Document ID: chunk:federal_register_of_legislation:C2010A00054:clause:1_32jg:p1
Version: federal_register_of_legislation:C2010A00054
Segment Type: clause
Provision Reference: sch 1 cl 32JG (pt 1/2)
Character Range: 144348–147090

32JG  Secretary may require information etc. about biologicals exempt for special and experimental uses

Approval under subsection 32CK(1)
 (1) The Secretary may give to a person who is granted an approval under subsection 32CK(1) in relation to a biological a written notice requiring the person to give to the Secretary specified information, or to produce to the Secretary specified documents, relating to one or more of the following:
 (a) the supply of the biological;
 (b) the handling of the biological;
 (c) the monitoring of the supply of the biological;
 (d) the results of the supply of the biological;
 (e) any other matter prescribed by the regulations for the purposes of this paragraph in relation to a biological of that kind.

Approval under subsection 32CK(1)—use by another person
 (2) The Secretary may give to a person (the experimenter) using a biological that is the subject of an approval:
 (a) that is held by another person under subsection 32CK(1); and
 (b) that covers the importation into Australia, or the supply in Australia, of the biological for use solely for experimental purposes in humans;
a written notice requiring the experimenter to give to the Secretary specified information, or to produce to the Secretary specified documents, relating to either or both of the following:
 (c) the use of the biological;
 (d) any other matter prescribed by the regulations for the purposes of this paragraph in relation to a biological of that kind.

Authority under subsection 32CM(1)
 (3) The Secretary may give to a person who is granted an authority under subsection 32CM(1) in relation to a biological a written notice requiring the person to give to the Secretary specified information, or to produce to the Secretary specified documents, relating to one or more of the following:
 (a) the supply of the biological;
 (b) the handling of the biological;
 (c) the monitoring of the supply of the biological;
 (d) the results of the supply of the biological;
 (e) any other matter prescribed by the regulations for the purposes of this paragraph in relation to a biological of that kind.

Compliance
 (4) A person given a notice under subsection (1), (2) or (3) must give the information, or produce the documents, to the Secretary:
 (a) within the period, of not less than 14 days after the day the notice is given, specified in the notice; and
 (b) in the form specified in the notice.
Note: Section 32JI contains criminal offences for failing to comply with the notice and for giving false or misleading information or documents and section 32JJ contains a civil penalty for giving false or misleading information or documents.
 (5) The form may require or permit the information to be given, or the documents