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--the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.
Notification of preliminary assessment of application and period within which evaluations must be completed | |||
Item | Column 1 Kind of application | Column 2 Notification of preliminary assessment | Column 3 Completion of evaluation |
1 | L(A)1 application | Within 40 working days after the Secretary receives the application | Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment |
2 | L(A)2 application | Within 40 working days after the Secretary receives the application | Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment |
3 | L(A)3 application | Within 40 working days after the Secretary receives the application | Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment |
3A | L(A)C1 (section 23) application | Within 40 working days after the Secretary receives the application | Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment |
3B | L(A)C2 (section 23) application | Within 40 working days after the Secretary receives the application | Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment |
4 | RCM1 application | Within 40 working days after the Secretary receives the application | Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment |
5 | RCM2 application | Within 40 working days after the Secretary receives the application | Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment |
6 | RCM3 application | Within 40 working days after the Secretary receives the application | Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment |
7 | RCM4 application | Within 40 working days after the Secretary receives the application | Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment |
8 | RCM5 application | Within 40 working days after the Secretary receives the application | Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment |
9 | RCMC1 (section 23) application | Within 40 working days after the Secretary receives the application | Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment |
10 | RCMC2 (section 23) application | Within 40 working days after the Secretary receives the application | Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment |
11 | RCMC3 (section 23) application | Within 40 working days after the Secretary receives the application | Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment |
12 | RCMC4 (section 23) application | Within 40 working days after the Secretary receives the application | Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment |
(2) A failure to complete an evaluation of an application
mentioned in column 1 of an item of the table in subregulation (1)
within the period mentioned in column 3 of the item 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.