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Report a problem or side effect
This page is for reporting:
- side effects to medicines and problems with medical devices (adverse events)
- counterfeit (fake) medicines and medical devices
- issues with a medicine's packaging or storage.
For all other reports, complaints or enquiries, visit the contact the TGA page.
To begin, click on the consumer, health professional or industry tab below.
If you think you may be experiencing a side effect to a medicine or a problem with a medical device, seek advice from a health professional as soon as possible. The TGA collects adverse event reports to monitor the safety of medicines and medical devices, but we cannot provide you with healthcare or health advice.
I want to report a medicine or vaccine side effect (adverse event)
There are three ways you can report a medicine or vaccine side effect (adverse event): over the phone, online, or by email.
Report over the phone
Call the NPS Medicinewise Adverse Medicine Events (AME) line on 1300 134 237 to report a medicine or vaccine side effect over the phone. You will speak with a pharmacist who will lodge your report and can provide advice on how to manage the side effect. This service is for medicines only.
Report online
Complete the online form to report a medicine or vaccine side effect.
Report by email
Email the TGA to report a medicine or vaccine side effect. Your email should include:
- your contact details
- a description of the side effect (what happened, when it happened and how long it lasted)
- a description of the medicine or vaccine you think caused the side effect (including any other medicines or medical devices you are using).
I want to report a problem with a medical device (adverse event)
Complete the online form to report a problem with a medical device.
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.
I want to report a counterfeit (fake) medicine or medical device
Complete the online form to report a counterfeit medicine or medical device.
I want to report an issue with a medicine's packaging or storage.
Complete the online form to report an issue with a medicine's packaging or storage.
I want to report an adverse event from a medicine or vaccine
There are two main ways to report medicine or vaccine adverse events: report online or download a template.
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.
I want to report an adverse event from a medical device
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.
I want to report a counterfeit medicine or medical device
Complete the online form to report a counterfeit medicine or medical device.
I want to report an issue with a medicine's packaging or storage
Complete the online form to report an issue with a medicine's packaging or storage.
As the sponsor of a medicine or a medical device in Australia, you have a responsibility to report adverse events. Find out more by reading our safety information for industry.
I want to report an adverse event from a medicine or vaccine
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.
I want to report an adverse event from a medical device
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.
More information on adverse event reporting
Reporting adverse events (side effects to medicines and problems with medical devices) helps make medicines and medical devices safer for everyone.
Read the reporting adverse events overview to learn more, including what type of details should be included in a report, what will happen to a report once we receive it, and other frequently asked questions.
You can also find a list of adverse events that have already been reported to the TGA in the Database of Adverse Event Notifications (DAEN).