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.

Reportable medicines

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.

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

• Decision tree – What is the shortage rating of my medicine shortage and do I need to report it to the TGA?
  Interactive tool to help you identify the rating of your shortage and the associated mandatory reporting timeframes.

Reporting medicine shortages

• Reporting medicine shortages and discontinuations in Australia – Guidance for sponsors
  Guidance for sponsors and suppliers describing compliance obligations, mandatory reporting requirements and when to report a medicine shortage or discontinuation to the TGA.
• Medicine shortages/discontinuations – Electronic notification form: user guide
  Guidance on submitting a medicine shortage notification form, using the TGA Business Services (TBS) portal.

Medicine shortages educational materials

Mandatory Reporting Scheme

• Medicine Shortage Reports Database
  The public database of the medicine shortages and discontinuations reported to the TGA
• Medicine Shortages in Australia: Reporting obligations and the TGA's compliance framework
  Details about TGA’s mandatory medicine shortages reporting scheme and approach to compliance
• Management and communication of medicine shortages and discontinuations in Australia - The medicine shortages information initiative
  High-level historical account of changes to how medicines shortages and discontinuations are managed in Australia

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.

• Supplying medicines during a shortage under section 19A
  Information on applying to import and supply a medicine not included in the Australian Register of Therapeutic Goods
• Database of section 19A approvals to import and supply medicines to address medicine shortages
  The public database detailing all medicines approved for import and supply during a shortage

Alerts

You can subscribe to the medicine shortages alert service to receive email or RSS feed notifications of new and updated medicine shortages information.