On Friday 6 September 2019, the original "fee-free" period to update existing ARTG listings to permitted indications expired. However, CMA advocacy has resulted in an application for an extension to this period.

We are expecting a full 18-month extension period to 6 March 2021 for fee-free ARTG listing updates.

We are aware that the fee has now been turned on, contrary to original advice that the fee would not be turned on, and have spoken to the TGA who have provided the following updated information.

The legislation has been drafted, however, the Australian Government committee that approves regulations need to approve the final draft. The extended fee-free period will not be in effect until the final approval and legislative change occurs which is expected to be either in mid-September or mid-October (2-6 weeks). They have drafted the fee-free legislation to be backdated to 6 September so there will be no period where a fee is payable.

While the TGA prefers not to turn on the grouping fee for applications to change to permitted indications in the short-term, they have been advised that they should until the new legislation is in effect.

This means that in the next 2-6 weeks until the change is made and the fee turned off, sponsors can choose to:

1. Pay the fee when changing to permitted indications, and receive a refund* when the legislation is changed and backdated to 6 September.

*It's expected that the TGA will only refund applications that currently pass fee-free arrangements, that don't include other changes that trigger a 'new' or 'grouping' application such as changing a medicine name.

OR

2. Wait until the TGA remove the fee, when the extended fee-free period is legislated in mid-September or October.