Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) Subject to paragraph (4) (d), this regulation applies to an evaluation of a medicine that is a product of a kind specified in Part 1 of Schedule 10 if the application in relation to the evaluation:
(a) is received by the Secretary on or after 1 February 1992; and
(b) requires an evaluation under section 25 of the Act; and
(c) is not an application to which subregulation 16G applies.
(2) A reference in this regulation to a period in relation to an evaluation to which this regulation applies is a reference to the period that commences on the day on which the Secretary sends a notification to the applicant under regulation 16B that indicates acceptance of the application in relation to the evaluation.
(3) An evaluation to which this regulation applies must be completed within whichever of the following periods applies:
(a) if the evaluation satisfies the conditions stated in subregulation (4) -- 175 working days;
(b) in any other case -- 255 working days.
(4) The conditions referred to in paragraph (3) (a) are:
(a) that the evaluation relates to a medicine that, in each of 2 acceptable countries, has been approved for general marketing;
(b) that the formulation, directions for use and indications of the medicine are identical to those evaluated and approved for marketing in those 2 countries; and
(c) that the Secretary has, in relation to the evaluation, 2 evaluation reports on the medicine that satisfy the requirements of subregulation (5); and
(d) that the application is received by the Secretary on or after 1 September 1992.
(5) The requirements referred to in paragraph (4) (c) for the evaluation reports (in this subregulation called the relevant reports ) are:
(a) that the relevant reports were made respectively by a competent regulatory authority in each of the 2 countries referred to in paragraph (4) (b); and
(b) that neither of the relevant reports is, wholly or in part, based on:
(i) the other relevant report; or
(ii) any other evaluation report that is a report on which the other relevant report was based; or
(iii) any other evaluation report that is based on another report (being an evaluation report) if the other relevant report was based on that other report or any evaluation report that was based on that other report.
(6) In this regulation:
"acceptable country means a country that the Minister has notified in the Gazette" as an acceptable country for the purposes of this regulation.
"evaluation report" does not include a report prepared by or on behalf of the applicant or sponsor and submitted to a regulatory authority in connection with an application for registration of, or variation of information in a register about, therapeutic goods.
"based on" , in relation to an evaluation report, includes compiled by reference to or in reliance on.
"relevant period , in relation to an acceptable country, means the period stated in relation to the country in a notice under the definition of acceptable country" .