Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) Subject to paragraph (4) (d), this regulation applies to an application (other than an application to which regulation 16F applies) concerning an evaluation of a medicine that is a product of a kind specified in Part 1 of Schedule 10 if the application:
(a) is received by the Secretary on or after 1 February 1992; and
(b) asks the Secretary under subsection 9D (3) of the Act to vary the entry of the medicine in the Register.
(2) A reference in this regulation to a period, in relation to an evaluation of an application 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.
(3) An application to which this regulation applies must be decided, and notification given to the applicant, within whichever of the following periods applies:
(a) if the application 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 application 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 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) The definitions in subregulation 16C (6) apply to this regulation.