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Submissions received: International harmonisation of ingredient names

19 January 2015

The TGA is working on the complex and important task of updating Australian ingredient names to align with international naming systems, such as the World Health Organization's International Non-proprietary Name (INN) system. As part of this activity, we are also looking at changes to improve the consistency of ingredient names used in Australia.

Consultation

In May 2013, TGA and the New Zealand regulator, Medsafe, sought comments from interested parties on proposed changes to approximately 472 ingredient names, and an update to the guidance document TGA approved terminology for medicines.

Submissions received

Thirty-one submissions were received - 28 were submitted to TGA and 3 were submitted to Medsafe. Responses were received from the pharmaceutical industry, as well as healthcare professional and consumer organisations. TGA also held focus groups with some stakeholders to discuss the proposed name changes and seek feedback on implementation strategies.

Submissions were received from the following organisations and individuals.

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Next steps

TGA is currently considering all submissions that were received as well as those received as part of the Medicine Labelling consultation. TGA thanks those who took the time to make a submission and to make comments and suggestions.

A Regulation Impact Statement (RIS) for the ingredient name changes is being developed based on the issues raised during consultation. The RIS will assess different options for the harmonisation of ingredient names, including their approximated costs and benefits. The RIS will be published once a decision on harmonisation is made.

Update to the TGA approved terminology for medicines

TGA will publish an updated TGA approved terminology for medicines guidance document shortly. The update will remove out-of-date lists of approved terminology and include additional guidance on terminology policies.

The current list of approved terminology (such as approved ingredient names, dosage forms, container types and routes of administration) is available through the Code Tables and databases on the eBusiness website.

Further information

Any questions relating to these submissions should be directed to the Project Officer, by email at IHIN@tga.gov.au or by telephone on 02 6232 8575.