Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 38

             (1)  Where:

                     (a)  a person has made an application to carry out steps in the manufacture of therapeutic goods at particular manufacturing premises; and

                     (b)  the prescribed application fee has been paid; and

                     (c)  any applicable prescribed inspection fees have been paid; and

                     (d)  the applicant has complied with any requirements made by the Secretary under subsection 37(2) in relation to the application;

the Secretary must grant the applicant a licence to carry out those steps at those premises unless the Secretary is satisfied that:

                     (e)  the applicant will be unable to comply with the manufacturing principles; or

                      (f)  the premises are not satisfactory for the manufacture of the goods; or

                     (g)  the applicant is not a fit and proper person to hold a licence; or

                     (h)  a person who is participating in, or is likely to participate in, managing the applicant's affairs is not a fit and proper person to participate in the management of the affairs of a holder of a licence; or

                      (i)  a person who has, or is likely to have, effective control over the applicant is not a fit and proper person to have effective control over a holder of a licence.

          (1A)  Without limiting the matters to which the Secretary may have regard in considering whether the applicant or person is not a fit and proper person for the purposes of paragraph (1)(g), (h) or (i), the Secretary must have regard to:

                     (a)  any suspension or revocation of a manufacturing licence granted to:

                              (i)  the applicant or person; or

                             (ii)  another person who controls the applicant or person (whether directly, or indirectly through one or more interposed entities); or

                            (iii)  another person whom the applicant or person controlled (whether directly, or indirectly through one or more interposed entities) at the time of the suspension or revocation; or

                     (b)  any conviction, for an offence against a law of the Commonwealth or a law of a State or Territory, against:

                              (i)  the applicant or person; or

                             (ii)  another person who controls the applicant or person (whether directly, or indirectly through one or more interposed entities); or

                            (iii)  another person whom the applicant or person controlled (whether directly, or indirectly through one or more interposed entities) at the time the offence was committed or the time of the conviction; or

                    (ba)  an order requiring any of the following persons to pay a pecuniary penalty for the contravention of a civil penalty provision:

                              (i)  the applicant or person;

                             (ii)  another person who controls the applicant or person (whether directly, or indirectly through one or more interposed entities);

                            (iii)  another person whom the applicant or person controlled (whether directly, or indirectly through one or more interposed entities) at the time the civil penalty provision was contravened or at the time of the order; or

                     (c)  any failure to comply with a condition of a manufacturing licence by:

                              (i)  the applicant or person; or

                             (ii)  another person who controls the applicant or person (whether directly, or indirectly through one or more interposed entities); or

                            (iii)  another person whom the applicant or person controlled (whether directly, or indirectly through one or more interposed entities) at the time of the failure.

          (1B)  In subsection (1A):

"manufacturing licence" means:

                     (a)  a licence granted under this Part; or

                     (b)  a licence, granted under a law of a State or Territory relating to therapeutic goods, relating to manufacturing therapeutic goods.

             (2)  Notwithstanding paragraphs (1)(g), (h) and (i), the Secretary may grant a licence to an applicant who, apart from this subsection, could not be granted a licence because of one or more of those paragraphs if, in the opinion of the Secretary, special circumstances make it appropriate to do so.

             (3)  Where the Secretary grants or refuses to grant a licence to an applicant, the Secretary must:

                     (a)  give the applicant written notice of the decision; and

                     (b)  in the case of a refusal--include in the notice the reasons for the refusal.

             (4)  Where the Secretary grants a licence, the Secretary must cause particulars of the decision to be published in the Gazette as soon as is practicable after the decision is made.