If you are a sponsor or manufacturer of a therapeutic good, it is important to have a good understanding of the ingredients (or substances) in your product and the specific requirements and restrictions associated with the use of these ingredients.
Ingredients can be harmful if used incorrectly, so the higher the risk of the ingredient, the stricter the requirements will be. It is your responsibility to ensure your therapeutic good is compliant with all ingredient requirements.
Registered medicines typically contain higher-risk ingredients, which are scheduled in the Poisons Standard (Standard for the Uniform Scheduling of Medicines and Poisons).
Listed and assessed listed medicines can only contain low-risk, pre-approved ingredients called permissible ingredients, which are found in the Therapeutic Goods (Permissible Ingredients) Determination.
For more information about other ingredient requirements, see Ingredients in therapeutic goods.
We have developed guidance to help you understand and interpret the two relevant legislative instruments for ingredients:
- Introduction to the Poisons Standard - this guidance will help you to understand what the Poisons Standard is and how to use it.
- Introduction to the Permissible Ingredients Determination - this guidance will help you to understand what the Therapeutic Goods (Permissible Ingredients) Determination is and how to use it.