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Changes to the Permissible Ingredients Determination

25 March 2020

The Therapeutic Goods (Permissible Ingredients) Determination ('the Determination') is a legislative instrument made under section 26BB of the Therapeutic Goods Act 1989 ('the Act'). This instrument specifies all of the ingredients that are available for use in listed medicines and the requirements for their use. The Determination is continually reviewed by the TGA to ensure that all ingredients are safe for use in low-risk medicines. It is updated through the addition or removal of ingredients, and the clarification, removal or addition of restrictions or warning statements.

Notices of updates to the Determination

Why are changes made to the Determination?

The Determination may be changed to incorporate new ingredients or requirements following a paid application to update the instrument (under section 26BE of the Act). The Delegate of the Minister of Health approves the addition of new ingredients to the Determination following the evaluation of these ingredients by the TGA.

The TGA also undertakes safety reviews of existing ingredients when the TGA receives information that warrants further investigation. For example, the TGA may receive a report of a serious adverse event such as liver failure which may indicate the safety of consumers could be adversely impacted.

Ingredients already on the Determination may also occasionally be amended to correct errors, provide clarification, or update the name following revision of a scientific or botanical name.

Depending on the conclusions of the review, the TGA may add a new ingredient, or a change the restrictions or warning statements associated with an existing ingredient. In cases where the safety concern cannot be mitigated via restrictions or warning statements, or where insufficient data can be located for the Delegate to be assured of the safety of the ingredient, the TGA may remove the ingredient from the Determination.

How often is the Determination updated?

The Determination will be updated as soon as possible at the conclusion of a paid application to provide greater predictability and timely availability of new ingredients.

Changes to ingredients already on the Determination are first reviewed and risk assessed. Each proposed change is categorised as either 'low-negligible' or 'high-moderate' risk. The assessment considers the safety risk posed to consumers by existing listed medicines and whether an urgent update to the Determination is commensurate to that risk.

High-moderate risk changes

Where a delay to implementation of a change to an ingredient is likely to pose an imminent or serious safety risk to consumers (high-moderate), the Determination will be updated according to section 26BC of the Act as soon as considered appropriate by the Delegate of the Minister of Health to minimise any risk to consumers. Sponsors will need to take immediate action to ensure existing listed medicines are compliant with the new requirements. This is required to maintain appropriate safety of listed medicines for consumers and maintain the integrity of listed medicines within the low-risk regulatory framework.

Notifications of final decisions to update the Determination - High-moderate risk

Low-negligible risk changes

Where a delay to implementation of a change to an ingredient is not likely to pose an imminent or serious safety risk to consumers, the TGA will publish an annual proposal for these changes (and associated reasons) on this webpage. Stakeholders will be provided with a 6-week period to comment on these proposed changes. The TGA will consider any comments and will publish the final decision on this webpage at least 3 months prior to update of the Determination. Sponsors will be provided a 12 months transition period from commencement of the Determination to bring existing listed medicines into compliance.

Transition expectations

Transition periods provide sponsors of existing listed medicines with time to make arrangements to bring their products into compliance.

Sponsors should ensure that no product is released for supply after the expiry of the transition period, unless the product (including the details in the ARTG listing) is compliant with any new applicable requirements.

After the expiry of the transition period, any ARTG listings or product released for supply that does not comply with the new requirements may be targeted for review.

The table below outlines the anticipated schedule for low-negligible risk changes for 2019-2020.

Stage Scheduled timeframe TGA Action
Review & risk assessment Up to 29 August 2019 Review of existing ingredients issues and assessment of the risk category.
Proposal Friday, 30 August 2019 List of proposed low-negligible risk changes published on the TGA website for public comment.
Consideration Friday, 11 October 2019 Comment period closes and TGA commences review of consultation responses.
Notification Monday, 2 December 2019 TGA publishes finalised list of upcoming changes and implementation timeframes.
Commencement Monday, 2 March 2020 New Determination commences on the Federal Register of Legislation.
Finalisation Monday, 2 March 2021 Transition period ends.

Proposed changes to ingredients - Low-negligible risk

Notifications of final decisions to update the Determination - Low-negligible risk