You are legally responsible to meet your pharmacovigilance reporting requirements for all the medicines you have registered or listed on the Australian Register of Therapeutic Goods (ARTG), regardless of marketing status. Please refer to the Pharmacovigilance responsibilities of medicine sponsors guidance document for further information.
Please submit a separate form for each safety issue you wish to report.
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.