Report an adverse event or problem (industry)

You can report adverse events from:

• medicines or vaccines
• medical devices.

Read more about your obligations related to monitoring safety and shortages.

Medicine or vaccine adverse event

There are two main ways to report medicine and vaccine adverse events: completing an online form or electronic data interchange.

Complete the online form

You can report an adverse event for a medicine or vaccine by logging-in to your TGA Business Services (TBS) account and using the Adverse Event Management System (AEMS).

For further information about the Adverse Event Management System (AEMS), refer to our AEMS guidance for sponsors.

Setup electronic data interchange

You can report an adverse event for a medicine or vaccine by setting up electronic data interchange between your database and the TGA database using the E2B R2 format.

Report by email

Email the TGA a completed CIOMS form (pdf 107kb) to report a medicine or vaccine side effect relating to your medicine or vaccine.

Medical device adverse event

To report an adverse event for a medical device, you will need to use the Medical Device Incident Reporting (MDIR) system.

If you require assistance to report a medical device problem, call 1800 809 361 (08:30 am to 5:00 pm, Monday to Friday) or email IRIS@health.gov.au