Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS REGULATIONS 1990 - SCHEDULE 2

Prohibited and required representations

(regulation   6B)

Part   1 -- Prohibited representations

 

 

Column 1
Item No.

Column 2
Representation

Column 3
Therapeutic goods

3

a representation with respect to the use of goods in which it is stated or implied that those 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

all therapeutic goods

4

a representation that states or implies that:

(a) analgesic consumption is safe; or

(b) analgesics will relax, relieve tension, sedate or stimulate

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 the Phenol Coefficient; or

(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; or

(d) contradicting or conflicting with the common name; or

(e) that is not more specific than the common name as a description or measure of activity against micro organisms; or

(f) containing a reference to an effect against viruses, except a representation that is approved in writing by the Secretary; or

disinfectants and antiseptics

 

(g) containing a reference to an effect against Mycobacterium tuberculosis and related acid fast bacteria, except a representation that is approved in writing by the Secretary; or

(h) containing a reference to the disinfection of inaccessible parts of drains

 

7

a representation that antiseptics promote healing

antiseptics

8

a representation that states or implies that vitamin or mineral supplements:

(a) are a substitute for good nutrition or a balanced diet; or

(b) are in any way superior to or more beneficial than dietary nutrients

vitamin or mineral supplements

9

a representation that:

(a) purports to show the recommended daily or 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

(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

vitamins and minerals

10

The following:

(a) a representation regarding abortifacient action;

(b) a representation regarding the treatment, cure, prevention, diagnosis (including screening) or monitoring of, or the susceptibility or pre - disposition to, one or more of the following:

(i) neoplastic disease;

(ii) sexually transmitted diseases;

(iii) human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS);

(iv) hepatitis C virus (HCV);

(v) mental illness

all therapeutic goods

Part   2 -- Required representations

 

 

Column 1
Item

Column 2
Representation

Column 3
Therapeutic goods

1

if the advertisement is in the form of a label on the retail container--a statement that:

(a) vitamins can only be of assistance if the dietary vitamin intake is inadequate; or

(b) vitamin supplements should not replace a balanced diet

vitamin preparations for oral ingestion supplied in Australia

Part   3 -- Vitamins referred to in Item   3 of Part   1 of this Schedule

 

 

Column 1
Item

Column 2
Substance

Column 3
Name

1

Vitamin A

--

2

Thiamine

Vitamin B1

3

riboflavin

Vitamin B2

4

Nicotinic Acid

 

5

Pantothenic Acid

Vitamin B5

6

Pyridoxine

Vitamin B6

7

Cyanocobalamin

Vitamin B12

8

Ascorbic Acid

Vitamin C

9

Ergocalciferol

Vitamin D2

10

colecalciferol

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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