Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:52
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 52
Character Range: 115981–116850

52                                                                          A change to a label for the medicine to include a warning or cautionary statement if:                                                                                                                                                                      LWSR
                                                                            (a) the Secretary, under subsection 9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and
                                                                            (b) the Secretary, under subsection 25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection 25AA(1) of the Act to add that warning or cautionary statement