FED Medicine Suppliers Must Give 12 Months' Notice Before Stopping Supply and Fines for Failing to Report Changes to That Decision

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

12 Aug 2026: This bill has passed its first house and is now before the second house for its own debate.

House of Representatives

Senate

Assent

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Topics

clinical trials criminal penalties drug shortages healthcare healthcare regulation medical shortages medicine availability medicine supply pharmaceuticals public health regulatory compliance therapeutic goods +7 more

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 provide information on whether the medicine is available in Australia, if there is a shortage, and if they plan to stop supplying it permanently.
People who decide to permanently stop supplying a medicine must tell the Health Secretary at least 12 months before they stop; if they cannot give 12 months' notice, they must do so as soon as possible after making the decision.
People who have notified the Health Secretary that they are stopping a medicine supply must report any changes to that decision, including changes to the stop date or decisions to keep supplying the medicine.
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 (2026: $36,400) fine and bodies corporate face a 1,000 penalty unit (2026: $364,000) fine for failing to notify changes to a discontinuation decision.
Authorized officers can now enter, search, and inspect premises that store or use experimental therapeutic goods for humans, as well as any related records.
The Health Secretary must follow guidelines from the Health Chief Executives Forum and its subcommittees when using certain powers.
The Health Secretary can group biologicals that share common characteristics.

The Debate

What different members said when this bill was debated:

Rebecca White ALP

“I move: That this bill be now read a second time. Today, I introduce the Therapeutic Goods Amendment (Medicines Shortages and Other Measures) Bill 2026. This bill amends the Therapeutic Goods Act 1989 (the Therapeutic Goods Act) to implement several important public health measures, including in relation to the management of medicines shortages and discontinuations.”

Official source →

Melissa McIntosh LIB

“I rise to speak on the Therapeutic Goods Amendment (Medicines Shortages and Other Measures) Bill 2026 and the related Therapeutic Goods (Charges) Amendment Bill 2026, and I move: That all words after ”That” be omitted with a view to substituting the following words: ”whilst not declining to give the bill a second reading, the House: (1) notes that: (a) Australia imports around 90 per cent of the m…”

Official source →

Nita Green ALP

“I move: That these bills be now read a second time. I seek leave to have the second reading speeches incorporated in Hansard. Leave granted. The speeches read as follows— THERAPEUTIC GOODS AMENDMENT (MEDICINES SHORTAGES AND OTHER MEASURES) BILL 2026 Today, I introduce the Therapeutic Goods Amendment (Medicines Shortages and Other Measures) Bill 2026.”

Official source →