Document ID: chunk:federal_register_of_legislation:C2024C00632:section:40:p2
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 40 (pt 2/3)
Character Range: 587946–590421

to enter, at any reasonable time, each manufacturing site covered by the licence; and
 (ii) while at such a site, to inspect the site, any therapeutic goods at the site and the processes relating to the manufacture of therapeutic goods at the site and to examine, take measurements of, conduct tests on or take samples of any therapeutic goods at the site or any thing at the site that relates to any therapeutic goods; and
 (iii) while at such a site, to make any still or moving image or any recording of that site or those goods or processes; and
 (c) where an authorised person enters a site as mentioned in subparagraph (b)(i), require the holder or his or her employees at that site to answer questions relating to procedures carried out at that site; and
 (d) if requested to do so by an authorised person:
 (i) produce to the person such documents relating to the manufacture of therapeutic goods manufactured at that site as the person requires and allow the person to copy the documents; or
 (ii) produce to the person for examination any batch samples kept by the holder; and
 (e) comply with such other conditions (if any) as are specified in the regulations for the purposes of this section.
 (5) The information with which paragraph (4)(ab) is concerned is information of the following kinds:
 (a) information that indicates that the use of the goods in accordance with the recommendations for their use may have an unintended harmful effect;
 (b) information that indicates that the goods, when used in accordance with the recommendations for their use, may not be as effective as was suggested by:
 (i) the application for registration or listing of the goods; or
 (ii) information already furnished by the holder of the licence under this Act; or
 (iii) if the holder of the licence is not the sponsor of the goods—information already furnished by the sponsor of the goods under this Act;
 (c) information that indicates that the quality, safety or efficacy of the goods is unacceptable.
 (6) The Secretary may, by notice in writing given to the holder of a licence, require the holder to give the Secretary, within the specified period and in the specified manner, specified information to be used by the Secretary in deciding whether to revoke or suspend the licence under section 41 in the circumstances referred to in paragraph 41(1)(a).
 (7) The period specified in a notice given under subsection (6) must be at least 14 days after the notice is given.