The Therapeutic Goods (Permissible Ingredients) Determination is the official legal list of ingredients that can be used in listed medicines. It lists the ingredients, the way these ingredients can be used and all the requirements that must be met if the ingredients are to be used in listed medicines. It’s also known as the ’26BB Determination’ because it’s made under section 26BB of the Therapeutic Goods Act 1989 or just ‘the Determination’.
Ingredients that are not included in the Determination or ingredients that do not comply with all the requirements in the Determination cannot be included in listed medicines. Any medicine which contains non-compliant ingredients is ‘ineligible for listing’ and subject to being removed from the Australian Register of Therapeutic Goods (which means supplying it in Australia is illegal).
This Determination only came into effect in January 2016 and replaced hundreds of other pieces of legislation which once contained all these requirements. This means that the Determination is a very comprehensive document and captures the most important requirements for these ingredients. However; this document should be read in conjunction with the other regulatory requirements in the Poisons Standard (also known as the Standard for the Uniform Scheduling of Medicines and Poisons/SUSMP), Therapeutic Goods Orders, Advertising Code and manufacturing requirements.
The compilation of the Determination was a manual process which means some human and historic errors have been retained in the list. If something in the Determination does not seem right or consistent with your understanding, get in touch with Avicenna Consulting and we can help you figure out if your hunch is right and contact the TGA on your behalf to arrange the legislative changes necessary to correct this issue.
Follow the links below to learn more about your regulatory requirements: