the application was made by an overseas manufacturer or representative acting on behalf of the overseas manufacturer instead of an Australian sponsor or agent acting on behalf of the Australian sponsor
If an inspection is warranted, we will schedule one. This could take up to six months depending on the completeness of the application and inspector availability. It is your responsibility that you submit your application with this timeframe in mind.
Advising us of changes
Once you have submitted your application you cannot change it via TGA Business Services.
If your anticipated timeline changes or you would like to vary the scope of your application, email the Manufacturing Quality Branch. We will review your request and accommodate the changes where possible. However, we may not be able to change the scope or duration of the inspection if you do not give us enough notice.
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.