How we manage your medicines adverse event reports

Medicine and vaccine adverse event reports that we receive are entered into the Adverse Event Management System (AEMS).

Information recorded in this database includes the adverse event, the product involved and other relevant information. For example medical history, laboratory results and how the adverse event was treated.

You can submit a report for yourself or on behalf of another person. 

Each report is given a unique ID number. You should use this number if you need to add more information about the event to your existing report.

Adverse events are risk-assessed and the information is put into our internal AEMS database for future reference.

The information helps us identify safety signals, which are 'flags' for possible safety concerns. All safety signals are assessed thoroughly.  

After the information is checked and assessed, it is transferred to the public-access searchable database: Database of Adverse Event Notification (DAEN) - Medicines.

When we identify a safety concern, we can:

• inform health professionals and consumers through alerts and Medicine safety updates
• require changes to product labelling, or add warnings, precautions and adverse event information to the Product Information and Consumer Medicine Information
• take market action to resolve a problem with therapeutic goods supplied in the Australian market (see Database of Recalls, Product Alerts and Product Corrections)
• cancel or suspend the registration of the product, or limit the population in which it can be used (see the cancellations and suspensions database)
• require the sponsor to undertake post-marketing studies to investigate the safety concern, if more information is needed before a judgment can be made about the need for further action.