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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.
Reports must be provided by email to SAS.Support@health.gov.au.