Document ID: chunk:federal_register_of_legislation:F2025C00036:clause:9_1
Version: federal_register_of_legislation:F2025C00036
Segment Type: clause
Provision Reference: sch 9 cl 1
Character Range: 653560–655097

1         Evaluation fee for the purposes of subparagraph 19(2)(b)(iii) of the Act
          (a) if:                                                                                                                                                                                                                                                                                                                                                                                                                                            2,046
          (i) the goods are medicines for use solely for experimental purposes in humans; and
          (ii) the evaluation consists of the consideration of:
          (A) a summary of chemical, pharmaceutical and biological information about the goods; and
          (B) descriptive information about the proposed clinical trial of the goods; and
          (C) information about adverse events associated with the use of the goods; and
          (D) information about the goods provided to the relevant ethics committee;
          —for each medicine
          (b) if the goods are medicines for use solely for experimental purposes in humans (other than medicines to which paragraph (a) applies)—for each medicine                                                                                                                                                                                                                                                                                          25,426