THERAPEUTIC GOODS ACT 1989 - SECT 41FH Selecting applications for auditing

THERAPEUTIC GOODS ACT 1989 - SECT 41FH

  (1A)   This section applies to applications that have passed preliminary assessment.

  (1)   The Secretary:

  (a)   must select for auditing any application for a kind of medical device to be included in the Register that is an application of the kind prescribed by the regulations; and

  (b)   may select for auditing any other application for a kind of medical device to be included in the Register.

Note:   An application audit assessment fee is payable in respect of any application that the Secretary must select for auditing: see Part   4 - 10.

  (2)   If an application is selected for auditing:

  (a)   the Secretary must give the applicant a written notice (the selection notice ) that:

  (i)   informs the applicant of the selection; and

  (ii)   requires the applicant to provide, within the period specified in the notice, information or documents that the Secretary is satisfied is relevant to the audit; and

  (b)   the application must be dealt with under this Subdivision and not under Subdivision B.

  (3)   The selection notice must be given within:

  (a)   20 working days after the application is made and the prescribed application fee is paid; or

  (b)   if the regulations prescribe a longer period for that kind of application--that longer period.

  (4)   Subparagraph   (2)(a)(ii) does not limit section   41JA (Secretary may require information).