Reporting adverse events for industry
As the sponsor of a medicine or a medical device in Australia, you have a responsibility to report adverse events.
Read more about your obligations to monitor your product and report problems.
Report a medicine or vaccine adverse event
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For more information about using the Adverse Event Management System (AEMS) web portal, see AEMS guidance for sponsors.
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For information about setting up an electronic data interchange between your database and the TGA database, see Electronic submission of individual case safety reports.
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Use this form from the Council for International Organizations of Medical Sciences to report adverse events for medicines and vaccines.
Save the PDF document of the form to your computer, enter the adverse event details, then email the completed PDF form to us.
Report a medical device incident
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Make a report through the Medical Device Incident Reporting system.
If you need help to make a report, call 1800 809 361 or email iris@health.gov.au.