Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) If the Secretary receives an application of a kind mentioned in column 1 of an item in the following table:
(a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and
(b) if the application passes preliminary assessment--subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.
Notification of preliminary assessment of applications and period within which decisions on recommendations must be made | |||
Item | Column 1 Kind of application | Column 2 Notification of preliminary assessment | Column 3 Decision on recommendation |
1 | IN1 application | Within 40 working days after the Secretary receives the application | The period of 70 working days beginning on the later of the following days: (a) the day the Secretary notifies the applicant that the application has passed preliminary assessment; (b) the day the evaluation fee is paid for the application |
2 | IN2 application | Within 40 working days after the Secretary receives the application | The period of 120 working days beginning on the later of the following days: (a) the day the Secretary notifies the applicant that the application has passed preliminary assessment; (b) the day the evaluation fee is paid for the application |
3 | IN3 application | Within 40 working days after the Secretary receives the application | The period of 150 working days beginning on the later of the following days: (a) the day the Secretary notifies the applicant that the application has passed preliminary assessment; (b) the day the evaluation fee is paid for the application |
4 | IN4 application | Within 40 working days after the Secretary receives the application | The period of 180 working days beginning on the later of the following days: (a) the day the Secretary notifies the applicant that the application has passed preliminary assessment; (b) the day the evaluation fee is paid for the application |
(a) an application (the current application ) is made under subsection 26BD(1) of the Act in relation to an ingredient; and
(b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and
(c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and
(d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application ) that:
(i) have already been made under subsection 26BD(1) of the Act in relation to that ingredient; and
(ii) have already been the subject of notices given under subsection 26BD(5) of the Act; and
(iii) have not been finally determined;
then a decision on whether to make a recommendation on the current application must be made within the period of:
(e) if the current application is an IN1 application--70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or
(f) if the current application is an IN2 application--120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or
(g) if the current application is an IN3 application--150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or
(h) if the current application is an IN4 application--180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.
(1B) For the purposes of this regulation, the start day is:
(a) the day after all the related applications have been finally determined, unless paragraph (b) applies; or
(b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient--the day on which that determination commences.
(1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.
(2) A failure to make a decision on whether to make a
recommendation on an application within the period applicable under this
regulation does not make the Commonwealth, the Secretary or a delegate of the
Secretary liable to a person for loss, damage or injury, of any kind, that is
caused by or arises out of the failure.