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THERAPEUTIC GOODS ACT 1989 - SECT 46A Searches of certain premises to monitor compliance with Act

THERAPEUTIC GOODS ACT 1989 - SECT 46A

Searches of certain premises to monitor compliance with Act

  (1)   An authorised person may, subject to subsections   (2) and (3), and to the extent that it is reasonably necessary for the purpose of finding out whether this Act or the regulations have been complied with, enter premises to which this section applies and do any of the following:

  (a)   search the premises and any thing on the premises;

  (aa)   examine or observe any activity conducted on the premises;

  (b)   inspect, examine, take measurements of, conduct tests on or take samples of any therapeutic goods on the premises or any thing on the premises that relates to any therapeutic goods;

  (c)   make any still or moving image or any recording of the premises or any thing on the premises;

  (d)   inspect any book, record or document on the premises;

  (e)   take extracts from or make copies of any such book, record or document.

  (2)   An authorised person must not, under subsection   (1), enter premises that are a residence unless:

  (a)   the occupier of the premises has consented to the entry; or

  (b)   the premises are used for commercial purposes in relation to therapeutic goods, in addition to residential purposes.

  (3)   An authorised person is not entitled to exercise any powers under subsection   (1) in relation to premises if:

  (a)   the occupier of the premises has required the authorised person to produce his or her identity card for inspection by the occupier; and

  (b)   the authorised person fails to comply with the requirement.

  (4)   This section applies to:

  (a)   premises of a person:

  (ia)   who is required to comply with a condition of an exemption of therapeutic goods under section   18A; or

  (i)   who has been granted an approval or authority under subsection   19(1) or (5); or

  (ii)   who has been granted an approval under section   19A; or

  (iiaaa)   who is required to comply with a condition of an exemption of biologicals under section   32CB; or

  (iiaab)   who has been granted an approval under subsection   32CK(1) or an authority under subsection   32CM(1); or

  (iiaac)   who has been granted an approval under subsection   32CO(1), (1A) or (2); or

  (iiaa)   who is required to comply with a condition of an exemption of a kind of medical device under section   41GS; or

  (iia)   who has been granted an approval or authority under subsection   41HB(1) or 41HC(1); or

  (iib)   who has been granted an approval under subsection   41HD(1), (1A) or (2); or

  (iii)   in relation to whom therapeutic goods are registered, listed or included in the Register;

    being premises connected with:

  (iv)   the importation, export, manufacture or supply of therapeutic goods; or

  (v)   the keeping of documents relating to the importation, export, manufacture or supply of therapeutic goods; or

  (vi)   the keeping of records in compliance with a condition under paragraph   28(5)(c) or (ca) or 32EC(2)(c); and

  (b)   premises to which the person in relation to whom therapeutic goods are registered, listed or included in the Register, or the sponsor of the goods, must allow access as a condition of the registration, listing or inclusion; and

  (c)   premises in relation to which a licence has been granted under Part   3 - 3 for, or a conformity assessment certificate issued under Part   4 - 4, in relation to the manufacture of therapeutic goods, or premises at which records are kept in relation to such manufacture; and

  (d)   premises of a person who has been issued with, or who has applied for, an Australian conformity assessment body certificate.

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