Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 46A

             (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;

                     (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.

             (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 section 19; or

                             (ii)  who has been granted an approval under section 19A; 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 section 41HB or 41HC; or

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

                            being premises connected with the importation, export, manufacture or supply of therapeutic goods, or the keeping of records relating to the importation, export, manufacture or supply of therapeutic goods; 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 or listing of the therapeutic goods; 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.