Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:10aad
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 10AAD
Character Range: 134093–135430

10AAD  Variation of entries in Register—biologicals

Kinds of variations
 (1) For the purposes of paragraph 9D(3AC)(b) of the Act, a variation:
 (a) of an entry in the Register that relates to a biological; and
 (b) that is listed in the table in subregulation (2);
is specified.

Conditions
 (2) For the purposes of paragraph 9D(3AC)(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 1 of an item in the following table:
 (a) the variation reflects a change that will be made to, or in relation to, the biological;
 (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.

Kinds of variations—biologicals
Item                             Column 1                                                                                                                                                                                                                                  Column 2

                                 Variation                                                                                                                                                                                                                                 Code