Drugs, Poisons and Controlled Substances and
Therapeutic Goods (Victoria) Acts
(Amendment) Bill
Circulation Print
EXPLANATORY MEMORANDUM
General
The main purposes of this Bill are to amend the Drugs, Poisons and
Controlled Substances Act 1981 in relation to the scheduling of poisons, to
amend certain licence permit and warrant provisions, to repeal the licensing
requirements in relation to Schedule 5 and Schedule 6 poisons and to
consequentially amend other Bills. The Bill also amends the Therapeutic
Goods (Victoria) Act 1994 to provide for Codes of Practice in relation to
therapeutic goods.
Clause Notes
PART 1—PRELIMINARY
Clause 1
sets out the main purposes of the Bill.
Clause 2
is the commencement provision and provides that the Bill will
come into operation on the day after the day on which it receives
the Royal Assent.
PART 2—DRUGS POISONS AND CONTROLLED
SUBSTANCES ACT 1981—REPEAL OF LICENSING
REQUIREMENTS FOR SCHEDULE 5 POISONS AND
SCHEDULE 6 POISONS
Clause 3
amends section 13 of the Drugs, Poisons and Controlled
Substances Act 1981 to authorise a person to—

sell or supply by wholesale;

manufacture and sell or supply by retail;

manufacture and sell or supply by wholesale—
any Schedule 5 poison or Schedule 6 poison.
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BILL LA CIRCULATION 17/9/2004
Clause 4
amends section 20 of the Drugs, Poisons and Controlled
Substances Act 1981 to provide that a licence is no longer
required to manufacture and sell or supply by wholesale or retail
Schedule 5 poisons or Schedule 6 poisons as a consequence of
the amendments in clause 3.
Clause 5
inserts a new section 138 into the Drugs, Poisons and
Controlled Substances Act 1981 to empower the Secretary to
refund a proportion of a licence fee to a licence holder who holds
a licence issued under Division 4 of Part II of that Act for—

the sale or supply by wholesale; or

the manufacture and sale or supply be retail; or

the manufacture and sale or supply by wholesale
of a Schedule 5 poison or a Schedule 6 poison. A refund may
only be made if, at commencement of this Bill the licence has a
period of at least 6 months to run before its expiry. The clause
also provides that the refund will be paid from the Consolidated
Fund.
Clause 5 also inserts a new section 139 which is a transitional
provision. It provides that applications for licences or for
renewal of licences under section 20(1)(b) or (e) made before the
commencement of this Bill and licences issued under section
20(1)(b) or (e) before the commencement of this Bill are taken to
have been made or issued under the Drugs, Poisons and
Controlled Substances Act 1981 as amended by this Bill.
The amendments in this Bill do not affect the continuity or
suspension of a licence in force immediately before the
commencement of this Bill.
PART 3—DRUGS POISONS AND CONTROLLED
SUBSTANCES ACT 1981—POISONS CODE AND OTHER
AMENDMENTS
Clause 6
amends the definition of "drug of dependence" in section 4(1) of
the Drugs, Poisons and Controlled Substances Act 1981 to
omit references to the making of regulations under section 12M
which is repealed by this Bill.
The definitions of Scheduled Poisons in section 4(1) are amended
to reflect the fact that Schedules 2 to 9 poisons are now those
contained in the Commonwealth Standard for the Uniform
Scheduling of Drugs and Poisons and no longer in the Poisons
List which contains Schedule 1 poisons only.
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Clause 7
amends section 12A(1) of the Drugs, Poisons and Controlled
Substances Act 1981 to provide that the Poisons List—

may contain Schedule 1 poisons, being 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;

may contain a list of any substances in Schedule 1 of the
Poisons List or Schedules 2 to 9 of the Commonwealth
standard that are not for general sale by retail;

may contain a list of exemptions from Schedule 1 of the
Poisons List or Schedules 2 to 9 of the Commonwealth
standard.
Section 12A(2) and (3)(a) are repealed. They are no longer
applicable to the Poisons List as the List only contains
Schedule 1 poisons.
Section 12A(4) is amended consequently to reflect the changes to
the Poisons Table and List. The Table in that section is also
repealed.
Clause 8
amends section 12E of the Drugs, Poisons and Controlled
Substances Act 1981 regarding amending the Poisons Code.
The reference to "Schedules" in section 12E(1)(d) is replaced
with a reference to "Schedule 1", as this is now the only Schedule
contained in the Poisons List.
New section 12E(1C) provides that the Minister may amend the
Poisons Code to specify in the Poisons List a list of substances
that are not for general sale by retail but can only be supplied to
persons authorised specifically to obtain them and may make
changes to that list.
New section 12E(1D) provides that the Minister may amend the
Poisons Code to specify a list of exemptions from Schedule 1 of
the Poisons List or Schedules 2 to 9 of the Commonwealth
standard and may make changes to that list.
Clause 9
repeals section 12M which dealt with making amendments to
Schedule Eleven of the Drugs, Poisons and Controlled
Substances Act 1981 containing drugs of addiction. Changes to
Schedule Eleven will be no longer be made by regulation.
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Clause 10 amends section 13(2B) of the Drugs, Poisons and Controlled
Substances Act 1981 to take account of the amendments to the
Poisons List made by this Bill.
Clause 11 inserts new section 18A into the Drugs, Poisons and Controlled
Substances Act 1981 containing definitions.
Clause 12 amends section 19(4) of the Drugs, Poisons and Controlled
Substances Act 1981 to provide that restrictions on the premises
to which a licence relates apply only to a licence, permit or
warrant issued under Division 4 of Part II of that Act as defined
by the new section 18A and not to other licences issued under the
Act.
Clause 13 inserts a new section 20(3A) to provide that a holder of a permit
under section 20(3) for the provision of health services is
authorised to sell or supply any poison or controlled substance to
which the permit relates without obtaining a further licence, if the
sale and supply is carried out by a person who is authorised under
section 13(1)(a), 13(1)(ba) or 13(1)(c) to sell or supply that
poison or controlled substance in the lawful practice of his or her
profession and the sale or supply by that person is for the
purposes of the provision of health services.
Clause 14 amends section 27A of the Drugs, Poisons and Controlled
Substances Act 1981 to provide for offences to sell or supply a
poison or controlled substance with a label, or in a container, that
does not comply with the requirements of the Poisons Code in the
case of Schedule 1 poisons or the Commonwealth standard in the
case of Schedule 2 to Schedule 9 poisons, or to store, package or
advertise for sale poisons and controlled substances otherwise
than in accordance with the requirements of the Poisons Code in
the case of Schedule 1 poisons or the Commonwealth standard in
the case of Schedule 2 to 9 poisons.
It also amends section 29 of the Drugs, Poisons and Controlled
Substances Act 1981 to provide that the requirements of the
Commonwealth standard are not affected by the operation of that
section in relation to the containers in which drugs or medicines
which are or contain poisons or controlled substances may be
sold.
Clause 15 substitutes section 32 of the Drugs, Poisons and Controlled
Substances Act 1981 with a new section to provide that a person
who is licensed to manufacture, sell, supply or distribute any
Schedule 8 or 9 poison must record or cause to be recorded
details of the poisons obtained, the quantities of those poisons
used, sold supplied or otherwise disposed of, and other prescribed
particulars, and that the record may be kept in written or
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electronic format. A penalty of 60 penalty units applies to a
breach of this section.
Clause 16 defines "for a continuous period" for the purposes of section 35
of the Drugs, Poisons and Controlled Substances Act 1981.
That section sets out the conditions under which a registered
medical practitioner may administer, supply or prescribe a
Schedule 8 or Schedule 9 poison and a nurse practitioner may
administer, supply or prescribe a Schedule 8 poison to drugdependent and other persons.
Clause 17 repeals the power to make regulations amending Schedule Eleven
of the Drugs, Poisons and Controlled Substances Act 1981
in accordance with section 12M. Section 12M is repealed by
clause 9 of this Bill.
Clause 18 inserts new section 135A which is a transitional provision.
It provides that any warrant to which section 19(2) of the Drugs
Poisons and Controlled Substances (Amendment) Act 1994
applied immediately before it was repealed by this Bill must be
taken to have been issued under Drugs, Poisons and Controlled
Substances Act 1981 and may be amended, suspended or
cancelled accordingly.
Clause 19 adds "Buprenorphine" into the list of drugs of dependence in
Part 3 of Schedule Eleven of the Drugs, Poisons and Controlled
Substances Act 1981 and specifies the traffickable quantity of
that drug in the Schedule.
Clause 20 repeals the Drugs, Poisons & Controlled Substances
(Amendment) Act 1994 as this Act is now spent.
Clause 21 makes a consequential amendment to the Corrections Act 1986.
PART 4—THERAPEUTIC GOODS (VICTORIA) ACT 1994
Clause 22 inserts a new definition of "Code of Practice" into the
Therapeutic Goods (Victoria) Act 1994 and omits a redundant
reference to "Part 5".
Clause 23 substitutes existing Part 5 of the Therapeutic Goods (Victoria)
Act 1994 with a new Part 5 containing sections 45 to 52.
Section 45—

empowers the Victorian Secretary to make and adopt
Codes of Practice;

provides that the Minister must approve a Code of
Practice before it is made or adopted;
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
provides that a Code of Practice may apply, adopt or
incorporate wholly or partially any matter contained in
other documents, codes, standards and rules published
by other bodies or authorities;

provides for the amendment of any matter applied,
adopted or incorporated from another source.
Section 46 provides that a Code of Practice is a subordinate
instrument for the purposes of the Interpretation of Legislation
Act 1984 except for section 32 of that Act. Specific tabling
provisions for the Code of Practice are contained in new
section 50.
Section 47 sets out the procedure for the making of a Code of
Practice requiring that notice be given of the intention to make or
adopt a Code of Practice, and that in the case of the making
(rather than the adopting) of a Code of Practice, submissions
must be taken, and then notice given of the intention to make that
Code of Practice.
Section 48 provides for the commencement of a Code of Practice.
Section 49 provides that notice must be given of when a Code of
Practice comes into operation, and where it is available to the
public.
Section 50 provides that Codes of Practice must be tabled in
Parliament.
Section 51 that provides a defence to liability for non-compliance
with a Code of Practice if it is proved that notice of the Code had
not been published in the Government Gazette or a copy of the
Code was not available for inspection.
Section 52 makes it an offence not to comply with a Code of
Practice when carrying out an activity to which the Code relates
and imposes a penalty of 10 penalty units.
Clause 24 repeals redundant sections 72(1)(e) and 76 of the Therapeutic
Goods (Victoria) Act 1994.
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