Australia’s TGA Proposes Major Update of 2001 Labeling Regulations

Regulatory NewsRegulatory News | 25 August 2014 |  By 

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Australia’s Therapeutic Goods Administration (TGA) is seeking comments on multiple proposals for the first major revision of its 2001 Drug Labeling Regulations.

The regulations are intended to address safety risks posed by issues such as:

  • The difficulty of finding information about a medicine's active ingredient
  • The use of a single brand name across a range of products (i.e. brand extensions)
  • Medicine names that look alike and sound alike, which can lead to use of the incorrect medicine
  • Medicine containers and packaging which appear similar to that of another medicine
  • Lack of a standardized format for information included on medicines labels and packaging
  • Dispensing stickers that cover up important information

TGA is calling for public comment on revisions contained in the following documents:

 The closing date for comments is 7 October 2014.


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