Federal Register of Legislation - Australian Government

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PB 66 of 2012 Arrangements as made
This instrument amends the National Health (Growth Hormone Program) Special Arrangement 2011 (No. PB 88 of 2011) relating to the growth hormone program which provides for the supply of pharmaceutical benefits with recombinant growth hormone (somatropin) to eligible children and adolescents.
Administered by: Health
General Comments: Transitional: see section 4 of this instrument for transitional provisions.
Registered 22 Aug 2012
Tabling HistoryDate
Tabled HR23-Aug-2012
Tabled Senate23-Aug-2012
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

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.