The second list of permitted indications has been published by the TGA, titled the Therapeutic Goods (Permissible Indications) Determination (No 1.) of 2019.

This second Permissible Indications Determination includes new indications for sponsors, and other changes, notably re-instated label warning statements.

The TGA have also published additional information on the outcomes of the permissible indications consultation, including a list of some of the industry-proposed indications from the consultation that are not currently included in the Determination.

More details for sponsors, including key changes for sponsors, are here.