Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 37

             (1)  An application for a licence must:

                     (a)  be made in accordance with a form approved by the Secretary; and

                     (b)  identify the therapeutic goods or classes of therapeutic goods that the applicant proposes to manufacture; and

                     (c)  identify the manufacturing premises that will be used in the manufacture of those goods; and

                     (d)  identify the steps in the manufacture of those goods that the applicant proposes to carry out under the licence; and

                    (da)  if the applicant proposes to carry out steps in the manufacture of blood or blood components under the licence--contain information relating to those steps set out in regulations made for the purposes of this paragraph; and

                     (e)  state the names, qualifications and experience of the persons who are to have control of the production of the goods and of the quality control measures that are to be employed; and

                      (f)  be delivered to an office of the Department specified in the form; and

                     (g)  be accompanied by the prescribed application fee.

             (2)  The Secretary may, by notice in writing given to an applicant for a licence, require the applicant:

                     (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 the premises, equipment, processes and facilities that will be used in the manufacture of the goods, or other goods on those premises.

             (3)  An approval of a form mentioned in paragraph (1)(a), or a notice mentioned in subsection (2), 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.