THERAPEUTIC GOODS ACT 1989 - SECT 37 Application for licence
THERAPEUTIC GOODS ACT 1989 - SECT 37
Application for licence(1) An application for a licence must:
(a) be made in accordance with a form approved by the Secretary; and
(b) identify the therapeutic goods or classes of therapeutic goods that the applicant proposes to manufacture; and
(c) in accordance with subsections (1A) and (1B), identify one or more manufacturing sites that will be used in the manufacture of those goods; and
(d) identify the steps in the manufacture of those goods that the applicant proposes to carry out under the licence; and
(da) if the applicant proposes to carry out steps in the manufacture of blood or blood components under the licence--contain information relating to those steps set out in regulations made for the purposes of this paragraph; and
(e) state the names, qualifications and experience of the persons who are to have control of the production of the goods and of the quality control measures that are to be employed; and
(f) be delivered to an office of the Department specified in the form; and
(g) be accompanied by the prescribed application fee ; and
(h) if there are one or more absolute prohibitions in force for the purposes of subsection 9K(1) or (3)--be accompanied by a statement from the applicant certifying that the manufacture in Australia of the therapeutic goods or classes of therapeutic goods the subject of the application will not contravene those prohibitions; and
(i) if there are one or more prohibitions in force for the purposes of subsection 9K(1) or (3) that are subject to conditions--be accompanied by a statement from the applicant certifying that the manufacture in Australia of the therapeutic goods or classes of therapeutic goods the subject of the application will not contravene those conditions.
(1A) Subject to subsection (1B), an application under subsection (1) must relate to one manufacturing site only. This does not prevent other applications from relating to other manufacturing sites.
(1B) If an applicant is of the view that, having regard to the guidelines under section 38A, a licence could be granted covering 2 or more manufacturing sites, the applicant may:
(a) identify those sites in the application; and
(b) state the applicant's reasons for the applicant's view.
(2) The Secretary may, by notice in writing given to an applicant for a licence, require the applicant:
(a) to give to the Secretary, within such reasonable time as is specified in the notice, such further information concerning the application as is specified in the notice; or
(b) to allow an authorised person, at any reasonable time specified in the notice, to inspect each manufacturing site identified in the application and the equipment, processes and facilities that will be used in the manufacture of the goods, or other goods at that site.
Applications or information may be given electronically
(3) An approval of a form mentioned in paragraph (1)(a), or a notice mentioned in subsection (2), may require or permit an application or information to be given in accordance with specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.