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Therapeutic Goods (Excluded Goods) Determination 2018

Authoritative Version
  • - F2019C00515
  • In force - Superseded Version
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Determinations/Health as amended, taking into account amendments up to Therapeutic Goods Amendment (Excluded Goods) Determination 2019
This instrument specifies certain goods to be excluded goods for the purposes of the Therapeutic Goods Act 1989.
Administered by: Health
Registered 03 Jul 2019
Start Date 22 Jun 2019
End Date 15 Jul 2019
Table of contents.

Therapeutic Goods (Excluded Goods) Determination 2018

made under section 7AA of the

Therapeutic Goods Act 1989

Compilation No. 1

Compilation date:                          22 June 2019

Includes amendments up to:         Therapeutic Goods Amendment (Excluded Goods) Determination 2019

 

 

 


About this compilation

This compilation

This is a compilation of the Therapeutic Goods (Excluded Goods) Determination 2018 that shows the text of the law as amended and in force on 22 June 2019 (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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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........................................................................................................................ 2

Excluded goods when used, advertised or presented for supply in a particular way................ 2

Schedule 1       Specified goods                                                                                      3

Schedule 2       Specified goods used, advertised or presented for supply in a particular way    5

Endnotes                                                                                                                      10

Endnote 1—About the endnotes                                                                            10

Endnote 2—Abbreviation key                                                                               11

Endnote 3—Legislation history                                                                            12

Endnote 4—Amendment history                                                                           13


1            Name

This instrument is the Therapeutic Goods (Excluded Goods) Determination 2018.

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 the Act including:

(a)     advertise;

(b)     label;

(c)     medical device;

(d)     Register;

(e)     supply; and

(f)      therapeutic use.

          In this instrument:

 

Act means the Therapeutic Goods Act 1989.

 

AS 2896–2011 means the document, Australian Standard: Medical gas systems – Installation and testing of non-flammable medical gas pipeline systems (AS 2896–2011), prepared by Committee HE-017 (Medical Gas Systems), approved on behalf of the Council of Standards Australia on 13 January 2011, and published by SAI Global Limited under licence from Standards Australia on 8 May 2011, as in force or existing immediately before the commencement of this instrument.

 

AS/NZS 2604:1998 means the document, Australian/New Zealand Standard: Sunscreen products – Evaluation and classification (AS/NZS 2604:1998), prepared by the Joint Technical Committee CS/42 (Sunscreen Agents), approved on behalf of the Council of Standards Australia on 31 July 1998 and the Council of Standards New Zealand on 24 August 1998, and published jointly by Standards Australia and Standards New Zealand on 5 October 1998, as in force or existing immediately before the commencement of this instrument.

 

AS/NSZ 2604:2012 means the document, Australian/New Zealand Standard: Sunscreen products – Evaluation and classification (AS/NZS 2604:2012), prepared by the Joint Technical Committee CS-042 (Sunscreen Agents), approved on behalf of the Council of Standards Australia on 9 May 2012 and the Council of Standards New Zealand on 9 May 2012, and published by SAI Global Limited under licence from Standards Australia on 30 May 2012, as in force or existing immediately before the commencement of this instrument.

 

Note:       Section 2B of the Acts Interpretation Act 1901 defines Standards Australia.

 

haematopoietic progenitor cells has the meaning given by clause 1 of Part 1 of Schedule 9 to the Regulations.

 

Poisons Standard means the legislative instrument made under section 52D of the Act, as in force immediately before the commencement of this instrument.

 

Regulations means the Therapeutic Goods Regulations 1990.

5            Excluded goods

For subsection 7AA(1) of the Act, the goods specified in Schedule 1 are excluded goods for the purposes of the Act.

6            Excluded goods when used, advertised or presented for supply in a particular way

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

 


 

Schedule 1        Specified goods

(section 5)

 

Specified goods

Column 1

Item

Column 2

Specified goods

1

adhesive removers and non-medicated skin cleansers relating to colostomy and ileostomy

2

antiperspirant preparations that derive their antiperspirant properties from inorganic salts of aluminium, zinc or zirconium only

3

dental bleaches and dental whiteners

4

devices for measuring alcohol content in body fluids or exhaled air

5

disinfectant and sterilant gases

6

drinking water purification and treatment equipment

7

ear candles

8

hair bleaches, hair dyes, hair-colorants and hair-perming preparations

9

household and personal aids, or furniture and utensils, for people with disabilities

10

incontinence pads, mattress overlays and mattress protectors

11

menstrual pads other than tampons and menstrual cups

12

sanitation, environmental control and environmental detoxification equipment

13

topical preparations applied to the nails to harden, or deter the biting of, nails

14

products intended for application to the lips, that contain sunscreen, and do not contain any substance included in Schedules 2, 3, 4 or 8 to the Poisons Standard, in relation to which one of the following two paragraphs applies:

(a)     for a product imported into, or manufactured in, Australia before 1 August 2018, both:

(i)         the product is a secondary sunscreen product within the definition of secondary sunscreen product in AS/NZS 2604:1998 or AS/NZS 2604:2012; and

(ii)       any protection factor or equivalent category description stated on the product’s label is in accordance with clauses 6.2 and 6.3 of AS/NZS 2604: 1998 or clauses 5 and 6 of AS/NSZ 2604:2012; or

(b)     for a product imported into, or manufactured in, Australia on or after 1 August 2018, all of the following:

(i)         the product is a secondary sunscreen product within the definition of secondary sunscreen product in AS/NZS 2604:2012; and

(ii)       any protection factor or equivalent category description stated on the product’s label is in accordance with clauses 5 and 6 of AS/NSZ 2604:2012; and

(iii)      if the product’s label states a protection factor, the label meets the requirements of clauses 7.1 and 7.3 of AS/NZS 2604: 2012; and

(iv)     the product must meet the performance requirements for a broad-spectrum product set out in clause 6.3 of AS/NZS 2604: 2012 and Table 1 in clause 5.2 of AS/NZS 2604: 2012

15

tinted bases and foundations, such as liquids, pastes or powders, that contain sunscreen, and do not contain any substance included in Schedules 2, 3, 4 or 8 to the Poisons Standard, in relation to which one of the following two paragraphs applies:

(a)     for a product imported into, or manufactured in, Australia before 1 August 2018, both:

(i)         the product is a secondary sunscreen product within the definition of secondary sunscreen product in AS/NZS 2604:1998 or AS/NZS 2604:2012; and

(ii)       any protection factor or equivalent category description stated on the product’s label is in accordance with clauses 6.2 and 6.3 of AS/NZS 2604: 1998 or clauses 5 and 6 of AS/NSZ 2604:2012; or

(b)     for a product imported into, or manufactured in, Australia on or after 1 August 2018, all of the following:

(i)         the product is a secondary sunscreen product within the definition of secondary sunscreen product in AS/NZS 2604:2012; and

(ii)       any protection factor or equivalent category description stated on the product’s label is in accordance with clauses 5 and 6 of AS/NSZ 2604:2012; and

(iii)      if the product’s label states a protection factor, the label meets the requirements of clauses 7.1 and 7.3 of AS/NZS 2604: 2012; and

(iv)     the product must meet the performance requirements for a broad-spectrum product set out in clause 6.3 of AS/NZS 2604: 2012 and Table 1 in clause 5.2 of AS/NZS 2604: 2012

 


 

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

(section 6)

 

Specified goods

 

Column 1

Item

Column 2

Specified goods

Column 3

When used, advertised or presented for supply in a particular way

1

anti-acne skin care products, including spot treatments, cleansers, face scrubs and masks, that do not contain any substance included in Schedules 2, 3, 4 or 8 to Poisons Standard

when advertised or presented for supply as controlling or preventing acne only through cleansing, moisturising, exfoliating or drying the skin

2

antibacterial skin care products that do not contain any substance included in Schedules 2, 3, 4 or 8 to the Poisons Standard

when advertised or presented for supply as being active against bacteria and not advertised or presented for supply as being:

(a)     active against viruses, fungi or other microbial organisms (other than bacteria); or

(b)     for use in connection with disease, disorders or medical conditions; or

(c)     active against a named bacterium that is known to be associated with a disease, disorder or medical condition; or

(d)     for use in connection with piercing of the skin or mucous membrane, for cosmetic or any other purpose; or

(e)     for use in connection with any procedure associated with the risk of transmission of disease from contact with blood or other bodily fluids; or

(f)      for use before physical contact with a person who is accessing medical or health services, or who is undergoing any medical or health care procedure; or

(g)     for use in connection with a procedure involving venepuncture or delivery of an injection


 

3

anti-dandruff hair care products

when advertised or presented for supply as controlling or preventing dandruff only through cleansing, moisturising, exfoliating or drying the scalp

4

compressed gases

when used as a power source for medical devices

4A

goods in relation to which the following paragraphs apply:

(a)    the goods comprise, contain or are derived from, human cells or human tissues collected from a patient (the relevant patient) who is under the clinical care of a medical or dental practitioner (the relevant practitioner);

(b)    the relevant practitioner is registered in a State or internal Territory;

(c)    subject to paragraph (d), all steps in the manufacture of the goods are carried out by, or under the professional supervision of, the relevant practitioner in a hospital in a State or internal Territory (the relevant hospital);

(d)    if a step in the manufacture of the goods relating to the storage or testing of the goods is not carried out in the relevant hospital, it is carried out by a person under contract with the relevant hospital

when the goods are:

(a)   used for the relevant patient, who is a patient of the relevant hospital; and

(b)    not advertised directly to consumers

 

4B

goods that are fresh viable human haematopoietic progenitor cells

when used for direct donor-to-host transplantation for the purpose of haematopoietic reconstitution

4C

goods that are fresh viable human organs or parts of human organs

when used for direct donor-to-host transplantation

4D

goods that are human reproductive tissue

when used in assisted reproductive therapy

5

moisturising skin care products, that contain sunscreen, and do not contain any substance included in Schedules 2, 3, 4 or 8 to the Poisons Standard, for dermal application, including anti-wrinkle, anti-ageing and skin whitening products, in relation to which one of the following two paragraphs applies:

(a)     for a product imported into, or manufactured in, Australia before 1 August 2018, both:

(i)         the product is a secondary sunscreen product within the definition of secondary sunscreen product in AS/NZS 2604:1998 or AS/NZS 2604:2012; and

(ii)       any protection factor or equivalent category description stated on the product’s label is in accordance with clauses 6.2 and 6.3 of AS/NZS 2604: 1998 or clauses 5 and 6 of AS/NSZ 2604:2012; or

(b)     for a product imported into, or manufactured in, Australia on or after 1 August 2018, all of the following:

(i)         the product is a secondary sunscreen product within the definition of secondary sunscreen product in AS/NZS 2604:2012; and

(ii)       the product meets the performance requirements for a broad-spectrum product set out in clause 6.3 of AS/NZS 2604:2012 and Table 1 in clause 5.2 of AS/NZS 2604:2012; and

(iii)      any protection factor or equivalent category description stated on the product’s label is in accordance with clauses 5 and 6 of AS/NSZ 2604:2012; and

(iv)     if the product’s label states a protection factor, the label meets the requirements of clauses 7.1 and 7.3 of AS/NZS 2604: 2012

when the product:

(a)     is not advertised or presented for supply as having a sun protection factor of more than 15; and

(b)     is not advertised or presented for supply as being water-resistant;
and

(c)     if the product is not stable for at least 36 months – includes an expiry date on its label; and

(d)     has a pack size not larger than 300mL or 300g; and

(e)     except in the manner provided below, does not have any therapeutic claims made in relation to it, including claims about skin cancer; and

therapeutic claims made in relation to the product are limited to those in relation to premature ageing in connection with sun exposure, and are only made if the product meets the performance requirements for broad-spectrum product set out in:

(a)     clause 7.2 of AS/NZS 2604:1998; or

(b)     both clause 6.3 of AS/NZS 2604:2012 and Table 1 in clause 5.2 of AS/NZS 2604:2012

6

oral hygiene products for the care of the teeth and the mouth, including dentifrices, mouth washes and breath fresheners, that do not contain any substance included in Schedules 2, 3, 4 or 8 to Poisons Standard

when advertised or presented for supply, the following two paragraphs apply:

(a)     the only benefits claimed to result from the use of the product is consequential on improvements to oral hygiene, including for the prevention of tooth decay or the use of fluoride for the prevention of tooth decay; and

(b)     benefits in relation to such other diseases or aliments, such as gum or other oral disease or periodontal condition, are not claimed to result from use of the product

7

packs and kits containing medical devices for the prevention of blood borne and sexually transmissible diseases where each individual therapeutic good contained within the packs or kits is already included on the Register

when advertised or presented for supply as a part of a Government endorsed health promotion program, having been expressly authorised by that Government as part of that program

8

piped medical gas systems

when installed and used in compliance with AS 2896–2011

9

preparations containing a sunscreening substance, if the primary purpose of the preparation is neither protection from solar radiation nor another therapeutic purpose

when the preparation is not advertised or presented for supply with:

(a)     a statement of claimed sun protection factor; or

(b)     a description of a claimed sun protection factor; or

(c)     a reference to another therapeutic use in respect of the preparation

10

sunbathing skin care products, such as oils, creams, gels, tanning products without sun and after-sun care products, that contain sunscreen with a sun protection factor of at least 4 and not more than 15, and do not contain any substance included in Schedules 2, 3, 4 or 8 to the Poisons Standard, in relation to which one of the following two paragraphs applies:

(a)     for a product imported into, or manufactured in, Australia before 1 August 2018, both:

(i)         the product is a secondary sunscreen product within the definition of secondary sunscreen product in AS/NZS 2604:1998 or AS/NZS 2604:2012; and

(ii)       any protection factor or equivalent category description stated on the product’s label is in accordance with clauses 6.2 and 6.3 of AS/NZS 2604: 1998 or clauses 5 and 6 of AS/NSZ 2604:2012; or

(b)     for a product imported into, or manufactured in, Australia on or after 1 August 2018, all of the following:

(i)         the product is a secondary sunscreen product within the definition of secondary sunscreen product in AS/NZS 2604:2012; and

(ii)       the product meets the performance requirements for a broad-spectrum product set out in clause 6.3 of AS/NZS 2604:2012 and Table 1 in clause 5.2 of AS/NZS 2604:2012; and

(iii)      any protection factor or equivalent category description stated on the product’s label is in accordance with clauses 5 and 6 of AS/NSZ 2604:2012; and

(iv)     if the product’s label states a protection factor, the label meets the requirements of clauses 7.1 and 7.3 of AS/NZS 2604: 2012

when the product:

(a)     is not advertised or presented for supply as having a sun protection factor of more than 15; and

(b)     is not advertised or presented for supply as being water-resistant; and

(c)     if the product is not stable for at least 36 months – includes an expiry date on its label;

(d)     has a pack size not larger than 300mL or 300g; and

(e)     except in the manner provided below, does not have any therapeutic claims made in relation to it, including claims about skin cancer; and

therapeutic claims made in relation to the product are limited to those in relation to premature ageing in connection with sun exposure, and are only made if the product meets the performance requirements for broad-spectrum product set out in:

(a)     clause 7.2 of AS/NZS 2604:1998; or

(b)     both clause 6.3 of AS/NZS 2604:2012 and Table 1 in clause 5.2 of AS/NZS 2604:2012

11

therapeutic goods for retaining, cushioning or repairing dentures

when advertised or presented for supply to the ultimate consumer



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 Amendment (Excluded Goods) Determination 2019

21 Jun 2019 (F2019L00853)

22 Jun 2019

 


 

Endnote 4—Amendment history

 

Provision affected

How affected

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

rep LA s 48D

s 3........................................

am F2019L00853

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

am F2019L00853

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

am F2019L00853

Note.....................................

rep F2019L00853