Users of the system will be required to register an account before they can begin drafting and submitting online SAS applications and notifications to the TGA.
Note: users who have registered with other systems hosted by the TGA should login (rather than register) using the username and password to which they registered with the first TGA system.
Upon registration of an account, health practitioners can then draft and submit SAS applications and notifications to the TGA.
All registered account holders will have a personal dashboard that displays information specific to SAS applications and notifications they have drafted or submitted via the system. This portal will allow you to:
The online system has been designed to guide health practitioners when seeking access to unapproved therapeutic goods. The online system will determine which information is required by the TGA based on the specific application/notification using internal logic.
The system will use information provided by the user about the prescribing health practitioner type, the unapproved product and its proposed use to ensure use in accordance with regulatory requirements.
The TGA and relevant State or Territory Health Department will each conduct their own evaluation processes on the information submitted via the system. As part of the evaluation process, the TGA and State or Territory Health Department may contact the prescriber seeking further information in support of the application.
The prescriber will receive a single email from the TGA containing both the TGA and state or territory outcome letters within 48 hours (2 business days) of having received all information required to evaluate the application.
If both state and TGA requirements are satisfied, then the pharmacy or hospital that the doctor has arranged to supply the product can dispense it.
For more information on the Special Access Scheme, please contact our team.