Therapeutic Goods Administration Therapeutic Goods Administration

Adverse Event Reporting

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Welcome to the Adverse Event Management System.

In this system, you can report an adverse event associated with a medicine (including complementary, over-the-counter or prescription medicines) or a vaccine.

Privacy statement

For general privacy information, go to www.tga.gov.au/privacy

Information in this report is collected to assist in the post market monitoring of the safety of therapeutic goods under the Therapeutic Goods Act 1989 (the Act). All reports are entered into the Therapeutic Goods Administration’s (TGA’s) Adverse Event Management System (AEMS). Further information about how the TGA uses reported adverse event information is available at www.tga.gov.au/safety/safety

The TGA collects personal information in this report to:
  • monitor the safety of medicines (including vaccines) and biologicals under the Act
  • contact the reporter of the adverse event if further information is required
  • contact representatives of entities that supply therapeutic goods, to discuss reported adverse events
  • check that the same information has not been received multiple times for the same adverse event.

At times, this information is collected from someone other than the individual to whom the personal information relates. This can occur when an adverse event is reported to a person or an entity other than the TGA (such as a health professional, a hospital or a sponsor), and that person or entity passes the information on to the TGA. In those cases, ordinarily the TGA will not collect the name and contact details of patients. However, the TGA may collect other information relating to patients, including the date of birth or age, gender, weight, initials and information about the relevant adverse event.

Personal information collected in this report may be disclosed as permitted under the Privacy Act 1988, including by consent or where the disclosure is required by, or authorised under, a law (for example, under section 61 of the Act). Where a report relates to vaccine events, personal information about the reporter or the patient may be disclosed to State and Territory health agencies under subsection 61(3) of the Act.

De-identified information from this report may also be released to other organisations who have a role in monitoring the safety of medicines and vaccines, including medicine sponsors, where the disclosure is authorised under a law (for example, under section 61 of the Act). A subset of this de-identified information is published on the public Database of Adverse Event Notifications on the TGA website.