Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:45:p1
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 45 (pt 1/4)
Character Range: 416479–419241

45  Waiver or reduction of fees

Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable
 (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:
 (a) is in the interest of public health; and
 (b) would not be commercially viable for the sponsor of the goods if the full amount of the fee were paid.

Waiver or reduction of evaluation fee for certain goods—goods with same active ingredient and common information
 (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:
 (a) the goods to which each application relates contain the same active ingredient;
 (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.

Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information
 (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:
 (a) the application is of a kind mentioned in subregulation (3B); and
 (b) the applicant makes one or more additional applications of the same kind; and
 (c) each application relates to goods that contain the same therapeutically active ingredient; and
 (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.
 (3B) The applications are as follows:
 (a) an L(A)1 application;
 (b) an L(A)2 application;
 (c) an L(A)3 application;
 (d) an RCM1 application;
 (e) an RCM2 application;
 (f) an RCM3 application;
 (g) an RCM4 application;
 (h) an RCM5 application.

Waiver or reduction of evaluation fees for certain goods—abridged evaluation procedure
 (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):
 (a) to register goods; or
 (aa) to list goods under section 26AE of the Act; or
 (b) in relation to registered goods that are a medicine—to vary the information