Notification Obligations and Penalties for Discontinuing Medicine Supply

Therapeutic Goods Amendment (Medicines Shortages and Other Measures) Bill 2026

1st House

2nd House

Law

Links to official parliament websites

Official page: progress through parliament

Effects of this bill

If this bill passes, it means that:

People who register or list medicines must give the Secretary information about shortages and availability in Australia.
People who decide to permanently stop supplying a medicine must notify the Secretary of any changes to that decision.
Notifications of changes to discontinuation dates must be made within two working days if the impact is critical; otherwise, they must be made within 10 working days.
Individuals face a 100 penalty unit fine; bodies corporate face a 1,000 penalty unit fine for failing to notify changes to a discontinuation decision.
Authorized officers can now enter and search premises to inspect clinical trial goods used or stored for human experiments.
The Secretary must follow Health Chief Executives Forum guidelines when using certain powers.
The Secretary can group biologicals that share common characteristics.

News articles and press releases