Australian Medicine shortages: Information for sponsors

Australian Medicine shortages: Information for sponsors

12 March 2022

According to the TGA Website 12th March 2022

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.

Reportable medicines include:

registered Schedule 4 (Prescription Medicine) medicines

registered Schedule 8 (Controlled Drug) medicines

Over-the-counter medicines included in the Therapeutic Goods (Reportable Medicines) Determination

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

Clearly this method relies on the Sponsors reporting their drug shortages to the Australian authorities (TGA) and an effective solution being implemented within the time-frame to the shortage. Could AI play a role here in this process?