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Transition for permitted indications for listed medicines ends 5 March 2021
On 6 March 2018, the TGA implemented a list of permitted indications for medicines listed under section 26A of the Therapeutic Goods Act 1989 (the Act). All new listed medicines included in the Australian Register of Therapeutic Goods (ARTG) since this time have only been able to use permitted indications. Listed medicines included in the ARTG prior to 6 March 2018 were given a 3-year transition period to re-list their medicines using permitted indications.
Sponsors should be aware that the transition period for permitted indications ends on 5 March 2021.
Listed medicines that have not been updated to include permitted indications will be automatically cancelled and removed from the ARTG on 6 March 2021 under transitional provisions in Part 2 of Schedule 2 to the Therapeutic Goods Amendment (2017 Measures No.1) Act 2018. This cancellation process is not associated with any appeal rights and no letter proposing to cancel the listing will be issued prior to the completion of this cancellation process.
If sponsors do not take action to update the ARTG entries of their listed medicines by 5 March 2021 the TGA will cancel these ineligible medicines from the ARTG, and sponsors will no longer be able to supply these medicines. There will be no exemptions available for listed medicines that have not transitioned to permitted indications.
When re-listing their medicine listing to include permitted indications, sponsors will need to make sure that all details for their medicine are correct, current and compliant with all applicable legislative requirements (e.g. manufacturer licence, ingredient requirements). Sponsors should be aware that if not all their medicine details are correct, they may experience validation issues while updating their medicine entry. To meet the 5 March 2021 deadline, the application for re-listing must pass validation in the electronic application portal (that is, the application cannot be ‘pending’ on 6 March 2021, due to validation errors). The TGA therefore strongly advise sponsors to transition their listed medicines as soon as possible (before 5 March 2021) to ensure a smooth transition.
For information on transitioning to permitted indications refer to: