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SLI 2005 No. 194 Regulations as made
These Regulations increase charges payable for registration or listing of therapeutic goods and devices by 1.6%, increase charges in relation to prescription medicines and human blood manufacture by 19% and 30% respectively and technical amendments.
Administered by: Health
Registered 19 Aug 2005
Tabling HistoryDate
Tabled HR05-Sep-2005
Tabled Senate05-Sep-2005
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

Therapeutic Goods (Charges) Amendment Regulations 2005 (No. 1)1

Select Legislative Instrument 2005 No. 194

I, PHILIP MICHAEL JEFFERY, Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the Therapeutic Goods (Charges) Act 1989.

Dated 18 August 2005

P. M. JEFFERY

Governor-General

By His Excellency’s Command

CHRISTOPHER PYNE


1              Name of Regulations

                These Regulations are the Therapeutic Goods (Charges) Amendment Regulations 2005 (No. 1).

2              Commencement

                These Regulations commence on the day after they are registered.

3              Amendment of Therapeutic Goods (Charges) Regulations 1990

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


Schedule 1        Amendments

(regulation 3)

  

[1]           Paragraph 3 (2) (j)

omit

manufacture of human blood and blood components

insert

manufacture of human blood and blood components (other than haematopoietic progenitor cells)

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

insert

               (ja)    for a licence for the manufacture of haematopoietic progenitor cells at manufacturing premises covered by the licence — $4 300;

[3]           Subregulation 3 (4)

substitute

         (4)   For subregulation (2):

haematopoietic progenitor cells means primitive pluripotent haematopoietic cells capable of self-renewal as well as maturation into any of the haematopoietic lineages, including committed and lineage-restricted progenitor cells.

primary site means the principal premises in the capital city of each State and Territory where human blood and blood components are manufactured.

[4]           Further amendments — amounts of charge

 

Provision

omit

insert

Subparagraph 3 (1) (a) (i)

$720;

$730;

Subparagraph 3 (1) (a) (ii)

$1 910;

$1 940;

Subparagraph 3 (1) (a) (iii)

$1 090;

$1 110;

Subparagraph 3 (1) (b) (i)

$3 050;

$3 630;

Subparagraph 3 (1) (b) (ii)

$1 820;

$2 170;

Subparagraph 3 (1) (c) (i)

$530;

$540;

Subparagraph 3 (1) (c) (ii)

$960;

$980;

Subparagraph 3 (1) (c) (iii)

$550.

$560.

Subparagraph 3 (1A) (a) (i)

$720;

$730;

Subparagraph 3 (1A) (a) (ii)

$1 910;

$1 940;

Subparagraph 3 (1A) (a) (iii)

$1 090;

$1 110;

Subparagraph 3 (1A) (b) (i)

$3 050;

$3 630;

Subparagraph 3 (1A) (b) (ii)

$1 820;

$2 170;

Subparagraph 3 (1A) (c) (i)

$530;

$540;

Subparagraph 3 (1A) (c) (ii)

$960;

$980;

Subparagraph 3 (1A) (c) (iii)

$550.

$560.

Paragraph 3 (1B) (a)

$50;

$60;

Paragraph 3 (1B) (b)

$670;

$680;

Paragraph 3 (1B) (c)

$880.

$890.

Paragraphs 3 (2) (a) and (b)

$8 210;

$8 340;

Paragraphs 3 (2) (c), (d), (e), (f), (g) and (h)

$4 230;

$4 300;

Subparagraph 3 (2) (j) (i)

$98 300;

$99 900;

Subparagraph 3 (2) (j) (ii)

$3 770;

$4 910;

Paragraph 3 (2) (k)

$4 230;

$4 300;

Paragraph 3 (2) (l)

$8 210.

$8 340.

Subregulation 3 (3), note

$65 000

$66 000

Subregulation 4E (1)

$90.

$100.

Subregulation 4E (2)

$11 300,

$11 500,

Note

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