Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:10aac
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 10AAC
Character Range: 123221–124556

10AAC  Variation of entries in Register—biological medicines

Kinds of variations
 (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.

Conditions
 (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:
 (a) the variation reflects a change that will be made to, or in relation to, the medicine;
 (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.

Kinds of variations—biological medicines
Column 1                                  Column 2                                                                                                                                                                                                                      Column 3
Item                                      Variation                                                                                                                                                                                                                     Code