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Therapeutic Goods Regulations (Amendment)

Authoritative Version
  • - F1996B00412
  • No longer in force
SR 1992 No. 332 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 HR05-Nov-1992
Tabled Senate05-Nov-1992
Gazetted 27 Oct 1992
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

Statutory Rules 1992   No. 3321


Therapeutic Goods Regulations2 (Amendment)

I, The 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 20 October 1992.


                                                                                    BILL HAYDEN


         By His Excellency’s Command,




Minister of State for Aged, Family and Health Services


1.   Amendment

1.1   The Therapeutic Goods Regulations are amended as set out in these Regulations.

[NOTE:  These Regulations commence on gazettal: see Acts Interpretation Act 1901, s.48.]


2.   Regulation 2 (Interpretation)

2.1   Definition of “drugs”, paragraph (a):

Omit the paragraph, substitute:

            “(a)   therapeutic goods that are represented to achieve, or are likely to achieve, their principal intended action by pharmacological, chemical, immunological or metabolic means in or on the body of a person or an animal; and”.

3.   Regulation 46 (Release of information)

3.1   Add at the end:

            “(3)   For the purposes of subsection 61 (6) of the Act, the Secretary may release therapeutic goods information of a kind that relates to the evaluation of therapeutic goods by the Australian Drug Evaluation Committee by publishing the information in the Gazette.”.

4.   New regulation 46A

4.1   Before regulation 46, insert in Part 8:

Delegation under the Act

         “46A.   The appointment of National Manager, Therapeutic Goods Administration is declared for the purposes of paragraph 57 (1) (c) of the Act to be an appointment the holder of which may be a delegate of the Minister or the Secretary under section 57 of the Act.”.

5.   Regulation 47 (Delegation—powers and functions of the Secretary)

5.1   Subregulation 47 (1):

Omit the subregulation, substitute:

            “(1)   The Secretary may delegate a power or function of the Secretary under these Regulations to:

              (a)   an officer of the Department; or

              (b)   the National Manager, Therapeutic Goods Administration.”.

6.   Review of decisions

6.1   Subregulation 48 (1) (definition of “initial decision”):

After “9,”, insert “paragraph 11 (2) (d),”.

6.2   Subregulation 48 (1A):

Omit the subregulation, substitute:

          “(1A)   The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to:

              (a)   an officer of the Department; or

              (b)   the National Manager, Therapeutic Goods Administration.”.

7.   Schedule 1 (Part 2 does not apply to members of an Australian Branch of one of these bodies)

7.1   Item 23 (second occurring):

Omit “23”, substitute “24”.

7.2   Item 24:

Omit “24”, substitute “25”.

7.3   Add at the end:


The Acupuncture Association of Australia, New Zealand and Asia



The New South Wales Research Association of Traditional Chinese Medicine”.

8.   Schedule 5 (Therapeutic goods exempt from the operation of Part 3 of the Act)

8.1   Item 7, paragraph (j):

Omit the paragraph, substitute:


             “(j)    protective clothing for patients or health workers, except:

                                    (i)    clothing supplied in a sterile state; or

                                   (ii)    surgeon’s gloves, patient examination gloves and other protective gloves for the prevention of contact with body fluids or body tissue; or

                                  (iii)    patient nuclear radiation shields and radiation shielding apparel; or”.


8.2   Item 7, subaragraph (m) (ii):

Omit “and”, substitute “or”.


8.3   Item 7, paragraphs (n) and (o):

Add at the end “or”.

9.   Schedule 10

9.1   Omit the heading, substitute:


                                      SCHEDULE 10                     Subregulations 16C (1), 16D (1) and 16F (1)




1.     Notified in the Commonwealth of Australia Gazette on 27 October 1992.

2.     Statutory Rules 1990 No. 394 as amended by 1991 Nos. 84 and 485; 1992 Nos.19, 89, and 109 .