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TGA medicine labelling and packaging review


24 May 2012

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Labels and packaging advisory committee

The TGA proposes to establish a panel to provide advice on the acceptability of proposed names, labels and packaging, particularly for products involving potential umbrella branding or look-alike sound-alike issues.

It is important for the TGA to have access to independent expert advice on a range of matters relevant to the TGA's responsibilities as a regulator of therapeutic goods. Currently, the TGA has access to such expertise via its expert advisory committees that include subject matter experts who provide the TGA with advice on matters relating to applications for prescription medicines, non-prescription medicines, complementary medicines and medical devices, as well as post-market safety matters.

The TGA does not currently have access to specific expertise relating to the quality use of medicines for labelling and packaging. It is proposed that the panel will consist of persons who represent medicine users (including carers), community and hospital pharmacists, nurses, doctors and health care practitioners and the pharmaceutical industry.

It is proposed that this expert advisory body will provide advice to the TGA on product-specific as well as general matters relating to medicine labels and packaging.

General question on the proposed establishment of a labels and packaging advisory committee

To what extent do you think that a Labels and Packaging Advisory Committee will assist the TGA to manage consumer health risks associated with medicine labels and packaging?

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