Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 9D

             (1)  The Secretary may:

                     (a)  following a request by a person in relation to whom therapeutic goods are entered on the Register; or

                     (b)  on the Secretary's own initiative;

vary the entry in the Register in relation to the goods if the entry contains information that is incomplete or incorrect.

             (2)  If:

                     (a)  the person in relation to whom therapeutic goods are registered or listed has requested the Secretary to vary product information included in the entry in the Register that relates to the goods; and

                     (b)  the only effect of the variation would be:

                              (i)  to reduce the class of persons for whom the goods are suitable; or

                             (ii)  to add a warning, or precaution, that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;

the Secretary must vary the entry in accordance with the request.

             (3)  If:

                     (a)  the person in relation to whom therapeutic goods are registered or listed has requested the Secretary to vary information included in the entry in the Register that relates to the goods; and

                     (b)  subsection (2) does not apply to the request; and

                     (c)  the Secretary is satisfied that the variation requested does not indicate any reduction in the quality, safety or efficacy of the goods for the purposes for which they are to be used;

the Secretary may vary the entry in accordance with the request.

             (4)  If:

                     (a)  particular therapeutic goods cease to be medical devices because of a declaration under subsection 41BD(3); and

                     (b)  those goods are included in the Register under Chapter 4 as a kind of medical device;

the Secretary must move the entry relating to the goods from the part of the Register for medical devices to the part for goods to be known as registered goods or to the part for goods to be known as listed goods (whichever is applicable).

             (5)  In this section:

"product information" , in relation to therapeutic goods, means information relating to the safe and effective use of the goods, including information regarding the usefulness and limitations of the goods.

Note:          Variations to the Register also occur to give effect to limited cancellations of entries of kinds of medical devices from the Register: see subsection 41GO(2).