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Regulation impact statement: International harmonisation of ingredient names

Version 1, November 2015

22 November 2015

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1. Introduction

This Regulation Impact Statement (RIS) assesses options for changing Australian ingredient names used in existing therapeutic goods to align with international nomenclature systems.

The Therapeutic Goods Administration (TGA) proposes to update approved names (for both active and excipient ingredients) to bring them into line with international nomenclature as far as possible. Further associated name changes are also proposed - to improve consistency within Australian approved terminology and remove unharmonised, duplicate and out-of-date names.

In May 2013, TGA released a consultation paper2 seeking feedback on this proposal, which affects 473 ingredient names. In total, 31 submissions3 were received. As part of the consultation process, TGA also held focus groups with stakeholders to discuss the proposed name changes and seek feedback on implementation strategies. This RIS outlines options developed based on the issues raised during consultation.


  1. Consultation: International harmonisation of ingredient names - 13 May 2013 to 10 July 2013
  2. Submissions received

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