Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 19

             (1)  The Secretary may, by notice in writing, grant an approval to a person for the importation into, or the exportation from, Australia or the supply in Australia of specified therapeutic goods that are not registered goods, listed goods or exempt goods:

                     (a)  for use in the treatment of another person; or

                     (b)  for use solely for experimental purposes in humans;

and such an approval may be given subject to such conditions as are specified in the notice of approval.

          (1A)  An approval for the purpose mentioned in paragraph (1)(b) is subject to the conditions (if any) specified in the regulations. Those conditions (if any) are in addition to any conditions imposed on the approval under subsection (1).

             (2)  An application for an approval must be made to the Secretary and must:

                     (a)  in the case of an application for use of the kind referred to in paragraph (1)(a)--be accompanied by such information relating to the goods the subject of the application as is required by the Secretary; and

                     (b)  in the case of an application for use of the kind referred to in paragraph (1)(b):

                              (i)  be made in writing; and

                             (ii)  be accompanied by such information relating to the goods the subject of the application as is required by the Secretary; and

                            (iii)  be accompanied by the prescribed evaluation fee.

             (3)  Without limiting the conditions to which an approval under subsection (1) may be made subject, those conditions may include a condition relating to the charges that may be made for the therapeutic goods to which the approval relates.

             (4)  Where an application for an approval is made, the Secretary must, after having considered the application and, in the case of an application for the use of therapeutic goods for experimental purposes in humans, after having evaluated the information submitted with the application, notify the applicant of the decision on the application within 28 days of making the decision and, in the case of a decision not to grant the approval, of the reasons for the decision.

          (4A)  The use by a person for experimental purposes in humans of specified therapeutic goods that are the subject of an approval granted to someone else under paragraph (1)(b) is subject to the conditions (if any) specified in the regulations relating to one or more of the following:

                     (a)  the preconditions on the use of the goods for those purposes;

                     (b)  the principles to be followed in the use of the goods for those purposes;

                     (c)  the monitoring of the use, and the results of the use, of the goods for those purposes;

                     (d)  the circumstances in which the person must cease the use of the goods for those purposes.

             (5)  The Secretary may, in writing, authorise a specified medical practitioner to supply:

                     (a)  specified therapeutic goods for use in the treatment of humans; or

                     (b)  a specified class of such goods;

to the class or classes of recipients specified in the authority.

          (5A)  An authority may be given subject to the conditions (if any) specified in the authority.

          (5B)  The Secretary may impose conditions (or further conditions) on an authority given to a person under subsection (5) by giving to the person written notice of the conditions (or further conditions).

             (6)  An authority under subsection (5) may only be given:

                     (a)  to a medical practitioner included in a class of medical practitioners prescribed by the regulations for the purposes of this paragraph; and

                    (aa)  to a medical practitioner who has the approval of an ethics committee to supply the specified therapeutic goods or the specified class of such goods; and

                     (b)  in relation to a class or classes of recipients prescribed by the regulations for the purposes of this paragraph.

Paragraph (aa) does not apply in the exceptional circumstances (if any) prescribed by the regulations for the purposes of this subsection.

             (7)  The regulations may prescribe the circumstances in which therapeutic goods may be supplied under an authority under subsection (5).

             (8)  The giving of an authority under subsection (5) does not render the Commonwealth, the Secretary or a delegate of the Secretary liable to a person in respect of loss, damage or injury of any kind suffered by the person as a result of, or arising out of, the use of therapeutic goods by that person or another person.

             (9)  In this section, medical practitioner means a person who is registered, in a State or internal Territory, as a medical practitioner.