Federal Register of Legislation - Australian Government

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SLI 2012 No. 144 Regulations as made
This regulation amends the Therapeutic Goods (Charges) Regulations 1990 to make a small number of minor amendments, principally in order to ensure that manufacturers who manufacture only biologicals are not required to pay an annual charge arising from the fact they hold a manufacturing licence.
Administered by: Health
Registered 29 Jun 2012
Tabling HistoryDate
Tabled HR14-Aug-2012
Tabled Senate14-Aug-2012
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

Commonwealth Coat of Arms

Therapeutic Goods (Charges) Amendment Regulation 2012 (No. 1)1

Select Legislative Instrument 2012 No. 144

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

Dated 28 June 2012



By Her Excellency’s Command


1              Name of regulation

                This regulation is the Therapeutic Goods (Charges) Amendment Regulation 2012 (No. 1).

2              Commencement

                This regulation is taken to have commenced on 31 May 2011.

3              Amendment of Therapeutic Goods (Charges) Regulations 1990

                Schedule 1 amends the Therapeutic Goods (Charges) Regulations 1990.

Schedule 1        Amendments

(section 3)


[1]           Paragraph 3 (2) (l)


$10 800.


$10 800;

[2]           After paragraph 3 (2) (l)


              (m)    despite paragraphs (a) to (l)—for a licence for the manufacture of a biological only—Nil.

[3]           Subregulation 3 (3)


         (3)   If, but for this subregulation, more than one charge referred to in subregulation (1) or any of paragraphs (2) (a) to (l) would otherwise apply in respect of a financial year in relation to:

                (a)    the registration or listing of particular goods; or

               (b)    a particular licence;

the charge that is the greatest applicable charge (other than a charge payable under any of paragraphs (2) (a) to (l) only because biologicals are manufactured) is the only charge that applies in respect of the registration or listing of those goods or in relation to that licence in that year.


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