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Therapeutic Goods Amendment Regulations 2003 (No. 6)

Authoritative Version
  • - F2003B00378
  • No longer in force
SR 2003 No. 361 Regulations as made
These Regulations amend the Therapeutic Goods Regulations 1990; Therapeutic Goods (Medical Devices) Regulations 2002.
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 HR10-Feb-2004
Tabled Senate10-Feb-2004
Gazetted 23 Dec 2003
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014
Table of contents.

Therapeutic Goods Amendment Regulations 2003 (No. 6)1

Statutory Rules 2003 No. 3612

I, PHILIP MICHAEL JEFFERY, 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 18 December 2003

P. M. JEFFERY

Governor-General

By His Excellency’s Command

TRISH WORTH


Contents

                        1     Name of Regulations                                                       2

                        2     Commencement                                                              2

                        3     Amendment of Therapeutic Goods Regulations 1990         2

                        4     Amendment of Therapeutic Goods (Medical Devices) Regulations 2002          2

Schedule 1              Amendments of Therapeutic Goods Regulations 1990   3

Schedule 2              Amendment of Therapeutic Goods (Medical Devices) Regulations 2002    9

 


1              Name of Regulations

                These Regulations are the Therapeutic Goods Amendment Regulations 2003 (No. 6).

2              Commencement

                These Regulations commence on gazettal.

3              Amendment of Therapeutic Goods Regulations 1990

                Schedule 1 amends the Therapeutic Goods Regulations 1990.

4              Amendment of Therapeutic Goods (Medical Devices) Regulations 2002

                Schedule 2 amends the Therapeutic Goods (Medical Devices) Regulations 2002.



 

Schedule 1        Amendments of Therapeutic Goods Regulations 1990

(regulation 3)

  

[1]           Regulation 2, definition of authorised person

substitute

authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.

Note   Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.

[2]           Regulation 3

substitute

2A           Authorised officers

                The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:

                (a)    an officer of the Department, of another Department or of an authority of the Commonwealth;

               (b)    an officer of:

                          (i)    a Department of State of a State; or

                         (ii)    a Department or administrative unit of the Public Service of a Territory; or

                        (iii)    an authority of a State or of a Territory;

                        being a Department, unit or authority that has functions relating to health matters.

3              Corresponding State law

         (1)   In this regulation:

the Regulations means:

                (a)    the Therapeutic Goods Regulations 1990; and

               (b)    the Therapeutic Goods (Medical Devices) Regulations 2002.

         (2)   For the definition of corresponding State law in subsection 3 (1) of the Act, the Therapeutic Goods (Victoria) Act 1994 is declared to correspond to the Act.

         (3)   For the definition of corresponding State law in subsection 3 (1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:

                (a)    the Poisons and Therapeutic Goods Act 1966 (NSW);

               (b)    the Poisons and Therapeutic Goods Regulation 2002 (NSW);

                (c)    the Therapeutic Goods Act 2001 (Tas);

               (d)    the Therapeutic Goods Regulations 2002 (Tas).

[3]           Regulation 12AC, heading

substitute

12AC      Powers of authorised officers in relation to goods imported etc for experimental uses

[4]           Paragraph 12B (4) (b)

omit

authorised person

insert

medical practitioner

[5]           Subregulation 23 (1), definition of authorised officer

omit

[6]           Subregulation 42D (2)

omit

3 consecutive terms.

insert

4 consecutive terms.

[7]           Paragraph 42J (2B) (a)

substitute

                (a)    Commercial Television Australia and Commercial Radio Australia Limited; and

[8]           Subregulation 42U (2)

omit

3 consecutive terms.

insert

4 consecutive terms.

[9]           Subregulation 45 (1)

after

therapeutic goods

insert

(other than goods of a kind mentioned in Part 1 of Schedule 10)

[10]         Regulation 47AA

omit

[11]         Schedule 4, Part 4, Division 2, item 35

substitute

35

Piper methysticum

   (a)  if the herbal substance is for oral use:

         (i)   it is any of the following:

            (A)   aqueous dispersion of whole or peeled rhizome;

            (B)   aqueous extract of whole or peeled rhizome;

            (C)   dried whole or peeled rhizome; and

        (ii)   the preparation does not contain, for its recommended daily dose, more than 250mg of kavalactones; and

       (iii)   if the preparation is in the form of a tablet or capsule — the amount of kavalactones does not exceed 125mg for each tablet or capsule; and

       (iv)   if the preparation is in the form of a tea bag — the amount of dried whole or peeled rhizome does not exceed 3g for each tea bag; and

 

 

        (v)   if the preparation contains more than 25mg of kavalactones per dose — the label on the goods includes the following warnings (or words to the same effect):

               ·   Not for prolonged use. If symptoms persist, seek advice from a health care practitioner

               ·   Not recommended for use by pregnant or lactating women

               ·   May harm the liver

 

 

  (b)  if the herbal substance is for topical application to the rectum or vagina or by spray to the throat — it is any of the following:

         (i)   aqueous dispersion of whole or peeled rhizome;

        (ii)   aqueous extract of whole or peeled rhizome;

       (iii)   dried whole or peeled rhizome;

 

 

   (c)  if the herbal substance is not a substance to which paragraph (a) or (b) applies, the herbal substance may be:

         (i)   used in homeopathic preparations more dilute than a 1 000-fold dilution of a mother tincture; or

        (ii)   used in a preparation for topical application to the skin if the preparation does not contain, for its daily dose, more than 250mg of kavalactones

[12]         Further amendments  — authorised officer

 

Provision

omit

insert

Subparagraph 12AB (2) (b) (i)

authorised person,

authorised officer,

Subparagraph 12AB (2) (b) (ii)

authorised person

authorised officer

Subregulation 12AC (1)

authorised person

authorised officer

Subparagraph 12AC (1) (f) (i)

authorised person;

authorised officer;

Subparagraph 12AC (1) (f) (ii)

authorised person.

authorised officer.

Subregulation 12AC (2)

authorised person

authorised officer

Paragraphs 12AC (2) (a) and (b) and 30 (6) (b)

authorised person

authorised officer

[13]         Further amendments — Schedule 4

                Schedule 4 is amended in accordance with the following table:

 

Provision

omit

insert

Part 1, item 3, subparagraph (d) (ii)

column 2

column 3

Part 1, item 3, sub-subparagraph (d) (ii) (B)

column 1

column 3

Part 1, item 3, subparagraph (f) (i)

column 2

column 3

Part 1, item 3, subparagraph (f) (ii)

column 3

column 4

Part 5, Division 2, Subdivision 1, item 1

column 2

column 3

Part 5, Division 2, Subdivision 1, item 1

column 1

column 2

Part 5, Division 2, Subdivision 1, item 1

column 2

column 3

Part 5, Division 2, Subdivision 1, item 2

column 3

column 4

Part 5, Division 2, Subdivision 1, item 2

column 1

column 2

Part 5, Division 2, Subdivision 1, item 3

column 1

column 2

Part 5, Division 2, Subdivision 1, item 3, paragraph (b)

column 3

column 2

Part 5, Division 2, Subdivision 1, item 3, example

column 1

column 2


 

Schedule 2        Amendment of Therapeutic Goods (Medical Devices) Regulations 2002

(regulation 4)

  

[1]           Regulation 10.1

substitute

10.1        Authorised persons

                The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:

                (a)    an officer of the Department, of another Department or of an authority of the Commonwealth;

               (b)    an officer of:

                          (i)    a Department of State of a State; or

                         (ii)    a Department or administrative unit of the Public Service of a Territory; or

                        (iii)    an authority of a State or of a Territory;

                        being a Department, unit or authority that has functions relating to health matters.


Notes

1.       These Regulations amend (in Schedule 1) 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, 247 and 369; 1999 Nos. 62, 209 and 324; 2000 Nos. 29, 48, 70, 123, 124, 267 and 358; 2001 Nos. 159, 160, 252 and 343; 2002 Nos. 9, 84, 114, 143, 234, 315 and 345; 2003 Nos. 111, 151, 257, 258 and 301.

          These Regulations also amend (in Schedule 2) Statutory Rules 2002 No. 236, as amended by 2003 Nos. 153 and 259.

2.       Notified in the Commonwealth of Australia Gazette on 23 December 2003.