As a health professional, you can report:
- medicine or vaccine adverse events
- medical device adverse events
- counterfeit products
- issues with medicine packaging or storage.
Medicine or vaccine adverse events
There are two main ways to report medicine or vaccine adverse events: report online or download a template.
We have detected intermittent issues with the online reporting form in the link below. We are investigating the problem. If you can't log in, register or submit an adverse event report using the form, please email us at: ADR.Reports@health.gov.au.
If you are a consumer and would like to report an adverse event to the TGA, please call 1300 MEDICINE (1300 633 424) and a pharmacist will submit the report for you. For more information, go to our consumer information page.
Report online
Complete the online form to report a medicine or vaccine adverse event.
For further information on the features and functionality of the online adverse event reporting forms, users should refer to the Adverse Event Management System (AEMS) Guidance for Health Professionals.
Download a template
General Practitioners using the Best Practice or Medical Director software can download and install templates into their software to create medicine adverse event reports.
Medical device adverse events
Complete the online form to report a medical device adverse event.
Additional information on reporting medical device adverse events and frequently asked questions can be found at: Medical device incident reporting & investigation scheme (IRIS).
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.
Counterfeit products
Complete the online form to report a counterfeit medicine or medical device.
Issues with medicine packaging or storage
Complete the online form to report an issue with a medicine's packaging or storage.
More information
- AEMS guidance for health professionals
- National Adverse Events Following Immunisation (AEFI) reporting form
- Medicine or vaccine defect report
- Blue card adverse reaction reporting form
- Reporting medical device adverse incidents
Use Best Practice or Medical Director
- Adverse drug reaction reporting using Best Practice: Installing the ADR reporting template
- Adverse drug reaction reporting using Best Practice: Using the ADR reporting template
- Adverse drug reaction reporting using Medical Director: Installing the ADR reporting template
- Adverse drug reaction reporting using Medical Director: Using the ADR reporting template