Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:12ac
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 12AC
Character Range: 183009–184599

12AC  Powers of authorised officers in relation to goods imported etc for experimental uses
 (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:
 (a) enter a site of the trial; and
 (b) search the site and any thing on the site; and
 (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and
 (d) take photographs, make video recordings or make sketches of the site or any thing on the site; and
 (f) request the principal investigator to:
 (i) answer any questions put by the authorised officer; and
 (ii) produce any book, record or document requested by the authorised officer.
Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.
 (2) An authorised officer is not entitled to do a thing mentioned in subregulation (1) if:
 (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and
 (b) the authorised officer fails to comply with the request.
Note: For identity cards, see regulation 46AA.
 (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.
 (4) Subregulation (3) does not prevent 2 or more areas of the site being searched at the same time.