Commonwealth Coat of Arms of Australia

 

Therapeutic Goods (Medicines and OTG—Authorised Supply) Rules 2022

made under subsection 19(7A) of the

Therapeutic Goods Act 1989

Compilation No. 5

Compilation date: 21 August 2025

Includes amendments: F2025L00947

About this compilation

This compilation

This is a compilation of the Therapeutic Goods (Medicines and OTG—Authorised Supply) Rules 2022 that shows the text of the law as amended and in force on 21 August 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. The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. Any uncommenced amendments affecting the law are accessible on the Register (www.legislation.gov.au).

Application, saving and transitional provisions

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. Any modifications affecting the law are accessible on the Register.

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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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

5A  Authorisation—therapeutic vaping goods

Schedule 1—Medicines authorised for supply

Schedule 1A—Therapeutic vaping goods

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 and OTG—Authorised Supply) Rules 2022.

  This instrument is made under subsection 19(7A) of the Therapeutic Goods Act 1989.

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

(a) health practitioner;

(b) listed goods;

(c) medicine;

(d) Register;

(e) registered goods;

(f) sponsor;

(g) supply;

(h) therapeutic goods.

  In this instrument:

Act means the Therapeutic Goods Act 1989.

active ingredient has the same meaning as in the Regulations.

nurse practitioner means a person who is:

 (a) registered under a law of a state or internal territory as a registered nurse; and

 (b) endorsed as a nurse practitioner by the Nursing and Midwifery Board of Australia.

Note: The Nursing and Midwifery Board of Australia works in partnership with the Australian Health Practitioner Regulation Agency.

Regulations means the Therapeutic Goods Regulations 1990.

  SAS Guidance means the document titled Special Access Scheme (SAS): Guidance for health practitioners accessing unapproved therapeutic goods (Version 3.0, October 2024) published by the Therapeutic Goods Administration, as in force or existing on 1 October 2024.

Note: The SAS Guidance is published at www.tga.gov.au.

Therapeutic Goods Administration has the same meaning as in the Therapeutic Goods Regulations 1990.

therapeutic vaping kit has the same meaning as in the Regulations.

therapeutic vaping pack has the same meaning as in Regulations.

therapeutic vaping substance has the same meaning as in the Regulations.

Supply by a medical practitioner

 (1) A health practitioner who is a medical practitioner is authorised to supply a medicine to a patient of that practitioner where:

 (a) the medicine contains an active ingredient specified in column 2 of an item in the table in Schedule 1 and does not contain any other active ingredient; and

 (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and

 (c) the medicine is in the dosage form specified in column 3 of that item; and

 (d) the medicine is to be administered by the route specified in column 4 of that item; and

 (e) the supply is for the indication specified in column 5 of that item; and

 (f) the conditions specified in subsection (2) are satisfied.

 (2) The medical practitioner must:

 (a)  inform the patient, or a parent or guardian of the patient, that the medicine is not a listed good or registered good; and

 (b)  obtain informed consent from the patient, or a parent or guardian of the patient, in relation to, and before, the supply of the medicine; and

 (c)  supply the medicine in accordance with good medical practice; and

 (d)  if the medical practitioner becomes aware that the patient has suffered an adverse event in relation to the medicine—notify the Therapeutic Goods Administration and the sponsor of the medicine about the adverse event in accordance with the reporting guidelines set out in the SAS Guidance; and

 (e)  if the medical practitioner becomes aware of a defect in the medicine—notify the Therapeutic Goods Administration and the sponsor of the medicine in accordance with the reporting guidelines set out in the SAS Guidance.

Supply to a patient of a medical practitioner

 (3) A health practitioner is authorised to supply a medicine to a patient of a medical practitioner (the treating practitioner) where:

 (a)  the medicine contains an active ingredient specified in column 2 of an item in the table in Schedule 1 and does not contain any other active ingredient; and

 (b)  the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and

 (c)  the supply is requested by the treating practitioner; and

 (d)  the medicine is in the dosage form specified in column 3 of that item; and

 (e)  the medicine is to be administered by the route specified in column 4 of that item; and

 (f)  the supply is for the indication specified in column 5 of that item; and

 (g)  the conditions specified in subsection (4) are satisfied.

 (4) The health practitioner supplying the medicine must:

 (a)  if the health practitioner becomes aware that the patient has suffered an adverse event in relation to the medicine—notify the Therapeutic Goods Administration and the sponsor of the medicine about the adverse event in accordance with the reporting guidelines set out in the SAS Guidance; and

 (b)  if the health practitioner becomes aware of a defect in the medicine—notify the Therapeutic Goods Administration and the sponsor of the medicine in accordance with the reporting guidelines set out in the SAS Guidance.

Supply by a medical practitioner or nurse practitioner

 (1) A health practitioner who is a medical practitioner or a nurse practitioner is authorised to supply a therapeutic good to a patient of that practitioner where:

 (a) the therapeutic good is within the class of therapeutic goods specified in column 2 of an item in the table in Schedule 1A; and

 (b) the therapeutic good is in the dosage form specified in column 3 of that item; and

 (c) the therapeutic good is to be administered by the route specified in column 4 of that item; and

 (d) the supply is for the indication specified in column 5 of that item; and

 (e) the supply is to a patient who is 16 years of age or over; and

 (f) the conditions specified in subsection (2) are satisfied.

 (2) The medical practitioner or nurse practitioner must:

 (a) inform the patient, or a parent or a guardian of the patient, that the therapeutic good is not a listed good or registered good; and

 (b) obtain informed consent from the patient, or a parent or a guardian of the patient, in relation to, and before, the supply of the therapeutic good; and

 (c) supply the therapeutic good in accordance with good medical practice or good nursing practice (as the case requires); and

 (d) if the medical practitioner or nurse practitioner becomes aware that the patient has suffered an adverse event in relation to the therapeutic good—notify the Therapeutic Goods Administration and the sponsor of the therapeutic good about the adverse event in accordance with the reporting guidelines set out in the SAS Guidance; and

 (e) if the medical practitioner or nurse practitioner becomes aware of a defect in the therapeutic good—notify the Therapeutic Goods Administration and the sponsor of the therapeutic good in accordance with the reporting guidelines set out in the SAS Guidance.

Supply by a pharmacist—with prescription

 (3) A pharmacist is authorised to supply a therapeutic good to a patient of a medical practitioner or a nurse practitioner (the treating practitioner) where:

 (a) the therapeutic good is within the class of therapeutic goods specified in column 2 of an item in the table in Schedule 1A; and

 (b) the supply is requested by the treating practitioner; and

 (c) the therapeutic good is in the dosage form specified in column 3 of that item; and

 (d) the therapeutic good is to be administered by the route specified in column 4 of that item; and

 (e) the supply is for the indication specified in column 5 of that item; and

 (f) the supply is to a patient who is 16 years of age or over; and

 (g) the conditions specified in subsection (4) are satisfied.

 (4) The pharmacist supplying the therapeutic good must:

 (a) if the pharmacist becomes aware that the patient has suffered an adverse event in relation to the therapeutic good—notify the Therapeutic Goods Administration and the sponsor of the therapeutic good about the adverse event in accordance with the reporting guidelines set out in the SAS Guidance; and

 (b) if the pharmacist becomes aware of a defect in the therapeutic good—notify the Therapeutic Goods Administration and the sponsor of the therapeutic good in accordance with the reporting guidelines set out in the SAS Guidance.

Supply by a pharmacist—without prescription

 (5) A pharmacist is authorised to supply a therapeutic good to a patient where:

 (a) the therapeutic good is within the class of therapeutic goods specified in column 2 of an item in the table in Schedule 1A; and

 (b) the therapeutic good is in the dosage form specified in column 3 of that item; and

 (c) the therapeutic good is to be administered by the route specified in column 4 of that item; and

 (d) the supply is for the indication specified in column 5 of that item; and

 (e) the supply is to a patient who is 18 years of age or over; and

 (f) the pharmacist requests and sights evidence of the patient’s identity and age; and

 (g) the quantity of the goods does not exceed the quantity that is reasonably required for a patient’s therapeutic use for 1 month and that quantity is supplied to the patient only once in a month; and

 (h) the concentration of nicotine in the goods does not exceed 20 mg/mL; and

 (i) the conditions specified in subsections (6) and (7) are satisfied.

 (6) The pharmacist must:

 (a) inform the patient, or a parent or a guardian of the patient, that the therapeutic good is not a listed good or registered good; and

 (b) obtain informed consent from the patient, or a parent or a guardian of the patient, in relation to, and before, the supply of the therapeutic good; and

 (c) supply the therapeutic good in accordance with good pharmacy practice; and

 (d) provide professional advice to the patient on alternative cessation supports and therapies, appropriate dose and frequency depending on age, weight and severity of condition, length of treatment, suitable titration, and interactions with other medicines; and

 (e) provide contact details about smoking cessation support services to the patient; and

 (f) if the pharmacist becomes aware that the patient has suffered an adverse event in relation to the therapeutic good—notify the Therapeutic Goods Administration and the sponsor of the therapeutic good about the adverse event in accordance with the reporting guidelines set out in the SAS Guidance; and

 (g) if the pharmacist becomes aware of a defect in the therapeutic good—notify the Therapeutic Goods Administration and the sponsor of the therapeutic good in accordance with the reporting guidelines set out in the SAS Guidance.

 (7) The pharmacist must store the therapeutic good in a part of the pharmacy premises to which the public does not have access.


Note: See section 5.

Specified therapeutic goods

Column 1

Column 2

Column 3

Column 4

Column 5

Item

Active ingredient

Dosage form

Route of administration

Indication

1

allergens—multiple, various (including control solutions)

drops

intradermal

confirmation of suspected allergic reactions

2

allergens – multiple, various (including control solutions)

drops

skin prick

confirmation of suspected allergic reactions

3

amiloride

tablet

oral

treatment of hypokalemia

4

betaxolol 0.25%
(preservative free)

eye drops

ophthalmic

treatment of elevated intraocular pressure where other treatments are inappropriate

5

bismuth subcitrate

tablet

oral

treatment of resistant Helicobacter Pylori infection

6

buspirone

tablet

oral

treatment of generalised anxiety disorders

7

calcitriol

liquid

oral

prevention of hypophosphatemic rickets in children; or

treatment of hypoparathyroidism (with severe hypocalcaemia)

8

carbidopa

tablet

oral

premedication for F18 DOPA imaging

9

ciclosporin, 0.05%

eye drops, emulsion

ophthalmic

treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)

10

cinnarizine

tablet

oral

treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease)

11

clobetasol propionate 0.05%

cream

topical

treatment, or prolongation of flarefree intervals, of dermatitis/eczema where other treatments have failed

12

clobetasol propionate 0.05%

lotion

topical

treatment, or prolongation of flarefree intervals, of dermatitis/eczema where other treatments have failed

13

clobetasol propionate 0.05%

ointment

topical

treatment, or prolongation of flarefree intervals, of dermatitis/eczema where other treatments have failed

14

clofazimine

capsule

oral

treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed mycobacterium avium paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, nontuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist

15

colecalciferol

capsule

oral

treatment of severe vitamin D deficiency and prevention of osteoporosis

16

colecalciferol

injection

intramuscular

treatment of severe vitamin D deficiency and prevention of osteoporosis

17

cyclopentolate, 0.2%, and phenylephrine, 1%

eye drops

ophthalmic

production of mydriasis

18

deflazacort

tablet

oral

treatment of Duchenne muscular dystrophy

19

dehydrated ethanol (alcohol) 96% 100%

ampoule

topical

treatment of progressive keratoconus and intraoperative use in superficial keratectomy (single use per procedure)

20

dexamethasone (preservative free)

eye drops

ophthalmic

treatment of inflammatory conditions of the eye that are noninfected and steroid responsive in patients sensitive to preservativecontaining formulations

21

diazoxide

capsule

oral

treatment of hypoglycaemia, hyperinsulinaemia, BeckwithWeiderman Syndrome or insulinoma

22

diazoxide

suspension

oral

treatment of hypoglycaemia, hyperinsulinaemia, BeckwithWeiderman Syndrome or insulinoma

23

diazoxide

tablet

oral

treatment of hypoglycaemia, hyperinsulinaemia, BeckwithWeiderman Syndrome or insulinoma

24

diflunisal

tablet

oral

treatment of amyloidosis

25

dimethyl sulfoxide (DMSO)

solution

intravesical

symptomatic relief of interstitial cystitis

27

doxycycline

injection

intralesional

sclerotherapy of lymphatic malformations

27A

escherichia coli/klebsiella pneumoniae/enterococcus faecalis/proteus vulgaris

spray

sublingual

management of recurrent urinary tract infections

28

F18 DCFPyl (PSMA)

injection

intravenous

prostate cancer imaging study

29

F18 myocardial perfusion tracer (18F flurpiridaz)

injection

intravenous

myocardial perfusion study

30

F18 NaF (sodium fluoride)

injection

intravenous

bone study

31

flunarizine

capsule

oral

treatment of vestibular disorders or prophylactic treatment of migraine

32

flunarizine

tablet

oral

treatment of vestibular disorders or prophylactic treatment of migraine

33

furazolidone

tablet

oral

treatment of resistant Helicobacter Pylori infection

33A

gallium-68 DOTA (Tyr3) octreotate

injection

intravenous

PET imaging for localisation of somatostatin receptor positive neuroendocrine tumours (NETs)

34

gallium-68 (Ga-68)

aerosol

inhalation

lung ventilation study

35

gallium68 (Ga68) - MAA

injection

intravenous

lung perfusion study

37

ganciclovir

gel

ophthalmic

treatment of cytomegalovirus

38

glycopyrronium bromide

tablet

oral

treatment of excessive salivation in patients with neurological conditions

39

hyoscine hydrobromide

patch

transdermal

treatment of excessive salivation

40

hypertonic sodium chloride, 5%

eye drops

ophthalmic

temporary relief of corneal oedema (hypertonicity)

41

hypertonic sodium chloride, 5%

eye ointment

ophthalmic

temporary relief of corneal oedema (hypertonicity)

42

iloprost

injection

intravenous infusion

treatment of patients with severe disabling Raynaud’s phenomenon; or

treatment of peripheral ischaemia

42A

imipenem/cilastatin

injection

intravenous

treatment of non-tuberculosis mycobacteria

43

indigo carmine

injection

intravenous

intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures

44

indocyanine green dye

injection

intravenous

intraoperative diagnostic use

45

interferon alpha-2b

eye drops

ophthalmic

treatment of ocular surface squamous neoplasia

45A

isoniazid/rifampicin

dispersible tablets

oral

treatment of latent tuberculosis infection

45B

isoniazid/rifampicin

tablets

oral

treatment of latent tuberculosis infection

45C

isoniazid/rifapentine

tablets

oral

treatment of latent tuberculosis infection

46

ketotifen

tablet

oral

treatment of allergic conditions

47

levofloxacin

tablet

oral

treatment of resistant Helicobacter Pylori infection or drug resistant tuberculosis

48

levomepromazine

injection

subcutaneous

treatment of nausea and vomiting or agitation

49

levomepromazine

tablet

oral

treatment of nausea and vomiting or agitation

50

lifitegrast

eye drops

ophthalmic

treatment of dry eye disease

53

melatonin

lozenge

oral

treatment of sleep disorders

55

metolazone

tablet

oral

treatment of fluid overload

56

mexiletine

capsule

oral

treatment of ventricular arrhythmia or myotonic disorders

57

mexiletine

tablet

oral

treatment of ventricular arrhythmia or myotonic disorders

58

moxifloxacin 0.5%

eye drops

ophthalmic

treatment of refractory bacterial conjunctivitis

58A

mycobacterium bovis (bacillus calmette and guerin (BCG) strain)

injection

intradermal

immunisation against tuberculosis

59

nadolol

tablet

oral

treatment of ventricular tachycardia or long QT Syndrome

60

natamycin 5%

eye drops

ophthalmic

treatment of refractory fungal blepharitis, conjunctivitis or keratitis

61

neomycin

tablet

oral

sepsis prevention for colorectal operation

62

nitazoxanide

suspension

oral

treatment of giardiasis, cryptosporidiosis or blastocystis

63

nitazoxanide

tablet

oral

treatment of giardiasis, cryptosporidiosis or blastocystis

64

paromomycin

capsule

oral

antiprotozoal treatment of any of the following amoebic infections:

(a) blastocystis hominis;

(b) dientomoeba fragilis;

(c) entamoeba histolytica;

(d) parasite infection

65

pimozide

tablet

oral

treatment of schizophrenia, chronic psychosis or Tourette syndrome

66

pristinamycin

tablet

oral

treatment of confirmed methicillinresistant Staphylococcus aureus or vancomycinresistant enterococci infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or

treatment of refractory or resistant mycoplasma genitalium infections; or

treatment of other infections as prescribed by an infectious disease specialist

69

pyrazinamide

tablet

oral

treatment of tuberculosis

70

riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)

eye drops

ophthalmic

intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus

71

riboflavin, 0.1% in 20% dextran

eye drops

ophthalmic

intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus

72

riboflavin, 0.1% in sodium chloride

eye drops

ophthalmic

intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus

73

riboflavin, 0.22% in sodium chloride

eye drops

ophthalmic

intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus

74

ripasudil 0.4%

eye drops

ophthalmic

treatment of refractory corneal oedema or refractory glaucoma

75

sodium benzoate

tablet

oral

treatment of urea cycle disorders

76

tacrolimus 0.03%

ointment

topical

treatment, or prolongation of flarefree intervals, of moderate to severe atopic dermatitis/eczema in children

77

tacrolimus 0.1%

ointment

topical

treatment, or prolongation of flarefree intervals, of moderate to severe atopic dermatitis/eczema in adults

78

technetium-99m (99m Tc) prostate specific membrane antigen (PSMA)-I&S

injection

intravenous

prostate cancer imaging study

79

tetracycline

capsule

oral

treatment of resistant Helicobacter Pylori infection

80

tetracycline

tablet

oral

treatment of resistant Helicobacter Pylori infection

81

tickborne encephalitis vaccine

injection

intramuscular

prevention of tickborne encephalitis

82

tinidazole

tablet

oral

treatment of trichomonas vaginalis infections of the genitourinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or

treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or

prevention of infection of the surgical site

83

tizanidine

capsule

oral

treatment of spasticity where other treatments have failed

84

tizanidine

tablet

oral

treatment of spasticity where other treatments have failed

85

triamcinolone acetonide

suspension for injection

ophthalmic

treatment of noninfectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or postoperative macular oedema (cataract surgery)

86

verteporfin

powder for injection

intravenous infusion

photosensitisation for photodynamic therapy

87

yttrium90 (Y90) citrate

injection

intraarticular

radiosynovectomy treatment

Note: See section 5A.

Specified therapeutic goods

Column 1

Column 2

Column 3

Column 4

Column 5

Item

Class of therapeutic goods

Dosage form

Route of administration

Indication

1

therapeutic vaping substances or therapeutic vaping substance accessories that:

(a) contain nicotine as the only active ingredient;

(b) are the subject of a notification under item 15 in Schedule 5A to the Regulations; and

(c) are not the subject of a determination by the Secretary under item 15 in Schedule 5A to the Regulations

liquid or solid

inhalation

any one or more of the following:

(a) use for smoking cessation;

(b) management of nicotine dependence

2

therapeutic vaping substances or therapeutic vaping substance accessories that:

(a) do not contain any active ingredients;

(b) are the subject of a notification under item 15 in Schedule 5A to the Regulations; and

(c) are not the subject of a determination by the Secretary under item 15 in Schedule 5A to the Regulations

liquid or solid

inhalation

any one or more of the following:

(a) use for smoking cessation;

(b) management of nicotine dependence

3

therapeutic vaping kits that:

(a) contain one or more therapeutic vaping substances or therapeutic vaping substance accessories; and

(b) are the subject of a notification under item 15 in Schedule 5A to the Regulations; and

(d) are not the subject of a determination by the Secretary under item 15 in Schedule 5A to the Regulations

liquid or solid

inhalation

any one or more of the following:

(a) use for smoking cessation;

(b) management of nicotine dependence

4

goods in a therapeutic vaping pack that:

(a) are or contain one or more therapeutic vaping substances or therapeutic vaping substance accessories; and

(b) are the subject of a notification under item 15 in Schedule 5A to the Regulations; and

(c) are not the subject of a determination by the Secretary under item 15 in Schedule 5A to the Regulations

liquid or solid

inhalation

any one or more of the following:

(a) use for smoking cessation;

(b) management of nicotine dependence

 

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.

 

 

ad = added or inserted

orig = original

am = amended

p = page(s)

amdt = amendment

para = paragraph(s)/subparagraph(s)

C[x] = Compilation No. x

/subsubparagraph(s)

ch = Chapter(s)

pres = present

cl = clause(s)

prev = previous

cont. = continued

(prev…) = previously

def = definition(s)

pt = Part(s)

Dict = Dictionary

r = regulation(s)/Court 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

gaz = gazette

s = section(s)/subsection(s)

LA = Legislation Act 2003

/rule(s)/subrule(s)/order(s)/suborder(s)

LIA = Legislative Instruments Act 2003

sch = Schedule(s)

(md not incorp) = misdescribed amendment

SLI = Select Legislative Instrument

cannot be given effect

SR = Statutory Rules

mod = modified/modification

sub ch = SubChapter(s)

No. = Number(s)

sub div = Subdivision(s)

Ord = Ordinance

sub pt = Subpart(s)

 

underlining = whole or part not

 

commenced or to be commenced

 

 

Name

Registration

Commencement

Application, saving and transitional provisions

Therapeutic Goods (Medicines—Authorised Supply) Rules 2022

23 Dec 2022

(F2022L01766)

24 Dec 2022

Therapeutic Goods (Medicines—Authorised Supply) Amendment (Vaping) Rules 2023

15 Dec 2023

(F2023L01683)

1 Jan 2024

Therapeutic Goods (Authorised Supply) Amendment (SAS Guidance) Rules 2024

6 Jun 2024

(F2024L00639)

5 Jun 2024

Therapeutic Goods (Authorised Supply) Amendment (SAS Guidance) Rules (No. 2) 2024

16 Oct 2024

(F2024L01321)

17 Oct 2024

Therapeutic Goods (Authorised Supply) Amendment Rules 2025

20 Aug 2025

(F2025L00947)

Sch 1, Part 1: 21 Aug 2025 (s 2(1) item 2)

Sch 1, Part 2: awaiting commencement (s 2(1) item 3)

 

Act

Number and year

Assent

Commencement

Application, saving and transitional provisions

Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024

50, 2024

27 June 2024

Sch 4 (items 6-11, 18): 1 Oct 2024 (s 2(1) item 5)

Sch 4 (item 18)

 

 

 

Provision affected

How affected

s 1……………………………….

am F2023L01683

s 2……………………………….

rep LA s 48D

s 4……………………………….

am F2023L01683; F2024L00639; F2024L01321; F2025L00947

s 5……………………………….

am F2025L00947

s 5A……………………………..

ad F2023L01683

am Act No. 50, 2024; F2025L00947

s 6……………………………….

rep LA s 48C

Schedule 1………………………

am F2024L00639; F2025L00947

Schedule 1A…………………….

ad F2023L01683

Schedule 2………………………

rep LA s 48C