Samples of the medicine have been delivered to the TGA (only if requested).
We rely on information in your application cover letter to confirm the application level and corresponding data requirements.
If your application cover letter does not contain information critical to verify the application level, we may not detect an application submitted at the incorrect level until evaluation in Step 10. This can have implications for you as explained in Step 10.
Opportunity for minor corrections
You will have an opportunity to make minor corrections, detected during the screening process, if the issue can be rectified promptly. For example, if we cannot locate an attachment that is mentioned in the cover letter, we will give you an opportunity to provide the attachment.
If your application is effective, we will:
undertake the evaluation
send you both:
a notification email, advising the application has been accepted for evaluation
an invoice for the remaining evaluation fees, if applicable.
Not effective applications
If your application is not effective:
not accept it for evaluation
remove your application from business services
write to you and explain why the application is not effective
refund the evaluation fee.
you will forfeit the application fee.
If you reapply to register the medicine on the ARTG, ensure your application meets the requirements for an effective application.
You cannot lawfully import, supply or export the medicine until you have an ARTG registration.
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.