Commonwealth Numbered Regulations

1992 No. 109 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - REG 4

4.1 After regulation 16F, insert in Part 3A:
Shorter evaluation period in certain cases

"16G. (1) Subject to subregulation (2), this regulation applies to an
application to register a drug that is a product of a kind specified in
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 drug 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.".