Adverse Event Reporting Portal

This portal is for registered Assisted Reproductive Treatment (ART) providers to notify the Department of Health of any incident that is, or may be, harmful to the health or wellbeing of patients, gametes or embryos.
Notifications must be submitted through this portal in accordance with the Assisted Reproductive Treatment Act 2008, the Assisted Reproductive Treatment Regulations 2019, and relevant Conditions on Registration.

Reporting timeframes Reporting occurs in two stages:

Stage 1 – Notification Submit an initial notification within the following timeframes (from the date of the event or when the duty-holder became aware of it):
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  • Adverse event: within 10 business days; or
  • Serious adverse event: within 3 business days
Stage 2 – Investigation Submit the investigation report within the following timeframes (from the date the stage one notification was submitted):
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  • Adverse event: within 40 business days; or
  • Serious adverse event: within 30 business days
Providing accurate information

It is an offence under the Assisted Reproductive Treatment Act 2008 to provide false or misleading information to the Secretary.
Providers must ensure all information and documents submitted through this portal are accurate and complete to the best of their knowledge.

Privacy

The Department is committed to protecting your privacy. The Department collects and handles personal information (and, where provided, health information) through the ART Adverse Event Portal to support the Health Regulator’s functions, including receiving and assessing incident notifications and investigation reports, monitoring compliance, and identifying sector trends to improve quality and safety in ART services.

The Department may share this information within the Department and, where required or authorised by law, with other government agencies or statutory bodies to perform regulatory functions.

If you do not provide the information requested, the Department may not be able to properly assess the notification or undertake its regulatory functions.

For more information, see the Department’s privacy policy – https://www.health.vic.gov.au/department-of-health-privacy-policy.

You can request access to, or correction of, the personal information you provide. To do so, contact the ART Regulation Team at artregulation@health.vic.gov.au. You can also contact the Department’s Privacy Unit at privacy@health.vic.gov.au or 1300 024 759.

Need help? For assistance with reporting, please contact the ART Regulation Team:
artregulation@health.vic.gov.au