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This is a Bill, not an Act. For current law, see the Acts databases.
2016-2017
The Parliament of the
Commonwealth of Australia
HOUSE OF REPRESENTATIVES
Presented and read a first time
Agricultural and Veterinary Chemicals
Legislation Amendment (Operational
Efficiency) Bill 2017
No. , 2017
(Agriculture and Water Resources)
A Bill for an Act to amend the law relating to
agricultural and veterinary chemicals, and for
related purposes
No. , 2017
Agricultural and Veterinary Chemicals Legislation Amendment
(Operational Efficiency) Bill 2017
i
Contents
1
Short title ........................................................................................... 1
2
Commencement ................................................................................. 1
3
Schedules ........................................................................................... 2
Schedule 1--Amendments
3
Part 1--Annual returns and record-keeping
3
Agricultural and Veterinary Chemical Products (Collection of Levy)
Act 1994
3
Agricultural and Veterinary Chemicals (Administration) Act 1992
6
Part 2--Preliminary assessments
8
Agricultural and Veterinary Chemicals Code Act 1994
8
Part 3--Variation of relevant particulars and conditions
10
Agricultural and Veterinary Chemicals Code Act 1994
10
Part 4--Variation of label approval while approval suspended
11
Agricultural and Veterinary Chemicals Code Act 1994
11
Part 5--False and misleading information
13
Agricultural and Veterinary Chemicals (Administration) Act 1992
13
Agricultural and Veterinary Chemicals Code Act 1994
14
Part 6--Notification about variation to Maximum Residue
Limits Standard
16
Agricultural and Veterinary Chemicals Code Act 1994
16
Part 7--Expiry date
17
Agricultural and Veterinary Chemicals Code Act 1994
17
Part 8--Other amendments
18
Agricultural and Veterinary Chemicals (Administration) Act 1992
18
Agricultural and Veterinary Chemicals Code Act 1994
18
No. , 2017
Agricultural and Veterinary Chemicals Legislation Amendment
(Operational Efficiency) Bill 2017
1
A Bill for an Act to amend the law relating to
1
agricultural and veterinary chemicals, and for
2
related purposes
3
The Parliament of Australia enacts:
4
1 Short title
5
This Act is the Agricultural and Veterinary Chemicals Legislation
6
Amendment (Operational Efficiency) Act 2017.
7
2 Commencement
8
(1) Each provision of this Act specified in column 1 of the table
9
commences, or is taken to have commenced, in accordance with
10
column 2 of the table. Any other statement in column 2 has effect
11
according to its terms.
12
2
Agricultural and Veterinary Chemicals Legislation Amendment
(Operational Efficiency) Bill 2017
No. , 2017
1
Commencement information
Column 1
Column 2
Column 3
Provisions
Commencement
Date/Details
1. Sections 1 to 3
and anything in
this Act not
elsewhere covered
by this table
The day this Act receives the Royal Assent.
2. Schedule 1,
Part 1
The day after this Act receives the Royal
Assent.
3. Schedule 1,
Part 2
The day after the end of the period of 12
months beginning on the day this Act
receives the Royal Assent.
4. Schedule 1,
Parts 3, 4 and 5
The day after the end of the period of 3
months beginning on the day this Act
receives the Royal Assent.
5. Schedule 1,
Parts 6, 7 and 8
The day after this Act receives the Royal
Assent.
Note:
This table relates only to the provisions of this Act as originally
2
enacted. It will not be amended to deal with any later amendments of
3
this Act.
4
(2) Any information in column 3 of the table is not part of this Act.
5
Information may be inserted in this column, or information in it
6
may be edited, in any published version of this Act.
7
3 Schedules
8
Legislation that is specified in a Schedule to this Act is amended or
9
repealed as set out in the applicable items in the Schedule
10
concerned, and any other item in a Schedule to this Act has effect
11
according to its terms.
12
Amendments Schedule 1
Annual returns and record-keeping Part 1
No. , 2017
Agricultural and Veterinary Chemicals Legislation Amendment
(Operational Efficiency) Bill 2017
3
Schedule 1--Amendments
1
Part 1--Annual returns and record-keeping
2
Agricultural and Veterinary Chemical Products (Collection
3
of Levy) Act 1994
4
1 Subsection 3(1)
5
Insert:
6
active constituent has the same meaning as in the Agricultural and
7
Veterinary Chemicals Code set out in the Schedule to the
8
Agricultural and Veterinary Chemicals Code Act 1994.
9
2 After section 34
10
Insert:
11
35 Annual returns by interested persons
12
(1) The interested person in relation to a chemical product who is
13
liable to pay levy in respect of leviable disposals of the product that
14
took place anywhere in Australia at any time during a financial
15
year must give the APVMA, before 30 November in the next
16
financial year, a return setting out the total quantity of the chemical
17
product covered by those leviable disposals.
18
(2) Subsection (1) does not apply:
19
(a) to that interested person in relation to that chemical product
20
and to a financial year if the total quantity of that product
21
covered by those leviable disposals in that year is not more
22
than the quantity prescribed by the regulations for the
23
purposes of this paragraph; or
24
(b) to a chemical product prescribed by the regulations for the
25
purposes of this paragraph.
26
Strict liability offence
27
(3) A person commits an offence of strict liability if the person
28
contravenes subsection (1).
29
Schedule 1 Amendments
Part 1 Annual returns and record-keeping
4
Agricultural and Veterinary Chemicals Legislation Amendment
(Operational Efficiency) Bill 2017
No. , 2017
Penalty: 50 penalty units.
1
Civil penalty
2
(4) Subsection (1) is a civil penalty provision.
3
Note 1:
For monitoring and investigation powers of inspectors in relation to
4
this Act, see Part 7AA of the Agricultural and Veterinary Chemicals
5
(Administration) Act 1992.
6
Note 2:
Division 1 of Part 7AB of the Agricultural and Veterinary Chemicals
7
(Administration) Act 1992 provides for pecuniary penalties for
8
contraventions of civil penalty provisions.
9
Note 3:
For infringement notices, enforceable undertakings and formal
10
warnings in relation to contraventions of subsection (1), see
11
Divisions 2, 3 and 6 of Part 7AB of the Agricultural and Veterinary
12
Chemicals (Administration) Act 1992.
13
Statement to Department
14
(5) From the returns given to the APVMA in relation to a financial
15
year, the APVMA must give the Secretary of the Department,
16
before the end of the next financial year, a statement setting out the
17
total quantities of each active constituent for each chemical product
18
covered by those returns.
19
Alternative constitutional bases
20
(6) Without limiting its effect apart from this subsection, this section
21
also has the effect it would have if its operation were expressly
22
confined to:
23
(a) matters relating to census and statistics; or
24
(b) acts or omissions of corporations to which paragraph 51(xx)
25
of the Constitution applies; or
26
(c) acts or omissions taking place in the course of, or in relation
27
to, trade or commerce:
28
(i) between Australia and places outside Australia; or
29
(ii) among the States; or
30
(iii) within a Territory, between a State and a Territory or
31
between 2 Territories; or
32
(d) acts or omissions taking place in a Territory.
33
Amendments Schedule 1
Annual returns and record-keeping Part 1
No. , 2017
Agricultural and Veterinary Chemicals Legislation Amendment
(Operational Efficiency) Bill 2017
5
(7) A term used in subsection (6) and the Constitution has the same
1
meaning in that subsection as it has in the Constitution.
2
3 After section 36
3
Insert:
4
37 Records to be kept by interested persons
5
(1) The interested person in relation to a chemical product who is
6
liable to pay levy in respect of leviable disposals of the product that
7
took place anywhere in Australia at any time during a financial
8
year must:
9
(a) keep any records relating to those disposals that are
10
reasonably necessary to enable the APVMA to find out
11
whether section 35 has been complied with; and
12
(b) retain those records for 6 years.
13
Strict liability offence
14
(2) A person commits an offence of strict liability if the person
15
contravenes subsection (1).
16
Penalty: 50 penalty units.
17
Civil penalty
18
(3) Subsection (1) is a civil penalty provision.
19
Note 1:
For monitoring and investigation powers of inspectors in relation to
20
this Act, see Part 7AA of the Agricultural and Veterinary Chemicals
21
(Administration) Act 1992.
22
Note 2:
Division 1 of Part 7AB of the Agricultural and Veterinary Chemicals
23
(Administration) Act 1992 provides for pecuniary penalties for
24
contraventions of civil penalty provisions.
25
Note 3:
For infringement notices, enforceable undertakings and formal
26
warnings in relation to contraventions of subsection (1), see
27
Divisions 2, 3 and 6 of Part 7AB of the Agricultural and Veterinary
28
Chemicals (Administration) Act 1992.
29
Schedule 1 Amendments
Part 1 Annual returns and record-keeping
6
Agricultural and Veterinary Chemicals Legislation Amendment
(Operational Efficiency) Bill 2017
No. , 2017
Alternative constitutional bases
1
(4) Without limiting its effect apart from this subsection, this section
2
also has the effect it would have if its operation were expressly
3
confined to:
4
(a) matters relating to census and statistics; or
5
(b) acts or omissions of corporations to which paragraph 51(xx)
6
of the Constitution applies; or
7
(c) acts or omissions taking place in the course of, or in relation
8
to, trade or commerce:
9
(i) between Australia and places outside Australia; or
10
(ii) among the States; or
11
(iii) within a Territory, between a State and a Territory or
12
between 2 Territories; or
13
(d) acts or omissions taking place in a Territory.
14
(5) A term used in subsection (4) and the Constitution has the same
15
meaning in that subsection as it has in the Constitution.
16
4 Application provisions
17
(1)
Section 35 of the Agricultural and Veterinary Chemical Products
18
(Collection of Levy) Act 1994, as inserted by this Part, applies in
19
relation to leviable disposals that take place in the 2017-18 financial
20
year or in a later financial year.
21
(2)
Section 37 of the Agricultural and Veterinary Chemical Products
22
(Collection of Levy) Act 1994, as inserted by this Part, applies in
23
relation to leviable disposals that take place on or after the
24
commencement of this item.
25
Agricultural and Veterinary Chemicals (Administration) Act
26
1992
27
5 Section 69E
28
Repeal the section.
29
6 Subsection 69EA(1) (heading)
30
Repeal the heading, substitute:
31
Amendments Schedule 1
Annual returns and record-keeping Part 1
No. , 2017
Agricultural and Veterinary Chemicals Legislation Amendment
(Operational Efficiency) Bill 2017
7
Records relating to compliance with sections 69B and 69C
1
7 Paragraph 69EA(1)(a)
2
Omit "69B, 69C and 69E", substitute "69B and 69C".
3
8 Saving provisions
4
(1)
Despite the repeal of section 69E of the Agricultural and Veterinary
5
Chemicals (Administration) Act 1992 made by this Part, that section, as
6
in force immediately before the commencement of this item, continues
7
to apply on and after that commencement in respect of the following:
8
(a) the import, manufacture or export of active constituents
9
referred to in paragraph 69E(1)(a) of that Act that occurred in
10
the 2016-17 financial year or in an earlier financial year;
11
(b) the import, manufacture or export of chemical products
12
referred to in paragraph 69E(1)(b) of that Act that occurred in
13
the 2016-17 financial year or in an earlier financial year.
14
(2)
Despite the amendments of section 69EA of the Agricultural and
15
Veterinary Chemicals (Administration) Act 1992 made by this Part, that
16
section, as in force immediately before the commencement of this item,
17
continues to apply on and after that commencement in relation to the
18
keeping and retaining of records in respect of the matters covered by
19
paragraphs (1)(a) and (b) of this item.
20
Schedule 1 Amendments
Part 2 Preliminary assessments
8
Agricultural and Veterinary Chemicals Legislation Amendment
(Operational Efficiency) Bill 2017
No. , 2017
Part 2--Preliminary assessments
1
Agricultural and Veterinary Chemicals Code Act 1994
2
9 Subsection 11(2) of the Code set out in the Schedule
3
Omit "from the preliminary assessment", substitute "to the APVMA,
4
after completing a preliminary assessment of the application or after
5
defects in the application have been rectified in response to a notice
6
under subsection (3),".
7
10 Subsection 11(3) of the Code set out in the Schedule
8
Repeal the subsection, substitute:
9
(3) If it appears to the APVMA, after completing a preliminary
10
assessment of the application, that the application does not meet
11
the application requirements but that the defects in the application
12
can reasonably be rectified, the APVMA must, within 14 days,
13
give written notice to the applicant:
14
(a) stating that the application does not meet the application
15
requirements; and
16
(b) giving particulars of the defects in the application; and
17
(c) requiring the defects to be rectified within 1 month.
18
(3A) The APVMA must refuse the application if:
19
(a) the APVMA is not satisfied that defects in the application
20
can reasonably be rectified; or
21
(b) the defects are not rectified to the satisfaction of the APVMA
22
within the period mentioned in paragraph (3)(c).
23
Note:
For notice of refusal, see section 8G.
24
11 Subsection 28(2) of the Code set out in the Schedule
25
Omit "from the preliminary assessment", substitute "to the APVMA,
26
after completing a preliminary assessment of the application or after
27
defects in the application have been rectified in response to a notice
28
under subsection (3),".
29
Amendments Schedule 1
Preliminary assessments Part 2
No. , 2017
Agricultural and Veterinary Chemicals Legislation Amendment
(Operational Efficiency) Bill 2017
9
12 Subsection 28(3) of the Code set out in the Schedule
1
Repeal the subsection, substitute:
2
(3) If it appears to the APVMA, after completing a preliminary
3
assessment of the application, that the application does not meet
4
the application requirements but that the defects in the application
5
can reasonably be rectified, the APVMA must, within 14 days,
6
give written notice to the applicant:
7
(a) stating that the application does not meet the application
8
requirements; and
9
(b) giving particulars of the defects in the application; and
10
(c) requiring the defects to be rectified within 1 month.
11
(3A) The APVMA must refuse the application if:
12
(a) the APVMA is not satisfied that defects in the application
13
can reasonably be rectified; or
14
(b) the defects are not rectified to the satisfaction of the APVMA
15
within the period mentioned in paragraph (3)(c).
16
Note:
For notice of refusal, see section 8G.
17
13 Subsection 110A(2) of the Code set out in the Schedule
18
Omit "from the preliminary assessment", substitute "to the APVMA,
19
after completing a preliminary assessment of the application or after
20
defects in the application have been rectified in response to a notice
21
under subsection (3),".
22
14 Subsection 110A(3) of the Code set out in the Schedule
23
Omit "from the preliminary assessment", substitute "to the APVMA,
24
after completing a preliminary assessment of the application,".
25
15 Application provision
26
The amendments made by this Part apply in relation to applications
27
lodged under section 10, 27 or 110 of the Code set out in the Schedule
28
to the Agricultural and Veterinary Chemicals Code Act 1994 on or after
29
the commencement of this item.
30
Schedule 1 Amendments
Part 3 Variation of relevant particulars and conditions
10
Agricultural and Veterinary Chemicals Legislation Amendment
(Operational Efficiency) Bill 2017
No. , 2017
Part 3--Variation of relevant particulars and
1
conditions
2
Agricultural and Veterinary Chemicals Code Act 1994
3
16 At the end of subsection 8S(1) of the Code set out in the
4
Schedule (before the note)
5
Add:
6
; or (c) varies, under section 29, relevant particulars or conditions in
7
a way other than set out in the application.
8
17 After paragraph 8S(2)(a) of the Code set out in the
9
Schedule
10
Insert:
11
(b) for notice under paragraph (1)(c)--set out the proposed
12
variation; and
13
18 Paragraphs 29(1)(b), (c) and (d) of the Code set out in the
14
Schedule
15
Omit "in accordance with the application", substitute "in a particular
16
way (which may not be the same way as set out in the application)".
17
19 After paragraph 167(1)(c) of the Code set out in the
18
Schedule
19
Insert:
20
(ca) a decision under subsection 29(1) to vary relevant particulars
21
or conditions in a way other than set out in the application for
22
variation;
23
20 Application provision
24
The amendments made by this Part apply in relation to an application
25
lodged under section 27 of the Code set out in the Schedule to the
26
Agricultural and Veterinary Chemicals Code Act 1994 on or after the
27
commencement of this item.
28
Amendments Schedule 1
Variation of label approval while approval suspended Part 4
No. , 2017
Agricultural and Veterinary Chemicals Legislation Amendment
(Operational Efficiency) Bill 2017
11
Part 4--Variation of label approval while approval
1
suspended
2
Agricultural and Veterinary Chemicals Code Act 1994
3
21 Subsection 43(2) of the Code set out in the Schedule
4
Omit "An", substitute "Subject to this section, an".
5
22 At the end of section 43 of the Code set out in the
6
Schedule
7
Add:
8
(4) A suspension under section 36 or subsection 41(2) or 44(2) of the
9
approval of a label for containers for a chemical product does not
10
prevent:
11
(a) the lodging of a notice under section 26AB of one or more
12
notifiable variations of the relevant particulars of the
13
approval or the dealing with the notice; or
14
(b) an application being made under section 26B for one or more
15
prescribed variations of the relevant particulars of the
16
approval or the dealing with the application; or
17
(c) an application being made under subsection 27(1) for
18
variation of the relevant particulars or conditions of the
19
approval or the dealing with the application; or
20
(d) a variation under section 29A of the relevant particulars or
21
conditions of the approval.
22
(5) A notice referred to in paragraph (4)(a), an application referred to
23
in paragraph (4)(b) or (c) or a variation referred to in
24
paragraph (4)(d) must be in relation to the reasons for the
25
suspension of the approval.
26
23 Subsection 45A(2) of the Code set out in the Schedule
27
Omit "subsection (1)", substitute "paragraph (1)(a)".
28
Schedule 1 Amendments
Part 4 Variation of label approval while approval suspended
12
Agricultural and Veterinary Chemicals Legislation Amendment
(Operational Efficiency) Bill 2017
No. , 2017
24 Paragraph 45A(2)(b) of the Code set out in the Schedule
1
Omit "in respect of a suspension or cancellation of the approval of an
2
active constituent for a proposed or existing chemical product or the
3
registration of a chemical product--".
4
25 Application provisions
5
(1)
The amendments of section 43 of the Code set out in the Schedule to the
6
Agricultural and Veterinary Chemicals Code Act 1994 made by this
7
Part apply in relation to:
8
(a) a suspension made on or after the commencement of this
9
item; and
10
(b) a suspension made before the commencement of this item
11
that was in effect immediately before that commencement.
12
(2)
The amendments of section 45A of the Code set out in the Schedule to
13
the Agricultural and Veterinary Chemicals Code Act 1994 made by this
14
Part apply in relation to a suspension or cancellation made on or after
15
the commencement of this item.
16
Amendments Schedule 1
False and misleading information Part 5
No. , 2017
Agricultural and Veterinary Chemicals Legislation Amendment
(Operational Efficiency) Bill 2017
13
Part 5--False and misleading information
1
Agricultural and Veterinary Chemicals (Administration) Act
2
1992
3
26 Before subsection 69ER(1)
4
Insert:
5
Offences
6
27 At the end of section 69ER
7
Add:
8
Civil penalties
9
(3) A person must not, for the purposes of, or in connection with, the
10
making of a decision by the APVMA as to whether it should give a
11
consent under section 69B:
12
(a) give information (whether orally or in writing) that the
13
person knows to be false or misleading in a material
14
particular; or
15
(b) produce a document that the person knows to be false or
16
misleading in a material particular without:
17
(i) indicating to the person to whom the document is
18
produced that it is false or misleading and the respect in
19
which it is false or misleading; and
20
(ii) providing correct information to that person if the
21
person producing the document is in possession of, or
22
can reasonably acquire, the correct information.
23
(4) A person must not, in compliance or purported compliance with a
24
requirement made by an inspector under Part 7A, Part 7AA or this
25
Part or for the purposes of, or in connection with, any provision of
26
Part 7A (other than section 69B), Part 7AA or this Part:
27
(a) give information (whether orally or in writing) that the
28
person knows to be false or misleading in a material
29
particular; or
30
Schedule 1 Amendments
Part 5 False and misleading information
14
Agricultural and Veterinary Chemicals Legislation Amendment
(Operational Efficiency) Bill 2017
No. , 2017
(b) produce a document that the person knows to be false or
1
misleading in a material particular without:
2
(i) indicating to the person to whom the document is
3
produced that it is false or misleading and the respect in
4
which it is false or misleading; and
5
(ii) providing correct information to that person if the
6
person producing the document is in possession of, or
7
can reasonably acquire, the correct information.
8
(5) Subsections (3) and (4) are civil penalty provisions.
9
Note:
Division 1 provides for pecuniary penalties for contraventions of civil
10
penalty provisions.
11
Agricultural and Veterinary Chemicals Code Act 1994
12
28 Before subsection 146(1) of the Code set out in the
13
Schedule
14
Insert:
15
Offences
16
29 At the end of section 146 of the Code set out in the
17
Schedule
18
Add:
19
Civil penalties
20
(3) A person must not, for the purposes of, or in connection with, the
21
consideration by the APVMA, in the course of the performance of
22
any of its functions or the exercise of any of its powers under this
23
Code, of any matters referred to in section 5A, 5B, 5C or 5D or
24
subsection 123(1):
25
(a) give information (whether orally or in writing) that the
26
person knows to be false or misleading in a material
27
particular; or
28
(b) produce a document that the person knows to be false or
29
misleading in a material particular without:
30
Amendments Schedule 1
False and misleading information Part 5
No. , 2017
Agricultural and Veterinary Chemicals Legislation Amendment
(Operational Efficiency) Bill 2017
15
(i) indicating to the person to whom the document is
1
produced that it is false or misleading and the respect in
2
which it is false or misleading; and
3
(ii) providing correct information to that person if the
4
person producing the document is in possession of, or
5
can reasonably acquire, the correct information.
6
(4) A person must not, for the purposes of, or in connection with, the
7
consideration by the APVMA, in the course of the performance of
8
any of its functions or the exercise of any of its powers under this
9
Code, of any matters other than matters referred to in
10
subsection (3):
11
(a) give information (whether orally or in writing) that the
12
person knows to be false or misleading in a material
13
particular; or
14
(b) produce a document that the person knows to be false or
15
misleading in a material particular without:
16
(i) indicating to the person to whom the document is
17
produced that it is false or misleading and the respect in
18
which it is false or misleading; and
19
(ii) providing correct information to that person if the
20
person producing the document is in possession of, or
21
can reasonably acquire, the correct information.
22
(5) Subsections (3) and (4) are civil penalty provisions.
23
Note:
Division 2 provides for pecuniary penalties for contraventions of civil
24
penalty provisions.
25
30 Application provision
26
The amendments made by this Part apply in relation to information
27
given, or a document produced, on or after the commencement of this
28
item.
29
Schedule 1 Amendments
Part 6 Notification about variation to Maximum Residue Limits Standard
16
Agricultural and Veterinary Chemicals Legislation Amendment
(Operational Efficiency) Bill 2017
No. , 2017
Part 6--Notification about variation to Maximum
1
Residue Limits Standard
2
Agricultural and Veterinary Chemicals Code Act 1994
3
31 Paragraph 8E(2)(c) of the Code set out in the Schedule
4
Repeal the paragraph, substitute:
5
(c) be given to Food Standards Australia New Zealand before the
6
approval, registration, variation or permit is given, made or
7
issued.
8
32 Application provision
9
The amendment made by this Part applies in relation to notifications on
10
or after the commencement of this item.
11
Amendments Schedule 1
Expiry date Part 7
No. , 2017
Agricultural and Veterinary Chemicals Legislation Amendment
(Operational Efficiency) Bill 2017
17
Part 7--Expiry date
1
Agricultural and Veterinary Chemicals Code Act 1994
2
33 Section 3 of the Code set out in the Schedule (definition of
3
expiry date)
4
Omit "should", substitute "must".
5
34 Application provision
6
The amendment made by this Part applies in relation to a supply
7
referred to in subsection 85(1) or 91(1) or (2) of the Code set out in the
8
Schedule to the Agricultural and Veterinary Chemicals Code Act 1994
9
that occurs on or after the commencement of this item.
10
Schedule 1 Amendments
Part 8 Other amendments
18
Agricultural and Veterinary Chemicals Legislation Amendment
(Operational Efficiency) Bill 2017
No. , 2017
Part 8--Other amendments
1
Agricultural and Veterinary Chemicals (Administration) Act
2
1992
3
35 Part 7B
4
Repeal the Part.
5
36 Saving provision
6
Despite the repeal of Part 7B of the Agricultural and Veterinary
7
Chemicals (Administration) Act 1992 made by this Part, section 69EZ
8
of that Act, as in force immediately before the commencement of this
9
item, continues to apply on and after that commencement in relation to
10
an approval referred to in that section that was given before that
11
commencement.
12
Agricultural and Veterinary Chemicals Code Act 1994
13
37 Subparagraph 8A(a)(v) of the Code set out in the Schedule
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Omit "subparagraph.", substitute "subparagraph; and".
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38 Subsection 46(1) of the Code set out in the Schedule
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Omit "relevant file", substitute "relevant APVMA file".
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39 Paragraph 51(c) of the Code set out in the Schedule
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Omit "relevant file", substitute "relevant APVMA file".
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