Complying with changes to the Permissible Ingredients Determination

This guidance can help sponsors of listed and assessed listed medicines comply with changes to the Permissible Ingredients Determination (the Determination).

The Determination is a legislative instrument that lists medicine ingredients that are low risk to consumers. These ingredients are suitable for use in listed and assessed listed medicines.

This information will help sponsors:

• understand their obligations to stay up to date about any changes
• know how to comply with high-moderate and low-negligible risk changes.

We regularly review and update the Determination to make sure all ingredients remain safe. Before making a proposed change, we assess the risk to the public of not making the change.

There are 2 risk categories for changes:

• 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 that may impact their medicines. It’s your responsibility as a sponsor to stay informed about the proposed changes to the Determination. You should regularly check:

• consultation periods
• final updates
• transition periods.

As a sponsor, your obligations to comply with the changes vary depending on our risk assessment.

High-moderate risk changes

You must take immediate action to ensure your listed medicines comply with the new requirements.

Check for high-moderate risk changes on our Scheduled changes to the Determination page.

Low-negligible risk changes

Most changes to the Determination are in this category. 

These changes follow a set schedule, known as the Annual Proposal.