Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 41

             (1)  Subject to subsection (2), the Secretary may, by notice in writing given to the holder of a licence, revoke the licence, or suspend the licence for a period specified in the notice, if:

                     (a)  the holder has been convicted of an offence against this Act; or

                    (aa)  the holder has been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision; or

                    (ab)  the holder controls another person (whether directly, or indirectly through one or more interposed entities) and that other person:

                              (i)  has been convicted of an offence against this Act or a law of a State or Territory relating to therapeutic goods; or

                             (ii)  has been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision; or

                    (ac)  the holder controlled another person (whether directly, or indirectly through one or more interposed entities) when that other person:

                              (i)  committed an offence against this Act or a law of a State or Territory relating to therapeutic goods, being an offence for which the person was convicted; or

                             (ii)  contravened a civil penalty provision, being a contravention for which the person was ordered to pay a pecuniary penalty; or

                    (ad)  the holder is controlled by another person (whether directly, or indirectly through one or more interposed entities) when that other person:

                              (i)  has been convicted of an offence against this Act or a law of a State or Territory relating to therapeutic goods; or

                             (ii)  has been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision; or

                     (b)  the holder has breached a condition of the licence; or

                     (c)  the holder is controlled by another person (whether directly, or indirectly through one or more interposed entities) and that other person has breached a condition of a licence; or

                    (ca)  the holder controls another person (whether directly, or indirectly through one or more interposed entities) and that other person has, while controlled by the holder, breached a condition of a licence; or

                    (cb)  the holder is not a fit and proper person to hold a licence; or

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

                    (cd)  a person who has effective control over the holder is not a fit and proper person to have effective control over a holder of a licence; or

                     (d)  the holder requests in writing that the licence be revoked or suspended, as the case may be; or

                     (e)  the holder ceases to carry on the business of manufacturing the goods to which the licence relates; or

                      (f)  the annual licensing charge, or any applicable prescribed inspection fees, have not been paid within 28 days after they become payable; or

                     (g)  the goods are exempt under section 18A and the holder has breached a condition of the exemption in relation to those goods.

          (1A)  Without limiting the matters to which the Secretary may have regard in considering whether the holder or another person is not a fit and proper person for the purposes of paragraph (1)(cb), (cc) or (cd), the Secretary must have regard to the matters set out in paragraphs 38(1A)(a), (b), (ba) and (c).

             (2)  Where the Secretary proposes to revoke a licence or suspend a licence otherwise than at the request of the holder of the licence, the Secretary must, unless the Secretary considers that failure to revoke or suspend the licence immediately would create an imminent risk of death, serious illness or serious injury:

                     (a)  by notice in writing given to the holder, inform the holder of the action that the Secretary proposes to take and of the reasons for that proposed action; and

                     (b)  except where the proposed action is to be taken as a result of a failure to pay the annual licensing charge or an applicable prescribed inspection fee--give the holder an opportunity to make, within such reasonable time as is specified in the notice, submissions to the Secretary in relation to the proposed action.

             (3)  Where the holder makes submissions in accordance with paragraph (2)(b), the Secretary is not to make a decision relating to the revocation or suspension of the licence before taking into account the submissions.

             (4)  A licence may be revoked notwithstanding that the licence is suspended.

             (5)  Where a licence is suspended, the Secretary may, by notice in writing given to the holder of the licence, revoke the suspension.

             (6)  Where the Secretary revokes or suspends 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.