If your request is regarding the use of an unapproved product, a completed SAS Category A notification form/SAS Category B approval letter from the TGA is required before Merck can legally supply the product. As a part of the application process, you will be required to upload the SAS notification form or approval letter when you submit a patient specific request for an unapproved product. Click here for further details: https://www.tga.gov.au/form/special-access-scheme.