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Medicine shortages: Information for sponsors (suppliers)

16 June 2021

Mandatory reporting of medicine shortages

Sponsors of ‘reportable medicines’ must notify the TGA when the medicine is in shortage or being discontinued.

A medicine shortage occurs when the supply of a medicine is not likely to meet the normal or projected consumer demand within Australia at any point during the next 6 months. A discontinuation is a permanent shortage.

The legal definition of a medicine shortage:

There is a shortage of a medicine in Australia at a particular time if at any time in the six months after that particular time, the supply of that medicine in Australia will not, or will not be likely to, meet the demand for the medicine for all of the patients in Australia who take, or who may need to take, the medicine.

Reportable medicines

Reportable medicines include:

If you are a sponsor of a reportable medicine, you must report all shortages and discontinuations affecting the medicine to us within mandated timeframes.

Reporting timeframes and shortage impact ratings

The timeframe in which you must report a shortage or discontinuation to the TGA depends on its shortage impact rating.

When you becomes aware of a medicine shortage, you must assess the shortage impact rating to determine how quickly you must notify the TGA.

  • Shortages with a critical shortage impact rating must be reported as soon as possible, but no later than 2 working days after discovering the shortage.
  • All other shortages must be reported within 10 working days.

Determining impact rating

Reporting medicine shortages

The Medicine Shortage Notification form in TBS was updated on Tuesday 1 June 2021.

This Quick Reference Guide will help you understand the changes and give you an overview of the differences you will see when submitting Medicine Shortage notifications.

Medicine shortages educational materials

Mandatory Reporting Scheme

Supplying alternative medicines during a shortage under section 19A

During a shortage, sponsors can apply to supply alternative medicines not included in the Australian Register of Therapeutic Goods under section 19A of the Therapeutic Goods Act 1989.


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