Medicine shortages: Information for sponsors (suppliers)

Mandatory reporting of medicine shortages

Sponsors of ‘reportable medicines’ must notify the TGA when the medicine is in shortage at a particular time 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 new 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 at that time 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 changes to the period of a medicine shortage and resolution of a medicine shortage

You must report any change to the shortage duration or end date to the TGA. You must notify us when the shortage has resolved. Reporting timeframes are in-line with the initial impact rating.

• For medicines first notified with critical shortage impact rating the notification must occur as soon as possible , but no later than 2 working days after discovering the change to the shortage period or end date
• In any other case - before the end of 10 working days beginning on the first day the person knows, or ought reasonably to have known, of the change to the period or end date.

You will need to vary the notification form for your submitted shortage to notify us of these changes. You are able to vary your submitted notification after we have assessed it and moved it into the ‘Medicine Shortage’ list. See our guidance on electronic notification for further information.

Reporting medicine shortages links

• 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

Registering prescription medicines to manage shortages

• Registration of prescription medicines to manage shortages
  The TGA welcomes applications to register new generics of medicines included in the Australian Register of Therapeutic Goods (ARTG) that are in long-term 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.