Commonwealth Numbered Regulations

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THERAPEUTIC GOODS (CHARGES) AMENDMENT REGULATIONS 2005 (NO. 1) (SLI NO 194 OF 2005) - 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,



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