Drugs, Poisons and Controlled Substances and
Therapeutic Goods (Victoria) Acts (Amendment)
Act 2004
Act No. 74/2004
TABLE OF PROVISIONS
Section
Page
PART 1—PRELIMINARY
1.
2.
1
Purposes
Commencement
1
2
PART 2—DRUGS, POISONS AND CONTROLLED SUBSTANCES
ACT 1981—REPEAL OF LICENSING REQUIREMENTS FOR
SCHEDULE 5 POISONS AND SCHEDULE 6 POISONS
3.
4.
5.
Authorisation to sell or supply by retail Schedule 5 poisons or
Schedule 6 poisons
Licence no longer required to manufacture and sell or supply by
wholesale or retail Schedule 5 poisons or Schedule 6 poisons
New sections 138 and 139 inserted
138.
Refund of licence fee in relation to Schedule 5 poisons
and Schedule 6 poisons
139.
Transitional provisions relating to licences—Drugs,
Poisons and Controlled Substances and Therapeutic
Goods (Victoria) Acts (Amendment) Act 2004
PART 3—DRUGS, POISONS AND CONTROLLED SUBSTANCES
ACT 1981—POISONS CODE AND OTHER AMENDMENTS
6.
7.
8.
9.
10.
11.
12.
13.
14.
Definitions
The Poisons List
Amendment of Poisons Code
Repeal of section 12M
Authorisations
New section 18A inserted
18A. Definitions
Licences under Division 4 of Part II
Permits for the provision of health services
Offences concerning labelling, containers and advertising
i
3
3
3
4
4
5
7
7
8
9
10
10
10
10
11
11
11
Section
15.
16.
17.
18.
19.
20.
21.
Page
Section 32 substituted
32.
Record keeping in relation to sale or supply of drugs
of addiction
Prohibition on administration of drugs for continuous period
greater than 8 weeks
Repeal of regulation-making power to amend Schedule Eleven
New section 135A inserted
135A. Transitional provisions—Drugs, Poisons and
Controlled Substances (Amendment) Act 1994
Schedule Eleven amended
Repeal of Drugs, Poisons and Controlled Substances
(Amendment) Act 1994
Amendment of Corrections Act 1986
PART 4—THERAPEUTIC GOODS (VICTORIA) ACT 1994
22.
23.
24.
13
13
14
15
15
15
16
16
16
17
Definitions
Part 5 substituted
17
17
PART 5—CODES OF PRACTICE
17
45.
Codes of Practice
46.
Status of a Code of Practice
47.
Procedure for making or adopting Codes of Practice
48.
Commencement of Code of Practice
49.
Availability of Codes of Practice
50.
Tabling in Parliament
51.
Conviction of offence under Code of Practice
52.
Requirement to comply with Code of Practice
Repeal of redundant sections
═══════════════
17
18
19
20
20
21
22
22
22
ENDNOTES
23
ii
Victoria
No. 74 of 2004
Drugs, Poisons and Controlled
Substances and Therapeutic Goods
(Victoria) Acts (Amendment) Act 2004†
[Assented to 9 November 2004]
The Parliament of Victoria enacts as follows:
PART 1—PRELIMINARY
1. Purposes
The main purposes of this Act are—
(a) to amend the Drugs, Poisons and
Controlled Substances Act 1981 to provide
for the scheduling of poisons, to amend
certain licence, permit and warrant
1
Drugs, Poisons and Controlled Substances and Therapeutic
Goods (Victoria) Acts (Amendment) Act 2004
Act No. 74/2004
s. 2
Part 1—Preliminary
provisions and to repeal certain licensing
requirements in relation to Schedule 5
poisons and Schedule 6 poisons;
(b) to amend the Therapeutic Goods (Victoria)
Act 1994 to provide for Codes of Practice in
relation to therapeutic goods.
2. Commencement
This Act comes into operation on the day after the
day on which it receives the Royal Assent.
__________________
2
Drugs, Poisons and Controlled Substances and Therapeutic
Goods (Victoria) Acts (Amendment) Act 2004
Act No. 74/2004
Part 2—Drugs, Poisons and Controlled Substances Act 1981—Repeal of
Licensing Requirements for Schedule 5 Poisons and Schedule 6 Poisons
PART 2—DRUGS, POISONS AND CONTROLLED
SUBSTANCES ACT 1981—REPEAL OF LICENSING
REQUIREMENTS FOR SCHEDULE 5 POISONS AND
SCHEDULE 6 POISONS
3. Authorisation to sell or supply by retail Schedule 5
poisons or Schedule 6 poisons
After section 13(4) of the Drugs, Poisons and
Controlled Substances Act 1981 insert—
"(4A) A person is authorised to sell or supply by
wholesale, subject to and in accordance with
the regulations—
(a) any Schedule 5 poison; or
(b) any Schedule 6 poison.
(4B) A person is authorised to manufacture and
sell or supply by retail, subject to and in
accordance with the regulations—
(a) any Schedule 5 poison; or
(b) any Schedule 6 poison.
(4C) A person is authorised to manufacture and
sell or supply by wholesale, subject to and in
accordance with the regulations—
(a) any Schedule 5 poison; or
(b) any Schedule 6 poison.".
4. Licence no longer required to manufacture and sell
or supply by wholesale or retail Schedule 5 poisons
or Schedule 6 poisons
(1) For section 20(1)(b) of the Drugs, Poisons and
Controlled Substances Act 1981 substitute—
"(b) manufacture and sell or supply by wholesale
any Schedule 2 poison, Schedule 3 poison,
Schedule 4 poison or Schedule 7 poison;".
3
s. 3
See:
Act No.
9719.
Reprint No. 7
as at
1 July 2004
and
amending
Act No.
16/2004.
LawToday:
www.dms.
dpc.vic.
gov.au
Drugs, Poisons and Controlled Substances and Therapeutic
Goods (Victoria) Acts (Amendment) Act 2004
Act No. 74/2004
s. 5
Part 2—Drugs, Poisons and Controlled Substances Act 1981—Repeal of
Licensing Requirements for Schedule 5 Poisons and Schedule 6 Poisons
(2) In section 20(1)(c) of the Drugs, Poisons and
Controlled Substances Act 1981 omit "Schedule
5 poison, Schedule 6 poison or a".
(3) For section 20(1)(e) of the Drugs, Poisons and
Controlled Substances Act 1981 substitute—
"(e) sell or supply by wholesale any Schedule 2
poison, Schedule 3 poison, Schedule 4
poison or Schedule 7 poison;".
5. New sections 138 and 139 inserted
After section 137 of the Drugs, Poisons and
Controlled Substances Act 1981 insert—
"138. Refund of licence fee in relation to
Schedule 5 poisons and Schedule 6 poisons
(1) The Secretary may refund to a licence holder
an amount equal to the proportion of the fee
paid for a licence in relation to the period
that starts on the date of the commencement
of the Drugs, Poisons and Controlled
Substances and Therapeutic Goods
(Victoria) Acts (Amendment) Act 2004 and
ends on the expiry of the licence if—
(a) the licence is issued under Division 4 of
Part II for—
(i) the sale or supply by wholesale of
a Schedule 5 poison or a Schedule
6 poison; or
(ii) the manufacture and sale or
supply by retail of a Schedule 5
poison or a Schedule 6 poison; or
(iii) the manufacture and sale or
supply by wholesale of a Schedule
5 poison or a Schedule 6 poison;
and
4
Drugs, Poisons and Controlled Substances and Therapeutic
Goods (Victoria) Acts (Amendment) Act 2004
Act No. 74/2004
Part 2—Drugs, Poisons and Controlled Substances Act 1981—Repeal of
Licensing Requirements for Schedule 5 Poisons and Schedule 6 Poisons
(b) at that commencement, the licence has
a period of at least 6 months to run
before its expiry.
(2) A refund paid to a licence holder under subsection (1) is to be paid from the
Consolidated Fund which is, to the necessary
extent, appropriated accordingly.
139. Transitional provisions relating to
licences—Drugs, Poisons and Controlled
Substances and Therapeutic Goods
(Victoria) Acts (Amendment) Act 2004
(1) An application for a new licence of a kind
referred to in section 20(1)(b) or (e) of this
Act as in force immediately before the
commencement of the Drugs, Poisons and
Controlled Substances and Therapeutic
Goods (Victoria) Acts (Amendment)
Act 2004 or for the renewal of such a licence
must be taken to be an application for a
licence or for its renewal (as the case
requires) of a kind of licence referred to in
the relevant section as amended by the
Drugs, Poisons and Controlled Substances
and Therapeutic Goods (Victoria) Acts
(Amendment) Act 2004.
(2) A licence—
(a) of a kind referred to in section 20(1)(b)
or (e) of this Act as in force
immediately before the commencement
of the Drugs, Poisons and Controlled
Substances and Therapeutic Goods
(Victoria) Acts (Amendment) Act
2004 (including a suspended licence);
and
5
s. 5
Drugs, Poisons and Controlled Substances and Therapeutic
Goods (Victoria) Acts (Amendment) Act 2004
Act No. 74/2004
s. 5
Part 2—Drugs, Poisons and Controlled Substances Act 1981—Repeal of
Licensing Requirements for Schedule 5 Poisons and Schedule 6 Poisons
(b) in existence at the date of that
commencement—
must be taken to have been issued under this
Act as amended by the Drugs, Poisons and
Controlled Substances and Therapeutic
Goods (Victoria) Acts (Amendment)
Act 2004 and may be renewed, amended,
suspended or cancelled accordingly.
(3) The amendments to section 20(1)(b) and (e)
made by the Drugs, Poisons and
Controlled Substances and Therapeutic
Goods (Victoria) Acts (Amendment)
Act 2004 do not affect the continuity or
suspension of a licence of a kind referred to
in section 20(1)(b) or (e) of this Act as in
force immediately before the commencement
of that Act.".
__________________
6
Drugs, Poisons and Controlled Substances and Therapeutic
Goods (Victoria) Acts (Amendment) Act 2004
Act No. 74/2004
Part 3—Drugs, Poisons and Controlled Substances Act 1981—Poisons Code
and Other Amendments
PART 3—DRUGS, POISONS AND CONTROLLED
SUBSTANCES ACT 1981—POISONS CODE AND OTHER
AMENDMENTS
6. Definitions
(1) In section 4(1) of the Drugs, Poisons and
Controlled Substances Act 1981, in the
definition of "drug of dependence"—
(a) in paragraph (a) omit "or added thereto by
regulations made under section 12M" (where
twice occurring);
(b) in paragraph (b) omit "or added thereto by
regulations made under section 12M";
(c) in paragraph (c) omit "or added thereto by
regulations made under section 12M" (where
twice occurring).
(2) In section 4(1) of the Drugs, Poisons and
Controlled Substances Act 1981—
(a) in the definition of "Schedule 2 Poison", for
"in the Poisons List" substitute "of the
Commonwealth standard";
(b) in the definition of "Schedule 3 Poison", for
"in the Poisons List" substitute "of the
Commonwealth standard";
(c) in the definition of "Schedule 4 Poison", for
"in the Poisons List" substitute "of the
Commonwealth standard";
(d) in the definition of "Schedule 5 Poison", for
"in the Poisons List" substitute "of the
Commonwealth standard";
(e) in the definition of "Schedule 6 Poison", for
"in the Poisons List" substitute "of the
Commonwealth standard";
7
s. 6
Drugs, Poisons and Controlled Substances and Therapeutic
Goods (Victoria) Acts (Amendment) Act 2004
Act No. 74/2004
s. 7
Part 3—Drugs, Poisons and Controlled Substances Act 1981—Poisons Code
and Other Amendments
(f) in the definition of "Schedule 7 Poison", for
"in the Poisons List" substitute "of the
Commonwealth standard";
(g) in the definition of "Schedule 8 Poison", for
"in the Poisons List" substitute "of the
Commonwealth standard";
(h) in the definition of "Schedule 9 Poison", for
"in the Poisons List" substitute "of the
Commonwealth standard".
7. The Poisons List
(1) In section 12A(1) of the Drugs, Poisons and
Controlled Substances Act 1981—
(a) for "must contain" substitute "may contain";
(b) for paragraph (a) substitute—
"(a) a list of substances that are of plant,
animal or mineral origin that in the
public interest should be available only
from a person registered under the
Chinese Medicine Registration
Act 2000 or authorised under another
Act, being Schedule 1 poisons; and";
(c) in paragraph (b), for "those Schedules"
substitute "Schedule 1 of the Poisons List or
Schedules 2 to 9 of the Commonwealth
standard";
(d) in paragraph (c), for "those Schedules"
substitute "Schedule 1 of the Poisons List or
Schedules 2 to 9 of the Commonwealth
standard".
(2) Section 12A(2) of the Drugs, Poisons and
Controlled Substances Act 1981 is repealed.
(3) Section 12A(3)(a) of the Drugs, Poisons and
Controlled Substances Act 1981 is repealed.
8
Drugs, Poisons and Controlled Substances and Therapeutic
Goods (Victoria) Acts (Amendment) Act 2004
Act No. 74/2004
Part 3—Drugs, Poisons and Controlled Substances Act 1981—Poisons Code
and Other Amendments
(4) For section 12A(4) of the Drugs, Poisons and
Controlled Substances Act 1981 substitute—
"(4) In this Act, a reference to a particular
substance in Schedule 1 of the Poisons List
or to a particular substance in Schedules 2 to
9 of the Commonwealth standard excludes
that substance to the extent that it is included
in the list of exemptions under sub-section
(1)(c).".
(5) The table at the end of section 12A of the Drugs,
Poisons and Controlled Substances Act 1981 is
repealed.
8. Amendment of Poisons Code
(1) In section 12E(1)(d) of the Drugs, Poisons and
Controlled Substances Act 1981, for "any of the
Schedules" substitute "Schedule 1".
(2) After section 12E(1B) of the Drugs, Poisons and
Controlled Substances Act 1981 insert—
"(1C) The Minister may, at any time, amend the
Poisons Code to—
(a) specify the substances to be included in
the Poisons List in the list of substances
that are not for general sale by retail but
can only be supplied to persons
specifically authorised by this Act or
the Regulations, or with a permit or
warrant under this Act, to obtain them;
and
(b) amend, revoke, substitute or insert
substances in the list referred to in
paragraph (a).
9
s. 8
Drugs, Poisons and Controlled Substances and Therapeutic
Goods (Victoria) Acts (Amendment) Act 2004
Act No. 74/2004
s. 9
Part 3—Drugs, Poisons and Controlled Substances Act 1981—Poisons Code
and Other Amendments
(1D) The Minister may, at any time, amend the
Poisons Code to—
(a) specify the substances to be included in
the Poisons List in the list of
exemptions from Schedule 1 of the
Poisons List or Schedules 2 to 9 of the
Commonwealth standard; and
(b) amend, revoke, substitute or insert
substances in the list of exemptions
referred to in paragraph (a).".
9. Repeal of section 12M
Section 12M of the Drugs, Poisons and
Controlled Substances Act 1981 is repealed.
10. Authorisations
In section 13(2B) of the Drugs, Poisons and
Controlled Substances Act 1981—
(a) omit "the Table to section 12A or";
(b) omit "number";
(c) for "Poisons List" substitute
"Commonwealth standard".
11. New section 18A inserted
Before section 19 of the Drugs, Poisons and
Controlled Substances Act 1981 insert—
'18A. Definitions
In this Division—
"licence" means a licence issued under this
Division;
"permit" means a permit issued under this
Division;
"warrant" means a warrant issued under
this Division.'.
10
Drugs, Poisons and Controlled Substances and Therapeutic
Goods (Victoria) Acts (Amendment) Act 2004
Act No. 74/2004
Part 3—Drugs, Poisons and Controlled Substances Act 1981—Poisons Code
and Other Amendments
12. Licences under Division 4 of Part II
In section 19(4) of the Drugs, Poisons and
Controlled Substances Act 1981, for "Act"
substitute "Division".
13. Permits for the provision of health services
After section 20(3) of the Drugs, Poisons and
Controlled Substances Act 1981 insert—
"(3A) A person who is the holder of a permit issued
under sub-section (3) authorising the person
to purchase or otherwise obtain poisons or
controlled substances for the provision of
health services is authorised to sell or supply
any poison or controlled substance to which
that permit relates without obtaining a
further licence to do so under this section if
that sale or supply—
(a) is carried out by a person who is
authorised under section 13(1)(a), (ba)
or (c) to sell or supply that poison or
controlled substance in the lawful
practice of his or her profession; and
(b) is for the purposes of the provision of
health services.".
14. Offences concerning labelling, containers and
advertising
(1) For section 27A(1) of the Drugs, Poisons and
Controlled Substances Act 1981 substitute—
"(1) A person must not sell or supply a poison or
controlled substance with a label that does
not comply with the requirements of—
(a) in the case of a Schedule 1 poison, the
Poisons Code; or
11
s. 12
Drugs, Poisons and Controlled Substances and Therapeutic
Goods (Victoria) Acts (Amendment) Act 2004
Act No. 74/2004
s. 14
Part 3—Drugs, Poisons and Controlled Substances Act 1981—Poisons Code
and Other Amendments
(b) in the case of any other poison or
controlled substance, the
Commonwealth standard.
Penalty: 20 penalty units.
(1A) A person must not sell or supply a poison or
controlled substance in a container that does
not comply with the requirements of—
(a) in the case of a Schedule 1 poison, the
Poisons Code; or
(b) in the case of any other poison or
controlled substance, the
Commonwealth standard.
Penalty: 20 penalty units.".
(2) In section 27A(2) of the Drugs, Poisons and
Controlled Substances Act 1981 for "poison or
controlled substance" substitute "Schedule 1
poison".
(3) After section 27A(2) of the Drugs, Poisons and
Controlled Substances Act 1981 insert—
"(2A) A person must not sell or supply a poison or
controlled substance (other than a Schedule 1
poison)—
(a) which the person has stored or
packaged otherwise than in accordance
with the Commonwealth standard; or
(b) which the person knows to have been
stored or packaged otherwise than in
accordance with the Commonwealth
standard.
Penalty: 20 penalty units.".
(4) In section 27A(3) of the Drugs, Poisons and
Controlled Substances Act 1981 for "poison or
controlled substance" substitute "Schedule 1
poison".
12
Drugs, Poisons and Controlled Substances and Therapeutic
Goods (Victoria) Acts (Amendment) Act 2004
Act No. 74/2004
Part 3—Drugs, Poisons and Controlled Substances Act 1981—Poisons Code
and Other Amendments
(5) After section 27A(3) of the Drugs, Poisons and
Controlled Substances Act 1981 insert—
"(3A) A person must not advertise for sale or
supply a poison or controlled substance
(other than a Schedule 1 poison) otherwise
than in accordance with the Commonwealth
standard.
Penalty: 20 penalty units.".
(6) In section 29(2) of the Drugs, Poisons and
Controlled Substances Act 1981, after "this
Act," insert "the Commonwealth standard,".
15. Section 32 substituted
For section 32 of the Drugs, Poisons and
Controlled Substances Act 1981 substitute—
"32. Record keeping in relation to sale or
supply of drugs of addiction
(1) A person who is licensed under this Part to
manufacture, sell, supply or distribute any
Schedule 8 poison or Schedule 9 poison
must record or cause to be recorded, in
accordance with sub-section (2)—
(a) details of any Schedule 8 poison or
Schedule 9 poison obtained by the
person; and
(b) quantities of those poisons used, sold,
supplied or otherwise disposed of; and
(c) such other particulars as are prescribed.
Penalty: 60 penalty units.
(2) For the purposes of sub-section (1), the
record kept must be recorded—
(a) by printing or writing in a legible form
in the English language; or
13
s. 15
Drugs, Poisons and Controlled Substances and Therapeutic
Goods (Victoria) Acts (Amendment) Act 2004
Act No. 74/2004
s. 16
Part 3—Drugs, Poisons and Controlled Substances Act 1981—Poisons Code
and Other Amendments
(b) in an electronic form that is readily
convertible into legible print in the
English language.".
16. Prohibition on administration of drugs for
continuous period greater than 8 weeks
After section 35(4) of the Drugs, Poisons and
Controlled Substances Act 1981 insert—
"(5) For the purposes of this section, a registered
medical practitioner administers, supplies or
prescribes a Schedule 8 poison or Schedule 9
poison to a patient for a continuous period
mentioned in sub-section (2), (2A) or (3) if
the registered medical practitioner—
(a) actually administers, supplies or
prescribes that Schedule 8 poison or
Schedule 9 poison for that period; or
(b) supplies a quantity or quantities of a
Schedule 8 poison or Schedule 9 poison
to the patient and instructs the patient to
take the drug for that period; or
(c) prescribes for the patient a quantity or
quantities of a Schedule 8 poison or
Schedule 9 poison which, if taken in
accordance with the prescription, would
be taken for that period.
(6) For the purposes of this section, a nurse
practitioner administers, supplies or
prescribes a Schedule 8 poison to a patient
for a continuous period mentioned in subsection (2AA), (2A) or (4) if the nurse
practitioner—
(a) actually administers, supplies or
prescribes that Schedule 8 poison for
that period; or
14
Drugs, Poisons and Controlled Substances and Therapeutic
Goods (Victoria) Acts (Amendment) Act 2004
Act No. 74/2004
Part 3—Drugs, Poisons and Controlled Substances Act 1981—Poisons Code
and Other Amendments
(b) supplies a quantity or quantities of a
Schedule 8 poison to the patient and
instructs the patient to take the drug for
that period; or
(c) prescribes for the patient a quantity or
quantities of a Schedule 8 poison
which, if taken in accordance with the
prescription, would be taken for that
period.".
17. Repeal of regulation-making power to amend
Schedule Eleven
Section 132(zcb) of the Drugs, Poisons and
Controlled Substances Act 1981 is repealed.
18. New section 135A inserted
After section 135 of the Drugs, Poisons and
Controlled Substances Act 1981 insert—
"135A. Transitional provisions—Drugs, Poisons
and Controlled Substances (Amendment)
Act 1994
Despite the repeal of the Drugs, Poisons
and Controlled Substances (Amendment)
Act 1994 by the Drugs, Poisons and
Controlled Substances and Therapeutic
Goods (Victoria) Acts (Amendment)
Act 2004, a warrant to which section 19(2)
of the Drugs, Poisons and Controlled
Substances (Amendment) Act 1994
(including a suspended warrant) applied
immediately before that repeal must be taken
to have been issued under this Act and may
be amended, suspended or cancelled
accordingly.".
15
s. 17
Drugs, Poisons and Controlled Substances and Therapeutic
Goods (Victoria) Acts (Amendment) Act 2004
Act No. 74/2004
s. 19
Part 3—Drugs, Poisons and Controlled Substances Act 1981—Poisons Code
and Other Amendments
19. Schedule Eleven amended
In Part 3 of Schedule Eleven to the Drugs,
Poisons and Controlled Substances Act 1981,
after the item relating to "AMPHETAMINE"—
(a) in column 1 insert "BUPRENORPHINE";
(b) in column 3 insert "2·0g".
20. Repeal of Drugs, Poisons and Controlled Substances
(Amendment) Act 1994
The Drugs, Poisons and Controlled Substances
(Amendment) Act 1994 is repealed.
21. Amendment of Corrections Act 1986
For section 29A(1)(c) of the Corrections
Act 1986 substitute—
"(c) any Schedule 8 poison or Schedule 9 poison
within the meaning of the Drugs, Poisons
and Controlled Substances Act 1981.".
__________________
16
Drugs, Poisons and Controlled Substances and Therapeutic
Goods (Victoria) Acts (Amendment) Act 2004
Act No. 74/2004
Part 4—Therapeutic Goods (Victoria) Act 1994
PART 4—THERAPEUTIC GOODS (VICTORIA) ACT 1994
22. Definitions
In section 3 of the Therapeutic Goods (Victoria)
Act 1994—
(a) after the definition of "British
Pharmacopoeia (Veterinary)" insert—
' "Code of Practice" means a Code of
Practice made or adopted under Part 5;';
(b) in the definition of "licence" omit "or
Part 5".
23. Part 5 substituted
For Part 5 of the Therapeutic Goods (Victoria)
Act 1994 substitute—
"PART 5—CODES OF PRACTICE
45. Codes of Practice
(1) The Victorian Secretary may make or adopt
Codes of Practice in accordance with this
Part.
(2) A Code of Practice must be approved by the
Minister before it is made or adopted.
(3) A Code of Practice may apply, adopt or
incorporate any matter contained in any
document, code, standard, rule, specification
or method formulated, issued, prescribed or
published by any authority or body
whether—
(a) wholly or partially or as amended by
the Code of Practice; or
17
s. 22
See:
Act No.
79/1994.
Reprint No. 1
as at
11 May 1999
and
amending
Act No.
67/2001.
LawToday:
www.dms.
dpc.vic.
gov.au
Drugs, Poisons and Controlled Substances and Therapeutic
Goods (Victoria) Acts (Amendment) Act 2004
Act No. 74/2004
s. 23
Part 4—Therapeutic Goods (Victoria) Act 1994
(b) as formulated, issued, prescribed or
published at the time the Code of
Practice is made or adopted or at any
time before then; or
(c) as formulated, issued, prescribed or
published from time to time.
(4) If a Code of Practice has applied, adopted or
incorporated any matter contained in any
document, code, standard, rule, specification
or method as formulated, issued, prescribed
or published from time to time and that
document, code, standard, rule, specification
or method is at any time amended, until the
Victorian Secretary causes notice to be
published in the Government Gazette of that
amendment, the document, code, standard,
rule, specification or method is to be taken
not to have been so amended.
(5) A Code of Practice may—
(a) confer a discretionary authority or
impose a duty on a specified person or
body or a specified class of persons and
bodies;
(b) leave any matter or thing to be from
time to time determined, applied,
dispensed with or regulated by the
Victorian Secretary;
(c) authorise an authorised person to
enforce the Code of Practice.
46. Status of a Code of Practice
A Code of Practice is a subordinate
instrument for the purposes of the
Interpretation of Legislation Act 1984
except section 32 of that Act.
18
Drugs, Poisons and Controlled Substances and Therapeutic
Goods (Victoria) Acts (Amendment) Act 2004
Act No. 74/2004
Part 4—Therapeutic Goods (Victoria) Act 1994
47. Procedure for making or adopting Codes
of Practice
(1) Before the Victorian Secretary makes or
adopts a Code of Practice, the Victorian
Secretary must give a notice stating—
(a) the purpose and general purport of the
proposed Code of Practice;
(b) where a copy of the proposed Code of
Practice can be obtained or inspected;
(c) in the case of the proposed making of a
Code of Practice, that any person may
make a submission on the proposed
Code of Practice to the Victorian
Secretary within the period specified in
the notice.
(2) In the case of the proposed making of a Code
of Practice, the Victorian Secretary must—
(a) allow at least 28 days after the day on
which a notice is given under subsection (1) for the making of
submissions; and
(b) if, after considering any submissions
made, the Victorian Secretary
determines to make the Code of
Practice, give a notice stating that the
Victorian Secretary intends to make the
Code of Practice.
(3) A notice under this section must be—
(a) published in the Government Gazette;
and
(b) published in a daily newspaper
generally circulating in Victoria; and
19
s. 23
Drugs, Poisons and Controlled Substances and Therapeutic
Goods (Victoria) Acts (Amendment) Act 2004
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(c) sent to bodies or organisations that the
Victorian Secretary considers are likely
to be affected by the proposed Code of
Practice.
48. Commencement of Code of Practice
A Code of Practice or a provision of a Code
of Practice comes into operation—
(a) on the day on which the Code of
Practice is approved by the Minister; or
(b) on such later day as is expressed in the
Code of Practice as the day on which
the Code of Practice or provision comes
into operation.
49. Availability of Codes of Practice
(1) Upon the making or adoption of a Code of
Practice, the Victorian Secretary must cause
to be published in the Government Gazette
notice of—
(a) the making or adoption of the Code of
Practice; and
(b) the date of commencement of the Code
of Practice; and
(c) the place where copies of the Code of
Practice may be obtained.
(2) A notice published under sub-section (1) or a
notice of an amendment published under
section 45(4) must include a statement that
the Code of Practice, any incorporated
document or any amendment to an
incorporated document (as the case may be)
may be inspected at the office of the
Victorian Secretary specified in the notice.
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Drugs, Poisons and Controlled Substances and Therapeutic
Goods (Victoria) Acts (Amendment) Act 2004
Act No. 74/2004
Part 4—Therapeutic Goods (Victoria) Act 1994
50. Tabling in Parliament
(1) The Minister must cause a copy of a Code of
Practice that is made or adopted under
section 45 and of the notice of its making or
adoption to be laid before each House of
Parliament within 7 sitting days of that
House after the notice is published in the
Government Gazette.
(2) If the Code of Practice has applied, adopted
or incorporated any matter contained in any
document, code, standard, rule, specification
or method as formulated, issued, prescribed
or published, the Minister must include that
applied, adopted or incorporated matter in
the material laid before each House of
Parliament under sub-section (1).
(3) If the Code of Practice has applied, adopted
or incorporated any matter contained in any
document, code, standard, rule, specification
or method as formulated, issued, prescribed
or published and that document, code,
standard, rule, specification or method is at
any time amended, the Minister must cause a
copy of the amendment and of the notice of
amendment under section 45(4) to be laid
before each House of Parliament within
7 sitting days of that House after the notice
under section 45(4) is published in the
Government Gazette.
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51. Conviction of offence under Code of
Practice
A person must not be convicted of an
offence or be prejudicially affected or made
subject to any liability under a Code of
Practice if it is proved that at the relevant
time—
(a) notice of the Code of Practice had not
been published in the Government
Gazette; or
(b) a copy of the Code of Practice and any
incorporated matter was not available
for inspection.
52. Requirement to comply with Code of
Practice
A person who carries out an activity to
which a Code of Practice relates must
comply with the relevant Code of Practice.
Penalty: 10 penalty units.".
24. Repeal of redundant sections
(1) Section 72(1)(e) of the Therapeutic Goods
(Victoria) Act 1994 is repealed.
(2) Section 76 of the Therapeutic Goods (Victoria)
Act 1994 is repealed.
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Goods (Victoria) Acts (Amendment) Act 2004
Act No. 74/2004
Endnotes
ENDNOTES
†
Minister's second reading speech—
Legislative Assembly: 16 September 2004
Legislative Council: 13 October 2004
The long title for the Bill for this Act was "to amend the Drugs, Poisons
and Controlled Substances Act 1981 in relation to the scheduling of
poisons and certain licence, permit and warrant provisions, to repeal the
licensing requirements in relation to Schedule 5 poisons and Schedule 6
poisons, to amend the Therapeutic Goods (Victoria) Act 1994 and to
consequentially amend other Acts and for other purposes."
23