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Report an adverse event or problem (health professionals)
Report an adverse event or problem related to a medicine, vaccine or medical device as a health professional.
You may experience outages and temporary issues related to medical devices adverse event reporting and access to the Database of Adverse Event Notification (DAEN) - medical devices due to scheduled maintenance around 10am-12pm AEST on 25 August and 1 September 2023.
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.
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
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.
- AEMS guidance for health professionals
- National Adverse Events Following Immunisation (AEFI) reporting form
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