National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2012 (No. 2) (No. PB 66 of 2012)

Link to law: https://www.comlaw.gov.au/Details/F2012L01733

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PB 66 of 2012
National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2012 (No.2)
National Health Act 1953
I, STEVE DUNLOP, A/g Assistant Secretary, Pharmaceutical Programs and Support Branch, Department of Health and Ageing, delegate of the Minister for Health, make this Instrument under subsections 100(1) and 100(2) of the National Health Act 1953.
Dated      16     August 2012
 
 
 
 
 
 
 
 
 
STEVE DUNLOP
A/g Assistant Secretary
Pharmaceutical Programs and Support Branch
Department of Health and Ageing
1          Name of Instrument
            (1)        This Instrument is the National Health (Growth Hormone Program)
                        Special Arrangement Amendment Instrument 2012 (No.2).
            (2)        This Instrument may also be cited as PB 66 of 2012.
2          Commencement
This Instrument commences on 1 September 2012.
3          Amendment of PB 88 of 2011
The Schedule amends the National Health (Growth Hormone Program) Special Arrangement 2011 (PB 88 of 2011).
 4         Transitionals
An application, approval, order, supply or claim for supply of an item in Table 1 made before 1 September 2012 is taken to be an application, approval, order, supply or claim for supply of the corresponding item in Table 2.
 
Table 1

Item
Drug
Form
Manner of administration
Brand

1
Somatropin
Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative)
Injection
Norditropin Nordiflex

2
Somatropin
Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative)
Injection
Norditropin FlexPro

3
Somatropin
Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative)
Injection
Norditropin Nordiflex

4
Somatropin
Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative)
Injection
Norditropin FlexPro

5
Somatropin
Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative)
Injection
Norditropin Nordiflex

6
Somatropin
Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative)
Injection
Norditropin FlexPro

 
 
 
Table 2

Item
Drug
Form
Manner of administration
Brand

1
Somatropin
Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) in a pre-filled pen
Injection
Norditropin Nordiflex

2
Somatropin
Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) in a pre-filled pen
Injection
Norditropin FlexPro

3
Somatropin
Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative) in a pre-filled pen
Injection
Norditropin Nordiflex

4
Somatropin
Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative) in a pre-filled pen
Injection
Norditropin FlexPro

5
Somatropin
Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative) in a pre-filled pen
Injection
Norditropin Nordiflex

6
Somatropin
Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative) in a pre-filled pen
Injection
Norditropin FlexPro

 
 
 
 
Schedule        Amendments
[1]   Schedule 1, entry for Somatropin in the form Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative)
substitute:
 
Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative)
Injection
Norditropin SimpleXx
NO
AMP
D

 
 
 
Omnitrope
SZ
AMP
D

 
Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) in a pre-filled pen
Injection
Norditropin NordiFlex
 
NO
AMP
D

 
 
 
Norditropin FlexPro
NO
AMP
D

[2]           Schedule 1, entry for Somatropin in the form Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative) 
substitute:
 
Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative)
Injection
Norditropin SimpleXx
NO
AMP
D

 
 
 
Omnitrope
SZ
AMP
D

 
Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative) in a pre-filled pen
Injection
Norditropin NordiFlex
 
NO
AMP
D

 
 
 
Norditropin FlexPro
NO
AMP
D

 
 
[3]           Schedule 1, entry for Somatropin in the form Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative)  
substitute:
 
Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative)
Injection
Norditropin SimpleXx
NO
AMP
D

 
Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative) in a pre-filled pen
Injection
Norditropin NordiFlex
NO
AMP
D

 
 
 
Norditropin FlexPro
NO
AMP
D

 
1Note
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.