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Determinations/Health as amended, taking into account amendments up to Therapeutic Goods Amendment (Excluded Goods—Hand Sanitisers) Determination 2020
This instrument excludes specified hand sanitisers from the operation of the Therapeutic Goods Act 1989 in order to facilitate the urgent and continued supply of hand sanitisers in Australia in response to the COVID-19 emergency.
Administered by: Health
Registered 22 Apr 2020
Start Date 01 Apr 2020
End Date 05 May 2020
Table of contents.

Commonwealth Coat of Arms of Australia

Therapeutic Goods (Excluded Goods—Hand Sanitisers) Determination 2020

made under section 7AA of the

Therapeutic Goods Act 1989

Compilation No. 1

Compilation date:                              1 April 2020

Includes amendments up to:            F2020L00359

 

About this compilation

This compilation

This is a compilation of the Therapeutic Goods (Excluded Goods—Hand Sanitisers) Determination 2020 that shows the text of the law as amended and in force on 1 April 2020 (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 Legislation 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 series page on the Legislation 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 series page on the Legislation 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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

  

  

  


Contents

1  Name........................................................................................................................................ 1

3  Authority.................................................................................................................................. 1

4  Definitions................................................................................................................................ 1

5  Excluded goods........................................................................................................................ 1

Schedule 1—Specified goods used, advertised, or presented for supply in a particular way    2

Schedule 2—Labels                                                                                                       4

Part 1—Ethanol hand sanitiser                                                                                   4

1  Front label................................................................................................................................ 4

2  Back label................................................................................................................................. 4

Part 2—Isopropyl alcohol hand sanitiser                                                                    5

1  Front label................................................................................................................................ 5

2  Back label................................................................................................................................. 5

Endnotes                                                                                                                        6

Endnote 1—About the endnotes                                                                              6

Endnote 2—Abbreviation key                                                                                 7

Endnote 3—Legislation history                                                                              8

Endnote 4—Amendment history                                                                             9

 


1  Name

                   This instrument is the Therapeutic Goods (Excluded Goods—Hand Sanitisers) Determination 2020.

3  Authority

                   This instrument is made under section 7AA of the Therapeutic Goods Act 1989.

4  Definitions

Note:          A number of expressions used in this instrument are defined in section 3 of the Act, including the following:

(a)    advertise;

(b)    British Pharmacopoeia;

(c)    default standard;

(d)    European Pharmacopoeia;

(e)    label;

(f)    supply; and

(g)    United States Pharmacopoeia-National Formulary.

                   In this instrument:

Act means the Therapeutic Goods Act 1989.

food standard grade means compliance with an applicable standard in the Food Chemicals Codex, as in force or existing at the commencement of this instrument.

Note:          The Food Chemicals Codex is available online at: www.foodchemicalscodex.org.

pharmacopoeial grade means compliance with an applicable default standard.

Note:          The default standards are the British Pharmacopoeia, European Pharmacopoeia and the United States Pharmacopoeia-National Formulary.

5  Excluded goods

                   For subsection 7AA(2) of the Act, the goods specified in column 2 of an item of the table in Schedule 1, when used, advertised, or presented for supply in a way specified in column 3 of that item, are excluded goods for the purposes of the Act.

Schedule 1—Specified goods used, advertised, or presented for supply in a particular way

Note: See section 5.

Specified goods that are excluded goods when used, advertised, or presented for supply in a particular way

Column 1

Column 2

Column 3

Item

Specified goods

Use, advertising or presentation

1

hand sanitiser in relation to which all of the following paragraphs apply:

(a)      the final formulation of the hand sanitiser contains only the following ingredients:

(i)      ethanol 80% v/v (pharmacopoeial grade or food standard grade) in an aqueous solution;

(ii)     sterile distilled water or boiled cold water;

(iii)    glycerol 1.45% v/v (pharmacopoeial grade);

(iv)   hydrogen peroxide 0.125% v/v (pharmacopoeial grade);

and does not contain any other active or inactive ingredients, including colours, fragrances or emollients;

(b)      the concentration of ethanol specified in subparagraph (a)(i) is verified by the manufacturer testing samples of each batch of the final formulation of the hand sanitiser using gas chromatography, alcoholmeter, hydrometer, or other chemical analysis of equivalent or greater accuracy;

(c)       the hand sanitiser is manufactured under sanitary conditions using equipment that is well maintained and fit for purpose;

(d)      records relating to the manufacture of the hand sanitiser are kept by the manufacturer in relation to each of the matters specified in paragraphs (a), (b), and (c)

when advertised or presented for supply using the front and back labels set out in Part 1 of Schedule 2, and not advertised or presented for supply in any other way, with the following exceptions:

(a)      the labels may include a company logo;

(b)      the labels may be printed in colour; and

(c)       the front and back labels may be combined into a single label

2

hand sanitiser in relation to which all of the following paragraphs apply:

(a)      the final formulation of the hand sanitiser contains only the following ingredients:

(i)      isopropyl alcohol 75% v/v (pharmacopoeial grade) in an aqueous solution;

(ii)     sterile distilled water or boiled cold water;

(iii)    glycerol 1.45% v/v (pharmacopoeial grade);

(iv)   hydrogen peroxide 0.125% v/v (pharmacopoeial grade);

and does not contain any other active or inactive ingredients, including colours, fragrances or emollients;

(b)      the concentration of isopropyl alcohol specified in subparagraph (a)(i) is verified by the manufacturer testing samples of each batch of the final formulation of the hand sanitiser using gas chromatography, alcoholmeter, hydrometer, or other chemical analysis of equivalent or greater accuracy;

(c)       the hand sanitiser is manufactured under sanitary conditions using equipment that is well maintained and fit for purpose;

(d)      records relating to the manufacture of the hand sanitiser are kept by the manufacturer in relation to each of the matters specified in paragraphs (a), (b), and (c)

when advertised or presented for supply using the front and back labels set out in Part 2 of Schedule 2, and not advertised or presented for supply in any other way, with the following exceptions:

(a)      the labels may include a company logo;

(b)      the labels may be printed in colour; and

(c)       the front and back labels may be combined into a single label

 


 

Schedule 2—Labels

Part 1—Ethanol hand sanitiser

Note: See item 1 of Schedule 1.

1  Front label

Ethanol hand sanitiser 80%

Hand rub [optional text: suitable for use in medical and health services]

[Insert volume of the product in mLs]

[Insert name of the manufacturer or supplier]

[Insert contact details of the manufacturer or supplier]

2  Back label

Contains:

Ethanol 80% v/v, water, glycerol and hydrogen peroxide.

Use:

Antiseptic hand rub when soap and water are not available.

Directions for use:

Apply sufficient amount of product on hands to cover all surfaces. Rub hands together until dry.

Warnings:

For external use only. Flammable. Keep away from heat or flame.

Keep out of eyes, ears and mouth.

Discontinue use if skin irritation or rash occurs.

Keep out of reach of children.

Store below 30 °C.

Date of manufacture: dd mm yyyy

 


 

Part 2—Isopropyl alcohol hand sanitiser

Note: See item 2 of Schedule 1.

1  Front label

Isopropyl alcohol hand sanitiser 75%

Hand rub [optional text: suitable for use in medical and health services]

[Insert volume of the product in mLs]

[Insert name of the manufacturer or supplier]

[Insert contact details of the manufacturer or supplier]

2  Back label

Contains:

Isopropyl alcohol 75% v/v, water, glycerol and hydrogen peroxide.

Use:

Antiseptic hand rub when soap and water are not available.

Directions for use:

Apply sufficient amount of product on hands to cover all surfaces. Rub hands together until dry.

Warnings:

For external use only. Flammable. Keep away from heat or flame.

Keep out of eyes, ears and mouth.

Discontinue use if skin irritation or rash occurs.

Keep out of reach of children.

Store below 30 °C.

Date of manufacture: dd mm yyyy

 

 


Endnotes

Endnote 1—About the endnotes

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 the amendment to be made. If, despite the misdescription, the amendment can be given effect as intended, the amendment is incorporated into the compiled law and the abbreviation “(md)” added to the details of the amendment included in the amendment history.

If a misdescribed amendment cannot be given effect as intended, the abbreviation “(md not incorp)” is added to the details of the amendment included in the amendment history.

 

Endnote 2—Abbreviation key

 

ad = added or inserted

o = order(s)

am = amended

Ord = Ordinance

amdt = amendment

orig = original

c = clause(s)

par = paragraph(s)/subparagraph(s)

C[x] = Compilation No. x

    /sub‑subparagraph(s)

Ch = Chapter(s)

pres = present

def = definition(s)

prev = previous

Dict = Dictionary

(prev…) = previously

disallowed = disallowed by Parliament

Pt = Part(s)

Div = Division(s)

r = regulation(s)/rule(s)

ed = editorial change

reloc = relocated

exp = expires/expired or ceases/ceased to have

renum = renumbered

    effect

rep = repealed

F = Federal Register of Legislation

rs = repealed and substituted

gaz = gazette

s = section(s)/subsection(s)

LA = Legislation Act 2003

Sch = Schedule(s)

LIA = Legislative Instruments Act 2003

Sdiv = Subdivision(s)

(md) = misdescribed amendment can be given

SLI = Select Legislative Instrument

    effect

SR = Statutory Rules

(md not incorp) = misdescribed amendment

Sub‑Ch = Sub‑Chapter(s)

    cannot be given effect

SubPt = Subpart(s)

mod = modified/modification

underlining = whole or part not

No. = Number(s)

    commenced or to be commenced

 

Endnote 3—Legislation history

 

Name

Registration

Commencement

Application, saving and transitional provisions

Therapeutic Goods (Excluded Goods—Hand Sanitisers) Determination 2020

27 Mar 2020

(F2020L00340)

28 Mar 2020

Therapeutic Goods Amendment (Excluded Goods—Hand Sanitisers) Determination 2020

31 Mar 2020

(F2020L00359)

1 Apr 2020

 

Endnote 4—Amendment history

 

Provision affected

How affected

s 2.............................................

rep LA s 48D

s 4.............................................

am F2020L00359

Schedule 2................................

am F2020L00359