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Obligations to report adverse events for medicines and biologicals

Information on reporting adverse drug reactions, adverse events and significant safety issues for medicines and biologicals.

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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 This is regardless of their Australian marketing status - that is, whether they are currently available for purchase, withdrawn from sale or otherwise supplied e.g. in a company-sponsored post-registration study.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:

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.

  • The Black Triangle Scheme

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    The 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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