Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:
(a) the application is received by the Secretary on or after 1 July 1992; and
(b) the application requires an evaluation under section 25 of the Act; and
(c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.
(2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre - clinical or bio - equivalence data.
(3) The provisions of subregulations 16F(3), (4) and (5)
apply to applications to which this regulation applies as if those
applications were applications to which regulation 16F applies.