Consistent with the Government's deregulation agenda, the TGA has rationalised the processes for applications for additional trade names and extension of indications and has streamlined the application pathways by developing new forms and guidance materials.

From 1 July 2015, applications to register (an) additional trade name(s) to an existing prescription medicine by the same sponsor on the Australian Register of Therapeutic Goods (ARTG) will be evaluated under section 16G of the Therapeutic Goods Regulations 1990 which applies a statutory limit of 45 working days to make a decision on the application or raise an objection concerning the application.

From 1 July 2015, applications to extend the indications for a registered medicine where the indications have already been approved for the reference medicine will also be evaluated under section 16G of the Regulations which applies a statutory limit of 45 working days to make a decision on the application or raise an objection concerning the application, where the application does not need to be supported with clinical, pre-clinical and/or bioequivalence data.

For more details, go to: https://www.tga.gov.au/media-release/changes-clone-and-extension-indications-no-data-application