Extension of indications applications that do not require supporting data

30 June 2015

This form is for applications for a new prescription medicine where:

  • the applicant proposes to group the new medicine with an already registered generic prescription medicine
  • the new medicine is an extension of indications and the proposed indication is in identical form to one already approved for the prescription medicine (the reference medicine) in respect of which the bioequivalence of the already registered generic medicine has been demonstrated
  • the application is one to which regulation 16G of the Therapeutic Goods Regulations 1990 applies (i.e. it does not need to be supported by clinical, pre-clinical or bio-equivalence data).

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