Statutory
Rules1991No. 84 1
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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
Governor-General
By His Excellency’s Command,
PETER STAPLES
Minister of State for the Aged,
Family and
Health Services
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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.”
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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.]”.
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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)”.
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12.4 Item
10:
Omit
the item.
12.5 Item
11:
Omit
the item, substitute:
“11 | 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
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- (b) which are supplied in Australia for use in humans not more than 6 months after the commencement
of the Act”.
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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)
THERAPEUTIC GOODS EXEMPT FROM THE OPERATION OF PART 3
OF THE ACT SUBJECT TO CONDITIONS
Column 1 Item No. | Column 2 Therapeutic goods | Column 3 Conditions |
1 | Goods imported into Australia that are held under
the direct control of the sponsor pending: (a) approval for
regis-tration or listing; or (b) approvalunder 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
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2 | 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
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SCHEDULE
5a— continued
Column 1 Item No. | Column 2 Therapeutic goods | Column 3 Conditions |
(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.”
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13.2 Add
at the end:
“3 | 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
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(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
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(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”.
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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:
“3 | 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:
| “14 | notification fee referred to in item 3 of Schedule 5a | $ 60”. |
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NOTES
1. Notified in the Commonwealth of
Australia Gazette on 30 April 1991.
2. Statutory Rules 1990 No.
394.