed Australia New Zealand Therapeutic Products Authority.
  4. In relation to batch traceability, the Therapeutic Goods Committee CONSIDERS that the ability of wholesalers to batch trace to retail level would be of benefit in the management of product recalls. The Therapeutic Goods Committee therefore RECOMMENDS that the NCCTG develop a strategy for inclusion in the Code that will require wholesalers to move towards implementing batch recording.

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