National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2014 (No. 8) (No. PB 64 of 2014) (Cth)

PB 64 of 2014

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2014 (No. 8)

National Health Act 1953

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I, Kim Bessell, Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this instrument under subsections 100(1) and (2) of the National Health Act 1953.

Dated 19 August 2014

KIM BESSELL

Assistant Secretary

Pharmaceutical Access Branch

Principal Pharmacy Advisor  

Pharmaceutical Benefits Division

Department of Health

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1              Name of Instrument

(1)This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2014 (No.8).

(2)This Instrument may also be cited as PB 64 of 2014.

2             Commencement

This Instrument commences on 1 September 2014.

3              Amendments to PB 79 of 2011

Schedule 1 amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011).

Schedule 1   Amendments

1. Schedule 1 Part 1 entry for ‘Carboplatin’ in each of the forms ‘Solution for I.V. injection 150 mg in 15 mL’; ‘Solution for I.V. injection 450 mg in 45 mL’; and ‘Solution for I.V. injection 50 mg in 5 mL’ with manner of administration Injection:

omit :

Carboplatin Ebewe SZ MP D

1. Schedule 1 Part 1, entry for ‘Epirubicin’ in the form ‘Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL’ with manner of administration Injection/Intravesical:

omit from the column headed ‘Brand’: Epirubicin Actavis 200   substitute: Epirubicin ACT

omit from the column headed ‘Responsible Person’: UA   substitute: VN

1. Schedule 1 Part 1, entry for ‘Epirubicin’ in the form ‘Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL’ with manner of administration Injection/Intravesical:

omit from the column headed ‘Brand’: Epirubicin Actavis 50   substitute: Epirubicin ACT

omit from the column headed ‘Responsible Person’: UA   substitute: VN

1. Schedule 1 Part 1 after the entry for ‘Fludarabine’ in the form ‘Powder for I.V. injection containing fludarabine phosphate 50 mg’ with manner of administration Injection and Brand ‘Fludara’:

insert :

Fludarabine ACT VN MP 3887 D

1. Schedule 1 Part 1 after the entry for ‘Gemcitabine’ in the form ‘Powder for I.V. infusion 200 mg (as hydrochloride)’ with manner of administration Injection:

omit :

Solution concentrate for I.V. infusion 1 g (as hydrochloride) in 25 mL Injection Gemcitabine Ebewe SZ MP D

1. Schedule 1 Part 1 after the entry for ‘Gemcitabine’ in the form ‘Solution concentrate for I.V. infusion 1000 mg (as hydrochloride) in 100 mL’ with manner of administration Injection:

omit :

Solution concentrate for I.V. infusion 2 g (as hydrochloride) in 50 mL Injection Gemcitabine Ebewe SZ MP D

Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 5 mL Injection Gemcitabine Ebewe SZ MP D

1. Schedule 1 Part 1 entry for ‘Irinotecan’ in the form ‘I.V injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL’ with manner of administration Injection:

omit :

Irinotecan SZ HX MP D

1. Schedule 1 Part 1 entry for ‘Oxaliplatin’ in each of the forms ‘Powder for I.V. infusion 100 mg’; and ‘Powder for I.V. infusion 50 mg’ with manner of administration Injection:

omit :

Oxaliplatin Alphapharm AF MP D

1. Schedule 2 after the entry for ‘Ondansetron’ in each of the forms ‘Tablet 4 mg (as hydrochloride dihydrate)’; and ‘Tablet 8 mg (as hydrochloride dihydrate)’ with manner of administration Oral and Brand ‘APO‑Ondansetron’:

insert :

Ondansetron AN EA EMP C3050 4 0

[10]  Schedule 2 after the entry for ‘Ondansetron’ in each of the forms ‘Tablet (orally disintegrating) 4 mg’; and ‘Tablet (orally disintegrating) 8 mg’ with manner of administration Oral:

insert :  

Ondansetron AN ODT EA EMP C3050 4 0

[11]  Schedule 3, Responsible Person codes, after entry for BX:

insert:

EA Amneal Pharmaceuticals Pty Ltd  21 147 854 484