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Special Access Scheme: Guidance for health practitioners and sponsors
Print version
Version 1.1, September 2017
5 January 2018
Reporting mechanisms - adverse events and defects
Reports for adverse events and defects can be made:
- online via the TGA website Report a problem section (preferred) (adverse events and defects for all types of therapeutic goods)
- via email to info@health.gov.au or adr.reports@health.gov.au (adverse events and defects for medicines and biologicals only)
- via the blue card (adverse events for medicines and biologicals only) reporting form which can be downloaded from the TGA website and mailed, faxed or emailed to TGA (details on web page above)
Please note that adverse events and defects for biologicals can be reported using the same mechanisms that currently exist for medicines.