Mandatory requirements and restrictions are placed on the use of each ingredient in a therapeutic good.
The Ingredients Table
The Ingredients Table is an ingredients database found in our TGA Business Services (TBS) portal. This is a list of approved ingredient names which can be used by all therapeutic goods. The table includes requirements and limitations of use for each ingredient.
After checking the Ingredients Table, further requirements and restrictions for ingredients may apply, for example in the Poisons Standard (also known as the Standard Uniform Scheduling of Medicines and Poisons or SUSMP). It’s important to check.
Search the Ingredients Table
For help using the Ingredients Table see How to search TBS for approved ingredients and accepted terminology.
The Permissible ingredients determination
Go to the Permissible ingredients determination
The Therapeutic Goods (Permissible Ingredients) Determination (the Determination) is a subset of the Ingredients Table. The Determination contains low-risk ingredients the TGA has evaluated for use in listed and assessed listed non-prescription medicines.
Search the Permissible Ingredients Determination
For help using the Determination see Introduction to the Permissible Ingredients Determination.
The Determination is updated at least four times a year, so make sure the version you are looking at is labelled ‘In force – Latest Version’.
The Poisons Standard
You must check the Poisons Standard to see how the ingredients in your formulation have been scheduled.
How an ingredient is scheduled determines if, and how, your therapeutic good can be supplied. For example, schedule 4 substances can only be used in prescription medicines; they cannot be used in listed medicines.
Search the Poisons Standard
Help interpreting the Poison standard can be found in the Introduction to the Poisons Standard.
The Poisons Standard is updated at least three times a year, so make sure the version you are looking at is labelled ‘In force – Latest Version’.
Ingredient not found in a database
If you cannot find an ingredient in our databases, do not presume that it is safe and can be used without restriction.
Not found in the Ingredients Table
If your medicine contains an ingredient not included in the Ingredients Table, you can apply to the TGA to have that ingredient included. See Request a new ingredient.
Not found in the Permissible Ingredients Determination
If your medicine contains an ingredient not included in the Permissible Ingredients Determination, but you would like to use that ingredient in your listed or assessed listed medicine, the following options are available:
- Check the Poisons Standard to see if your ingredient is subject to a schedule. If your ingredient is scheduled, your proposed medicine may be a registered medicine (for example a prescription medicine, over the counter medicine, or registered complementary medicine), which have different requirements from listed or assessed listed medicines.
- You may apply to the TGA to have your substance evaluated for inclusion in the Determination. See Request a new ingredient.
Not found in the Poisons Standard
You may not have searched the correct substance name or the TGA may not yet have considered the substance for scheduling, or the substance may not require scheduling.
See Introduction to Poisons Standard for more details and help.
Proprietary ingredients
A proprietary ingredient (also called a PI) is not a type of ingredient, but a mixture of ingredients put together to make a formulation. PIs are mixtures that manufacturers of medicines may use as colours, flavours, capsules and printing inks.
Proprietary ingredient suppliers notify the TGA of new PIs. Once the TGA has approved the new PI and added it to the PI Ingredients Table, then suppliers can sell their PI formulation to medicine sponsors for use in their products
Search the Proprietary ingredients table
In TGA Business Services:
- expand the ‘Public TGA Information’ menu
- select ‘Ingredients - Proprietary’.
Our Proprietary Ingredient Table can help with submitting a new medicine application. Instead of having to write out every single ingredient in your formulation, you can search the Proprietary Ingredients Table (found in TGA Business Services) for the PI name and add the corresponding ID number to your application.