Commonwealth Numbered Regulations

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1990 No. 394 THERAPEUTIC GOODS REGULATIONS - SCHEDULE 2

SCHEDULE 2
Regulation 8
PROHIBITED AND REQUIRED REPRESENTATIONS FOR THE
PURPOSES OF PARAGRAPHS 6 (1) (a) AND (b)
PART 1
PROHIBITED REPRESENTATIONS
Column 1  Column 2                                     Column 3

Item No.  Representation                               Therapeutic

goods
1    a representation referred to in clause 4 of the

     Therapeutic Goods Advertising Code                 all therapeutic

goods
2    a representation referred to in Clause 7 of the

     Therapeutic Goods Advertising Code                 all therapeutic

goods
3    a representation with respect to the use of goods

in which it is stated or implied that those goods: all therapeutic
goods

   (a)  are, or contain, a vitamin - unless those
goods are composed of, or contain, a substance
specified in column 2 of an item in Part 3 of this
Schedule or a salt or derivative of a substance and
that substance is described either by the name
referred to in Column 2 of that item, or by the name
of its salt or derivative, or by the name specified in
Column 3 of that item and not otherwise; or

   (b)  are, or contain, a substance described as a
vitamin otherwise than by a description specified in
Column 2 or 3 of Part 3 of this Schedule
4    a representation referred to in clause 5.3 of the

     Therapeutic Goods Advertising Code                      analgesics

5    a representation containing a reference to

bacteriostatic activity, except where it is made in
     conjunction with a reference to bactericidal activity   disinfectants

6    a representation:


   (a)  containing reference to the Rideal-Walker test
     or to the Phenol Coefficient; or                         disinfectants
and
antiseptics

   (b)  on any label, containing a reference to the
results of laboratory tests on micro-organisms, other
than a representation provided by leaflet or on a
label enclosed with the goods in their package; or

   (c)  containing a reference to the achievement of
sterility except where the representation is approved
in writing by the Secretary
7    a representation that antiseptics promote healing           antiseptics

8    a representation referred to in clause 6.1 of the           vitamins

Therapeutic Goods Advertising Code
9    a representation that:                                      vitamins and

     (a)  purports to show the recommended daily or              minerals

dietary intake or allowance of a vitamin or a mineral
unless the amount shown is that recommended by the
National Health and Medical Research Council; or
minerals

   (b)  expresses the quantity of a vitamin or a
mineral contained in a preparation as a percentage or
proportion of the recommended daily or dietary intake
or allowance
PART 2
REQUIRED REPRESENTATIONS
Column 1   Column 2                                   Column 3

Item No.   Representation                             Therapeutic goods

1          a statement that vitamins can only be o

assistance if the dietary vitamin intakes
is inadequate < vitamin

preparations
supplied in
Australia
PART 3
VITAMINS REFERRED TO IN ITEM 3 OF PART 1 OF THIS SCHEDULE
Column 1  Column 2                                 Column 3

Item No.  Substance                                Name

 1        Vitamin A                                -

 2        Thiamine                         Vitamin B1

 3        Riboflavine                      Vitamin B2

 4        Nicotinic Acid                   Vitamin B3

 5        Pantothenic Acid                 Vitamin B5

 6        Pyridoxine                       Vitamin B6

 7        Cyanocobalamin                   Vitamin B12

 8        Ascorbic Acid                    Vitamin C

 9        Ergocalciferol                   Vitamin D2

10        Cholecalciferol                  Vitamin D3

11        alpha-Tocopherol                 Vitamin E

12        Biotin                           Vitamin H

13        Phytomenadione                   Vitamin K1

14        Menadione                        Vitamin K3

15        Folic Acid


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