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Therapeutic Goods Amendment Regulations 1998 (No. 3)

Authoritative Version
  • - F1998B00386
  • No longer in force
SR 1998 No. 369 Regulations as made
These Regulations amend the Therapeutic Goods Regulations.
Administered by: Health
General Comments: This instrument was backcaptured in accordance with Section 36 of the Legislative Instruments Act 2003
Registered 01 Jan 2005
Tabling HistoryDate
Tabled HR08-Feb-1999
Tabled Senate15-Feb-1999
Gazetted 22 Dec 1998
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014
Table of contents.

Therapeutic Goods Amendment Regulations 1998 (No. 3)

Statutory Rules 1998    No. 369

I, WILLIAM PATRICK DEANE, Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulations under the Therapeutic Goods Act 1989.

Dated 17 December 1998.

WILLIAM DEANE
Governor-General

By His Excellency’s Command,

grant tambling

Parliamentary Secretary to the Minister for Health
and Aged Care

for the Minister for Health and Aged Care

 


Therapeutic Goods Amendment Regulations 1998 (No. 3)1

Statutory Rules 1998    No. 3692

made under the

 

 

 

Contents

                                                                                                                 Page

                        1     Name of regulations                                                       

                        2     Commencement                                                             

                        3     Amendment of Therapeutic Goods Regulations               

Schedule 1       Amendment of Therapeutic Goods Regulations 

 


Do not delete : Part placeholder

Do not delete : Division placeholder

1           Name of regulations

                     These regulations are the Therapeutic Goods Amendment Regulations 1998 (No. 3).

2           Commencement

                     These regulations commence on 1 January 1999.

3           Amendment of Therapeutic Goods Regulations

                     Schedule 1 amends the Therapeutic Goods Regulations.

 


Schedule 1        Amendment of Therapeutic Goods Regulations

(regulation 3)

Do not delete : Schedule Part placeholder

[1]         Regulation 1

             substitute

1       Name of regulations

                These regulations are the Therapeutic Goods Regulations 1990.

[2]         Regulation 2

             insert

CHCA means the Complementary Healthcare Council of Australia.

NFAA means the Nutritional Foods Association of Australia.

[3]         Regulation 5B, definition of complementary use

             omit

                  National Medical and Research Council

             insert

                  National Health and Medical Research Council

[4]         Regulation 5B, definition of NFAA

             omit

[5]         Regulation 5B

             insert

withdraw, in relation to an approved advertisement, includes withdrawal by any delegate under subregulation 5Q (2) or (3), whether or not that delegate gave the approval and, in the case of an approval given by the NFAA, includes a withdrawal by the CHCA.

[6]         Subregulation 5Q (3)

             omit

                  NFAA

             insert

                  CHCA

[7]         Paragraph 9A (1) (a)

             omit

                  Schedule 10

             insert

                  Part 1 of Schedule 10

[8]         Regulation 42C

             omit

                  The Council

             insert

         (1)   The Council

[9]         Subparagraph 42C (a) (i)

             substitute

                          (i)    the CHCA;

[10]      Regulation 42C

             insert

         (2)   A member of the Council who, before 1 January 1999, was nominated under paragraph (1) (a) by the NFAA is taken to have been nominated by the CHCA.

[11]      Subregulation 42E (2)

             omit

                  NFAA

             insert

                  CHCA

[12]      Paragraph 42K (a)

             omit

                  NFAA

             insert

                  CHCA

[13]      Subparagraph 42T (1) (b) (i)

             substitute

                          (i)    the CHCA;

[14]      Subregulation 42T (3)

             omit each mention of

                  NFAA

             insert

                  CHCA

[15]      After subregulation 42T (3)

             insert

         (4)   A member of the Panel who, before 1 January 1999, was nominated under paragraph (1) (b) by the NFAA is taken to have been nominated by the CHCA.

[16]      Paragraph 42Y (b)

             omit

                  NFAA;

             insert

                  CHCA;

[17]      Schedule 4, Part 1, paragraph 3 (f)

             substitute

 

(f)         if a substance mentioned in Division 2 of Part 5 is an ingredient — the preparation is not sold or otherwise distributed:

(i)      in a form that exceeds the maximum amount per dosage form mentioned in column 2 of the table in that Division for that substance; and

(ii)     without the information about daily dosage mentioned in column 3 of the table for that substance;

[18]      Schedule 4, Part 5

             substitute

Part 5          Substances specified for item 3 of Part 1

Division 1

 

Bacterial strains of the genera Lactobacillus and Bifidobacterium (other than Bifidobacterium dentium) present in registered goods on 31 July 1998

 

Bioflavonoids (except quercetin)

 

Chitosan

 

Chlorophyll

 

Choline bitartrate

 

Dolomite

 

Fish oils used as a source of omega-3 marine triglycerides — if accompanied by information that the recommended daily intake of omega-3 marine triglycerides is less than 1 g

 

Fish oils used as a source of vitamins

 

Fructose

 

Glucosamine hydrochloride

 

Glucosamine sulphate

 

Glucose

 

Hydroxyapatite

 

Inositol

 

Inulin

 

Lecithin

 

Methylcellulose

 

Oligofructose

 

Oyster shell

 

Pectin

 

Propolis

 

Rice — hydrolysed

 

Royal jelly

 

Shark cartilage

 

Starch — maize — high amylose

 

 

Division 2

Subdivision 1   Interpretation

1.             A reference in column 2 of the table to a maximum amount per dosage form of a substance is a reference to the maximum amount of the substance that can be present in the particular form of preparation mentioned in that column in relation to the substance.

2.             A reference in column 3 of the table to a maximum daily dose of a substance is a reference to the daily maximum intake of the substance, in all forms in which it is present in preparations containing the substance.

Subdivision 2   Maximum amounts and daily doses of specified substances

 

 

Substance

Maximum amount per dosage form

Maximum daily dose (all forms)

 

chromium nicotinate

 

50 mg of chromium

 

chromium picolinate

 

50 mg of chromium

 

high chromium yeast

 

50 mg of chromium

 

creatine

 

3 g

 

creatine monohydrate

 

3 g of creatine

 

creatine phosphate

 

3 g of creatine

 

cupric citrate

 

750 mg of copper

 

high molybdenum yeast

 

62.5 mg of molybdenum

 

Piper methysticum

 

 

if in a tablet or capsule — 125 mg of kavalactones per tablet or capsule

250 mg of kavalactones

 

 

if in a tea bag — 3 g of dried rhizome per tea bag

 

 

 

 

 


Notes

1.       These regulations amend Statutory Rules 1990 No. 394, as amended by 1991 Nos. 84 and 485; 1992 Nos. 19, 89, 109, 332, 370 and 430; 1993 No. 141; 1994 Nos. 150, 222 and 364; 1995 Nos. 33, 111, 192, 208, 253, 320 and 328; 1996 Nos. 9, 25 (disallowed by the House of Representatives on 10 September 1996), 131, 200 and 208; 1997 Nos. 162, 398, 399, 400 and 401 (disallowed by the Senate on 31 March 1998); 1998 Nos. 227 and 247.

2.       Made by the Governor-General on 17 December 1998, and notified in the Commonwealth of Australia Gazette on 22 December 1998.  Administered by the Minister for Health and Aged Care.