Secretary may require information etc. about goods exempt under section 18A
31AA Secretary may require information etc. about goods exempt under section 18A
This section applies to a person who is required to comply with a condition of an exemption of therapeutic goods under section 18A.
The Secretary may, by written notice given to the person, require the person to give to the Secretary specified information or documents relating to one or more of the following:
the supply of any of those goods;
the handling of any of those goods;
the monitoring of the supply of any of those goods;
the results of the supply of any of those goods;
any other matter prescribed by the regulations for the purposes of this paragraph.
Compliance period
The notice must specify a reasonable period within which the person 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
The notice 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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