Federal Register of Legislation - Australian Government

Primary content

Therapeutic Goods Regulations (Amendment)

Authoritative Version
  • - F1996B00407
  • No longer in force
SR 1991 No. 84 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 HR07-May-1991
Tabled Senate08-May-1991
Gazetted 30 Apr 1991
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014








Statutory  Rules  1991   No. 841




Therapeutic Goods Regulations 2 (Amendment)



I, THE GOVERNOR-GENERAL of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, hereby make the following Regulations under the Therapeutic Goods Act 1989.


          Dated 29 April 1991.


                                                                                        BILL HAYDEN


          By His Excellency’s Command,




Minister of State for the Aged,

Family and Health Services



1.   Commencement

1.1   Regulations 3.1, 5.2, 7.1, 10.2, 11.1, 12.2, 12.4, 13.1 and 14.1 are taken to have commenced on 15 February 1991.



2.   Amendment

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


3.   Regulation 12 (Exempt goods)

3.1   After subregulation 12 (1), insert:



           “(1a)  For the purposes of subsection 18 (1) of the Act, the therapeutic goods or classes of therapeutic goods specified in an item in column 2 of Schedule 5a are exempt from the operation of Part 3 of the Act subject to compliance with the relevant conditions specified in column 3 of that Schedule.”.



4.   Regulation 24 (Authorised officer—powers and duties)

4.1   Paragraph 24 (1) (a):

After “licence holder”, insert “or wholesaler”.



5.   Regulation 45 (Waiver or reduction of fees)

5.1   Paragraph 45 (2) (a):

After “ingredient”, insert “or are therapeutic devices”.


5.2   Subregulation 45 (3):

Omit “payable in relation to the entry of therapeutic goods in the Register”, substitute “that are payable in relation to therapeutic goods”.



6.   Part 7 (Fees and costs)

6.1   Heading:

Omit the heading, substitute “FEES, COSTS AND CHARGES”.



7.   New regulation 45a

7.1   After regulation 45, insert in Part 7:


Charges reduced where annual turnover is not more than $50,000

          “45a.  If the wholesale turnover of therapeutic goods of a person who is required to hold a licence under Part 4 of the Act is not more than $50,000 in a financial year, the annual charge payable by the person for a licence that is in force at any time during that financial year is half of the amount otherwise payable under subregulation 3 (2) of the Therapeutic Goods (Charges) Regulations in respect of that licence.”.



8.   Regulation 46 (Release of information)

8.1   Subparagraph 46 (2) (e) (ii):

Omit “Poisons Schedule”, substitute “Poisons Standard”.



9.   Regulation 48 (Review of decisions)

9.1   After subregulation (1), insert:


           “(1a)  The Minister may, by signed instrument, delegate to an officer of the Department all or any of the Minister’s powers and functions under this Regulation other than the power of delegation.”.



10.   Schedule 3 (Therapeutic goods required to be included in the part of the Register for registered goods)

10.1   Item 3, paragraph (c):

Before “accessories”, insert “implantable”.


10.2   Item 3, paragraph (g):

Omit the paragraph, substitute:



  “(g)  devices of human or animal origin, other than devices for use on or in the body of a person, that:

(i)  are manufactured using animal-derived fats, waxes or varnishes; or

 (ii)  are used externally; or

(iii)  contain wax and are used internally; or

(iv)  incorporate heparin, unless heparin is being delivered as a drug; or

(v)  are sutures conforming to a standard determined under Part 2 of the Act; or

(vi)  are made from sintered hydroxyapatite.”




11.   Schedule 4 (Therapeutic goods required to be included in the

part of the Register for listed goods)

11.1   Part 3:

After “Magnesium sulfate”, insert “Manganese amino acid chelate as a source of manganese”.


11.2   Part 4 (item relating to Acorus calamus):

Omit “, Blue flag”.




11.3   Part 4:

Add at the end:


“[NOTE:  As to preparations containing a herbal substance derived from a herb not approved in Australia for therapeutic use in humans, see Schedule 3, item 2.]”.



12.   Schedule 5 (Therapeutic goods exempt from the operation of

Part 3 of the Act)

12.1   Heading:

Omit “Regulation 12”, substitute “Subregulation 12 (1)”.


12.2   Item 5:

Omit the item.


12.3   Item 7, paragraph (c):

Omit the paragraph, substitute:



“(c)  non-implantable, non-powered diagnostic tools that:

  (i)  are not supplied in a sterile state; and

 (ii)  are not intended to monitor a physiological process; and

(iii)  are not referred to in paragraph (b)”.


12.4   Item 10:

Omit the item.


12.5   Item 11:

Omit the item, substitute:



therapeutic goods:

    (a)    in relation to the importation of which a permission, licence or declaration under regulation 5a, 5b or 5c of the Customs (Pro-hibited Imports) Regulations granted or made before the commencement of the Act is in force; and



    (b)  which are supplied in Australia for use in humans not more than 6 months after the commencement  of the Act”.



13.   New schedule 5a (Therapeutic goods exempt from the operation of Part 3 of the Act subject to conditions)

13.1   After Schedule 5, insert:


                                        “SCHEDULE 5a               Subregulation 12(1a)





Column 1

Item No.


Column 2

Therapeutic goods

Column 3



Goods imported into Australia that are held under the direct control of the sponsor pending:

    (a)  approval for regis-tration or listing; or

    (b)  approval under subsection 19 (1) of the Act


(a)  the sponsor must:

  (i)  keep records relating to the source and supply of those goods; and

 (ii)  if requested by the Secretary, supply those records to the Secretary; and

(b)  if the goods are the subject of an approval under subsection 19 (1) of the Act, the supply of those goods must be in accordance with that approval


Japanese encephalitis vaccine

the vaccine must be:

(a)  imported by the undertaking known as Commonwealth Serum Labora-tories for supply to Fairfield Hospital in the State of Victoria; and

(b)  supplied to that Hospital for use in patients who have given adequately informed consent to the proposed treatment before it is commenced, being patients who:

  (i)  are to be resident for more than 12 months in an area in which Japanese encephalitis is endemic; or

 (ii)  make, or are to make, repeated short trips to areas in which Japanese encephalitis is endemic; or


SCHEDULE 5a—continued


Column 1

Item No.


Column 2

Therapeutic goods

Column 3




(iii)  intend to visit rural areas in which there is an epidemic of Japanese encephalitis; and

(c) approved for administration to each patient by, or at the direction of, the Director of Medical Services at that Hospital; and

(d) prescribed by a medical practitioner working at the hospital who is not the person who approved its administration to the patient to whom it is administered.



13.2  Add at the end:



Therapeutic goods used solely for experimental purposes in humans

(a)  before starting to use the goods, the sponsor must notify the Secretary in writing, in accordance with a form approved by the Secretary, that he or she intends to undertake a clinical trial using specified goods; and



(b)  the notification must be accompanied by the notification fee referred to in item 14 of Schedule 9; and

(c)  the goods must be approved for this purpose by the Chairperson of the Ethics Committee responsible for the hospital or institution in which the trial is to be undertaken; and



(d) that Ethics Committee must be constituted and operate in accordance with the current guidelines of the National Health and Medical Research Council; and

(e)  the Secretary must not, at any time:

  (i) have become aware that to undertake or continue the trial would be contrary to the public interest; and

 (ii)  have directed that the trial not be undertaken or be stopped, as appropriate in the circumstances of the case”.




14.   Schedule 7 (Therapeutic goods exempt from the operation of

Part 4 of the Act unless supplied as pharmaceutical benefits)

14.1   Item 3:

Omit the item, substitute:



components for therapeutic devices”.



15.   Schedule 9 (Fees)

15.1   Item 2, subparagraph (d) (i):

Omit “ingredient(s)”, substitute “ingredient or are therapeutic devices”.


15.2   Item 12:

After “modification to”, insert “, or variation of, the written information relating to”.


15.3   Add at the end:




notification fee referred to in item 3 of Schedule 5a








1.      Notified in the Commonwealth of Australia Gazette on 30 April 1991.


2.      Statutory Rules 1990 No. 394.