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Therapeutic Goods Amendment Regulations 2009 (No. 3)

Authoritative Version
  • - F2009L02019
  • No longer in force
SLI 2009 No. 141 Regulations as made
These Regulations amend the Therapeutic Goods Regulations 1990 to make changes in relation to the payment of specified annual charges and changes to the procedure for exemption from payment of annual charges on the basis of low value turnover exemption.
Administered by: Health
Registered 25 Jun 2009
Tabling HistoryDate
Tabled HR11-Aug-2009
Tabled Senate11-Aug-2009
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

Therapeutic Goods Amendment Regulations 2009 (No. 3)1

Select Legislative Instrument 2009 No. 141

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 24 June 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. 3).

2              Commencement

                These Regulations commence on 1 July 2009.

3              Amendment of Therapeutic Goods Regulations 1990

                Schedule 1 amends the Therapeutic Goods Regulations 1990.


Schedule 1        Amendments

(regulation 3)

[1]           Part 7,  heading

substitute

Part 7                 Charges for registration, listing and inclusion, licences, exemptions, costs and fees

[2]           Part 7, after heading

insert

Division 1              Charges for registration, listing and inclusion of therapeutic goods, exemptions and licences

Subdivision 1              Charges for registration, listing and inclusion of medical devices

43AAA   Time for payment of charge

                For paragraph 44 (1) (a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year must be paid by no later than the last day of the month immediately following the month when the goods were entered in the Register.

Subdivision 2              Low value turnover

43AAB   Definitions

         (1)   In this Subdivision:

approved person means a person who is a qualified accountant under section 88B of the Corporations Act 2001, but does not include:

                (a)    a person who, under this Subdivision, is required to submit to the Secretary a statement signed by an approved person; or

               (b)    an employee of that person.

existing entry, for a therapeutic good, means an entry for registration, listing or inclusion of the therapeutic good in the Register that is not a new entry.

low value turnover means a turnover of not more than 15 times the annual registration charge, the annual listing charge or the annual charge for inclusion in the Register payable for a financial year.

new entry, for a therapeutic good, means an entry for registration, listing or inclusion of the therapeutic good in the Register that commenced in the financial year.

turnover, for a therapeutic good, means gross dollar receipts (excluding GST) from sales of the therapeutic good in Australia for a financial year, including retail and wholesale sales.

43AAC   Application requirements

         (1)   For section 44A of the Act, the person liable to pay the annual registration charge, the annual listing charge or the annual charge for inclusion of a therapeutic good in the Register may apply to the Secretary for an exemption from liability to pay the charge for the current financial year on the ground that the turnover of that good for the applicable financial year is a low value turnover.

         (2)   The application must be:

                (a)    in writing, in a form approved by the Secretary; and

               (b)    accompanied by:

                          (i)    for an existing entry — a statement of the actual turnover of the therapeutic good for the previous financial year signed by an approved person; or

                         (ii)    for a new entry — a statement of the estimated turnover of the therapeutic good for the current financial year signed by the person liable to pay the charge; and

                         (iii)    subject to regulation 45A, the fee payable; and

                (c)    received by the Secretary:

                          (i)    for an existing entry — before 2 September of the financial year; and

                         (ii)    for a new entry — at least 21 days before the date for payment mentioned in regulation 43AAA.

         (3)   The statements mentioned in subparagraphs (2) (b) (i) and (ii) must be in a form approved by the Secretary.

43AAD   Decision by the Secretary — exemption application

         (1)   Within 21 days after receiving an application under subregulation 43AAC (1), the Secretary must:

                (a)    decide whether to grant the exemption; and

               (b)    give written notice to the person of the decision; and

                (c)    if the decision is a refusal, the reasons for the decision.

         (2)   If the Secretary refuses to grant the exemption, the applicant must pay the charge for which exemption was sought:

                (a)    for an existing entry — within the later of:

                          (i)    14 days after the notice is given under paragraph (1) (b); or

                         (ii)    the date mentioned in paragraph 44 (1) (b) of the Act; and

               (b)    for a new entry — within the later of:

                          (i)    14 days after the notice is given under paragraph (1) (b); or

                         (ii)    the date mentioned in regulation 43AAA.

43AAE   Actual turnover — new entries in the Register

         (1)   If an exemption has been granted under subregulation 43AAD (1)  for a new entry in the Register based on the estimated turnover of a therapeutic good for a financial year (the current year), the person must give to the Secretary by 1 September in the following financial year (the following year):

                (a)    details, in writing in a form approved by the Secretary, of the actual turnover of the therapeutic good for the current year; and

               (b)    a signed statement by an approved person, in a form approved by the Secretary, of the actual turnover of the therapeutic good for the current year.

         (2)   Before 1 September in the following year, the person may apply in writing for, and the Secretary may agree to, an extension of up to 28 days after the time mentioned in subregulation (1) for giving the information.

         (3)   If the person does not give the information to the Secretary within the time mentioned in subregulation (1) or within the extended time agreed to by the Secretary under subregulation (2):

                (a)    the exemption is taken to be cancelled on 30 September in the following year; and

               (b)    the person must pay the charge for which the exemption was granted by 31 October in the following year.

43AAF    Decision based on actual turnover

         (1)   Within 21 days after receiving the information mentioned in subregulation 43AAE (1), the Secretary must:

                (a)    decide whether the actual turnover of the therapeutic good was a low value turnover; and

               (b)    give to the person written notice of:

                          (i)    the decision; and

                         (ii)    if the decision is that the actual turnover was not a low value turnover — the reasons for the decision.

         (2)   If the Secretary decides that the turnover of the therapeutic good for the financial year was not a low value turnover and gives the person a notice under paragraph (1) (b), then:

                (a)    the exemption is cancelled; and

               (b)    the person who receives the notice mentioned in paragraph (1) (b) must pay the charge for which the exemption had been granted by 31 October of the following year.

43AAG   Requests by Secretary for additional information

         (1)   This regulation applies to a person who has been granted an exemption under regulation 43AAD.

         (2)   Within 2 years after the end of the financial year to which the charge for which the exemption was granted relates, the Secretary may, by notice in writing, ask the person for additional information or documents in relation to the granting of the exemption.

         (3)   The person must give the information or documents within 28 days after the notice is given under subregulation (2).

         (4)   The person may apply in writing for, and the Secretary may agree to, an extension of up to 28 days after the time mentioned in subregulation (3) for giving the information or documents.

         (5)   If the person does not give the information or documents within the time mentioned in subregulation (3) or within the extended time agreed to by the Secretary under subregulaton (4), the exemption is taken to be cancelled.

         (6)   If an exemption is cancelled under subregulation (5), the person must within 14 days after the day of cancellation, pay the charge for which the exemption was granted.

43AAH   Decision by the Secretary — new information

         (1)   The Secretary must within 21 days after receiving the information or documents mentioned in subregulation 43AAG (2):

                (a)    decide whether the turnover of the therapeutic good for the applicable financial year was a low value turnover; and

               (b)    give to the person written notice of:

                          (i)    the decision; and

                         (ii)    if the decision is that the turnover was not a low value turnover — reasons for the decision.

         (2)   If the Secretary decides that the turnover of the therapeutic good for the applicable year was not a low value turnover and gives the person a notice under paragraph (1) (b), then:

                (a)    the exemption is cancelled; and

               (b)    within 14 days after the date of the notice mentioned in paragraph (1) (b), the person must pay the charge for which the exemption had been granted.

43AAI     Appeal to AAT

                The person may appeal to the Administrative Appeals Tribunal for review of a decision made under the following provisions:

                (a)    paragraph 43AAD (1) (a);

               (b)    paragraph 43AAF (1) (a);

                (c)    paragraph 43AAH (1) (a).

Subdivision 3              Charges for licensing

43AAJ    Charges reduced if annual turnover not more than $76 800

         (1)   This regulation applies to a person if:

                (a)    the person is required to hold a licence under Part 3-3 of the Act; and

               (b)    the person’s turnover of therapeutic goods is not more than $76 800 in a financial year.

         (2)   The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subregulation 3 (2) of the Therapeutic Goods (Charges) Regulations 1990 for the licence.

Division 2              Fees and costs

[3]           Regulation 45A

substitute

45A         Maximum amount payable in exemption fees

                If the total amount payable under item 3AB of Schedule 9 for applications to which subparagraph 43AAC (2) (b) (iii) applies reaches $13 000 in a financial year, the applicant is not required to pay any further amounts for applications under that subparagraph in the financial year.

[4]           Schedule 9, Part 2, after item 3A

insert

3AB

Fee for an application for exemption under subparagraph 43AAC (2) (b) (iii) for a new entry or an existing entry

130


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.