Secretary may require information relating to approvals and authorities under section 19
31B Secretary may require information relating to approvals and authorities under section 19
Approval under subsection 19(1)
The Secretary may give to a person who is granted an approval under subsection 19(1) in relation to specified therapeutic goods a written notice requiring the person to give to the Secretary specified information or 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 for the purposes of this paragraph in relation to goods of that kind.
Approval under subsection 19(1)—use by another person
The Secretary may give to a person using specified therapeutic goods that are the subject of an approval granted to someone else under paragraph 19(1)(b) a written notice requiring the person to give to the Secretary specified information or documents relating to either of both of the following:
the use of the goods;
any other matter prescribed by the regulations for the purposes of this paragraph in relation to goods of that kind.
Authority under subsection 19(5)
The Secretary may give to a person who is granted an authority under subsection 19(5) in relation to specified therapeutic goods, or a specified class of therapeutic goods, a written notice requiring the person to give to the Secretary specified information or 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 for the purposes of this paragraph in relation to goods of that kind.
Authority under subsection 19(7A) rules
If a person is authorised, by subsection 19(7A) rules, to supply therapeutic goods, the Secretary may give the person a written notice requiring the person to give the Secretary specified information or 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 for the purposes of this paragraph in relation to goods of that kind.
Compliance period
A notice under subsection (1), (2), (3) or (3A) must specify a reasonable period within which the person to whom the notice is given must comply with it. The period must be at least 14 days starting on the day on which the notice is given.
Information may need to be given in accordance with specified software requirements
A notice under subsection (1), (2), (3) or (3A) may require information to be given 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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