Long-awaited Permissible Indications list released
The TGA announced the release of the much-anticipated Permissible Indications list on the 6th March.
Under the new scheme, there is no 'free-text field' for sponsors to enter their medicine indications when they apply to list their medicine in the ARTG using the Electronic Listing Facility. Sponsors who apply to list a new medicine will be required to select the indications for their medicine from the list of permitted indication. For existing products, there is a 3 year transition period for sponsors to re-list their products using permitted indications.
From 6 March 2021, all Listed Therapeutic Goods must only include permitted indications on their ARTG, and ARTG entries that have not transitioned to Permitted Indications will be cancelled.
Of note, sponsors who apply update their existing listing to include permitted indications will not be charged an application fee during the first 18 months of the transition period.