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Report adverse events for medicines and biologicals
Information on reporting adverse drug reactions, adverse events and significant safety issues for medicines and biologicals.
Pharmacovigilance is defined by the World Health Organization as the science and activity related to detecting, assessing, understanding and preventing adverse effects and other medicine-related problems.
You must meet your pharmacovigilance reporting responsibilities for all the medicines you have registered or listed on the Australian Register of Therapeutic Goods (ARTG). This is regardless of their Australian marketing status - that is, whether they are currently available for purchase, withdrawn from sale or otherwise supplied e.g. in a company-sponsored post-registration study.
Unapproved medicines used in Clinical trials or supplied under the Special Access Scheme (SAS) or Authorised Prescriber are subject to separate reporting requirements.
You, as a sponsor of medicines approved for supply in Australia, are legally responsible for meeting pharmacovigilance reporting requirements for your medicine. You must:
- let us know who your Australian pharmacovigilance contact person is
- submit any serious adverse reaction reports to us
- notify us of any significant safety issues you identify
- keep records pertaining to the reporting requirements and safety for your medicine (under Subsection 28(5)(ca) of the Therapeutic Goods Act 1989 (the Act))
- answer any request from us for additional information fully and within the specified timeframe (under Subsection 31(1) of the Act).
For more important details on your reporting responsibilities, please find more information below.
Reporting adverse drug reactions, adverse events and significant safety issues
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).
TGA Business Services (TBS) account
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.
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PageThe Black Triangle goes on medicine information documents for new prescription medicines in Australia. It is a reminder to people to report any adverse events related to these new medicines.
Guidance and Resources
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GuidanceAustralian recommendations and requirements
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GuidanceThis guidance will help you understand our pharmacovigilance inspection program (PVIP).
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User guideThis user guide outlines how sponsors can access and use the Adverse Event Management System (AEMS) web portal.
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User guideHow to install the ADR reporting template in the Best Practice software
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User guideHow to use the ADR reporting template in the Best Practice software
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User guideInstalling the ADR reporting template in the Medical Director software
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User guideUsing the ADR reporting template in the Medical Director software
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User guideUser guide on the Adverse Event Management System (AEMS) for health professionals.
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GuidanceThis guidance is for all sponsors of products regulated as biologicals.
More Information
- Information for registered users of the Australian Adverse Drug Reaction Reporting System
- Electronic submission of individual case safety reports
- E2B reports: frequently asked questions
- Reporting adverse events
- Report an adverse event or problem (consumers)
- Database of adverse event notifications
- Medicines safety monitoring