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Proprietary ingredient formulations and how they are used
A proprietary ingredient is a formulation, such as a flavour or fragrance, made with a mixture of ingredients. Sometimes details of these formulations are not in the public domain.
Ingredient suppliers notify us of their proprietary ingredient formulations, which are entered in the TGA Proprietary Ingredient Tables. Each is given a unique ID number and purpose, e.g. colour, capsule shell. Applicants for new therapeutic goods can then select the unique ID or proprietary ingredient name in their therapeutic good formulation, rather than submit a full list of ingredients to the TGA.
Proprietary ingredient names and their ID numbers can be found in the Proprietary Ingredient Tables in TGA Business services.
To learn more about submitting a notification for a new proprietary ingredient, go to the Notification of a new proprietary ingredient page.
We regulate the use of proprietary ingredients in therapeutic goods in different ways, depending on the type of good. For low risk medicines such as listed medicines, limits are placed on the amount of proprietary ingredient that can be used. Use of proprietary ingredients in registered medicines is assessed as part of the premarket approval process.
The TGA no longer allocates proprietary ingredient numbers to certain categories of ingredient mixtures. For more information see Streamlining proprietary ingredient categories.
Publicly displayed information about proprietary ingredients in therapeutic goods
Each therapeutic good (medicine, device and biological) approved for sale or supply in Australia is entered on the Australian Register of Therapeutic Goods (ARTG). The ARTG public summaries for medicines and biologicals include the name and quantity of their active ingredients and the names of their excipient ('inactive') ingredients. These ARTG summaries also show some information about the ingredients contained in proprietary ingredient mixes.
The trade names of proprietary ingredients are not shown in ARTG public summaries.
Flavour, fragrance and colour proprietary ingredients
Medicines and biologicals with flavour, fragrance or colour proprietary ingredients in their formulation include the word 'flavour', 'fragrance', or 'colour' in the list of ingredients in the ARTG public summary.
All other proprietary ingredients
Proprietary ingredients that do not have flavour, fragrance or colour as their purpose in the Proprietary Ingredient Tables are displayed differently. These are:
- active pre-mixes*
- capsule shell formulations
- coating materials
- cream (ointment) bases
- excipient mixes
- oral bases
- preservative mixes
When these other proprietary ingredients are used in a medicine or biological, the ARTG public summary shows the names of the ingredients within the proprietary ingredient mix. These ingredients will appear in alphabetical order, among all the other excipient ingredients that are in the product's formulation.
* The TGA no longer allocates proprietary ingredient numbers to new active pre-mixes and non-specific excipient mixes. For more information see Streamlining proprietary ingredient categories.