Document ID: chunk:federal_register_of_legislation:C2024C00632:section:32jg:p1
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 32JG (pt 1/2)
Character Range: 554090–556864

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.

Authority under subsection 32CM(7A) rules
 (3A) If a person is authorised, by subsection 32CM(7A) rules, to supply a biological, the Secretary may give the person a written notice requiring the person to give 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