Secretary may require information etc. about biologicals exempt to deal with emergencies
32JF Secretary may require information etc. about biologicals exempt to deal with emergencies
This section applies to a person who is required to comply with a condition of an exemption of a biological under section 32CB.
The Secretary may, by written notice given to the person, require 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.
The person 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
5 more instruments made under this Act are listed on the Act’s overview.
This Act’s bill:Second reading speech
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