A new Therapeutic Goods(Permissible Indications Determination (No. 1) 2021 has been approved by the TGA delegate and is now available on the Federal Register of Legislation. 

The addition of 3 new indications to the new Determination means that sponsors may, if they wish, make additional fee-free changes to their indications on the ARTG entries before the end of the transition period for permitted indications on 5 March 2021.

In addition, there are other minor changes expected to reduce regulatory burden. A total of 16 changes appear in the Determination. A summary of the changes includes:

 - 3 new indications

 - Broadening the wording of the required label statement for 11 indications

 - Broadening the evidence base for one indication

 - Combining two duplicative indications into one indication

Please read today’s technical alert and the information on the TGA website to be aware of the changes, particularly, the changes to the <VIT> warning statement.