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Therapeutic Goods (Declared Goods) Order 2019

Authoritative Version
Orders/Other as amended, taking into account amendments up to Therapeutic Goods Amendment (Declared Goods) Order (No. 1) 2020
Administered by: Health
Registered 08 May 2020
Start Date 24 Apr 2020
Table of contents.

Commonwealth Coat of Arms of Australia

Therapeutic Goods (Declared Goods) Order 2019

made under section 7 of the

Therapeutic Goods Act 1989

Compilation No. 2

Compilation date:                          24 April 2020

Includes amendments up to:         F2020L00465

 

 

 


About this compilation

This compilation

This is a compilation of the Therapeutic Goods (Declared Goods) Order 2019 that shows the text of the law as amended and in force on 24 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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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  Declared goods¾therapeutic goods......................................................................................... 1

6  Declared goods¾not therapeutic goods................................................................................... 1

Schedule 1—Therapeutic goods                                                         2

Part 1—Therapeutic goods                                                                                          2

Part 2—Therapeutic goods when used, advertised, or presented for supply in a particular way                                                                                                                                 3

Schedule 2—Not therapeutic goods                                                   4

Part 1—Not therapeutic goods                                                                                    4

Part 2—Not therapeutic goods when used, advertised, or presented for supply in a particular way                                                                                                                                 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 (Declared Goods) Order 2019.

3  Authority

                   This instrument is made under section 7 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)    manufacture;

(c)    presentation;

(d)    supply;

(e)    therapeutic device;

(f)    therapeutic goods; and

(g)    therapeutic use.

                   In this instrument:

Act means the Therapeutic Goods Act 1989.

Trefriw Wells mineral water means naturally-occurring mineral water sourced from Trefriw Wells Spa in the United Kingdom.

Declared goods¾therapeutic goods

             (1)  The goods or classes of goods specified in Part 1 of Schedule 1 to this instrument are declared to be therapeutic goods.

             (2)  The goods or classes of goods specified in column 2 of an item in the table in Part 2 of Schedule 1 to this instrument, when used, advertised, or presented for supply, in a way specified in column 3 of that item, are declared to be therapeutic goods.

6  Declared goods¾not therapeutic goods

             (1)  The goods or classes of goods specified in Part 1 of Schedule 2 to this instrument are declared not to be therapeutic goods.

             (2)  The goods or classes of goods specified in column 2 of an item in the table in Part 2 of Schedule 2 to this instrument, when used, advertised, or presented for supply, in a way specified in column 3 of that item, are declared not to be therapeutic goods.

Schedule 1—Therapeutic goods

Note: See section 5.

Part 1Therapeutic goods

Goods that are therapeutic goods

Column 1

Column 2

Item

Goods or classes of goods

1

goods that are or contain Cellasene

2

goods that:

(a)   contain fibre; and

(b)   are manufactured in the dosage form of a tablet, capsule or pill

3

goods that:

(a)   contain, or are promoted to contain, isolated b-hydroxy-b-methylbutyrate (HMB) or its salts; and

(b)   are manufactured in the dosage form of a tablet, capsule, pill or powder

4

goods that:

(a)   contain shark cartilage; and

(b)   are manufactured in the dosage form of:

(i)     a tablet, capsule or pill; or

(ii)    a powder, where that powder is not a wholesale product for use as an ingredient in food


 

Part 2—Therapeutic goods when used, advertised, or presented for supply in a particular way

Goods that are therapeutic goods when used, advertised, or presented for supply in a particular way

Column 1

Column 2

Column 3

Item

Goods or classes of goods

Use, advertising or presentation

1

goods that are labelled or promoted for cosmetic purposes

when used, advertised or presented for supply for oral consumption

2

goods that contain Trefriw Wells mineral water

when used, advertised or presented for supply for therapeutic use:

(a)   as an iron supplement; and

(b)   in a single use sachet

3

goods that:

(a)   contain one or more of the following folate substances:

(i)    folic acid; or

(ii)   folinic acid; or

(iii)  levomefolic acid; or

(iv)  any other form of folate that may be characterised as an active principle, precursor, derivative, salt, ester, ether or stereoisomer; and

(b)   are represented as being food for special medical purposes, or being for dietary management of a disease, disorder or medical condition;

whether or not the recommended single dose of the goods contains sufficient macronutrients to feed, either exclusively or partially, the person for whom the dose is intended

when used, advertised, or presented for supply:

(a)   for therapeutic use; or

(b)   in a way that is likely to be taken to be for therapeutic use;

including, but not limited to, one or more of the following therapeutic uses:

(c)   preventing, curing or alleviating depression;

(d)   curing or alleviating an inborn error of folate metabolism;

(e)   preventing, curing or alleviating folate deficiency;

and that therapeutic use can be taken to relate to a substance mentioned in paragraph (a) in column 2 of this item


 

Schedule 2—Not therapeutic goods

Note: See section 6.

Part 1—Not therapeutic goods

Note   This Part is reserved for future use.


 

Part 2—Not therapeutic goods when used, advertised, or presented for supply in a particular way

Goods that are not therapeutic goods when used, advertised, or presented for supply in a particular way

Column 1

Column 2

Column 3

Item

Goods or classes of goods

Use, advertising or presentation

1

deodorant preparations

when used:

(a)   for dermal application; or

(b)   with therapeutic devices

2

depilatory preparations

when used for dermal application

3

non-prescription spectacles

when used solely for:

(a)   magnification of images; or

(b)   sun protection

4

non-sterile apparel including fitted support or insulating garments

when used solely to:

(a)   aid physical comfort; or

(b)   relieve discomfort

6

soaps and detergents, other than medicated soaps and detergents

when used for cleansing skin or hair

7

spa water or natural mineral water

when the goods are not used, advertised or presented for supply for therapeutic use

8

substances for use in the purification or treatment of drinking water

when the goods are not used, advertised or presented for supply for therapeutic use

9

unmedicated dental chewing gum

when advertised or presented for supply, the only benefits claimed to result from the use of the goods are consequential on improvements to oral hygiene

 



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 (Declared Goods) Order 2019

21 Oct 2019

(F2019L01352)

22 Oct 2019

¾

Therapeutic Goods Amendment (Declared Goods) Order 2019

4 Nov 2019

(F2019L01419)

5 Nov 2019

¾

Therapeutic Goods Amendment (Declared Goods) Order (No. 1) 2020

23 Apr 2020 (F2020L00465)

24 Apr 2020

¾

 


 

Endnote 4—Amendment history

 

Provision affected

How affected

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

rep LA s 48D

Schedule 1...........................

am F2019L01419

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

am F2020L00465