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Therapeutic Goods (Declared Goods) Order 2019

Authoritative Version
Orders/Other as made
This instrument declares particular goods or classes of goods to be, or not to be, therapeutic goods for the puropses of the Therapeutic Goods Act 1989.
Administered by: Health
Registered 21 Oct 2019
Tabling HistoryDate
Tabled HR22-Oct-2019
Tabled Senate11-Nov-2019
Table of contents.

Commonwealth Coat of Arms of Australia

 

Therapeutic Goods (Declared Goods) Order 2019

 

I, Jane Cook, as delegate of the Secretary of the Department of Health, make the following order.

Dated 18 October 2019

Dr Jane Cook                                                                     

First Assistant Secretary

Medicines Regulation Division

Health Products Regulation Group

Department of Health

 

 


Contents

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

2  Commencement........................................................................................................................ 1

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

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

5  Declared goods¾therapeutic goods......................................................................................... 1

6  Declared goods¾not therapeutic goods................................................................................... 2

Schedule 1—Therapeutic goods                                                                                  3

Part 1—Therapeutic goods                                                                                          3

Part 2—Therapeutic goods when used, advertised, or presented for supply in a particular way         4

Schedule 2—Not therapeutic goods                                                                             5

Part 1—Not therapeutic goods                                                                                    5

Part 2—Not therapeutic goods when used, advertised, or presented for supply in a particular way   6

 

 


1  Name

                   This instrument is the Therapeutic Goods (Declared Goods) Order 2019.

2  Commencement

             (1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  The whole of this instrument

The day after this instrument is registered.

 

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

             (2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

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


 

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 (other than apparel specified in item 5), including fitted support or insulating garments

when used solely to:

(a)   aid physical comfort; or

(b)   relieve discomfort

5

non-sterile protective or safety apparel or equipment

when used:

(a)   in the home; or

(b)   for occupational or recreational use

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