Document ID: chunk:federal_register_of_legislation:C2024C00632:section:19:p1
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 19 (pt 1/4)
Character Range: 134939–137575

19  Approvals or authorities for certain uses
 (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 or listed 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.
Note: For variation of an approval for use of the kind referred to in paragraph (1)(b), see subsection (4B).
 (1AA) An approval for use of the kind referred to in paragraph (1)(a) must not be granted to a person unless the person is a health practitioner.
 (1A) An approval mentioned in paragraph (1)(a) or (b) is subject to the conditions (if any) specified in the regulations for the purposes of that paragraph. 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 in a form (if any) approved, in writing, by the Secretary and 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 in a form (if any) approved, in writing, by the Secretary; 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