Updated list of ‘permissible ingredients’ for use in listed medicines Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2016

An amendment to the Therapeutic Goods (Permissible Ingredients) Determination No. 2 was registered on the Federal Register of Legislation (FRL) in October 2016. The updated determination retains the title the Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2016.The update to Determination No. 2 of 2016 has been undertaken under section 26BC of the Therapeutic Goods Act 1989 and its function remains the same. The 60 changes in the updated Determination include: The addition of 12 new ingredients. Changes to 47 ingredient entries, including: clarification of information for 13 ingredients making requirements for 6 ingredients less restrictive alignment of 17 ingredients with requirements for these substances included in the Standard for the Uniform Scheduling of Medicines and Poisons correcting 11 typographical errors. Removal of one ingredient name which is a synonym of another ingredient. This amendment involves the removal of the synonym name only, without removing the availability of the ingredient to be used in listed medicines. A list of changes to ingredient availability is available at: List of affected ingredients. A copy of the instrument can be found on the Therapeutic goods determinations page. More information can be found at 26BB Legislative Instrument: Frequently asked questions.

TGA, 12 October 2016 ;http://www.tga.gov.au/ ;