National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2011 (No. 9) (No. PB 70 of 2011) (Cth)

Case

PB 70 of 2011

National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2011 (No. 9)

National Health Act 1953

___________________________________________________________________________

I, KIM BESSELL, Acting First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under subsections 100(1) and (2) of the National Health Act 1953.

Dated  22  September 2011

KIM BESSELL

Acting First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health and Ageing

___________________________________________________________________

1              Name of Instrument

(1)This Instrument is the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2011 (No.9).

(2)This Instrument may also be cited as PB 70 of 2011.

2             Commencement

    This Instrument commences on 1 October 2011.

3              Amendments to PB 117 of 2010

 Schedule 1 amends the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2010 (PB 117 of 2010).

.

Schedule 1                   Amendments

  1. Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 2 mL

substitute:

Solution concentrate for I.V. infusion 20 mg in 2 mL Injection DBL Docetaxel Concentrated Injection HH EMP C1194 C1742 C2416 C2439 C2732 C3051 C3428 P3051 1 0
Docetaxel Ebewe HX EMP C1194 C1742 C2416 C2732 C3051 C3428 P3051 1 0
Docetaxel Sandoz SZ EMP C1194 C1742 C2416 C2439 C2732 C3051 C3428 P3051 1 0
DBL Docetaxel Concentrated Injection HH EMP C1194 C1742 C2416 C2439 C2732 C3051 C3428 P1194 P1742 P2416 P2439 P2732 P3428 2 0
Docetaxel Ebewe HX EMP C1194 C1742 C2416 C2732 C3051 C3428 P1194 P1742 P2416 P2732 P3428 2 0
Docetaxel Sandoz SZ EMP C1194 C1742 C2416 C2439 C2732 C3051 C3428 P1194 P1742 P2416 P2439 P2732 P3428 2 0
  1. Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 8 mL

substitute:

Solution concentrate for I.V. infusion 80 mg in 8 mL Injection DBL Docetaxel Concentrated Injection HH EMP C1194 C1742 C2416 C2439 C2732 C3051 C3428 1 0
Docetaxel Ebewe HX EMP C1194 C1742 C2416 C2732 C3051 C3428 1 0
Docetaxel Sandoz SZ EMP C1194 C1742 C2416 C2439 C2732 C3051 C3428 1 0
  1. Schedule 1, entry for Docetaxel, after Solution concentrate for I.V. infusion 160 mg in 16 mL

insert:

Powder for I.V. infusion 20 mg with solvent Injection Docetaxel SUN ZF EMP C1194 C1742 C2732 C3428 2 0
Powder for I.V. infusion 80 mg with solvent Injection Docetaxel SUN ZF EMP C1194 C1742 C2732 C3428 1 0
  1. Schedule 1, entry for Fludarabine in the form Powder for I.V. injection containing fludarabine phosphate 50 mg, in the column headed ‘Responsible Person’

omit:

GQ

substitute:

TA

  1. Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 200 mg (as hydrochloride), in the column headed ‘Responsible Person’

omit:

GQ

substitute:

TA

  1. Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 1 g (as hydrochloride), in the column headed ‘Responsible Person’

omit:

GQ

substitute:

TA

  1. Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL

substitute:

Irinotecan I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL Injection Camptosar PF EMP C3184 1 3
Hospira Pty Limited HH EMP C3184 1 3
Irinotecan Actavis TA EMP C3184 1 3
Irinotecan Alphapharm AF EMP C3184 1 3
Irinotecan Ebewe SZ EMP C3184 1 3
Irinotecan Kabi PK EMP C3184 1 3
Omegapharm Irinotecan OE EMP C3184 1 3
Tecan WQ EMP C3184 1 3
  1. Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL

substitute:

I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL Injection Camptosar PF EMP C3184 2 3
Hospira Pty Limited HH EMP C3184 2 3
Irinotecan Actavis TA EMP C3184 2 3
Irinotecan Alphapharm AF EMP C3184 2 3
Irinotecan Ebewe SZ EMP C3184 2 3
Irinotecan Kabi PK EMP C3184 2 3
Omegapharm Irinotecan OE EMP C3184 2 3
Tecan WQ EMP C3184 2 3
  1. Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 50 mg in 10 mL

insert in alphabetical order by brand name:

Oxaliplatin SUN ZF EMP C2717 C3449 C3450 1 2

[10]  Schedule 1, entry for Oxaliplatin in the form Powder for I.V. infusion 50 mg, in the column headed ‘Responsible Person’

omit:

GQ

substitute:

TA

[11]  Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 100 mg in 20 mL

insert in alphabetical order by brand name:

Oxaliplatin SUN ZF EMP C2717 C3449 C3450 1 2

[12]  Schedule 1, entry for Oxaliplatin in the form Powder for I.V. infusion 100 mg, in the column headed ‘Responsible Person’

omit:

GQ

substitute:

TA

[13]  Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 200 mg in 40 mL

insert in alphabetical order by brand name:

Oxaliplatin SUN ZF EMP C2717 C3449 C3450 1 2

[14]  Schedule 1, entry for Paclitaxel in the form Solution Concentrate for I.V. infusion 30 mg in 5 mL, in the column headed ‘Responsible Person’

omit:

GQ

substitute:

TA

[15]  Schedule 1, entry for Paclitaxel in the form Solution Concentrate for I.V. infusion 100 mg in 16.7 mL, in the column headed ‘Responsible Person’

omit:

GQ

substitute:

TA

[16]  Schedule 1, entry for Paclitaxel in the form Solution Concentrate for I.V. infusion 150 mg in 25 mL, in the column headed ‘Responsible Person’

omit:

GQ

substitute:

TA          

[17]  Schedule 1, entry for Paclitaxel in the form Solution Concentrate for I.V. infusion 300 mg in 50 mL, in the column headed ‘Responsible Person’

omit:

GQ

substitute:

TA

[18]  Schedule 1, entry for Vinorelbine

substitute:

Vinorelbine Solution for I.V. infusion 10 mg (as tartrate) in 1 mL Injection Hospira Pty Limited HH EMP C1194 C1741 16 2
Navelbine FB EMP C1194 C1741 16 2
Vinorelbine Ebewe SZ EMP C1194 C1741 16 2
Solution for I.V. infusion 50 mg (as tartrate) in 5 mL Injection Hospira Pty Limited HH EMP C1194 C1741 4 2
Navelbine FB EMP C1194 C1741 4 2
Vinorelbine Ebewe SZ EMP C1194 C1741 4 2
Vinorelbine Kabi PK EMP C1194 C1741 4 2

[19]  Schedule 2, Responsible Person Codes

omit:

FU Fresenius Kabi Australia Pty Limited  39 109 383 593

[20]  Schedule 2, Responsible Person Codes

omit:

GQ Generic Health Pty Ltd  93 110 617 859

Note

All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003.

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