Document ID: chunk:federal_register_of_legislation:F2025C00036:clause:9_2a
Version: federal_register_of_legislation:F2025C00036
Segment Type: clause
Provision Reference: sch 9 cl 2A
Character Range: 672051–676158

2A        Fee for varying an entry in the Register (not including evaluation of data) under section 9D (other than subsection 9D(2C)) of the Act, if the variation is for:
          (a) a registered medicine that is mentioned in Part 1 of Schedule 10—for each submission                                                                                                                                                                                                                                                                                                                                                           1,989
          (b) a listed medicine                                                                                                                                                                                                                                                                                                                                                                                                                              496
          (c) a disinfectant                                                                                                                                                                                                                                                                                                                                                                                                                                 1,466
          (d) a Class 3 or Class 4 IVD medical device that is not covered by paragraph (g)                                                                                                                                                                                                                                                                                                                                                                   1,832
          (e) an IVD medical device that is not:                                                                                                                                                                                                                                                                                                                                                                                                             1,047
          (i) a Class 3 or Class 4 IVD medical device; and
          (ii) covered by paragraph (g)
          (f) a medical device that is not:                                                                                                                                                                                                                                                                                                                                                                                                                  1,047
          (i) an IVD medical device; and
          (ii) covered by paragraph (g)
          (g) a medical device, if the following are satisfied:                                                                                                                                                                                                                                                                                                                                                                                              199 per 10 entries (or part thereof)
          (i) the reason for the variation is that the kind of medical device is affected by the EU transition (within the meaning of subregulation 9.1AA(3) of the Therapeutic Goods (Medical Devices) Regulations 2002);
          (ii) the variation only relates to an update to the manufacturer's evidence for the medical device recorded in the entry in the Register for that kind of medical device;
          (iii) the request is to vary one or more entries in the Register and the manufacturer's evidence to which the update relates is the same for each of the entries