TGC meeting 25, 7 September 2004

Meeting report

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TGC 25th meeting (7 September 2004) report (pdf,47kb)

Summary of key resolutions

Note: This summary has been prepared to provide advice of the Resolutions made by the Therapeutic Goods Committee at its 25th Meeting held on 7 September 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 24th meeting of the TGC

The Therapeutic Goods Committee NOTES that:

• The Minutes of the 24th Meeting of the TGC, held on 4 May 2004, were ratified out-of-session on 13 July 2004;
• The key resolutions made by the TGC at the 24th Meeting were released on the TGA website on 31 May 2004; and
• The Information for Stakeholders - Report on Meeting was released on the TGA website on 30 July 2004.

Trans Tasman terminology project

The Therapeutic Goods Committee NOTES:

• the progress of the trans-Tasman terminology project to date; and
• the implementation plan for the continuation and finalisation of this project, including time frames.

Establishment of Joint Expert Committee on Trans Tasman Labelling Requirements for Medicines

The Therapeutic Goods Committee NOTES the establishment of the Joint Expert Committee on Trans Tasman Labelling Requirements for Medicines, its Terms of Reference and Membership.

Trans-Tasman - Proposal for a Joint Expert Advisory Committee on Standards and an Interim Expert Advisory Committee

The Therapeutic Goods Committee NOTES:

• The functions and composition of the proposed Joint Expert Advisory Committee on Standards; and
• The proposal for formation of a Joint Interim Expert Advisory Committee on Standards to develop a single joint set of standards for implementation upon commencement of the trans-Tasman joint therapeutic products agency.

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