Download F2014C01314 F2014C01314

Determination—Exempt items (PB 58 of 2007)
as amended
made under section 84AH of the
National Health Act 1953
Compilation start date:
1 October 2014
Includes amendments up to:
PB 77 of 2014
Prepared by the Office of Parliamentary Counsel, Canberra
About this compilation
This compilation
This is a compilation of the Determination—Exempt items (PB 58 of 2007) as in force on
1 October 2014. It includes any commenced amendment affecting the legislation to that date.
This compilation was prepared on 28 November 2014.
The notes at the end of this compilation (the endnotes) include information about amending
laws and the amendment history of each amended provision.
Uncommenced amendments
The effect of uncommenced amendments is not reflected in the text of the compiled law but
the text of the amendments is included in the endnotes.
Application, saving and transitional provisions for provisions and amendments
If the operation of a provision or amendment is affected by an application, saving or
transitional provision that is not included in this compilation, details are included in the
endnotes.
Modifications
If a provision of the compiled law is affected by a modification that is in force, details are
included in the endnotes.
Provisions ceasing to have effect
If a provision of the compiled law has expired or otherwise ceased to have effect in
accordance with a provision of the law, details are included in the endnotes.
Contents
1
2
Commencement .......................................................................................................... 1
Determination ............................................................................................................. 1
Schedule 1
2
Endnotes
4
Endnote 1—About the endnotes
4
Endnote 2—Abbreviation key
5
Endnote 3—Legislation history
6
Endnote 4—Amendment history
Endnote 5—Uncommenced amendments [none]
8
Endnote 6—Modifications [none]
9
Endnote 7—Misdescribed amendments [none]
9
Endnote 8—Miscellaneous [none]
9
Determination—Exempt items (PB 58 of 2007)
9
i
Section 1
Determination—Exempt items (PB 58 of 2007)
1 Commencement
This instrument commences on 1 August 2007.
2 Determination
A pharmaceutical item that has a listed drug in the form and with the manner of
administration mentioned in Schedule 1 is an exempt item.
Determination—Exempt items (PB 58 of 2007)
1
Schedule 1
Schedule 1
Listed Drug
Form (strength, type, size, etc.)
Manner of
administration
Amisulpride
Oral solution 100 mg per mL, 60 mL
Oral
Amoxycillin
Powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL
Oral
Artemether with
Tablet (dispersible) 20 mg-120 mg
Oral
Azithromycin
Powder for oral suspension 200 mg (as dihydrate) per 5 mL, 15mL
Oral
Atenolol
Oral solution 50 mg in 10 mL, 300 mL
Oral
Baclofen
Intrathecal injection 10mg in 5mL
Injection
Captopril
Oral solution 5 mg per mL, 95 mL
Oral
Carbamazepine
Oral suspension 100 mg per 5 mL, 300 mL
Oral
Ciprofloxacin
Ear drops 3 mg (as hydrochloride) per mL, 5 mL
Application to the ear
Clarithromycin
Powder for oral liquid 250 mg per 5 mL, 50 mL
Oral
Clonazepam
Oral liquid 2.5 mg per mL, 10 mL
Oral
Clonazepam
Injection 1 mg in 2 mL (set containing solution 1 mg in 1 mL and 1 mL
Injection
Lumefantrine
diluent)
Clozapine
Oral liquid 50 mg per mL, 100 mL
Oral
Cefuroxime
Powder for oral suspension 125 mg (as axetil) per 5 mL, 70 mL
Oral
Cyclosporin
Oral liquid 100 mg per mL, 50 mL
Oral
Cyclosporin
Capsule 10 mg
Oral
Cyclosporin
Solution concentrate for I.V. infusion 50 mg in 1 mL
Injection
Diazepam
Injection 10 mg in 2mL
Injection
Diazepam
Oral liquid 1 mg in 1 mL, 100 mL
Oral
Diclofenac
Suppository containing diclofenac sodium 100 mg
Rectal
Digoxin
Paediatric oral solution 50 micrograms per mL, 60 mL
Oral
Efavirenz
Oral solution 30 mg per mL, 180 mL
Oral
Erythromycin
Powder for I.V. infusion 1 g (as lactobionate)
Injection
Escitalopram
Oral solution 10 mg (as oxalate) per mL, 28 mL
Oral
Fluconazole
Powder for oral suspension 50 mg in 5 mL, 35 mL
Oral
Frusemide
Oral solution 10 mg per mL, 30 mL
Oral
Glyceryl Trinitrate
Sublingual spray (pump pack) 400 micrograms per dose, 200 doses
Sublingual
Hydrocortisone
Tablet 4 mg
Oral
Indomethacin
Suppository 100 mg
Rectal
Ketoprofen
Suppository 100 mg
Rectal
Levetiracetam
Oral solution, 100 mg per mL, 300 mL
Oral
Levodopa with Carbidopa
Tablet 200 mg-50 mg (anhydrous) (modified release)
Oral
Methadone
Oral liquid containing methadone hydrochloride 25 mg per 5mL, 200 mL
Oral
Methadone
Injection containing methadone hydrochloride 10 mg in 1 mL
Injection
Metronidazole
Suppositories 500 mg, 10
Rectal
Metronidazole
Oral suspension containing metronidazole benzoate 320 mg per 5 mL,
Oral
100 mL
Mycophenolic Acid
Powder for oral suspension containing mycophenolate mofetil 1 g per 5 mL,
Oral
165 mL
Naproxen
Oral suspension 125 mg per 5mL, 474 mL
Oral
Nevirapine
Oral suspension 50 mg (as hemihydrate) per 5 mL, 240 mL
Oral
Oestradiol
Vaginal tablets 25 micrograms, 15
Vaginal
2
Determination—Exempt items (PB 58 of 2007)
Schedule 1
Schedule 1
Listed Drug
Form (strength, type, size, etc.)
Manner of
administration
Ondansetron
Syrup, 4 mg (as hydrochloride dihydrate) per 5 mL, 50mL
Oral
Oxycodone
Oral solution containing oxycodone hydrochloride 5 mg per 5 mL, 250 mL
Oral
Pantoprazole
Sachet containing granules 40 mg (as sodium sesquihydrate)
Oral
Paracetamol
Oral liquid 120 mg per 5 mL, 100 mL
Oral
Paracetamol
Oral liquid 240 mg per 5 mL, 200 mL
Oral
Paracetamol
Tablet 665 mg (modified release)
Oral
Paracetamol
Suppositories 500 mg, 24
Rectal
Prochlorperazine
Suppositories containing prochlorperazine equivalent to 25 mg
Rectal
prochlorperazine maleate, 5
Prochlorperazine
Injection containing prochlorperazine mesylate 12.5 mg in 1 mL
Injection
Ranitidine
Syrup 150 mg (as hydrochloride) per 10 mL, 300 mL
Oral
Risperidone
Oral solution 1mg per mL, 100 mL
Oral
Roxithromycin
Tablet for oral suspension 50 mg
Oral
Salbutamol
Oral solution 2 mg (as sulfate) per 5 mL, 150 mL
Oral
Salbutamol
Pressurised inhalation in breath actuated device 100 micrograms (as sulfate)
Inhalation by mouth
per dose, 200 doses (CFC-free formulation)
Terbinafine
Cream containing terbinafine hydrochloride 10 mg per g, 15 g
Application
Tramadol
Oral drops containing tramadol hydrochloride 100 mg per mL, 10 mL
Oral
Valganciclovir
Powder for oral solution 50 mg (as hydrochloride) per mL, 100 mL
Oral
Valproic Acid
Tablet, crushable, containing sodium valproate 100 mg
Oral
Valproic Acid
Oral liquid containing sodium valproate 200 mg per 5mL, 300 mL
Oral
Valproic Acid
Oral solution containing sodium valproate 200 mg per 5mL, 300 mL
Oral
Determination—Exempt items (PB 58 of 2007)
3
Endnotes
Endnote 1—About the endnotes
Endnotes
Endnote 1—About the endnotes
The endnotes provide details of the history of this legislation and its provisions. The
following endnotes are included in each compilation:
Endnote 1—About the endnotes
Endnote 2—Abbreviation key
Endnote 3—Legislation history
Endnote 4—Amendment history
Endnote 5—Uncommenced amendments
Endnote 6—Modifications
Endnote 7—Misdescribed amendments
Endnote 8—Miscellaneous
If there is no information under a particular endnote, the word “none” will appear in square
brackets after the endnote heading.
Abbreviation key—Endnote 2
The abbreviation key in this endnote sets out abbreviations that may be used in the endnotes.
Legislation history and amendment history—Endnotes 3 and 4
Amending laws are annotated in the legislation history and amendment history.
The legislation history in endnote 3 provides information about each law that has amended the
compiled law. The information includes commencement information for amending laws and
details of application, saving or transitional provisions that are not included in this
compilation.
The amendment history in endnote 4 provides information about amendments at the provision
level. It also includes information about any provisions that have expired or otherwise ceased
to have effect in accordance with a provision of the compiled law.
Uncommenced amendments—Endnote 5
The effect of uncommenced amendments is not reflected in the text of the compiled law but
the text of the amendments is included in endnote 5.
Modifications—Endnote 6
If the compiled law is affected by a modification that is in force, details of the modification
are included in endnote 6.
Misdescribed amendments—Endnote 7
An amendment is a misdescribed amendment if the effect of the amendment cannot be
incorporated into the text of the compilation. Any misdescribed amendment is included in
endnote 7.
Miscellaneous—Endnote 8
Endnote 8 includes any additional information that may be helpful for a reader of the
compilation.
4
Determination—Exempt items (PB 58 of 2007)
Endnotes
Endnote 2—Abbreviation key
Endnote 2—Abbreviation key
ad = added or inserted
pres = present
am = amended
prev = previous
c = clause(s)
(prev) = previously
Ch = Chapter(s)
Pt = Part(s)
def = definition(s)
r = regulation(s)/rule(s)
Dict = Dictionary
Reg = Regulation/Regulations
disallowed = disallowed by Parliament
reloc = relocated
Div = Division(s)
renum = renumbered
exp = expired or ceased to have effect
rep = repealed
hdg = heading(s)
rs = repealed and substituted
LI = Legislative Instrument
s = section(s)
LIA = Legislative Instruments Act 2003
Sch = Schedule(s)
mod = modified/modification
Sdiv = Subdivision(s)
No = Number(s)
SLI = Select Legislative Instrument
o = order(s)
SR = Statutory Rules
Ord = Ordinance
Sub-Ch = Sub-Chapter(s)
orig = original
SubPt = Subpart(s)
par = paragraph(s)/subparagraph(s)
/sub-subparagraph(s)
Determination—Exempt items (PB 58 of 2007)
5
Endnotes
Endnote 3—Legislation history
Endnote 3—Legislation history
6
Name
FRLI registration
Commencement
PB 58 of 2007
31 July 2007
(F2007L02404)
1 Aug 2007
PB 67 of 2007
23 Aug 2007
(F2007L02638)
1 Sept 2007
—
PB 96 of 2007
16 Nov 2007
(F2007L04368)
1 Dec 2007
—
PB 21 of 2008
15 Jan 2008
(F2008L00043)
1 Feb 2008
—
PB 69 of 2008
10 June 2008
(F2008L02060)
1 July 2008
—
PB 73 of 2008
2 July 2008
(F2008L02302)
(a)
—
PB 84 of 2008
25 July 2008
(F2008L02623)
1 Aug 2008
—
PB 112 of 2008
11 Nov 2008
(F2008L04304)
(b)
—
PB 60 of 2009
10 July 2009
(F2009L02722)
31 July 2009
—
PB 79 of 2009
17 Aug 2009
(F2009L03147)
1 Sept 2009
—
PB 26 of 2010
22 Apr 2010
(F2010L01008)
1 May 2010
—
PB 77 of 2010
19 July 2010
(F2010L02088)
1 Aug 2010
—
PB 100 of 2010
29 Oct 2010
(F2010L02859)
1 Nov 2010
—
PB 7 of 2011
19 Jan 2011
(F2011L00130)
20 Jan 2011
—
PB 10 of 2011
20 Jan 2011
(F2011L00137)
21 Jan 2011
—
PB 45 of 2011
23 June 2011
(F2011L01207)
1 July 2011
—
PB 61 of 2011
30 Aug 2011
(F2011L01768)
1 Sept 2011
—
PB 91 of 2011
30 Nov 2011
(F2011L02497)
1 Dec 2011
—
PB 11 of 2012
21 Feb 2012
(F2012L00344)
1 Mar 2012
—
PB 54 of 2012
30 July 2012
(F2012L01623)
1 Aug 2012
—
Determination—Exempt items (PB 58 of 2007)
Application, saving
and transitional
provisions
Endnotes
Endnote 3—Legislation history
Name
FRLI registration
Commencement
Application, saving
and transitional
provisions
PB 103 of 2012
29 Nov 2012
(F2012L02285)
1 Dec 2012
—
PB 65 of 2013
18 Sept 2013
(F2013L01706)
1 Oct 2013 (s 2)
—
PB 7 of 2014
15 Jan 2014
(F2014L00064)
1 Feb 2014 (s 2)
—
PB 33 of 2014
15 Apr 2014
(F2014L00412)
1 May 2014 (s 2)
—
PB 65 of 2014
29 Aug 2014
(F2014L01175)
1 Sept 2014 (s 2)
—
PB 77 of 2014
30 Sept 2014
(F2014L01305)
1 Oct 2014 (s 2)
—
(a)
Section 1 of PB 73 of 2008 provides as follows:
1. Commencement
This instrument commences immediately following the commencement of the
following instruments:
a) the Amendment to Special Arrangements made under subsection 100(1) of the
National Health Act 1953 for the Highly Specialised Drugs Program - being amending
instrument number PB 72 of 2008;
b) the Amendment to the instrument that makes Determinations under sections 85,
85A and 88 of the National Health Act 1953 – being amending instrument number PB
70 of 2008.
Note: Both of the amending instruments mentioned in a) and b) above are expressed to
commence at 11.59pm on 31 July 2008. It is intended that this instrument commence
immediately after that time and before the expiration of 31 July 2008.
(b)
Section 1 of PB 112 of 2008 provides as follows:
1. Commencement
This instrument commences immediately following the commencement of the
following instruments:
a) the Amendment to the Declarations made under sections 85(2) and 85(2AA)
and amendment determination under subsection 85(2A) of the National Health Act
1953 – being amending instrument number PB 108 of 2008;
b) the Amendment to Determinations made under sections 85, 85A and 88 of the
National Health Act 1953 – being amending instrument number PB 109 of 2008.
Note: Both of the amending instruments mentioned in a) and b) above are expressed to
commence at 11.59 pm on 30 November 2008. It is intended that this instrument commence
immediately after that time and before the expiration of 30 November 2008.
Determination—Exempt items (PB 58 of 2007)
7
Endnotes
Endnote 4—Amendment history
Endnote 4—Amendment history
Provision affected
How affected
Schedule 1
Schedule 1 .....................................
am. PB 67 and 96 of 2007; PB 21, 69, 73, 84 and 112 of 2008; PB 60 and 79 of 2009; PB 26,
77 and 100 of 2010; PB 7, 10, 45, 61 and 91 of 2011; PB 11, 54 and 103 of 2012; PB 65 of
2013; PB 7, 33, 65 and 77 of 2014
8
Determination—Exempt items (PB 58 of 2007)
Endnotes
Endnote 5—Uncommenced amendments [none]
Endnote 5—Uncommenced amendments [none]
Endnote 6—Modifications [none]
Endnote 7—Misdescribed amendments [none]
Endnote 8—Miscellaneous [none]
Determination—Exempt items (PB 58 of 2007)
9