The TGA have launched an online TBS application form for applying for the evaluation of a new substance, including the ability to upload supporting documentation online, and making the required declarations to submit the application. It also includes the ability to request the two year exclusivity period.

The online form is accompanied by a new application user guide describing all steps of submitting the online application for a new substance.

We recommend saving as you go where possible, as the portal is known to occasionally "time out", which can cause loss of any unsaved information on the application page you are in.

Please advise us if there are any process issues arising with the use of the new form or user guide.