Commonwealth Numbered Acts

THERAPEUTIC GOODS ACT 1989 No. 21 of 1990 - SECT 19

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 either exempt goods or
goods included in the Register:

   (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. (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.