Secretary may require information etc. about biologicals exempt under the regulations
32JE Secretary may require information etc. about biologicals exempt under the regulations
If a person is exempt under subsection 32CA(1) in relation to a biological, the Secretary may give the person 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:
the supply of the biological;
the handling of the biological;
the monitoring of the supply of the biological;
the results of the supply of the biological;
any other matter prescribed by the regulations for the purposes of this paragraph in relation to a biological of that kind.
If a biological is exempt under subsection 32CA(2), the Secretary may give the sponsor of the biological a written notice requiring the sponsor to give to the Secretary specified information, or to produce to the Secretary specified documents, relating to one or more of the following:
the supply of the biological;
the handling of the biological;
the monitoring of the supply of the biological;
the results of the supply of the biological;
any other matter prescribed by the regulations for the purposes of this paragraph in relation to a biological of that kind.
Compliance
A person given a notice under subsection (1) or (2) must give the information, or produce the documents, to the Secretary:
within the period, of not less than 14 days after the day the notice is given, specified in the notice; and
in the form specified in the notice.
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.
The form may require or permit the information to be given, or the documents to be produced, in accordance with specified software requirements:
on a specified kind of data processing device; or
by way of a specified kind of electronic transmission.
This provision refers to the regulations (prescribed by the regulations
). Made under this Act:
- Therapeutic Goods (Medical Devices) Regulations 2002 · under s 63
- Therapeutic Goods Regulations 1990 · under s 63
4 more instruments made under this Act are listed on the Act’s overview.
This Act’s bill:Second reading speech
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