Document ID: chunk:federal_register_of_legislation:C2009A00076:clause:2_40b:p2
Version: federal_register_of_legislation:C2009A00076
Segment Type: clause
Provision Reference: sch 2 cl 40B (pt 2/2)
Character Range: 23128–24718

be made in accordance with a form approved by the Secretary; and
 (b) set out the variation sought; and
 (c) be delivered to an office of the Department specified in the form; and
 (d) be accompanied by the prescribed application fee.
 (8) If an application is made under subsection (6) and any applicable prescribed inspection fees have been paid, the Secretary may, by notice in writing given to the holder of the licence, vary the manufacturing site authorisation.
 (9) A variation under subsection (8) takes effect on the day on which the notice is given to the holder.

Further information
 (10) The Secretary may, by notice in writing given to the holder of a licence who has made an application under subsection (1) or (6), require the holder:
 (a) to give to the Secretary, within such reasonable time as is specified in the notice, such further information concerning the application as is specified in the notice; or
 (b) to allow an authorised person, at any reasonable time specified in the notice, to inspect each manufacturing site identified in the application and the equipment, processes and facilities that will be used in the manufacture of therapeutic goods at that site.

Applications or information may be given electronically
 (11) An approval of a form mentioned in paragraph (2)(a) or (7)(a), or a notice mentioned in subsection (10), may require or permit an application or information to be given in accordance with specified software requirements:
 (a) on a specified kind of data processing device; or
 (b) by way of a specified kind of electronic transmission.