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Therapeutic Goods Amendment Regulations 2009 (No. 5)

Authoritative Version
  • - F2009L02935
  • No longer in force
SLI 2009 No. 228 Regulations as made
These Regulations amend the Therapeutic Goods Regulations 1990 to include a new part to administer and implement the infringement notices scheme.
Administered by: Health
Registered 10 Sep 2009
Tabling HistoryDate
Tabled HR14-Sep-2009
Tabled Senate14-Sep-2009
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

Therapeutic Goods Amendment Regulations 2009 (No. 5)1

Select Legislative Instrument 2009 No. 228

I, QUENTIN BRYCE, Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the Therapeutic Goods Act 1989.

Dated 7 September 2009

QUENTIN BRYCE

Governor-General

By Her Excellency’s Command

MARK BUTLER


1              Name of Regulations

                These Regulations are the Therapeutic Goods Amendment Regulations 2009 (No. 5).

2              Commencement

                These Regulations commence on the day after they are registered.

3              Amendment of Therapeutic Goods Regulations 1990

                Schedule 1 amends the Therapeutic Goods Regulations 1990.


Schedule 1        Amendments

(regulation 3)

 

[1]           After Part 7

insert

Part 7A               Infringement notices

  

45B         Purpose and effect of Part

         (1)   For sections 42YJ and 42YK of the Act, Schedule 15 sets up a system of infringement notices as an alternative to prosecution for an alleged offence of strict liability, or to the institution of civil proceedings for an alleged contravention of a civil penalty provision, under the Act.

         (2)   Schedule 15 does not:

                (a)    require an infringement notice to be issued to a person for an alleged offence or an alleged contravention; or

               (b)    affect a person’s liability to prosecution or to the institution of civil proceedings if an infringement notice for the alleged offence or the alleged contravention:

                          (i)    is not issued to the person; or

                         (ii)    is issued, but withdrawn;

                (c)    prevent the issue of 2 or more infringement notices to a person for an alleged offence of strict liability or an alleged contravention of a civil penalty provision; or

               (d)    affect a person’s liability to prosecution or to the institution of civil proceedings if the person does not pay the penalty for the alleged offence or the alleged contravention specified in an infringement notice in accordance with Schedule 15; or

                (e)    limit or otherwise affect the penalty that may be imposed by a court on a person for an offence of strict liability or for the contravention of a civil penalty provision.

[2]           After subregulation 47 (1)

insert

      (1A)   However, a delegation for Schedule 15 may be given only:

                (a)    to the Assistant Secretary, of a Branch or an Office, of the Therapeutic Goods Administration; or

               (b)    to the National Manager, Therapeutic Goods Administration.

[3]           After Schedule 14

insert

Schedule 15      Infringement notices

(regulation 45B)

  

1              Definitions

                 In this Schedule:

issuing officer means the Secretary, or an officer to whom the Secretary has given a delegation under subregulation 47 (1A).

2              Issue of infringement notice

     (1)       If there are reasonable grounds for believing that a person has committed an offence of strict liability against the Act, or has contravened a civil penalty provision, an issuing officer may serve an infringement notice, or cause an infringement notice to be served, on the person in accordance with clause 4.

     (2)       An infringement notice for an alleged offence or an alleged contravention must be served on a person within 12 months after the day the offence or contravention is alleged to have been committed.

     (3)       If an infringement notice given to a person for an alleged offence or an alleged contravention is withdrawn, an issuing officer may give the person a new infringement notice for the alleged offence or the alleged contravention.

     (4)       An infringement notice may be withdrawn by the issuing officer at any time before the person to whom the notice has been issued pays in full the amount of the penalty stated in the notice.

     (5)       An issuing officer who withdraws an infringement notice under subclause (4) must give written notice to the person against whom the notice was issued within 7 days after the withdrawal of the notice.

3              Contents of infringement notice

     (1)       An infringement notice must set out the following information:

                (a)    a unique identification code;

               (b)    the name of the issuing officer;

                (c)    its date of issue;

               (d)    the full name, or the surname and initials, and the address of the person to whom it is issued;

                (e)    brief details of the alleged offence or the alleged contravention, including:

                          (i)    the date, and (if known) the time, when it is alleged to have been committed; and

                         (ii)    the place where it is alleged to have been committed; and

                         (iii)    the provision of the Act alleged to have been contravened;

                (f)    the penalty for the alleged offence or the alleged contravention payable under the notice;

                (g)    the maximum penalty that a court could impose for the alleged offence or the alleged contravention;

                (h)    a statement that if the person prefers not to have the matter dealt with by a court, the person may signify that preference by paying the penalty specified in the infringement notice:

                          (i)    within 28 days after the service of the notice; or

                         (ii)    if a further period is allowed, before the end of that period; or

                         (iii)    if payment by instalments is permitted, in accordance with that permission;

                 (i)    how, and where, the penalty can be paid;

                (j)    a statement that, if an infringement notice is not withdrawn and the person to whom it is issued pays in full the penalty stated in the notice in accordance with this Schedule:

                          (i)    any liability of the person for the alleged offence or the alleged contravention is discharged; and

                         (ii)    the person will not be prosecuted in a court for the alleged offence, or proceedings will not be brought against the person for the alleged contravention; and

                         (iii)    the person will not be taken to have admitted liability for the alleged offence or the alleged contravention; and

                        (iv)    the person will not be taken to have been convicted of the offence or to be liable for the contravention;

               (k)    how the person can apply:

                          (i)    for an extension of time to pay the penalty stated in the notice; or

                         (ii)    to pay the penalty by instalments; or

                         (iii)    to have the notice withdrawn;

                 (l)    the telephone number or the address of an officer in the office of the Therapeutic Goods Administration to whom inquiries can be made about the notice;

               (m)    the signature of the issuing officer.

     (2)       An infringement notice may contain any other information that the issuing officer considers necessary.

4              Service of infringement notices

     (1)       An infringement notice must be served on the person to whom it is issued.

     (2)       An infringement notice may be served on an individual:

                (a)    by giving it to the individual; or

               (b)    by leaving it at, or by sending it by post or electronically to the address, including the electronic address, of the place of residence or business of the individual last known to the issuing officer, or the address given to the Secretary by the individual’s authorised agent; or

                (c)    by giving it to someone at that place who:

                          (i)    lives or is employed, or apparently lives or is employed, there; and

                         (ii)    is apparently over 16 years of age.

     (3)       An infringement notice may be served on a body corporate:

                (a)    by leaving it at, or by sending it by post or electronically to the address, including the electronic address, of the head office, a registered office, a principal office or the address given to the Secretary by an officer of the body corporate or its authorised agent; or

               (b)    by giving it to someone who is, or who the issuing officer has reason to believe is, a director of the body corporate residing in Australia.

     (4)       For paragraphs (2) (b) and (3) (a):

authorised agent means a person, including a body corporate, nominated in writing to the Therapeutic Goods Administration by an individual or body corporate to act on behalf of the individual or body corporate in relation to therapeutic goods.

5              Extension of time to pay penalty

     (1)       Within 28 days after being served with an infringement notice, a person may apply in writing to the issuing officer for a further period of up to 28 days after the initial 28 days in which to pay the penalty stated in the notice.

     (2)       A person cannot apply under subclause  (1) if the person has applied under clause 7 for withdrawal of the notice.

     (3)       The application must:

                (a)    include the notice’s unique specification code; and

               (b)    set out the reasons for the application.

     (4)       Within 14 days after receiving the application, the issuing officer must:

                (a)    grant, or refuse to grant, the application; and

               (b)    notify the person in writing of the decision and, if the decision is a refusal, the reasons for the decision.

     (5)       If the issuing officer has not granted or refused to grant the application within the period mentioned in subclause (4), the application is to be taken to have been granted.

     (6)       The person must pay the penalty:

                (a)    if the application is approved — in accordance with the decision; or

               (b)    if the application is refused — within the later of:

                          (i)    the end of the initial 28 days; and

                         (ii)    7 days after receiving the notice of the refusal; or

                (c)    if subclause (5) applies — within a further 28 days after the end of the initial 28 days mentioned in subclause (1).

6              Payment of penalty by instalments

     (1)       Within 28 days after being served with an infringement notice, a person may apply, in writing, to the issuing officer to pay the penalty stated in the notice by instalments, over a period of up to 6 months.

     (2)       A person cannot apply under subclause (1) if the person has applied under clause 7 for withdrawal of the notice.

     (3)       The applicant must:

                (a)    include the notice’s unique identification code; and

               (b)    set out the reasons for the application; and

                (c)    state the amount and frequency of the instalments that the person proposes to pay.

     (4)       Within 14 days after receiving the application, the issuing officer must:

                (a)    grant or refuse to grant the application; and

               (b)    give the person written notice of the decision, including:

                          (i)    if the application is granted — the amount and frequency of the instalments; or

                         (ii)    if the application is refused — the reasons for the decision.

     (5)       If the issuing officer has not granted or refused to grant the application within the period mentioned in subclause (4), the application is to be taken to have been granted.

     (6)       The person must pay the penalty:

                (a)    if the application is granted — in the manner outlined in the decision; or

               (b)    if the application is refused — within the later of:

                          (i)    28 days; and

                         (ii)    7 days after receiving the notice of the decision; or

                (c)    if subclause (5) applies:

                          (i)    within the 6 months mentioned in subclause (1); and

                         (ii)    unless otherwise agreed in writing by the issuing officer — in equal monthly instalments.

7              Withdrawal of infringement notice

     (1)       Within 28 days after being served with an infringement notice, a person who considers the notice to be defective may apply in writing to the issuing officer for the withdrawal of the infringement notice.

     (2)       The application must include:

                (a)    the notice’s unique identification code; and

               (b)    any facts or matters that the person believes should be taken into account about the alleged offence or contravention.

     (3)       Within 14 days after receiving the application, the issuing officer must:

                (a)    having regard to the information mentioned in subclause (2), withdraw or refuse to withdraw the notice; and

               (b)    notify the person, in writing, of the decision and, if the decision is a refusal, the reasons for the decision.

     (4)       If the issuing officer does not withdraw or refuse to withdraw the notice before the end of the period mentioned in subclause (3), the application is taken to have been granted.

     (5)       If the issuing officer decides to refuse the application, notice of the decision must state:

                (a)    that if the infringement notice penalty is paid by the person within 28 days after receiving notice of the decision, the person will not be prosecuted for the alleged offence or proceedings will not be instituted for the alleged contravention; and

               (b)    that if the penalty is not paid in accordance with paragraph (a), the person may be prosecuted for the alleged offence or proceedings instituted for the alleged contravention.

     (6)       If the issuing officer refuses to withdraw an infringement notice, and if the person elects to pay the penalty stated in the notice, the person must pay the penalty within 28 days after receiving the notice of the refusal.

8              Notice of withdrawal of infringement notice

                A notice withdrawing an infringement notice served on a person must:

                (a)    include the following information:

                          (i)    the person’s full name, or surname and initials, and address;

                         (ii)    the date of issue of the infringement notice; and

               (b)    state that the notice is withdrawn.

9              Effect of payment of infringement notice penalty

     (1)       If a person served with an infringement notice that is not withdrawn pays the infringement notice penalty in full in accordance with this Schedule:

                (a)    the person’s liability for the alleged offence or the alleged contravention is discharged; and

               (b)    further proceedings cannot be taken against the person for the alleged offence or the alleged contravention; and

                (c)    the person is not convicted of the alleged offence or found liable for the alleged contravention.

     (2)       Subclause (1) applies to a person who makes an arrangement to pay the infringement notice penalty by instalments, only if the person makes payments in accordance with the arrangement.

10            Refund of penalty

                If an infringement notice is withdrawn after any amount of the penalty stated in the notice has been paid, including when the penalty has not been fully paid or has been fully paid but not within the approved period, the Commonwealth must refund the amount of the penalty paid to the person who paid it.

11            Matter not to be taken into account in determining sentence

     (1)       This clause applies if a person served with an infringement notice:

                (a)    elects not to pay the penalty stated in the infringement notice; and

               (b)    is found by a court to have committed the offence or contravened the civil penalty provision mentioned in the infringement notice.

     (2)       In determining the penalty to be imposed, the court must not take into account the fact that the person chose not to pay the penalty stated in the infringement notice.

12            Infringement notice not compulsory

                Nothing in this Schedule is to be taken:

                (a)    to require an issuing officer to serve an infringement notice, or to cause an infringement notice to be served, on a person suspected of having committed an offence of strict liability or of having contravened a civil penalty provision under the Act; or

               (b)    to affect the liability of a person to be prosecuted for an alleged offence or an alleged contravention of a civil penalty provision, if:

                          (i)    an infringement notice is not served on the person for the offence or contravention; or

                         (ii)    an infringement notice is served, and withdrawn; or

                (c)    to limit the penalty that may be imposed by a court on a person convicted of an offence or found liable for the contravention of a civil penalty provision.


Note

1.       All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See http://www.frli.gov.au.