Prior to the changes of the Therapeutic Goods Act 1989 which was enforced in March 2023, sponsors are required to notify the Therapeutic Goods Administration (TGA) starting from 22 September 2023, 6 months after the grace period spared by the TGA for sponsors refining the medicines shortage reporting and adapting to the enforcement.
Sponsors are obliged to notify TGA of the shortage duration or the end date together with the resolution of the medicine’s shortages. For any shortage notifications made on or after 22 September 2023, sponsors must specify the shortage period of the medicines in Australia.
Additionally, regardless of when the notice was made, prior to or after the date the medication period ends, sponsors are expected to notify TGA of any changes to the shortage period and the resolutions. The status reporting must be done as soon as possible, or, sponsors are required to obey the legislated timeframe below:
For critical shortages: Changes to the shortage period or end date, must be reported within 2 working days, of becoming aware of them.
For all other shortages: Changes to the shortage period or end date, must be reported within 10 working days, of becoming aware of them.
TGA may approve the temporary import or supply of overseas medicines to substitute medicines registered in Australia including medicines listed in the cancelled or suspended list in ARTG and this applies only to clinically important medicines for continuous patient treatment.
This plan will act as an alleviation platform from the medicines shortage effects and provide the latest information to the patients and healthcare professionals.