New reporting requirements for medicine shortages

Companies supplying medicines in Australia will be required to provide additional information to the Therapeutic Goods Administration (TGA) if their products go into shortage.

Upcoming changes to reporting requirements will assist health professionals and patients in managing shortages by keeping our Medicine Shortage Reports Database as up-to-date as possible.

From 22 September 2023, companies supplying medicines (known as ‘sponsors’) will be required to specify the period of each medicine shortage in Australia. This follows changes to the Therapeutic Goods Act 1989 (Act) that came into force in March 2023. A six-month grace period allowed sponsors to refine their internal shortage reporting processes to manage the change.

Sponsors will be required to report:

• Changes to the shortage duration or end date and resolution of the shortage.
• The period of the shortage of the medicine in Australia.
• Any changes to the period and resolution date of a medicine shortage where the medicine shortage period ends on or after 22 September 2023, regardless of when the shortage was first notified.

Reporting timeframes are in line with the assessed impact rating on patients. Notification should occur as soon as possible in the interest of affected patients:

• For critical shortages, changes must be reported within 2 working days of discovering the change to the shortage period or resolution date.
• For all other shortages, changes must be reported within 10 working days of discovering the change to the period or resolution date.

The new requirement was an outcome from our consultation on Building a more robust supply of medicines.

Parallel change supports continued patient access

The changes to the Act also give us an additional management option to minimise the impact of medicine discontinuations.

We can now approve the temporary import or supply of an overseas medicine that could act as a substitute for a medicine that was registered in Australia at any point. This includes medicines that have since been cancelled or suspended from the Australian Register of Therapeutic Goods (ARTG). Put simply, if a medicine is cancelled or suspended from the ARTG, but is still clinically important, we can approve supply of a substitute overseas medicine to allow continued patient access.