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GMP clearance for overseas manufacturers
Appendix E - Electronic application on eBusiness
This section outlines the process for initial registration on the TGA eBusiness system. To complete an electronic application on the TGA's eBusiness system a new applicant must first establish an eBusiness account.
You will NOT be able to access any of the TGA eBusiness Services (eBS) systems without an account.
To establish an e-business account with the TGA visit the website and enter the eBusiness Access Forms area on the TGA eBusiness Services website.
- download the UserForms.zip file and download or copy the e-business and client details forms from the file (to view the page click on this link Document - Access Application Forms); and
- complete and fax both forms to the TGA on +61 (02) 6232 8581 (there is no requirement to send in the original forms, a fax copy is sufficient).
Within three working days of faxing these documents, you will receive 2 emails; one with your master e-business account the other with instructions about how to set up the e-business account. Using the master account you can log onto the user management area in eBS and establish the appropriate number of user accounts for your organisation.
If you have difficulties setting up your accounts please call the TGA eBusiness Services help desk on 1800010624.
A user support help line has been established to provide user support for the Manufacturers Information System (MIS) on 1800 446 443. A user manual can also be downloaded once MIS is accessed using your password.
The TGA will keep clients informed and up to date with news bulletins published in the 'What's New?' area of the TGA online services home page.