National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2012 (No. 1) (No. PB 3 of 2012)

Link to law: https://www.comlaw.gov.au/Details/F2012L00378

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PB 3 of 2012
National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2012 (No. 1)
 
National Health Act 1953
___________________________________________________________________________
 
I, FELICITY McNEILL, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health, make this instrument under subsections 100(1) and (2) of the National Health Act 1953.
Dated 16 February 2012
 
 
 
 
 
 
 
 
 
 
 
FELICITY McNEILL
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 2012 (No.1).
 
(2)                This Instrument may also be cited as PB 3 of 2012.
 
2             Commencement
                This Instrument commences on 1 March 2012.
3              Amendments to PB 87 of 2011
                      Schedule 1 amends the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2011 (PB 87 of 2011).
 
 
Schedule 1                   Amendments
 
[1]    Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL with manner of administration Injection/intravesical and brand Epirubicin Ebewe
substitute:

Epirubicin
Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL
Injection/intravesical
Epirubicin Actavis 10
TA
EMP
 
 
4
0
D

 
 
 
Epirubicin Ebewe
SZ
EMP
 
 
4
0
D

 
[2]    Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 20 mg in 10 mL with manner of administration Injection/intravesical and brand Pharmorubicin Solution
substitute:

 
Solution for injection containing epirubicin hydrochloride 20 mg in 10 mL
Injection/intravesical
Epirubicin Actavis 20
TA
EMP
 
 
4
0
D

 
 
 
Pharmorubicin Solution
PF
EMP
 
 
4
0
D

 
[3]    Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL with manner of administration Injection/intravesical and brand Epirubicin Ebewe
substitute:

 
Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL
Injection/intravesical
Epirubicin Actavis 50
TA
EMP
 
 
4
0
D

 
 
 
Epirubicin Ebewe
SZ
EMP
 
 
4
0
D

 
[4]    Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 100 mg in 50 mL with manner of administration Injection/intravesical and brand Epirubicin Ebewe
substitute:

 
Solution for injection containing epirubicin hydrochloride 100 mg in 50 mL
Injection/intravesical
Epirubicin Actavis 100
TA
EMP
 
 
2
0
D

 
 
 
Epirubicin Ebewe
SZ
EMP
 
 
2
0
D

 
[5]    Schedule 1, after entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL with manner of administration Injection/intravesical and brand DBL Epirubicin Hydrochloride Injection
insert in the columns in the order indicated:
 
 
 
Epirubicin Actavis 200
TA
EMP
 
 
1
0
D
 
 
 
[6]    Schedule 1, entry for Gemcitabine
omit from the column headed “Circumstances” (all instances):
C3889
C3890

C3906
C3913

C3914
 

 
[7]    Schedule 1, entry for Gemcitabine in the form Solution for injection 200 mg (as hydrochloride) in 5.3 mL
substitute:

Gemcitabine
Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 5 mL
Injection
Gemcitabine Ebewe
SZ
EMP
 
 
4
2
D

 
Solution for injection 200 mg (as hydrochloride) in 5.3 mL
Injection
DBL Gemcitabine Injection
HH
EMP
 
 
4
2
D

 
[8]    Schedule 1, after entry for Gemcitabine in the form Solution for injection 1 g (as hydrochloride) in 26.3 mL
insert in the columns in the order indicated:
 
 
Solution concentrate for I.V. infusion 1 g (as hydrochloride) in 25 mL
Injection
Gemcitabine Ebewe
SZ
EMP
 
 
2
2
D
 
[9]    Schedule 1, after entry for Gemcitabine in the form Powder for I.V. infusion 2 g (as hydrochloride) with manner of administration Injection and brand Gemcitabine Kabi
insert in the columns in the order indicated:
 
 
Solution concentrate for I.V. infusion 2 g (as hydrochloride) in 50 mL
Injection
Gemcitabine Ebewe
SZ
EMP
 
 
1
2
D
 
[10]  Schedule 3, omit entry for Gemcitabine
 
Note
All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. 
See http://www.frli.gov.au.