Permissible ingredients determination

The Permissible Ingredients Determination (the Determination) is a legislative instrument that lists medicine ingredients that pose a low safety risk to the consumer. These low-risk ingredients are suitable for use in listed and assessed listed medicines. If an ingredient isn’t listed in the Determination, it can’t be used in listed or assessed listed medicines.

The Determination also outlines how to use these ingredients. This includes (but isn’t limited to):

• if an ingredient needs a label advisory statement
• any quantity restrictions sponsors must follow
• restrictions on the type of use for the ingredient - for example, only for oral use
• information on any other restriction as required.

The Determination is a legislative document. This means sponsors of listed and assessed listed medicines must comply with the requirements for each ingredient in their medicines.

We regularly update the Determination to:

• add or remove ingredients
• clarify, correct, remove, or add restrictions to an existing ingredient
• clarify, remove, or add label advisory statements
• update names following revision of scientific or botanical names.

We also review existing ingredients if we receive information that warrants investigation. For example, we may receive a report of an adverse event that poses a safety risk to consumers.

If we find an ingredient poses a safety risk to the consumer, we change or update the Determination based on how urgent the update is.

We assess the risk of any proposed change as either:

• High-moderate risk where a delay in changing an ingredient could cause serious or immediate harm.
• Low-negligible risk where a delay is unlikely to cause serious or immediate harm.

We don't tell sponsors about changes we've made to the Determination because it is the sponsor’s responsibility to make sure they are up to date on any regulatory changes.

It's your responsibility to stay updated on:

• proposed changes
• consultation periods
• our final decisions.

Find the latest changes to the Determination.

As a sponsor, you'll need to ensure your medicines comply with changes to the Determination.

You can apply to have us:

• review an existing ingredient
• add a new ingredient.

We have mandatory requirements you must follow in your application.

Adding a new ingredient or reviewing an existing ingredient

If you're applying for a new ingredient in listed medicines, see Understanding the application requirements for new substances for listed medicines.

You can also find guidance on mandatory requirements for applications to change the Determination at Mandatory requirements for an effective application to vary the Determination

If you're applying for a microorganism to use as an active ingredient in listed medicines, see Understanding the application requirements for microorganism characterisation in listed medicines and registered complementary medicines.

Find out more about what to include when applying to vary the Determination.

Using the Business Services Portal

For support with completing the online application form using our TGA Business Services (TBS) portal, see User guide: Evaluation of substances for use in listed medicines and assessed listed medicines.

Complementary medicines

If you're a sponsor of a complementary medicine, the following resources can help:

• information about Comparable overseas bodies (COBs) for complementary medicines, the current list of COBs and COB checklists
• guidance on using reports from COBS and submission requirements for evaluation of these applications
• overview of compositional guidelines and templates and the list of Compositional guidelines.