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Therapeutic Goods (Medicines Watch List) Determination 2018

made under subsection 30EJ(1) of the

Therapeutic Goods Act 1989

Compilation No. 1

Compilation date: 7 March 2025

Includes amendments: F2025L00296

About this compilation

This compilation

This is a compilation of the Therapeutic Goods (Medicines Watch List) Determination 2018 that shows the text of the law as amended and in force on 7 March 2025 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the Register for the compiled law.

Self‑repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

 

 

 

1  Name

3  Authority

4  Definitions

5  Medicines Watch List

Schedule 1—Medicines Watch List

Endnotes

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

 

  This instrument is the Therapeutic Goods (Medicines Watch List) Determination 2018.

  This instrument is made under subsection 30EJ(1) of the Act.

Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:

(a) medicine;

(b) reportable medicine.

  In this instrument:

Act means the Therapeutic Goods Act 1989.

IV or intravenous, in relation to a medicine, means the route of administration that is delivered within or into a vein.

ml means millilitre.

mmol means millimole.

PO or per oral, in relation to a medicine, means the route of administration that is taken through the mouth into the gastrointestinal system or administered to the oral cavity to obtain a local or systemic effect.

  The medicines set out in Schedule 1, being reportable medicines, are determined for the purposes of subsections 30EF(2) and 30EG(2) of the Act.


(section 5)

Column 1

Item

Column 2

Medicine

1

medicines that contain any of the following antimicrobial agents:

(a) aciclovir IV

(b) amikacin

(c) amphotericin B IV (liposomal)

(d) ampicillin

(e) benzylpenicillin

(f) cefepime

(g) chloramphenicol IV

(h) ciprofloxacin IV

(i) colistin

(j) ethambutol

(k) ganciclovir

(l) gentamicin IV

(m) isoniazid

(n) metronidazole IV

(o) phenoxymethylpenicillin

(p) piperacillin and tazobactam

(q) rifampicin PO or IV

(r) sodium fusidate PO or IV

(s) trimethoprim and sulfamethoxazole IV

(t) vancomycin

(u)  voriconazole IV

2

medicines that are, or contain, any of the following antidotes or treatments for poisonings:

(a) activated charcoal

(b) desferrioxamine injection

(c) digoxin specific antibodies

(d) edetate calcium disodium injection

(e) ethanol injection

(f) folinic acid (calcium folinate) injection

(g) fomepizole

(h) methylene blue IV

(i)  n-acetylcysteine IV

(j) pralidoxime

(k) sodium nitrite IV

(l)   sodium thiosulfate IV

3

medicines for emergency or critical care that contain any of the following:

(a) adrenaline IV

(b) alteplase

(c) amiodarone IV

(d)       argipressin (vasopressin)

(e) calcium gluconate gel

(f) calcium gluconate injection

(g) cyproheptadine

(h) danaparoid

(i) dantrolene injection

(j) desmopressin IV

(k) dexamethasone IV

(l) diazepam IV

(m) glucagon injection

(n) glyceryl trinitrate IV

(o) hydralazine IV

(p) hydrocortisone IV

(q) isoprenaline

(r) mesna

(s) morphine IV

(t) methoxyflurane

(u) metoprolol IV

(v) neostigmine

(w) nimodipine PO or IV

(x) noradrenaline

(y) phenytoin IV

(z) phosphate IV

(za) prednisolone PO

(zb)  protamine

(zc)  pyridostigmine

(zd)  quinine injection

(ze)  rasburicase

(zf)  salbutamol IV

(zg)  sodium bicarbonate 100mmol per 100ml injection

(zh)  sodium polystyrene sulfonate

(zi) suxamethonium

(zj) terlipressin

(zk)  tenecteplase

(zl)  thiamine IV

(zm)  vitamin K (phytomenadione) IV

4

medicines that contain any of the following anticoagulants:

(a) enoxaparin

(b) heparin

(c) warfarin

5

medicines that are any of the following vaccines:

(a) a vaccine included in the National Immunisation Program Schedule, as in force or existing at 1 March 2025

(b) absorbed diphtheria tetanus vaccine

(c) bacillus calmette-guerin vaccine

6

medicines for use in obstetrics that contain any of the following:

(a) ergometrine

(b) magnesium sulfate IV

(c) misoprostol

7

medicines that are any of the following antivenoms:

(a) black snake antivenom

(b) box jellyfish antivenom

(c) brown snake antivenom

(d) death adder antivenom

(e) funnel web spider antivenom

(f) polyvalent snake antivenom

(g) red back spider antivenom

(h) sea snake antivenom

(i) stone fish antivenom

(j) taipan antivenom

(k) tiger snake antivenom

8

medicines that are any of the following:

(a) adrenaline autoinjector

(b) glyceryl trinitrate sublingual

(c) naloxone injection

(d) naloxone nasal spray

(e) salbutamol inhaler

 

 

 

The endnotes provide information about this compilation and the compiled law.

The following endnotes are included in every compilation:

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Abbreviation key—Endnote 2

The abbreviation key 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 (or will amend) the compiled law. The information includes commencement details for amending laws and details of any 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 (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.

Misdescribed amendments

A misdescribed amendment is an amendment that does not accurately describe how an amendment is to be made. If, despite the misdescription, the amendment can be given effect as intended, then the misdescribed amendment can be incorporated through an editorial change made under section 15V of the Legislation Act 2003.

If a misdescribed amendment cannot be given effect as intended, the amendment is not incorporated and “(md not incorp)” is added to the amendment history.

 

Endnote 2—Abbreviation key

 

ad = added or inserted

orig = original

am = amended

par = paragraph(s)/subparagraph(s)

amdt = amendment

/sub‑subparagraph(s)

c = clause(s)

pres = present

C[x] = Compilation No. x

prev = previous

Ch = Chapter(s)

(prev…) = previously

def = definition(s)

Pt = Part(s)

Dict = Dictionary

r = regulation(s)/rule(s)

disallowed = disallowed by Parliament

reloc = relocated

Div = Division(s)

renum = renumbered

exp = expires/expired or ceases/ceased to have

rep = repealed

effect

rs = repealed and substituted

F = Federal Register of Legislation

s = section(s)/subsection(s)

gaz = gazette

Sch = Schedule(s)

LA = Legislation Act 2003

Sdiv = Subdivision(s)

LIA = Legislative Instruments Act 2003

SLI = Select Legislative Instrument

(md not incorp) = misdescribed amendment

SR = Statutory Rules

cannot be given effect

Sub‑Ch = Sub‑Chapter(s)

mod = modified/modification

SubPt = Subpart(s)

No. = Number(s)

underlining = whole or part not

o = order(s)

commenced or to be commenced

Ord = Ordinance

 

 

 

Name

Registration

Commencement

Application, saving and transitional provisions

Therapeutic Goods (Medicines Watch List) Determination 2018

7 Dec 2018 (F2018L01679)

1 Jan 2019

—

Therapeutic Goods (Medicines Watch List) Amendment Determination 2025

6 Mar 2025 (F2025L00296)

7 Mar 2025

—

 

 

Provision affected

How affected

s 2………………………………..

rep LA s 48D

Schedule 1……………………….

am F2025L00296