Reporting medicine shortages and resolutions

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.

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 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.

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

When you become 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

Use our interactive decision tree tool to help you identify the rating of your shortage and the associated mandatory reporting timeframes:

• What is the patient impact of my medicine shortage and do I have to report it to the TGA?

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 two 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

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.

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.

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 (ARTG)
• Section 19A approvals database - 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.

You can subscribe to our medicine shortages alert service to receive emails or RSS feed notifications about medicine shortages.