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Regulation impact statement: International harmonisation of ingredient names

Version 1, November 2015

22 November 2015

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3. Objectives

The first objective of this harmonisation activity is to maintain clarity and consistency in ingredient naming (as far as possible) to support quality use of medicines. Unambiguous and internationally consistent ingredient names help health professionals and the public to compare similar therapeutic goods and avoid confusion between goods. Consistency in naming also supports the quality use of medicines by:

  • minimising the risk of prescribing, dispensing and self-selection errors
  • enhancing consumer safety (through easier international information sharing) and
  • avoiding consumer confusion and the inappropriate use of medicines.

The second objective is to minimise administrative costs for industry, thereby supporting the commercial viability of supplying medicines to Australian consumers and internationally. The use of internationally harmonised ingredient names in Australia can assist industry by reducing costs associated with preparing marketing and product information materials. Internal consistency within the Ingredients Table can also benefit industry as it assists TGA in more efficiently assessing applications for new medicines or variations to existing products.

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