Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:2:p37
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 2 (pt 37/40)
Character Range: 129950–132686

or document.
 (2) An authorised person 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 person to produce his or her identity card for inspection; and
 (b) the authorised person fails to comply with the request.
Note: See section 52 of the Act in relation to identity cards.
 (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 obstruct the search.
 (4) Subregulation (3) does not prevent 2 or more areas of the site being searched at the same time.

7.5  Conditions of approval—use of device by another person (Act s 41HB)
 (1) For subsection 41HB(7) of the Act, the conditions mentioned in this regulation apply to the use by a person, for experimental purposes in humans, of a kind of medical device that is the subject of an approval granted to someone else under paragraph 41HB(1)(e) of the Act.
 (2) The use of the device must comply with a procedural protocol approved by the ethics committee that is to be responsible for monitoring the conduct of the trial at each trial site (the responsible ethics committee).
 (3) The use of the device must be in accordance with the ethical standards set out in the 'National Statement on Ethical Conduct in Research Involving Humans', published by the National Health and Medical Research Council, as in force from time to time.
 (4) The person must cease using the device if the responsible ethics committee informs the principal investigator of the clinical trial that the use is inconsistent with:
 (a) the protocol mentioned in subregulation (2); or
 (b) any condition subject to which approval for the use was given.

Division 7.3—Exemptions for medical practitioners

7.6  Classes of medical practitioners and recipients (Act s 41HC)
 (1) A class of medical practitioners prescribed for the purposes of paragraph 41HC(4)(a) of the Act is the class of medical practitioners each of whom is:
 (a) a specialist medical practitioner who is engaged in clinical practice in a hospital and is endorsed by the ethics committee of the hospital; or
 (b) a specialist medical practitioner who is engaged in treating patients outside a hospital and is endorsed by an ethics committee that:
 (i) has expertise relating to the principal activities of the practitioner; or
 (ii) conducts its activities within the geographic area where the medical practitioner is engaged in treating patients.
 (2) A class of recipients prescribed for the purposes of paragraph 41HC(4)(c) of the Act is the class of recipients each of whom is