Regulation impact statement: International harmonisation of ingredient names

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Version 1, November 2015

22 November 2015

TGA maintains terminology for ingredients used in medicines. The approved ingredient names are used on medicine labels and in supporting documentation, such as Product Information and Consumer Medicine Information documents.

Problem

Over the years, some medicine ingredient names in Australia have become out of date with international terminology.

By using old ingredient names, the names of medicine ingredients in Australia were becoming more 'unique'. This led to potential confusion for Australian consumers and healthcare practitioners who travel overseas. It also added to ambiguity for practitioners who were trained internationally and are practicing in Australia.

The lack of synergy also leads to additional work for Australian sponsors who also market their products overseas.

Decision

Following consultation in 2013, this Regulation Impact Statement (RIS) documents the decision to update the Australian approved names of ingredients used in medicines to better align with international standards.

TGA is allowing a four year transition period for medicine labels to start using the new ingredient names. This transition period is expected to start from April 2016.

For further information on what is changing, see the list of ingredient name changes.

Next steps

Changes to medicine ingredient names can cause confusion for consumers and healthcare professionals. TGA is working closely with pharmaceutical, health and medication software industry, health and consumer organisations to help inform those affected about the ingredient name changes.

RIS certification

How to access a pdf document

Further information

Contact the Project Manager at IHIN@tga.gov.au.

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