Sponsors (importers/manufacturers) are reminded that they must report to the TGA every six months in relation to unapproved therapeutic goods supplied under the SAS and Authorised Prescriber (AP) schemes.
Regulation 47B of the Therapeutic Goods Regulations 1990 outlines the requirement for the sponsor (importer) to submit six-monthly supply reports to the TGA listing the product (brand name) details and quantities supplied in Australia in the relevant period. Reporting periods are 1 January - 30 June (inclusive) and 1 July - 31 December (inclusive). Reports must be submitted within 1 month of the end of the relevant reporting period.
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.