Document ID: chunk:federal_register_of_legislation:F2025C00036:clause:9_4
Version: federal_register_of_legislation:F2025C00036
Segment Type: clause
Provision Reference: sch 9 cl 4
Character Range: 684393–695341

4         Evaluation fee, for subsection 24(1A) of the Act, under a submission for evaluation relating to:
          (a) a new chemical entity (other than an entity to which paragraph (aa), (ab) or (ac) of this item, paragraph (a) of item 1AD or item 1AF applies)                                                                                                                                                                                                                                                                                                 227,825
          (aa) a new chemical entity incorporated as an ancillary medicinal component of a medical device if the evaluation of the new chemical entity involves an evaluation of:
          (i) documentation setting out the chemistry, quality control and manufacturing of the new chemical entity; or                                                                                                                                                                                                                                                                                                                                      76,055
          (ii) documentation relating to pre‑clinical studies; or                                                                                                                                                                                                                                                                                                                                                                                            76,055
          (iii) documentation mentioned in subparagraphs (i) and (ii)                                                                                                                                                                                                                                                                                                                                                                                        151,545
          (ab) a new prescription medicine in relation to which a therapeutic goods (priority applicant) determination is in force                                                                                                                                                                                                                                                                                                                           240,934
          (ac) a vaccine for COVID‑19, respiratory syncytial virus (RSV) or influenza that is a new chemical entity, if:                                                                                                                                                                                                                                                                                                                                     5,187
          (i) the vaccine is a new chemical entity only because the vaccine is for a new strain; and
          (ii) the vaccine is a closely related form of an existing vaccine, for another strain, in the Register in relation to which the applicant is the sponsor
          (b) an extension of indications (other than an extension of indications to which paragraph (bb), (bc) or (bd) of this item, paragraph (b) of item 1AD or item 1AF applies)                                                                                                                                                                                                                                                                         135,158
          (bb) an extension of indications or a major variation in respect of a medicine incorporated as an ancillary medicinal component of a medical device if the evaluation of the medicine involves an evaluation of:
          (i) documentation setting out the chemistry, quality control and manufacturing of the medicine; or                                                                                                                                                                                                                                                                                                                                                 for an evaluation relating to:
                                                                                                                                                                                                                                                                                                                                                                                                                                                             (a) an extension of indications—45,090
                                                                                                                                                                                                                                                                                                                                                                                                                                                             (b) a major variation—29,269
          (ii) documentation relating to pre‑clinical studies; or                                                                                                                                                                                                                                                                                                                                                                                            for an evaluation relating to:
                                                                                                                                                                                                                                                                                                                                                                                                                                                             (a) an extension of indications—45,090
                                                                                                                                                                                                                                                                                                                                                                                                                                                             (b) a major variation—29,269
          (iii) documentation mentioned in subparagraphs (i) and (ii)                                                                                                                                                                                                                                                                                                                                                                                        for an evaluation relating to:
                                                                                                                                                                                                                                                                                                                                                                                                                                                             (a) an extension of indications—90,067
                                                                                                                                                                                                                                                                                                                                                                                                                                                             (b) a major variation—58,878
          (bc) an extension of indications that is the subject of an application to which regulation 16G applies                                                                                                                                                                                                                                                                                                                                             5,187
          (bd) a new indications medicine in relation to which a therapeutic goods (priority applicant) determination is in force                                                                                                                                                                                                                                                                                                                            143,295
          (c) a new generic product                                                                                                                                                                                                                                                                                                                                                                                                                          87,016
          (d) an additional trade name                                                                                                                                                                                                                                                                                                                                                                                                                       14,239
          (g) a major variation (that is not a variation mentioned in any of paragraphs (a) to (d))                                                                                                                                                                                                                                                                                                                                                          88,146
          (h) a minor variation (that is not a variation mentioned in any of paragraphs (a) to (d))                                                                                                                                                                                                                                                                                                                                                          5,187