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International Harmonisation of Medicine Ingredient Names

Regulation Impact Statement – Department of Health

On 23 November 2015, the Therapeutic Goods Administration (TGA), part of the Department of Health, announced its decision to update the Australian approved names of ingredients used on medicine labels and product information to better align with international standards. The proposed changes address concerns that the names of medicine ingredients currently used in Australia are becoming increasingly out of step with international practice. This has caused potential confusion for Australian consumers and healthcare practitioners who travel overseas. It has also added to ambiguity for practitioners who were trained internationally and are practicing in Australia. There has also been additional work for Australian pharmaceutical businesses who market their products overseas. To minimise compliance costs, a four year transition period was agreed for medicine ingredient names to be updated on product labels and in product information documents. A Regulation Impact Statement (RIS) was prepared and certified by the TGA under the Australian Government best practice regulation requirements, and has been assessed as compliant and consistent with best practice by the Office of Best Practice Regulation (OBPR). The RIS estimates the net regulatory cost of making the changes is $0.13m a year. The OBPR has agreed to the estimate.