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Ingredients
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Listed medicines may only contain certain low risk ingredients permitted for use in listed medicines. The list of ingredients permitted for use in listed medicines is in the Permissible Ingredients Determination. You will need to check that all ingredients in your proposed listed medicine are permitted ingredients.
When searching the Permissible Ingredients Determination, use Australian approved terminology for the ingredient and note that the Permissible Ingredients Determination is separated into alphabetic volumes. You can also search for ingredients using our database of ingredients which is available on the TGA Business Services website.
There are requirements and restrictions associated with the use of some ingredients in listed medicines. You can find these in the Permissible Ingredients Determination. For your product to be eligible for listing, you must also comply with these requirements.
For example, you cannot use an ingredient in an oral preparation if it is specified as ‘topical use only’ in the Permissible Ingredients Determination.
Question
Are all of the ingredients for your proposed listed medicine in the Permissible Ingredients Determination?