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Aged care laws in Australia have now changed. The new Aged Care Act 2024 and Aged Care Rules 2025 now apply. While we complete updating of our website, including draft guidance and other materials, to align with the new laws, providers are advised to refer to the new Act and Rules for any required clarification of their obligations and legal responsibilities. Thank you for your patience.

Reporting adverse events

Reporting adverse events

Guidance,
Last updated

This resource provides information on identifying and reporting adverse events related to medicines, vaccines, and medical devices. It outlines who can report, how to submit a report, the importance of these reports for safety monitoring, and the steps taken by the TGA in response to reported safety concerns. 

This resource may refer to information that will be updated from 1 November 2025 to align with the new Aged Care Act and Quality Standards.

Author
Department of Health, Disability and Ageing
Key Theme
Medication management
Standard
5: Clinical Care
Outcomes
5.3: Safe and quality use of medicines
Reporting adverse events

This is not a Commission publication. Any views are those of the author. You are responsible for considering this in context, based on your circumstances and the Aged Care Act 2024 (Cth) requirements. See Terms of Use .