Secretary may require information about therapeutic goods approved under section 19A
31BA Secretary may require information about therapeutic goods approved under section 19A
The Secretary may give to a person who is granted an approval under subsection 19A(1), (1A), (2), (2A) or (2B) in relation to specified therapeutic goods 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 goods;
the handling of the goods;
the monitoring of the supply of the goods;
the results of the supply of the goods;
any other matter prescribed by the regulations.
Compliance
A person given a notice under subsection (1) must give the information, or produce the documents, to the Secretary:
within the period specified in the notice (which must not be less than 14 days after the day the notice is given); and
in the form specified in the notice.
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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