Document ID: chunk:federal_register_of_legislation:F2024C00984:reg:64
Version: federal_register_of_legislation:F2024C00984
Segment Type: reg
Provision Reference: reg 64
Character Range: 121100–122528

64  Independent review fee
 (1) A person may seek an independent review of a decision by the Committee in response to a submission not to recommend to, or advise, the Minister:
 (a) to declare a drug or medicinal preparation under subsection 85(2) of the Act; or
 (b) to determine, under subsection 85(7) of the Act, further circumstances in which a prescription for the supply of a pharmaceutical benefit may be written.
 (2) A submission in relation to which an independent review is sought must:
 (a) be submitted in the form in which it was originally considered by the Committee; and
 (b) have been rejected by the Committee in its entirety.
 (3) The fee for the independent review is the same as the fee that would have been payable under Part 3 of this instrument for submission services:
 (a) provided in response to a submission that is in Category 2 evaluation category; and
 (b) for which a notification under that Part is given at the same time as the submission is submitted under this section.
 (4) The fee for the independent review must be paid in full to the Commonwealth at the time the submission is submitted under this section.
Note: The independent review will not commence until the fee is paid.
 (5) There is no fee for the Committee to reconsider a submission following the independent review.
Note: Information about independent reviews is accessible through the PBS website at http://www.pbs.gov.au.