National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 3) (No. PB 8 of 2013)

Link to law: https://www.comlaw.gov.au/Details/F2013L00185

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now
PB 8 of 2013
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013
(No. 3)1
National Health Act 1953
I, KIM BESSELL, First Assistant Secretary (Acting), Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.
Dated 07 February 2013
 
 
 
 
 
 
 
 
 
 
 
KIM BESSELL
First Assistant Secretary (Acting)
Pharmaceutical Benefits Division
Department of Health and Ageing
 
1          Name of Instrument
            (1)        This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 3).
            (2)        This Instrument may also be cited as PB 8 of 2013.
2          Commencement
This Instrument commences on 1 March 2013.
3          Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)
            Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).
Schedule 1     Amendments
 
[1]           Schedule 1, column headings
omit:       Max Quantity    substitute:          Maximum Quantity
[2]           Schedule 1, entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids in the form
Oral powder 400 g (EleCare LCP)
delete last row of entry which incorrectly displays only the value:         1              in the column headed “Pack Quantity”
[3]           Schedule 1, entry for Azithromycin in the form Tablet 500 mg (as dihydrate) [Maximum Quantity 2; Number of Repeats 0]
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Azithromycin
TX
MP NP
C1405 C1838 C1839
P1838 P1839
2
0
2
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Chem mart Azithromycin
CH
MP NP
C1405 C1838 C1839
P1838 P1839
2
0
2
 
 
(c)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Terry White Chemists Azithromycin
TW
MP NP
C1405 C1838 C1839
P1838 P1839
2
0
2
 
 
[4]           Schedule 1, entry for Azithromycin in the form Tablet 500 mg (as dihydrate) [Maximum Quantity 2; Number of Repeats 2]
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Azithromycin
TX
MP NP
C1405 C1838 C1839
P1405
2
2
2
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Chem mart Azithromycin
CH
MP NP
C1405 C1838 C1839
P1405
2
2
2
 
 
(c)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Terry White Chemists Azithromycin
TW
MP NP
C1405 C1838 C1839
P1405
2
2
2
 
 
[5]           Schedule 1, entry for Diltiazem in each of the forms: Capsule (controlled delivery) containing diltiazem hydrochloride 240 mg; and Capsule (controlled delivery) containing diltiazem hydrochloride 360 mg
omit:
 
 
 
Diltahexal CD
HX
MP NP
 
30
5
30
 
 
[6]           Schedule 1, entry for Docetaxel in the form Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous)
in 2 mL with solvent
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
AS-Docetaxel
YA
MP
C3888 C3892 C3916 C3956 C4078 C4140 C4155 C4160
 
See Note 3
See Note 3
1
D(100)
[7]           Schedule 1, entry for Escitalopram in the form Tablet 10 mg (as oxalate)
omit from the column headed “Responsible Person” for the brand “Escicor 10”:           MI        substitute:             RA
[8]           Schedule 1, entry for Escitalopram in the form Tablet 20 mg (as oxalate)
omit from the column headed “Responsible Person” for the brand “Escicor 20”:           MI        substitute:             RA
[9]           Schedule 1, entry for Ibandronic acid
omit from the column headed “Responsible Person” (twice occurring):                                HH        substitute:             RO
[10]         Schedule 1, entry for Lamotrigine in the form Tablet 25 mg
omit from the column headed “Responsible Person” for the brand “Lamotrigine Aspen 25”:        AS        substitute:             FM
[11]         Schedule 1, entry for Lamotrigine in the form Tablet 100 mg
omit from the column headed “Responsible Person” for the brand “Lamotrigine Aspen 100”:      AS        substitute:             FM
[12]         Schedule 1, entry for Lamotrigine in the form Tablet 200 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Lamotrigine Aspen 200
FM
MP NP
C1426
 
56
5
56
 
 
[13]         Schedule 1, entry for Macrogol 3350
substitute:
Macrogol 3350
Sachets containing powder for oral solution 13.125 g with electrolytes, 30
Oral
Movicol
NE
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P3643
See Note 2
2
See Note 2
0
See Note 2
1
 
 

 
 
 
 
 
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P3642
See Note 2
2
See Note 2
3
See Note 2
1
 
 

 
 
 
 
 
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P1263 P1613 P2693 P2823
See Note 2
1
See Note 2
5
See Note 2
1
 
 

 
Sachets containing powder for oral solution 17 g, 30
Oral
MediHealth ClearLax
ON
MP NP
C4170 C4171 C4173 C4176 C4177 C4179 C4180
P4171 P4173 P4177 P4179 P4180
1
5
1
 
 

 
 
 
 
 
MP NP
C4170 C4171 C4173 C4176 C4177 C4179 C4180
P4170
2
0
1
 
 

 
 
 
 
 
MP NP
C4170 C4171 C4173 C4176 C4177 C4179 C4180
P4176
2
3
1
 
 

 
Powder for oral solution 510 g
Oral
MediHealth ClearLax
ON
MP NP
C4170 C4171 C4173 C4176 C4177 C4179 C4180
P4171 P4173 P4177 P4179 P4180
1
5
1
 
 

 
 
 
OsmoLax
KY
MP NP
C4170 C4171 C4173 C4176 C4177 C4179 C4180
P4171 P4173 P4177 P4179 P4180
1
5
1
 
 

 
 
 
MediHealth ClearLax
ON
MP NP
C4170 C4171 C4173 C4176 C4177 C4179 C4180
P4170
2
0
1
 
 

 
 
 
OsmoLax
KY
MP NP
C4170 C4171 C4173 C4176 C4177 C4179 C4180
P4170
2
0
1
 
 

 
 
 
MediHealth ClearLax
ON
MP NP
C4170 C4171 C4173 C4176 C4177 C4179 C4180
P4176
2
3
1
 
 

 
 
 
OsmoLax
KY
MP NP
C4170 C4171 C4173 C4176 C4177 C4179 C4180
P4176
2
3
1
 
 

[14]         Schedule 1, entry for Nevirapine in the form Tablet 200 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Nevirapine RBX
RA
MP
See Note 1
C3586 C3587 C3588 C3589
 
120
5
60
 
D(100)
[15]         Schedule 1, after entry for Prednisone in the form Tablet 25 mg [Sone]
insert:
Pregabalin
Capsule 25 mg
Oral
Lyrica
PF
MP NP
C4172
 
1
5
56
 

 
Capsule 75 mg
Oral
Lyrica
PF
MP NP
C4172
 
1
5
56
 
 

 
Capsule 150 mg
Oral
Lyrica
PF
MP NP
C4172
 
1
5
56
 
 

 
Capsule 300 mg
Oral
Lyrica
PF
MP NP
C4172
 
1
5
56
 
 

[16]         Schedule 1, entry for Ranitidine in the form Tablet 300 mg (as hydrochloride)
omit:
 
 
 
Ulcaid
RA
MP NP
 
30
5
30
 
 
[17]         Schedule 1, after entry for Testosterone in the form Transdermal patches 24.3 mg, 30
insert in the columns in the order indicated:
 
Transdermal solution (pump pack) 30 mg per 1.5 mL dose, 60 doses
Transdermal
Axiron
LY
MP
C1021 C1022 C1226
 
1
5
1
 
[18]         Schedule 1, entry for Venlafaxine in the form Capsule (modified release) 37.5 mg (as hydrochloride)
omit:
 
 
 
Venla RBX
RA
MP NP
C1211
 
28
0
28
 
[19]         Schedule 3, details relevant to Responsible person code CS
omit:       CSL Biotherapies Pty Ltd         substitute:             bioCSL (Australia) Pty Ltd
[20]         Schedule 4, Part 1, entry for Macrogol 3350
insert after existing text:

 
C4170
P4170
 
Constipation
Continuing treatment
Patient must be receiving palliative care
Compliance with Authority Required procedures - Streamlined Authority Code 4170

 
C4171
P4171
 
Constipation
Patient must have malignant neoplasia
Compliance with Authority Required procedures

 
C4173
P4173
 
Chronic constipation
The condition must be inadequately controlled with first line interventions such as bulk-forming agents
Compliance with Authority Required procedures

 
C4176
P4176
 
Constipation
Initial treatment
Patient must be receiving palliative care;
Patient must not receive more than 4 months treatment under this restriction
Compliance with Authority Required procedures - Streamlined Authority Code 4176

 
C4177
P4177
 
Faecal impaction
The condition must be inadequately controlled with first line interventions such as bulk-forming agents
Compliance with Authority Required procedures

 
C4179
P4179
 
Constipation
Patient must be receiving palliative care
Compliance with Authority Required procedures

 
C4180
P4180
 
Constipation
Patient must be paraplegic, quadriplegic or have severe neurogenic impairment of bowel function;
The condition must be unresponsive to other oral therapies
Compliance with Authority Required procedures

[21]         Schedule 4, Part 1, after entry for Prednisolone with Phenylephrine
insert:
Pregabalin
C4172
 
 
Neuropathic pain
The condition must be refractory to treatment with other drugs
Compliance with Authority Required procedures - Streamlined Authority Code 4172
 
 
 
 
 
 
 
 
 
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.comlaw.gov.au