The TGA has extended the fee-free period for sponsors of existing listed medicines to transition to using permitted indications until 6 March 2021. Any sponsors who were already charged a fee can request a refund for eligible applications via email at [email protected]. Further information is available on the TGA website.

Background

Indications available for use for listed medicines are now contained in a ‘list of permitted indications’ which is contained in the Therapeutic Goods (Permissible Indications) Determination. Sponsors must transition their products so that any indications made in relation to listed medicines comes from the Determination. Sponsors may also apply to have new indications added to the list.

Listed medicines that have not transitioned their indications will be automatically cancelled from the Australian Register of Therapeutic Goods on 7 March 2021.

Should you require assistance with transitioning your products, feel free to contact us. We’re here to help!