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Labelling and packaging practices: A summary of some of the evidence
Version 1.0, January 2013
The TGA is conducting a review of the requirements for labelling and packaging of medicines supplied in Australia.
This review is primarily concerned with the presentation of the information on the medicine containers or on the boxes within which they are supplied. Of particular interest are the visual aspects that contribute to the usability of the information provided and facilitate the safe use of the medicine by health care professionals and consumers.
The Summary of Some of the Evidence contains some of the published evidence that the TGA has gathered regarding key issues and concerns about labelling and packaging of medicines.
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Office of Medicines Authorisation
- The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and Ageing, and is responsible for regulating medicines and medical devices.
- The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary.
- The work of the TGA is based on applying scientific and clinical expertise to decision-making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices.
- The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action.
- To report a problem with a medicine or medical device, please see the information on Reporting problems on the TGA website.
© Commonwealth of Australia 2013
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