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Permissible ingredients determination
Guidance on the requirements for listed and assessed listed medicine formulations to comply with and how to submit and an application to amend, the Therapeutic Goods (Permissible Ingredients) Determination.
The Permissible Ingredients Determination also outlines specific requirements of use for individual ingredients. This includes (but is not limited to) how an ingredient can be used, if it requires a label advisory statement and any quantity restrictions that must be complied with.
Listed and assessed listed medicines may only use ingredients found in the Permissible Ingredients Determination. If you are a sponsor of a listed or assessed listed medicine, you must ensure that your medicine formulation complies with the Permissible Ingredients Determination.
To use a new substance that is not included in the Determination, or to vary the restrictions for an existing substance, you must make an application to have that substance evaluated.
Information about the Permissible Ingredients Determination
- Therapeutic Goods (Permissible Ingredients) Determination
See what ingredients are currently approved for use in listed medicines in the current Permissible Ingredients Determination.
- Introduction to the Permissible Ingredients Determination
Guidance on the Permissible Ingredients Determination, how to use it and regulatory responsibilities of sponsors.
- Changes to the Permissible Ingredients Determination
Information about why and how changes are made to the Permissible Ingredients Determination.
How do I apply for evaluation of a substance for use in listed medicines?
- See the information about Changes to applying for the evaluation of a new substance for listed medicines
- Review Mandatory requirements for an application to vary the Permissible Ingredients Determination and Application requirements for new substance for use in listed medicines.
- If applying for a microorganism that is intended to be used an active ingredient in listed medicines, review Requirements for microorganism characterisation in listed medicines and registered complementary medicines.
- Review Overview of compositional guidelines and templates and the list of Compositional guidelines.
- Review information on how to complete the online application form using the TGA Business services (TBS) portal in User guide: Evaluation of substances for use in listed medicines and assessed listed medicines.
- Permitted indications for listed medicines
- Applications for new substances in listed medicines
- Information required in an evaluation of a substance for use in listed medicines: guidance for sponsors
- User guide: Evaluation of substances for use in listed medicines and assessed listed medicines
- Changes to evaluation of substances for use in listed complementary medicines