Commonwealth Consolidated Acts

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THERAPEUTIC GOODS ACT 1989 - SECT 40

Conditions of licences

             (1)  A licence may be granted subject to such conditions relating to the manufacture of the goods as the Secretary thinks appropriate.

             (2)  The Secretary may, by notice in writing given to the holder of a licence, impose new conditions on the licence or vary or remove existing conditions.

             (3)  The imposition, variation or removal of a condition under subsection (2) takes effect:

                     (a)  if the notice states that the action is necessary to prevent imminent risk of death, serious illness or serious injury--on the day on which the notice is given to the person; or

                     (b)  in any other case--on the day specified in the notice, which must be at least 28 days after the notice is given to the person, unless the person has agreed to an earlier day.

          (3A)  For the purposes of paragraph (3)(b), the earlier day must not be earlier than the day the notice is given to the person.

             (4)  In addition to any conditions imposed under subsection (1) or (2), each licence is, except as otherwise specified in the licence, subject to the conditions that the holder of the licence will:

                     (a)  ensure that:

                              (i)  the goods conform to any standard applicable to the goods; and

                             (ii)  the holder of the licence observes the manufacturing principles in carrying out any steps in the manufacture of the goods under the licence;

                            unless:

                            (iii)  the goods are a biological and are for supply after the circumstances prescribed by the regulations for the purposes of paragraphs 14(9A)(b) and 14A(2A)(b) have occurred; or

                            (iv)  the goods are a biological and are for export after the circumstances prescribed by the regulations for the purposes of paragraphs 14(13A)(b) and 14A(3A)(b) have occurred; and

                    (aa)  if:

                              (i)  the holder of the licence carries out, or proposes to carry out, steps in the manufacture of blood or blood components under the licence; and

                             (ii)  regulations made for the purposes of this paragraph set out particular information relating to those steps;

                            comply with a request by the Secretary to provide such information, in accordance with those regulations; and

                   (ab)  as soon as the holder of the licence becomes aware of information of a kind mentioned in subsection (5), give the information to the Secretary in writing; and

                    (ac)  give the Secretary the information specified in a notice under subsection (6) within the period, and in the manner, specified in the notice; and

                     (b)  allow an authorised person:

                              (i)  to enter, at any reasonable time, each manufacturing site covered by the licence; and

                             (ii)  while at such a site, to inspect the site, any therapeutic goods at the site and the processes relating to the manufacture of therapeutic goods at the site and to examine, take measurements of, conduct tests on or take samples of any therapeutic goods at the site or any thing at the site that relates to any therapeutic goods; and

                            (iii)  while at such a site, to make any still or moving image or any recording of that site or those goods or processes; and

                     (c)  where an authorised person enters a site as mentioned in subparagraph (b)(i), require the holder or his or her employees at that site to answer questions relating to procedures carried out at that site; and

                     (d)  if requested to do so by an authorised person:

                              (i)  produce to the person such documents relating to the manufacture of therapeutic goods manufactured at that site as the person requires and allow the person to copy the documents; or

                             (ii)  produce to the person for examination any batch samples kept by the holder; and

                     (e)  comply with such other conditions (if any) as are specified in the regulations for the purposes of this section.

             (5)  The information with which paragraph (4)(ab) is concerned is information of the following kinds:

                     (a)  information that indicates that the use of the goods in accordance with the recommendations for their use may have an unintended harmful effect;

                     (b)  information that indicates that the goods, when used in accordance with the recommendations for their use, may not be as effective as was suggested by:

                              (i)  the application for registration or listing of the goods; or

                             (ii)  information already furnished by the holder of the licence under this Act; or

                            (iii)  if the holder of the licence is not the sponsor of the goods--information already furnished by the sponsor of the goods under this Act;

                     (c)  information that indicates that the quality, safety or efficacy of the goods is unacceptable.

             (6)  The Secretary may, by notice in writing given to the holder of a licence, require the holder to give the Secretary, within the specified period and in the specified manner, specified information to be used by the Secretary in deciding whether to revoke or suspend the licence under section 41 in the circumstances referred to in paragraph 41(1)(a).

             (7)  The period specified in a notice given under subsection (6) must be at least 14 days after the notice is given.



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