Therapeutic goods must contain ingredients approved for use by TGA, with approved names.
Ingredients need to be evaluated by the TGA to ensure:
- they are safe to use in products
- they are suitable for their intended purpose
- risk is minimised.
Approved ingredients have requirements and restrictions associated with their use and dosage form:
- An ingredient for use on skin but not the eye is restricted to topical use and not permitted in eye drops.
- We can require a warning statement on the product label with the particular use of an ingredient.
- We place limits on the amount of an ingredient used in a formulation.
Approved ingredient names
TGA approved ingredient names are known as Australian Approved Names (AANs).
The TGA uses strict ingredient naming protocols to ensure sponsors use correct ingredient names in online applications and any associated material (for example, labels).
Types of ingredients
There are two types of ingredients used in therapeutic goods, active ingredients and excipient ingredients.
- An active ingredient is a therapeutically active component in a products' final formulation. For example, iodine or paracetamol.
- An excipient ingredient is not therapeutically active in a products' final formulation. For example, preservatives or tablet coatings.
Proprietary ingredients
Proprietary ingredients (PIs) are not a type of ingredient.
They are a group of combined ingredients, that once combined have their own function. This might be flavour, fragrance or a tablet coating. PIs are commonly referred to by their trade or proprietary name.
For more information about PIs, see:
- Proprietary ingredient formulations and how they are used
- Streamlining proprietary ingredient categories
Herbal ingredients
Herbal ingredients can be both excipients and active ingredients. Their correct preparation and naming can be complex.
For more information see: herbal ingredients
Substances that are not considered an ingredient
Manufacturing aids are substances that help make the medicine but don't stay in it. Sometimes medicines have trace amounts of substances, but they’re not ingredients. For example, soy oil used as a lubricant or egg used to culture vaccines.
Scheduling of ingredients
Scheduling is how we categorise ingredients based on their potential for harm.
The higher the risk of harm, the stricter the requirements will be for an ingredient.
This means that the ingredients you use affects how your medicine is regulated.
For example:
- Ingredients in schedule 4 of the Poisons Standard pose a greater risk and have stricter requirements for use, like requiring a prescription.
- If any ingredients in your medicine fall into schedule 4, then your therapeutic good is regulated at this strictest level, a prescription medicine.
- If your ingredients fall into schedule 3 of the Poisons Standard (and no other higher-risk schedule), then they are pharmacist only medicines, regulated as over the counter medicines.
Listed and assessed listed non-prescription medicines can only contain low-risk, pre-approved ingredients called permissible ingredients. These are found in the Therapeutic Goods (Permissible Ingredients) Determination.
See: Searching ingredient requirements for access and help using the poisons standard and permissible ingredients determination.