Following registration and testing of your systems, you can begin submitting ICSRs to the TGA production E2B (R2) EDI service. The following sections describe the specifications for generating and submitting ICSRs.
Each ICH Safety Message should only contain a single adverse event report. Batches of adverse event reports in the same ICH Safety Message should not be submitted. There is a size restriction on the xml file of 2 megabytes.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.