Document ID: chunk:federal_register_of_legislation:F2025C00036:clause:9a_1
Version: federal_register_of_legislation:F2025C00036
Segment Type: clause
Provision Reference: sch 9A cl 1
Character Range: 739867–740964

1  Definitions
  In this table:
major variation, for a biological, means a change to the entry of the biological in the Register for any of the following, other than a change that would result in the biological becoming separate and distinct from other biologicals:
 (a) a change requiring submission and evaluation of clinical data;
 (c) a new strength;
 (d) a new route of administration;
 (e) a change in the intended patient group;
 (f) a change in dosage.
minor variation, for a biological, means a change to the entry of the biological in the Register that requires the evaluation of quality and manufacturing information, other than a change that is a major variation for the biological or that would result in the biological becoming separate and distinct from other biologicals.

Part 2—Table of fees

Item  Matter                                                                                                                                                                                                                                                                          Fee $