THERAPEUTIC GOODS ACT 1989 - SECT 41 Revocation and suspension of licences

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)   at least one of the following persons:

  (i)   the holder;

  (ii)   a person (a manager ) who makes, or participates in making, decisions that affect the whole, or a substantial part, of the holder's affairs;

  (iii)   if the holder is a body corporate--a major interest holder of the body corporate;

    has:

  (iv)   been convicted of an offence against this Act or a corresponding State law; or

  (v)   been convicted of an offence against a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or

  (vi)   been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of this Act or a corresponding State law; or

  (vii)   been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or

  (viii)   breached a condition of a manufacturing licence; or

  (ix)   had a manufacturing licence suspended or revoked; or

  (x)   been a manager, or a major interest holder, of a body corporate in respect of which subparagraph   (iv), (v), (vi), (vii), (viii) or (ix) applies, if the conduct resulting in that subparagraph applying occurred when the person was a manager or major interest holder of the body corporate; 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

  (ea)   the holder contravenes a manufacturing site authorisation in relation to the licence; 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; or

  (ga)   the licence covers a biological that is exempt under section   32CB and the holder has breached a condition of the exemption in relation to the biological; or

  (gb)   if there are one or more absolute prohibitions in force for the purposes of subsection   9K(1) or (3)--the Secretary is satisfied that the manufacture in Australia of the goods to which the licence relates would contravene one or more of those prohibitions; or

  (gc)   if there are one or more prohibitions in force for the purposes of subsection   9K(1) or (3) that are subject to conditions--the Secretary is satisfied that the manufacture in Australia of the goods to which the licence relates would contravene one or more of those conditions; or

  (h)   any other circumstances prescribed by the regulations for the purposes of this paragraph exist.

  (1A)   A reference in paragraph   (1)(a) to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence under:

  (a)   section   19B of the Crimes Act 1914 ; or

  (b)   a corresponding provision of a law of a State or Territory.

Note:   Section   19B of the Crimes Act 1914 empowers a court that has found a person to have committed an offence to take action without proceeding to record a conviction.

  (1B)   Paragraph   (1)(a) does not limit paragraph   (1)(h).

  (1C)   In paragraph   (1)(a):

"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)   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 or on the Department's website as soon as is practicable after the decision is made.