1 After section 8
Despite subsection 13(2) of the Acts Interpretation Act 1901 , the following
provisions that are included in the Schedule do not form part of this Act:
(a) the Table of contents that appears at the beginning of the Schedule;
(b) the list of terms defined by section 3 of the Schedule that
appears immediately after the Table of contents.
2 The Schedule
(section 3 of the Agvet Code, definition of approved person)
(a) in relation to the making of an application or request, or the giving of a
notice, consent, information, report, sample or any other thing, by a person:
4 The Schedule (section 3 of the Agvet Code, definition of deal with) 5 The Schedule
(section 3 of the Agvet Code, definition of eligible law) 6 The
Schedule (section 3 of the Agvet Code)
7 The Schedule (section 3 of the Agvet Code)
8 The Schedule (section 3 of the Agvet Code, definition of interested
person)
(a) subject to paragraphs (b), (c) and (d), the person (the original
applicant ) who applied for the approval, registration or listed registration
or, in the case of a chemical product whose registration or listed
registration has been renewed, applied for the renewal, or the last renewal,
as the case may be; or
10 The Schedule (section 3 of the Agvet Code)
11 The Schedule (section 3 of the Agvet Code)
12 The Schedule (section 3 of the Agvet Code, definition of penalty unit)
13 The Schedule (section 3 of the Agvet Code)
(a) any substance or thing of a kind used, or capable of being used, as food
or drink by human beings; or
14 The Schedule (section 3 of the Agvet Code)
15 The Schedule (section 3 of the Agvet Code, definition of relevant
particulars)
(a) in relation to the approval of an active constituent for a proposed or
existing chemical productthe distinguishing number, instructions for use
and other particulars that are required by paragraph 19(2)(a) to be entered in
the Record of Approved Active Constituents; and
16 The Schedule (section 3 of the Agvet Code)
17 The Schedule (section 3 of the Agvet Code)
18 The Schedule (section 3 of the Agvet Code)
19 The Schedule (section 3 of the Agvet Code, definition of residues)
(a) subject to paragraph (b), any remains, persisting in or on a
protected commodity, of: (2) The NRA may at any time
vary or revoke a determination made, approval or exemption given, or
other thing done, by it under subsection (1). (2) Division 2 deals with the giving of approvals
and the granting of registrations.
23 The Schedule (after paragraph 11(1)(b) of the Agvet Code)
(ba) if the application is covered by paragraph 10(a) or
(b)contain proposed instructions for the use of or other dealing
with the constituent or product; and ; and (e) be lodged with
the NRA. 26 The
Schedule (section 12 of the Agvet Code)
(1) The NRA must, within one month after an application is lodged under
section 11, make a preliminary assessment as to whether the application
complies with subsection 11(1). 13 NRA to publish notice before deciding whether to register
chemical product containing new active constituent 29 The
Schedule (subsections 14(4) and (5) of the Agvet Code) 30 The Schedule (at the end
of paragraph 14(5)(f) of the Agvet Code) 31 The Schedule
(subsection 14(6) of the Agvet Code) 32 The Schedule (subsection 14(7) of the Agvet
Code) 33 The
Schedule (after section 14 of the Agvet Code) 14A Approval of
active constituents for which information is not readily available
34 The Schedule (subsection 17(3) of the Agvet Code) (3) The Record is to be kept in 3 parts as follows: 19 How approval of
active constituent is effected 20 How registration
of chemical product is effected (1) If the NRA
decides to approve a label for containers for a chemical product, the
NRA must give a distinguishing number to, and approve, the label in
accordance with subsection (2), either unconditionally or subject
to conditions as mentioned in section 23. 39 The Schedule (at the end of
section 22 of the Agvet Code) (2) If:
40 The Schedule (paragraphs 24(1)(a) and 25(1)(a) of the Agvet Code) 41 The Schedule (paragraph
26(1)(b) of the Agvet Code) 42 The Schedule (paragraph 26(1)(b) of the Agvet
Code) 43 The Schedule (subsection 26(1)
of the Agvet Code) 44 The Schedule
(subsection 26(2) of the Agvet Code) (2)
If the NRA is satisfied that the particular or condition entered in the Record
or Register, or recorded in the NRA file, in relation to the constituent,
product or label is not correct, the NRA must change the entry or record
accordingly.
Division 3Application for variation of relevant particulars, or of
conditions, of approval or registration (ba) if the application relates to a
labelbe accompanied by a proposed new label; and ; and (e) be lodged with
the NRA. 49 The Schedule (paragraph
29(1)(a) of the Agvet Code) (a) that
subsection 28(1) has been complied with; 51 The
Schedule (paragraph 29(1)(e) of the Agvet Code) 52 The Schedule (paragraph 29(1)(f) of the Agvet
Code) 53 The Schedule
(paragraph 29(1)(h) of the Agvet Code) (h)
grant the application and vary those particulars or conditions: 55 The Schedule
(paragraph 29(4)(a) of the Agvet Code) 56 The Schedule (subsection 31(2) of
the Agvet Code) 57 The Schedule (subsection
32(1) of the Agvet Code) 58 The
Schedule (paragraph 32(1)(a) of the Agvet Code) 59 The Schedule (after paragraph
32(1)(a) of the Agvet Code) (aa) setting out the matters to
be dealt with in the reconsideration and stating the requirement or
requirements prescribed by the regulations for continued approval or
registration that form the basis for the reconsideration; and 61 The Schedule (subsection
32(2) of the Agvet Code)
62 The Schedule (subparagraphs 32(2)(b)(i) and (ii) of the Agvet Code)
63 The Schedule (subsection 32(4) of the Agvet
Code) (4) Subsection (3)
does not apply if, before the end of the period stated in the notice,
the interested person or an approved person requests the NRA under
section 42 to cancel the approval of the constituent, the
registration of the product or the approval of the label, as the case
may be, and the NRA complies with the request. 65 The Schedule (subsection 33(3) of the Agvet Code) 66 The Schedule (paragraph 34(1)(a) of the Agvet Code) 67 The Schedule
(paragraph 34(1)(b) of the Agvet Code) 68 The Schedule (paragraph 34(1)(c) of the
Agvet Code) (c) if the
reconsideration relates to an approval of a label: 70 The Schedule (subsection 34(4) of the Agvet
Code)
71 The Schedule (subsection 34(5) of the Agvet Code) (5) If the NRA is satisfied that the relevant
particulars or the conditions of the approval or registration can be
varied in such a way that the requirements prescribed by the
regulations for continued approval or registration will be complied
with:
(5B) If a variation of any relevant particulars or conditions under
subsection (5) would affect any instructions for the use of an active
constituent for an existing or proposed chemical product or for the use of a
chemical product or any instructions on a label for containers for a chemical
product, the NRA must not make the variation until it has consulted each
co-ordinator designated for a jurisdiction and taken into account any
recommendations made by the co-ordinators. 34A Reconsideration
of approval of label without notice in certain circumstances
(5) Sections 30 to 34 do not apply to a reconsideration under this
section. (a) at the end of the period stated in a notice given
to a person under subsection 32(2), the NRA is satisfied that the interested
person or an approved person is aware of information relevant to the
reconsideration but the information has not been given to the NRA; or 75 The Schedule (subsection 38(1) of the Agvet Code)
76 The Schedule (subsection
38(1) of the Agvet Code) 77 The Schedule
(section 40 of the Agvet Code) 78 The Schedule (at the end of section 40 of the
Agvet Code) (2) If, in the course of reconsidering the approval of a
label for containers for a chemical product:
79 The Schedule (subsection 41(1) of the Agvet Code) 80 The Schedule (subsection 41(2) of the Agvet
Code) 81 The Schedule
(subsection 41(3) of the Agvet Code) 82 The Schedule (at the end of section 41 of the
Agvet Code) (4) If:
83 The Schedule (paragraph 42(1)(a) of the Agvet Code) 84 The Schedule (subsections 45(2), (3), (4)
and (5) of the Agvet Code)
(1) Subject to subsection (3), if the NRA suspends or cancels an approval
or registration, it must, as soon as practicable, give written notice of the
suspension or cancellation to the interested person, or an approved person,
and to any other person to whom, in its opinion, such a notice should be
given.
(6) Subject to subsection (8), if:
Penalty: 300 penalty units. (7) In paragraph (6)(a), strict liability
applies to the physical element of circumstance, that the notice is a notice
given to the person under this section.
(8) Subsection (6) does not apply to a possession, custody or dealing
with a constituent or product if the constituent was an approved active
constituent or the product was a registered chemical product or a reserved
chemical product when the possession, custody or dealing took place because of
its having been approved or registered or having become reserved after its
previous approval or registration had been cancelled. 86 The Schedule (after subsection 47(4) of the Agvet Code) (4A) If:
87 The Schedule (at the end of subsection 49(1) of the Agvet Code) ;
and (e) be lodged with the NRA. 89 The Schedule (subsection 53(1) of the Agvet Code) 90 The Schedule (subsection 53(1) of the Agvet
Code) 91 The Schedule (paragraph
53(2)(a) of the Agvet Code) 92 The
Schedule (after paragraph 54(b) of the Agvet Code) (ba) containing
instructions for possessing, having custody of, using or otherwise dealing
with the product; and (2) If, after the
publication under this section of a notice stating that the
registration of a chemical product has ended, a person possesses, has
custody of, uses or otherwise deals with the product in accordance
with the instructions contained in the notice, the person is taken to
have been issued with a permit to possess, have custody of, use or
otherwise deal with the product in accordance with those instructions
until:
(3) Subject to subsection (5), if:
Penalty: 300 penalty units. (4) In paragraph (3)(a), strict liability
applies to the physical element of circumstance, that the publishing of the
notice was under this section.
(5) Subsection (3) does not apply to a possession, custody or dealing
with a product if the product was a registered chemical product or a reserved
chemical product when the possession, custody or dealing took place because of
its having been registered or having become reserved after the previous
registration had ended. 95 The
Schedule (paragraph 55(2)(e) of the Agvet Code) 96 The Schedule (at the end of
paragraph 55(2)(f) of the Agvet Code) 97 The Schedule
(subsection 55(3) of the Agvet Code) (3) If, after the publication under this section of a
notice of the suspension or cancellation of an approval or
registration, a person possesses, has custody of, uses or otherwise
deals with the constituent or product, or a product containing a
label, as the case may be, in accordance with the instructions
contained in the notice, the person is taken to have been issued with
a permit to possess, have custody of, use or otherwise deal with the
constituent or product, or a product containing the label, in
accordance with those instructions until:
98 The Schedule (subsection 55(4) of the Agvet Code) 99 The Schedule
(subsection 55(5) of the Agvet Code) 100 The Schedule (subsection 55(5) of the
Agvet Code) 101 The Schedule (subsection 55(6) of the Agvet Code) 102 The Schedule
(subsection 55(6) of the Agvet Code) 103 The Schedule (paragraph 55(7)(a) of the
Agvet Code) 104 The
Schedule (at the end of paragraph 55(7)(a) of the Agvet Code) 105 The Schedule (at the end of paragraph 55(8)(a) of the
Agvet Code) 106 The Schedule (after Part 2
of the Agvet Code)
Part 2AListable chemical products
(1) This Part contains provisions relating to:
(3) If the NRA is not satisfied as mentioned in subsection (1) it must
refuse the application.
Penalty: 60 penalty units. (2) If the NRA is satisfied that the particular or
condition entered in the Register of Chemical Products in relation to the
product is not correct, the NRA must change the entry accordingly.
(g) grant the application and vary those particulars or conditions by entering
in the Register of Chemical Products particulars of the variation and the date
on which the entry is made; and Penalty: 120 penalty units. (4) In
subsection (3), strict liability applies to the physical element of
circumstance, that the requirement is made of the person under
paragraph (2)(b).
(5) Subsection (3) does not apply if, before the end of the period stated
in the notice, the interested person or an approved person requests the NRA
under section 56ZG to cancel the listed registration of the product and
the NRA complies with the request. Penalty: 120 penalty units. (3) In subsection (2),
strict liability applies to the physical element of circumstance, that the
requirement is made of the person under subsection (1).
(4) Subsection (2) does not apply if, before the end of the period stated
in the notice, the interested person or an approved person requests the NRA
under section 56ZG to cancel the listed registration of the product and
the NRA complies with the request.
(e) give written notice to the interested person or to an approved person
stating that it affirms the listed registration on the conditions to which the
listed registration is currently subject and giving brief particulars of the
reasons for its decision; and
(2) Subject to subsection (4), the NRA must revoke a suspension imposed
under paragraph (1)(a) when it is satisfied that all the information
relevant to the reconsideration has been given to it.
(2) The NRA must give written notice of its decision on a request under
subsection (1) to the person or persons who made the request.
(7) Subject to subsection (9), if:
Penalty: 300 penalty units. (8) In paragraph (7)(a), strict liability
applies to the physical element of circumstance, that the notice is given to
the person under this section.
(9) Subsection (7) does not apply to a possession, custody or dealing
with a product if the product was a registered chemical product, a registered
listed chemical product or a reserved chemical product as the case may be,
when the possession, custody or dealing took place because of its having been
registered or granted listed registration or having become reserved after its
previous listed registration had been cancelled.
(5) If an amount (including an amount in respect of a tax or penalty) that is
payable (whether by the applicant or by any other person) to the NRA in
respect of the product under any law in force in any jurisdiction has not been
paid, the NRA may refuse to grant the application for renewal.
(2) If, after the publication under this section of a notice stating that the
listed registration of a chemical product has ended, a person possesses, has
custody of, uses or otherwise deals with the product in accordance with the
instructions contained in the notice, the person is taken to have been issued
with a permit to possess, have custody of, use or otherwise deal with the
product in accordance with those instructions until:
(3) Subject to subsection (5), if:
Penalty: 300 penalty units. (4) In paragraph (3)(a), strict liability
applies to the physical element of circumstance, that the publishing of the
notice was under this section.
(5) Subsection (3) does not apply to a possession, custody or dealing
with a product if the product was a registered listed chemical product, a
registered chemical product or a reserved chemical product when the
possession, custody or dealing took place because of its having been granted
listed registration, having been registered or having become reserved after
the previous listed registration had ended.
(e) a statement to that effect;
(4) Subject to subsection (6), if:
Penalty: 300 penalty units. (5) In paragraph (4)(a), strict liability
applies to the physical element of circumstance, that the publishing of the
notice was under this section.
(6) Subsection (4) does not apply to a possession, custody or dealing
with a product if the product was a registered listed chemical product or a
reserved chemical product when the possession, custody or dealing took place
because of its having been granted listed registration or having become
reserved after its previous listed registration had been cancelled.
Part 2BReserved chemical products 56ZU Regulations may contain
schedule of reserved chemical products 108 The Schedule (after subsection
59(1) of the Agvet Code) (1A) Subsection (1) does not
apply if the information is the same as information previously given
to the NRA otherwise than in compliance with a requirement referred to
in that subsection. (c) the supply of approved
constituents, registered products, registered listed products or
reserved products in contravention of the conditions of their
approval, registration, listed registration or reservation.
111 The Schedule (subsection 78(1) of the Agvet Code)
112 The Schedule (subparagraphs 78(1)(c)(i) to (iii) of the Agvet Code) (i) at a time or times before the
supply takes place, the product had been registered, granted listed
registration, or reserved, under this Code or had been registered under a
corresponding previous law; 114 The Schedule (at the end of subsection
78(3) of the Agvet Code) 115 The Schedule (after
section 79 of the Agvet Code) 79A Supply of registered
listed chemical products in contravention of conditions of listed
registration Penalty: 300 penalty units. 79B Supply of reserved chemical products contrary to conditions
specified in the regulations Penalty: 300 penalty units. (2) In subsection (1), strict liability applies to the physical
element of circumstance, that the conditions relating to the product
were specified in regulations made for the purposes of
section 56ZU.
116 The Schedule (subsection 80(1) of the Agvet Code)
117 The Schedule (subsection 80(2) of the Agvet Code) 118 The Schedule (subsection 81(1) of the Agvet Code,
excluding the penalty) (1) A person may
only supply, or cause or permit to be supplied, a registered chemical product
in a container if:
119 The Schedule (at the end of section 81 of the Agvet Code) (3)
Subsection (1) does not apply to the supply of a registered chemical
product in a container in the circumstances mentioned in that subsection if: 83A
Supply of substances whose constituents differ from constituents of
registered listed chemical product Penalty: 300 penalty units. (2) Subsection (1)
does not apply if the person has a reasonable excuse.
121 The Schedule (subsection 84(1) of the Agvet Code) 122 The Schedule (at the end of subsection 84(1) of the
Agvet Code) 123 The Schedule (subsection 86(1) of the Agvet Code) 124 The Schedule (subsection 87(1) of the Agvet
Code) 125 The Schedule (after section 87 of the Agvet Code) 87A Supply of registered listed chemical product that does not
conform to established standard Penalty: 300 penalty units. 126 The Schedule (subsection 88(1) of the Agvet Code)
127 The Schedule (paragraph 88(2)(b) of the Agvet Code) 128 The Schedule
(paragraph 88(2)(c) of the Agvet Code) 129 The Schedule (subparagraph 88(2)(d)(i) of the Agvet
Code) 130
The Schedule (at the end of paragraph 88(3)(b) of the Agvet Code) 131 The Schedule (before
section 90 of the Agvet Code)
This Division does not apply to a chemical product that is a listable chemical
product or is a reserved chemical product. 133 The Schedule (subsection 99(2) of the Agvet Code) 134 The Schedule (subsection 99(3) of the
Agvet Code) 135 The Schedule (subsection 101(1) of the Agvet
Code) (1) If:
136 The Schedule (paragraph 101(2)(c) of the Agvet Code) 137 The Schedule
(after paragraph 102(1)(a) of the Agvet Code) (aa) having regard to
the matters referred to in subsection 56E(2), the continued use of a
registered listed chemical product in accordance with the established standard
for the product: (ba) the constituents of stocks of a
registered listed chemical product or of a particular batch of such a
product differ by more than the prescribed extent from the
constituents stated in relation to the product in the Register of
Chemical Products; or (ca) the concentration of the constituents
of stocks of a registered listed chemical product or of a particular
batch of such a product differs by more than the prescribed extent
from the concentration of the constituents stated in relation to the
product in the Register of Chemical Products; or (e) the
composition or purity of any constituent of stocks of a registered
listed chemical product or of a particular batch of such a product
differs by more than the prescribed extent from the composition or
purity of the constituent stated in relation to the product in the
Register of Chemical Products; or (1) If it
appears to the NRA:
142 The Schedule (paragraph 103(2)(c) of the Agvet Code) 143 The Schedule (subsections 108(2) and (3) of the Agvet Code)
(2) Examples of circumstances in which a
permit could be sought are: (a) an
offence against section 74, 75, 76, 77, 78, 79, 79A, 79B, 80, 81,
84, 85, 87, 87A or 91; or (b) if:
(iii) the NRA must, by written notice given to the applicant, require the
applicant to give the additional information to the NRA; and 147 The Schedule (paragraph
112(2)(i) of the Agvet Code) 148 The Schedule (after section 120 of the Agvet
Code)
This Part does not apply to chemical products that are listable chemical
products or are reserved chemical products. ; and (e) be lodged with the NRA. 151 The Schedule (paragraph 124(1)(a) of the Agvet Code) 152 The Schedule (subsection
127(1) of the Agvet Code) 153 The Schedule (paragraph 127(2)(a) of the
Agvet Code) (a) by written notice given to
an approved person, set out the action that the NRA proposes to take and the
reasons for the proposed action; and
(1) A person commits an offence if, for the purposes of, or in connection
with, the consideration by the NRA, in the course of the performance of any of
its functions or the exercise of any of its powers under this Code, of any
matters referred to in subsection 14(4), (5) or (6), subsection 56K(1) or
paragraph 123(1)(a), the person: (1) This section has effect for the
purposes of any proceeding:
156 The Schedule (paragraph 149(3)(b) of the Agvet Code) 157 The Schedule (at the end of
paragraph 149(3)(c) of the Agvet Code) 158 The Schedule (paragraph 149(3)(g) of the Agvet Code) 159 The Schedule
(subsection 152(2) of the Agvet Code) 160 The Schedule (subsection
159(1) of the Agvet Code) For the purposes of:
161 The Schedule (paragraph 159(1)(g) of the Agvet Code) 162 The Schedule (after subsection 159(1) of the Agvet Code) (1A) The power of the NRA or another authority under
subsection (1) to require a person to give to the NRA or to that
authority information, a report or a sample includes a power to require the
person to give to the NRA or to that authority such information or such a
report or sample in addition to any information, report or sample previously
given by the person to the NRA or to that authority under any provision of
this Code other than this section or under a previous application of this
section. 164 The Schedule (after
section 160 of the Agvet Code) 160A Notification of new
information to NRA in respect of pending application Penalty:
300 penalty units. (3) A person is an appropriate person in relation to an
application referred to in paragraph (1)(a) if: 166 The Schedule
(paragraphs 161(2)(b) and (c) of the Agvet Code) 167 The Schedule (paragraph 161(2)(d) of the Agvet
Code) 168 The Schedule
(after subsection 161(2) of the Agvet Code) (2A) A corporation is
taken to be aware of any information if a related corporation is aware of that
information. 170 The Schedule
(subparagraph 162(3)(b)(i) of the Agvet Code) 171 The Schedule (subparagraph 162(3)(b)(ii) of the
Agvet Code) (ii) for the purposes of
the NRA's reconsideration of the registration of the product under
Division 4 of Part 2 or of the listed registration of the product
under Division 6 of Part 2Aby disclosing the relevant
particulars of the product; or (13A) A reference in this section to information
about:
173 The Schedule (before paragraph 167(1)(a) of the Agvet Code) (aa)
a decision under section 11A that the application does not comply with
subsection 11(1); (fa) a decision under Division 4 of Part 2A
to refuse an application for listed registration of a chemical
product; 176 The Schedule (after paragraph 167(1)(i) of the Agvet
Code) (ia) a decision under subsection 81(3) shortening, or
extending or refusing to extend, a period; approved person means:
(i) if that person is an individual residing, or a body corporate
incorporated, in Australiathat person; or
(ii) in any casean individual residing in Australia who, or a body
corporate incorporated in Australia which, that person has notified
the NRA in writing is authorised to make the application or request or
to give the notice, consent, information, report, sample or other
thing on that person's behalf; or
(b) in relation to the giving of a notice by the NRA that affects a person
who is the interested person in relation to an approved active
constituent for a chemical product, a registered chemical product, a
registered listed chemical product or an approved label for containers
for a chemical product or is the holder of a permit or a
licencean individual residing in Australia who, or a body
corporate incorporated in Australia which, that person has notified
the NRA in writing is authorised by that person to receive the notice
on that person's behalf.
3 The Schedule (section 3 of the Agvet
Code) continued use of an active constituent for a proposed
or existing chemical product, or of a chemical product, includes any
dealing with the constituent or product.
established standard
for a listable chemical product means a standard established for the product
under Division 3 of Part 2A.
instructions for
use of an active constituent for a proposed or existing chemical product, or
of a chemical product, includes instructions for any dealing with the
constituent or product.
interested person , in relation
to an approved active constituent for a chemical product, a registered
chemical product, a registered listed chemical product or an approved label
for containers for a chemical product, means:
(b) subject to paragraphs (c) and (d), if:
(i) the original applicant has entered into a contract with another person
in relation to the constituent or product under which, or as a result
of which, the other person will or may apply to the NRA to have the
other person's name entered in the relevant particulars in relation to
the constituent or product, or to have a label approved in relation to
containers for the product; and
(ii) the other person's name is entered in those relevant particulars, or
such a label is approved, on the application of the other person;
the other person; or
(c) if the person who, apart from this paragraph, would be the interested
person because of paragraph (a) or (b) was an individual who has
died or is an individual whose affairs are being lawfully administered
by another personthe legal personal representative of the
individual or the person administering the individual's affairs, as
the case may be; or
(d) if the person who, apart from this paragraph, would be the interested
person because of paragraph (a) or (b) was a body
corporatea successor in law of the body corporate.
9 The
Schedule (section 3 of the Agvet Code) listable
chemical product means a chemical product that is, or is included in a
class of chemical products that is, included in the Listing Schedule.
listed
registration means listed registration of a listable chemical product that is
in force under Part 2A of the Agvet Code of this jurisdiction.
Listing Schedule
means the schedule contained in the regulations under section 56C.
penalty unit has the same meaning as in
section 4AA of the Crimes Act 1914 .
protected
commodity means:
(b) any substance or thing of a kind used, or capable of being used, as an
ingredient or additive in, or any substance used in the preparation
of, a substance or thing referred to in paragraph (a); or
(c) any plant or animal; or
(d) any soil, water or other environmental component; or
(e) any other agricultural commodity; or
(f) any animal feed; or
(g) any other prescribed substance or thing; or
(h) any substance or thing that is capable of being made into anything
referred to in any of the above paragraphs; but does not include a
therapeutic good within the meaning of the Therapeutic Goods Act 1989
.
registered
listed chemical product means a listable chemical product that has been
granted listed registration.
relevant particulars means:
(b) in relation to the registration of a chemical productthe
distinguishing number and other particulars that are required by
paragraph 20(2)(a) to be entered in the Register of Chemical Products;
and
(c) in relation to the listed registration of a chemical productthe
notation, distinguishing number and other particulars that are
required by paragraph 56M(2)(a) to be entered in the Register of
Chemical Products; and
(d) in relation to the approval of a label for containers for a chemical
productthe distinguishing number, and the size and type of, and
particulars contained on, the label kept in the relevant NRA file as
required by paragraph 21(2)(d); and includes, in relation to the
approval of an active constituent or of a label or in relation to the
registration or listed registration of a chemical product, particulars
of a variation of relevant particulars that is made under paragraph
29(1)(h), subsection 34(5), section 34A, paragraph 56U(1)(e) or
subsection 56Z(5).
reserved means
reserved by being a chemical product that is, or is included in a class of
chemical products that is, specified in the Reserved Schedule.
reserved
chemical product means a chemical product that is, or is included in a class
of chemical products that is, specified in the Reserved Schedule.
Reserved
Schedule means the schedule contained in the regulations under
section 56ZU.
residues , in relation to an active
constituent for a proposed or existing chemical product, or in relation to a
chemical product, means:
(i) the active constituent, or the active constituents in the chemical
product; or
(ii) any derivatives, metabolites, or degradation products, of the active
constituent or of the active constituents in the chemical product; or
(b) if the NRA has published a notice in the Gazette for the purposes of
this paragraph that applies to the active constituent or chemical
productonly such of the remains referred to in
paragraph (a) as are specified in the notice to be remains that
constitute residues of the active constituent or of the chemical
product for the purposes of this Code.
20 The Schedule (at the end of
section 6 of the Agvet Code)
21 The Schedule
(subsection 9(2) of the Agvet Code)
22 The Schedule (heading to
Division 2 of the Agvet Code)
24 The Schedule (at the end of
subsection 11(1) of the Agvet Code)
25 The Schedule (subsections 11(2) and (3) of the Agvet
Code)
(2) If it appears to the NRA from the preliminary assessment that the
application complies with subsection 11(1), the NRA must, as soon as
practicable, give notice in writing to an approved person stating that the
application has passed a preliminary assessment and will be given a full
evaluation in due course.
(3) If it appears to the NRA from the preliminary assessment that the
application does not comply with subsection 11(1) but the defects in the
application can reasonably be rectified:
(a) the NRA must, as soon as practicable, give to an approved person
notice in writing:
(i) stating that the application does not comply with subsection 11(1);
and
(ii) giving particulars of the defects in the application; and
(iii) requiring the defects to be rectified within one month or within such
further period as the NRA allows; and
(b) if the defects are not rectified to the satisfaction of the NRA within
the period referred to in subparagraph (a)(iii), the NRA may:
(i) defer consideration of the application; or
(ii) treat the application as having been withdrawn;
and, if it does either of those things, it must immediately give to the
approved person notice in writing of its decision.
(4) If it appears to the NRA from the preliminary assessment that the
application does not comply with subsection 11(1) and that the defects in the
application cannot reasonably be rectified, it may reject the application on
the ground that the application has not been properly made and, if it does so,
any fee paid in respect of the application (other than a component of the fee
identified by the regulations as being in respect of the preliminary
assessment) is repayable.
(5) If the NRA rejects the application under subsection (4):
(a) it must, as soon as practicable, give notice in writing to an approved
person:
(i) stating that the application has been rejected on the ground that it
has not been properly made; and
(ii) setting out the defects in the application; and
(iii) giving brief particulars of the reasons why it considers that the
application cannot reasonably be rectified; and
(iv) telling the approved person that any fee paid in respect of the
application (other than a component of the fee identified by the
regulations as being in respect of the preliminary assessment) is
repayable; and
(b) it may return the application with the notice.
(6) Section 168 provides for additional matters to be included in a
notice under paragraph (3)(b) or (5)(a).
(7) An application that is rejected by the NRA on the ground that it was not
properly made is taken for the purposes of this Code other than this section,
and for the purposes of Part 7B of the Agricultural and Veterinary
Chemicals (Administration) Act 1992 , not to have been validly made.
12 NRA
to publish notice before deciding whether to approve new active constituent
(1) Before deciding whether to approve an active constituent not previously
contained in a chemical product registered in this or another jurisdiction
under the Agvet Code, or a corresponding previous law, of the jurisdiction
concerned, the NRA must cause to be published in the Gazette , and in any
other manner that it thinks appropriate, a notice:
(a) stating that it has to decide whether to approve the constituent and
setting out the following:
(i) the name of the constituent;
(ii) particulars of the constituent other than confidential commercial
information;
(iii) a summary of the NRA's evaluation of the constituent with regard to
the matters mentioned in paragraph 14(3)(e);
(iv) any other matters that the NRA thinks appropriate; and
(b) inviting any person who wishes to do so to make, within a period
stated in the notice that ends not earlier than 28 days after the day
on which the notice is published in the Gazette , a written submission
to the NRA as to whether the constituent should be approved and
stating the grounds on which the submission is based, which must be
grounds that relate to matters that the NRA is required to take into
account in deciding whether to approve the constituent.
(2) The NRA must take into account any submissions made in accordance with an
invitation contained in the notice published under subsection (1).
27
The Schedule (section 13 of the Agvet Code)
(1) Before deciding whether to register a chemical product containing an
active constituent not previously contained in a chemical product registered
in this or another jurisdiction under the Agvet Code, or a corresponding
previous law, of the jurisdiction concerned, the NRA must cause to be
published in the Gazette , and in any other manner that it thinks appropriate,
a notice:
(a) stating that it has to decide whether to register the product and
setting out the following:
(i) the name that the applicant for registration intends to use to
describe the product;
(ii) particulars of the product and its active constituents other than
confidential commercial information;
(iii) a summary of the NRA's evaluation of the product with regard to the
matters mentioned in paragraphs 14(3)(e) and (f);
(iv) any other matters that the NRA thinks appropriate; and
(b) inviting any person who wishes to do so to make, within a period
stated in the notice that ends not earlier than 28 days after the day
on which the notice is published in the Gazette , a written submission
to the NRA as to whether the product should be registered and stating
the grounds on which the submission is based, which must be grounds
that relate to matters that the NRA is required to take into account
in deciding whether to register the product.
(2) The NRA must take into account any submissions made in accordance with an
invitation contained in the notice published under subsection (1).
28
The Schedule (paragraphs 14(3)(e) and (f) of the Agvet Code)
Despite section 14, if:
(a) either of the following applies in relation to an active constituent
for a proposed or existing chemical product:
(i) the NRA considers that the information referred to in paragraph
11(1)(b) is not readily available in respect of the constituent;
(ii) the constituent is, or is part of, a product in respect of which a
standard is specified in the European Pharmacopoeia, the British
Pharmacopoeia (Veterinary), the United States Pharmacopoeia or any
other publication considered by the NRA to be appropriate; and
(b) the NRA is satisfied of all the matters mentioned in paragraph
14(3)(e) having regard to matters ( relevant matters ) mentioned in
subsection 14(4) where information about the relevant matters is
readily available; the NRA may decide to approve the constituent,
whether or not an application has been made for the approval.
(a) one part is to consist of confidential commercial information relating
to constituents approved under section 14;
(b) one part is to consist of other information relating to constituents
approved under section 14;
(c) one part is to consist of information relating to constituents
approved under section 14A.
35 The Schedule (section 19 of
the Agvet Code)
(2) Approval of an active constituent takes place by entering in the Record of
Approved Active Constituents:
(a) the relevant particulars, which are the distinguishing number, the
instructions for the use of the constituent and any other particulars
that are prescribed by the regulations; and
(b) any conditions of the approval.
36 The Schedule (section 20 of
the Agvet Code)
(2) Registration of a chemical product takes place by entering in the Register
of Chemical Products:
(a) the relevant particulars, which are the distinguishing number and any
other particulars that are prescribed by the regulations; and
(b) any conditions of the registration.
37 The Schedule (section 21
of the Agvet Code)
(2) Approval of a label takes place by:
(a) determining (if appropriate) the size and type of the label; and
(b) giving a distinguishing number to the label; and
(c) determining the particulars that are to be contained on the label
(which must include the distinguishing number, the instructions for
the use of the product and any particulars that are prescribed by the
regulations); and
(d) placing a label of the determined size and type, and containing the
particulars mentioned in paragraph (c), in the relevant NRA file;
and
(e) recording in that file any conditions of the approval.
38 The
Schedule (section 22 of the Agvet Code)
(a) any of the relevant particulars of:
(i) an approval of an active constituent for a proposed or existing
chemical product; or
(ii) a registration of a chemical product; or
(iii) an approval of a label for containers for a chemical product; or
(b) any of the conditions of such an approval or registration; are
varied pursuant to an application or request made under this Part,
then, the date of the approval of the constituent, of the registration
of the product, or of the approval of the label, as varied, or as
subject to the varied conditions, is the date on which particulars of
the variations are entered in the Record of Approved Active
Constituents or in the Register of Chemical Products or are recorded
in the relevant NRA file, as the case may be.
45 The Schedule (heading to Division 3 of Part 2 of
the Agvet Code)
46 The Schedule (after paragraph
28(1)(b) of the Agvet Code)
47 The Schedule (at
the end of subsection 28(1) of the Agvet Code)
48 The Schedule (subsections 28(2) and (3) of the Agvet Code)
50 The Schedule (paragraph 29(1)(e)
of the Agvet Code)
(i) if the application was for a variation of the relevant particulars or
the conditions of the approval of a constituent or the registration of
a productby entering in the relevant Record or Register
particulars of the variation and the date on which the entry is made;
or
(ii) if the application was for a variation of the relevant particulars of
the approval of a labelby placing in the relevant NRA file a new
label containing the relevant particulars as varied and recording in
the file the date on which the new label is placed in the file; or
(iii) if the application was for a variation of the conditions of approval
of a labelby recording in the file the conditions as varied; or
54 The Schedule (paragraph 29(1)(i) of the Agvet Code)
60 The
Schedule (paragraph 32(1)(b) of the Agvet Code)
64 The Schedule
(subsection 33(1) of the Agvet Code)
(i) the label would comply with any prescribed requirements under
paragraph 14(3)(d); and
(ii) the label would contain adequate instructions relating to the matters
referred to in paragraph 14(3)(g); and
69 The Schedule (paragraph
34(1)(e) of the Agvet Code)
(a) the NRA must vary the relevant particulars or conditions:
(i) if the variation relates to the relevant particulars or the conditions
of the approval of a constituent or the registration of a
productby entering in the relevant Record or Register
particulars of the variation and the date on which the entry is made;
or
(ii) if the variation relates to the relevant particulars of the approval
of a labelby placing in the relevant NRA file a new label
containing the relevant particulars as varied and recording in that
file the date on which the new label is placed in the file; or
(iii) if the variation relates to the conditions of the approval of a
labelby recording in the relevant NRA file particulars of the
variation and the date on which the record is made; and
(b) the NRA must:
(i) state in the notice referred to in subsection (4) that, although
it is not satisfied as mentioned in subsection (1), it is
satisfied that the relevant particulars or the conditions can be so
varied and has varied them accordingly; and
(ii) set out in the notice details of the variation.
(5A) The NRA may only vary the relevant particulars of the approval of a label
if the interested person gives to the NRA a new label containing the
particulars as proposed to be varied.
72 The Schedule (at the end of
Division 4 of Part 2 of the Agvet Code)
(1) The NRA may, at any time, reconsider the approval of a label for
containers for a chemical product for the purpose of deciding whether the
particulars on the label contain adequate instructions relating to matters
prescribed by the regulations for the purposes of this section.
(2) The matters that may be prescribed must be matters that are also
prescribed by the regulations in relation to such a label for the purposes of
paragraph 14(3)(d) or subparagraph 14(3)(g)(x).
(3) If the NRA considers that the particulars do not contain adequate
instructions in relation to a matter, the NRA must:
(a) vary the relevant particulars by placing in the relevant NRA file a
new label containing the relevant particulars as varied and recording
in that file the date on which the new label is placed in the file;
and
(b) give written notice to the interested person in relation to the
product, or to an approved person, setting out particulars of the
variation.
(4) The NRA may only vary the relevant particulars of the approval of a label
if the interested person gives to the NRA a new label containing the
particulars as proposed to be varied.
73 The Schedule (paragraph 37(1)(a) of the Agvet Code)
74 The
Schedule (paragraph 37(1)(b) of the Agvet Code)
(a) the NRA is satisfied that the relevant particulars of the approval of
the label can be varied in such a way that the requirements prescribed
by the regulations for continued approval will be complied with (see
subsection 34(5)); and
(b) the interested person does not give the NRA a label containing the
particulars as proposed to be varied in accordance with a request by
the NRA; the NRA may suspend or cancel the approval.
(a) the NRA considers that the particulars on a label for containers for a
chemical product do not contain adequate instructions relating to
matters prescribed by the regulations for the purposes of subsection
34A(1); and
(b) the interested person does not give the NRA a label containing the
particulars as proposed to be varied in accordance with a request by
the NRA; the NRA may suspend or cancel the approval of the label.
(2) A notice given to a person under subsection (1):
(a) must tell the person of the suspension or cancellation; and
(b) in respect of a suspension or cancellation of the approval of an
active constituent for a proposed or existing chemical product or the
registration of a chemical productmust contain the following
matters:
(i) brief reasons for the suspension or cancellation; and
(ii) instructions for possessing, having custody of, using or otherwise
dealing with the constituent or product; and
(iii) a warning of the consequences if the person fails to comply with the
instructions, including a statement of any period after which it will
be an offence against this Code to possess or have custody of the
constituent or product with the intention of supply, or to supply the
constituent or product; and
(iv) any other warnings or explanations in relation to the constituent or
product that the NRA thinks desirable;
excluding any matters that the NRA thinks it unnecessary for the notice to
contain.
(3) Subsection (1) does not require notice of the cancellation under
section 42 of an approval or registration to be given to the person who
requested the cancellation.
(4) Section 168 provides for additional matters to be included in a
notice given under subsection (1).
(5) After a notice of the suspension or cancellation of the approval or
registration is given to a person under this section, that person is taken to
have been issued with a permit to possess, have custody of, use or otherwise
deal with the constituent or product, or the product containing the label, as
the case may be, in accordance with the instructions contained in the notice
until:
(a) 2 years after the day of the suspension or cancellation; or
(b) the NRA revokes the suspension or cancellation; or
(c) the NRA, by notice published in the Gazette , declares that this
subsection ceases to apply in respect of the constituent or product;
whichever first occurs.
(a) a notice of the suspension or cancellation of the approval of an
active constituent for a proposed or existing chemical product or the
registration of a chemical product is given to a person under this
section; and
(b) the person has possession or custody of the constituent or product
with the intention of supply; the person may only possess, have
custody of or otherwise deal with the constituent or product if the
possession, custody or dealing is in accordance with the instructions
contained in the notice.
85 The Schedule
(subsection 46(2) of the Agvet Code)
(a) the registration of a chemical product ends; but
(b) a person is taken under subsection 54(2) to have been issued with a
permit to possess, have custody of, use or otherwise deal with the
product; the approval of a label for containers for the product
continues in force until the permit ceases to have effect.
88 The Schedule (subsections 49(2), (4) and
(6) of the Agvet Code)
(bb) containing a warning of the consequences if a person fails to comply
with the instructions, including a statement of any period after which
it will be an offence against this Code to possess or have custody of
the product with the intention of supply, or to supply the product;
and
(bc) containing any other warnings or explanations in relation to the
product that the NRA thinks desirable; and
93 The Schedule (at the
end of section 54 of the Agvet Code)
(a) 2 years after the day on which the registration ended; or
(b) the NRA, by notice published in the Gazette , declares that this
subsection ceases to apply in respect of the product; whichever
first occurs.
(a) a notice stating that the registration of a chemical product has ended
has been published under this section; and
(b) a person has possession or custody of the product for the purpose of
supply; the person may only possess, have custody of or otherwise
deal with the product if the possession, custody or dealing is in
accordance with the instructions contained in the notice.
(6) If a notice stating that the registration of a chemical product has ended
is published under this section, the NRA must:
(a) as soon as practicable cause a copy of the notice to be given to the
interested person in relation to the product or to an approved person;
and
(b) cause a copy of the notice to be given to any other person who, in the
opinion of the NRA, should be given notice of the ending of the
registration and of the instructions, warnings and explanations
contained in the notice.
94 The Schedule (paragraph 55(2)(c) of the
Agvet Code)
(a) 2 years after the day of the suspension or cancellation; or
(b) the NRA revokes the suspension or cancellation; or
(c) the NRA, by notice published in the Gazette , declares that this
subsection ceases to apply in respect of the constituent or product,
as the case may be; whichever first occurs.
(a) the listing of, and the establishment of standards for, certain
chemical products; and
(b) the listed registration of those chemical products.
(2) Division 2 provides for the regulations to list certain chemical
products that can be granted listed registration.
(3) Division 3 provides for the establishment of standards for the
listable chemical products.
(4) Division 4 provides how applications for listed registration are to
be dealt with.
(5) Division 5 deals with applications to vary listed registrations or to
vary the conditions of any listed registrations.
(6) Division 6 provides for the NRA to reconsider listed registrations
for the purpose of deciding whether they should remain in force.
(7) Division 7 sets out the circumstances in which the NRA may suspend or
cancel listed registrations.
(8) Division 8 specifies the period for which listed registrations are to
continue in force and makes provision for their renewal.
(9) Division 9 provides for the NRA to publish notices telling the public
of actions that it has taken under this Part.
This Part does not apply to chemical products that are restricted chemical
products.
(1) The regulations may contain a schedule listing chemical products, or
classes of chemical products, that can be granted listed registration under
this Part.
(2) Before the Governor-General makes a regulation listing a chemical product,
or a class of chemical products:
(a) the listing of the product, or class of products, must have been
recommended to the Minister by the NRA; and
(b) the NRA must have given to the Minister:
(i) written particulars of the product or class of products; and
(ii) a draft of the standard that the NRA proposes to submit for approval
by the Minister for the product, or for products in the class, if the
product or class is granted listed registration; and
(iii) a written explanation as to why the NRA is satisfied that use of the
product, or use of products in the class, in accordance with
instructions contained in the established standard for the product
would satisfy the NRA of all the matters mentioned in paragraphs
56E(1)(a) to (e) having regard to matters ( relevant matters )
mentioned in subsection 56E(2) where information about the relevant
matters is readily available; and
(iv) a written statement identifying the consultations held by, and setting
out the advice given to, the NRA in relation to the proposed listing
of the products or class of products.
(3) The Minister may, before the Governor-General makes a regulation listing a
chemical product or class of chemical products, require the NRA to cause to be
published in the Gazette , and to be published in any other manner that the
Minister thinks appropriate, a notice:
(a) stating that it has recommended the listing of the product or class of
products; and
(b) setting out particulars of the product or of products in the class;
and
(c) giving the reasons for the recommendation; and
(d) inviting any person who wishes to do so to make, within a period
stated in the notice that ends not earlier than 28 days after the day
on which the notice appears in the Gazette , a written submission to
the NRA as to whether the recommendation should be confirmed or
withdrawn and stating the grounds on which the submission is based,
which must be grounds relating to the matters mentioned in paragraphs
56E(1)(a) to (e).
(4) If the Minister requires the NRA to publish a notice under
subsection (3), the NRA must take into account any submissions made in
accordance with the invitation contained in the notice and must inform the
Minister whether it confirms or withdraws its recommendation.
Division 3Establishing standards for listable chemical products
(1) This section applies in respect of each listable chemical product, whether
or not the product is the subject of a monograph in the British Pharmacopoeia
or the British Pharmacopoeia (Veterinary) or in a similar publication.
(2) The NRA must prepare in writing a standard for each listable chemical
product and must submit the standard to the Minister for his or her approval
of the standard. A particular standard may relate to a specified chemical
product or specified chemical products or to each chemical product in a
specified class of chemical products.
(3) The standard for a listable chemical product must require that the product
be labelled in a manner, or kept in containers that comply with requirements,
specified in the standard.
(4) Without limiting the generality of subsection (3), the NRA may, in a
standard, direct that the particulars required by the standard be set out, in
a manner specified in the standard, on:
(a) chemical products, or a class of chemical products, identified in the
standard; or
(b) a container containing chemical products, or a class of chemical
products, identified in the standard; or
(c) a label for containers for chemical products, or a class of chemical
products, identified in the standard.
(5) Without limiting the generality of the preceding provisions of this
section, a standard for a listable chemical product:
(a) may be specified by reference to any one or more of the following:
(i) the composition and form of the constituents of the product;
(ii) the physical and chemical properties of the chemical product;
(iii) the quantity of the chemical product when contained in specified
containers;
(iv) procedures to be carried out in the manufacture of the chemical
product;
(v) a monograph in the British Pharmacopoeia or the British Pharmacopoeia
(Veterinary);
(vi) a monograph in another publication approved by the NRA for the
purposes of this subparagraph;
(vii) a monograph referred to in subparagraph (v) or (vi) as modified
in a manner specified in the standard;
(viii) a standard published by Standards Australia International Limited;
(ix) such other matters as the NRA thinks fit; and
(b) may require that a matter relating to the standard be determined in
accordance with a particular test.
(6) If the Minister decides not to approve a standard for a listable chemical
product:
(a) the Minister must inform the NRA of the reasons for the decision; and
(b) the NRA must prepare in writing such revised standard or standards for
the product as may be required until the Minister endorses his or her
approval on the instrument containing the standard concerned.
(7) If the Minister decides to approve a standard for a listable chemical
product:
(a) the approval is effected by the Minister endorsing his or her approval
on an instrument containing the standard; and
(b) that standard becomes the standard established for the product from
the time of endorsement.
(8) The NRA must cause a copy of the standard established for a listable
chemical product to be published in the Gazette .
(1) The NRA must not submit a standard for a chemical product to the Minister
for approval unless the NRA is satisfied that use of the product in accordance
with the standard:
(a) would ensure that the product would not be an undue hazard to the
safety of people exposed to it during its handling or people using
anything containing its residues; and
(b) would ensure that the product would not be likely to have an effect
that is harmful to human beings; and
(c) would ensure that the product would not be likely to have an
unintended effect that is harmful to animals, plants or things or to
the environment; and
(d) would not unduly prejudice trade or commerce between Australia and
places outside Australia; and
(e) would be effective according to criteria determined by the NRA for the
product; and
(f) would contain, or would require a label for containers for the product
to contain, adequate instructions relating to such of the following as
are appropriate:
(i) the circumstances in which the product should be used;
(ii) how the product should be used;
(iii) the times when the product should be used;
(iv) the frequency of the use of the product;
(v) the withholding period after the use of the product;
(vi) the re-entry period after the use of the product;
(vii) the disposal of the product when it is no longer required;
(viii) the disposal of containers of the product;
(ix) the safe handling of the product and first aid in the event of an
accident caused by the handling of the product;
(x) any other matters prescribed by the regulations.
(2) In satisfying itself for the purposes of subsection (1) whether a
standard would ensure that a chemical product would not be an undue hazard as
mentioned in paragraph (1)(a), would not be likely to have an effect that
is harmful as mentioned in paragraph (1)(b) or would not be likely to
have an unintended effect that is harmful as mentioned in
paragraph (1)(c), the NRA may have regard to such matters as it thinks
relevant but must have regard to the following:
(a) the toxicity of the product and its residues in relation to relevant
organisms and ecosystems, including human beings;
(b) the relevant poison classification of the product under the law in
force under this jurisdiction;
(c) how the product is formulated;
(d) the composition and form of the constituents of the product;
(e) the acceptable daily intake of each active constituent contained in
the product;
(f) whether any trials or laboratory experiments have been carried out to
determine the residues of the product and, if so, the results of those
trials or experiments and whether those results show that the residues
of the product will not be greater than limits that the NRA has
approved or approves;
(g) the stability of the product;
(h) the specifications for containers for the product;
(i) any other matters prescribed by the regulations.
(3) In satisfying itself for the purposes of paragraph (1)(e) whether the
use of a product in accordance with a standard would be effective, the NRA
must have regard to:
(a) whether any trials or laboratory experiments have been carried out to
determine the efficacy of the product and, if so, the results of those
trials or experiments; and
(b) any other matters prescribed by the regulations.
(1) The NRA may at any time prepare, in writing, a variation of the standard
established for a listable chemical product and submit the variation to the
Minister for his or her approval.
(2) If the Minister decides to approves the variation:
(a) the approval is effected by the Minister endorsing his or her approval
on an instrument varying the standard; and
(b) the standard as varied becomes the established standard for the
product from the time of endorsement.
(3) The NRA may, by writing, with the approval of the Minister, revoke the
standard established for a listable chemical product.
(4) The NRA must cause a copy of an instrument of variation or revocation of
the standard established for a listable chemical product to be published in
the Gazette .
(1) A standard established for a listable chemical product takes effect on the
day on which a copy of the instrument containing the standard is published in
the Gazette or on such later day as is specified in that instrument.
(2) An instrument varying or revoking a standard established for a listable
chemical product takes effect on the day on which a copy of the instrument of
variation or revocation is published in the Gazette or on such later day as is
specified in that instrument.
Instruments containing standards, and instruments varying or revoking
standards, established for listable chemical products are disallowable
instruments for the purposes of section 46A of the Acts Interpretation
Act 1901 .
Division 4Application for registration of listable
chemical products
A person may apply to the NRA for a chemical product:
(a) that is a listable chemical product; and
(b) for which there is an established standard;
(1) The application must: to be granted listed
registration.
(a) be in writing in or to the effect of the approved form; and
(b) contain, or be accompanied by, any information that the NRA requires;
and
(c) be signed by an approved person; and
(d) be accompanied by the prescribed fee (if any); and
(e) be lodged with the NRA.
(2) The NRA may, with the written consent of an approved person, alter the
application.
(3) At any time after an application has been made and before it has been
determined, an approved person:
(a) may give to the NRA information additional to or varying information
previously given to the NRA; and
(b) may withdraw the application by giving to the NRA a written notice of
the withdrawal signed by an approved person.
(1) The NRA must grant an application under section 56I if it is
satisfied:
(a) that the applicant has complied with subsection 56J(1); and
(b) that any requirement made under section 157 or 159 has been
complied with; and
(c) that, if necessary, paragraph 8A(2)(a) of the Agricultural and
Veterinary Chemicals (Administration) Act 1992 has been complied with;
and
(d) that the chemical product complies with the relevant established
standard and with such other requirements as are prescribed by the
regulations; and
(e) that the fee (if any) prescribed in respect of the listed
registration, and any other amount (including an amount in respect of
a tax or penalty) that is payable (whether by the applicant or by any
other person) to the NRA in respect of the product under this Code or
any other law in force in this or any other jurisdiction, have been
paid.
(2) In satisfying itself for the purposes of subsection (1), the NRA may:
(a) have regard to the results of its own inquiries; or
(b) rely on a written declaration produced to it by an approved person;
as it thinks appropriate.
The listed registration of a chemical product on the application of a person
does not preclude the listed registration of the same chemical product on the
application of another person.
(1) If the NRA grants an application for a listable chemical product to be
granted listed registration, it must give a distinguishing number to the
product and grant listed registration in respect of the product in accordance
with this section, either unconditionally or subject to conditions as
mentioned in section 56O.
(2) Listed registration of a chemical product takes place by entering in the
Register of Chemical Products:
(a) the relevant particulars, which are a notation that the product is a
listable chemical product, the distinguishing number and any other
particulars that are prescribed by the regulations; and
(b) any conditions of the listed registration.
(1) The date of listed registration of a chemical product is the date on which
the relevant particulars are entered in the Register of Chemical Products.
(2) If:
(a) any of the relevant particulars of the listed registration of a
chemical product; or
(b) any of the conditions of such a listed registration;
(1) The conditions of the listed registration of a chemical product are the
conditions that the NRA thinks appropriate. are varied
pursuant to an application or request made under this Part, then, the
date of the listed registration of the product, as varied, or as
subject to the varied conditions, is the date on which particulars of
the variations are entered in the Register of Chemical Products.
(2) Without limiting subsection (1), listed registration of a chemical
product may be granted:
(a) on the condition that the product is supplied only in a container of a
kind referred to in the condition or prescribed by the regulations; or
(b) on the condition that the product is not supplied in a container of a
kind referred to in the condition or prescribed by the regulations.
(3) Listed registration of a chemical product may be granted on the condition
that the listed registration remains in force only for a stated period that is
not more than one year.
(4) If the listed registration is subject to a condition referred to in
subsection (3) and the conditions of listed registration have not been
varied before the end of the period referred to in the condition, or the end
of that period as previously extended under this subsection, so as to remove
the condition, the NRA may vary the condition so as to extend the period for a
further period of not more than one year or for further periods each of which
is not more than one year.
(1) If an application for listed registration of a chemical product is
granted, the NRA:
(a) must give to an approved person written notice of the listed
registration; and
(b) may cause to be made publicly available, in an appropriate manner, a
material safety data sheet in respect of the product.
(2) The notice referred to in paragraph (1)(a) must contain the
information that is prescribed by the regulations.
(3) Section 168 provides for additional matters to be included in a
notice granting listed registration in respect of a chemical product subject
to conditions.
(1) If an application for listed registration of a chemical product is
refused, the NRA must:
(a) give to an approved person written notice of the refusal; and
(b) include in the notice brief particulars of the reasons for the
refusal.
(2) Section 168 provides for additional matters to be included in a
notice under this section.
(1) If a person:
(a) is the interested person in relation to a registered listed chemical
product; and
(b) has reasonable cause to believe that, because of a change in
circumstances, inaccurate recording or any other reason, a relevant
particular or a condition entered in the Register of Chemical Products
in relation to the product is not correct in a material respect; the
person must, as soon as practicable, give to the NRA a written notice,
signed by an approved person, identifying the incorrect particular or
condition and informing the NRA of the correct particular or
condition.
Division 5Application for variation of relevant particulars, or of
conditions, of listed registration
The interested person in relation to a registered listed chemical product may
apply to the NRA for variation of the relevant particulars, or variation of
the conditions, of the listed registration.
(1) The application must:
(a) be in writing in or to the effect of the approved form; and
(b) contain, or be accompanied by, the information that the NRA requires;
and
(c) be signed by an approved person; and
(d) be accompanied by the prescribed fee (if any); and
(e) be lodged with the NRA.
(2) The NRA may alter the application with the written consent of an approved
person.
(3) At any time after an application has been made and before it has been
determined, an approved person may withdraw the application by giving to the
NRA written notice of the withdrawal signed by an approved person.
(1) If the NRA is satisfied of the following:
(a) that subsection 56T(1) has been complied with;
(b) that any requirement made under section 157 or 159 has been
complied with;
(c) that, if necessary, paragraph 8A(2)(a) of the Agricultural and
Veterinary Chemicals (Administration) Act 1992 has been complied with;
(d) that any requirements prescribed by the regulations in relation to the
variation of the relevant particulars, or of the conditions, of a
listed registration have been complied with;
(e) that, if those particulars or conditions were varied in accordance
with the application, the continued use of, or any other dealing with,
the product in accordance with instructions contained in the
established standard:
(i) would not be an undue hazard to the safety of people exposed to it
during its handling or people using anything containing its residues;
and
(ii) would not be likely to have an effect that is harmful to human beings;
and
(iii) would not be likely to have an unintended effect that is harmful to
animals, plants or things or to the environment; and
(iv) would not unduly prejudice trade or commerce between Australia and
places outside Australia; and
(v) would be effective according to criteria determined by the NRA for the
product;
(f) that the fee (if any) prescribed in respect of the listed
registration, and any other amount (including an amount in respect of
a tax or penalty) that is payable (whether by the applicant or by any
other person) to the NRA in respect of the product under this Code or
any other law in force in this or any other jurisdiction, have been
paid; it must:
(h) give written notice to an approved person stating that the variation
has been made and setting out particulars of the variation.
(2) In satisfying itself for the purposes of subparagraph (1)(e)(i), (ii)
or (iii), the NRA must have regard to the matters referred to in subsection
56E(2).
(3) In satisfying itself for the purposes of subparagraph (1)(e)(v), the
NRA must have regard to the matters referred to in subsection 56E(3).
(4) If the NRA is not satisfied as mentioned in subsection (1), it must
refuse the application.
(5) If the application is refused, the NRA must:
(a) give to an approved person written notice of the refusal; and
(b) include in the notice brief particulars of the reasons for the
refusal.
(6) Section 168 provides for additional matters to be included in a
notice under subsection (5).
56V NRA may invite the public to propose
registered listed chemical products for reconsideration
(1) The NRA may cause to be published in the Gazette , and in any other manner
it thinks appropriate, notices inviting persons to propose chemical products
whose listed registration the NRA might reconsider.
(2) A notice under subsection (1) must state the criteria that are to be
taken into account by the NRA in reconsidering the listed registration.
(3) A proposal made by a person because of an invitation contained in a notice
under subsection (1) must submit reasons, based on the criteria stated in
the notice, in support of the proposal.
The NRA may at any time, in accordance with this Division, reconsider the
listed registration of a chemical product.
(1) Before reconsidering the listed registration of a chemical product, the
NRA may, if it thinks it desirable to do so, cause to be published, in a
manner that it thinks appropriate, a notice:
(a) stating that the NRA proposes to reconsider the listed registration
and setting out the relevant particulars of the listed registration of
the product; and
(b) setting out the matters to be dealt with in the reconsideration and
stating the requirement or requirements prescribed by the regulations
for continued approval or registration that form the basis for the
reconsideration; and
(c) inviting any person who wishes to do so to make, within a period
stated in the notice that ends not earlier than 28 days after the
publication of the notice, a written submission to the NRA as to
whether the listed registration complies with the prescribed
requirements for continued listed registration.
(2) The NRA must give written notice to the interested person in relation to
the product or to an approved person:
(a) telling the person the matter or matters that it proposes to
reconsider and its reasons for so proposing; and
(b) requiring the person, within a period stated in the notice that ends
not earlier than 28 days after the day on which the notice is given,
to give to the NRA:
(i) any information of a kind stated in the notice of which either the
interested person or the approved person is aware and which is
relevant to the reconsideration; or
(ii) any information of which either the interested person or the approved
person is aware that is relevant to the reconsideration; and
(c) inviting the person, within that period, to make a written submission
to the NRA about the matter or matters referred to in
paragraph (a).
(3) A person must comply with a requirement made of the person under
paragraph (2)(b).
(6) The NRA must take into account any submissions made in accordance with an
invitation contained in a notice published under subsection (1) or in a
notice given under subsection (2).
(1) The NRA may, by written notice given to the interested person in relation
to a registered listed chemical product or given to an approved person,
require the interested person, within a reasonable period stated in the
notice:
(a) to conduct, or cause to be conducted, trials or laboratory experiments
in relation to the product that the NRA thinks necessary for the
purposes of its reconsideration of the listed registration of the
product; and
(b) to give the results of the trials or experiments to the NRA.
(2) A person must comply with a requirement made of the person under
subsection (1).
(5) This section does not affect the NRA's powers under section 159.
(1) If the NRA is satisfied that:
(a) any requirement made under section 159 has been complied with;
and
(b) if necessary, paragraph 8A(2)(a) of the Agricultural and Veterinary
Chemicals (Administration) Act 1992 has been complied with; and
(c) provided that the conditions to which a listed registration is
currently subject are complied with, the continued use of, or other
dealing with, the product in accordance with instructions contained in
the established standard:
(i) would not be an undue hazard to the safety of people exposed to it
during its handling or people using anything containing its residues;
and
(ii) would not be likely to have an effect that is harmful to human beings;
and
(iii) would not be likely to have an unintended effect that is harmful to
animals, plants or things or to the environment; and
(iv) would not unduly prejudice trade or commerce between Australia and
places outside Australia; and
(v) would be effective according to criteria determined by the NRA for the
product; and
(d) any other prescribed requirements for the continued listed
registration would be complied with; the NRA must as soon as
practicable:
(f) if it caused a notice to be published under subsection 56X(1) in
relation to its proposed reconsideration of the listed
registrationcause to be published, in the same way as the
first-mentioned notice, a notice stating that it has affirmed the
listed registration on the conditions to which the listed registration
is currently subject.
(2) In satisfying itself as mentioned in subparagraph (1)(c)(i), (ii) or
(iii), the NRA must have regard to the matters referred to in subsection
56E(2).
(3) If the NRA is not satisfied as mentioned in subsection (1),
subsections (4) to (6) apply.
(4) The NRA must give written notice to the interested person or to an
approved person stating that the NRA is not so satisfied.
(5) If the NRA is satisfied that the relevant particulars or the conditions of
the listed registration can be varied in such a way that the requirements for
continued listed registration will be complied with:
(a) the NRA must vary the relevant particulars or conditions of listed
registration by entering in the Register of Chemical Products
particulars of the variation and the date on which the entry is made;
and
(b) the NRA must:
(i) state in the notice referred to in subsection (4) that, although
the NRA is not satisfied as mentioned in subsection (1), it is
satisfied that the relevant particulars or the conditions can be so
varied and has varied them accordingly; and
(ii) set out in the notice particulars of the variation.
(6) A notice given under subsection (4) must give brief particulars of
the reasons for the NRA's decision and, if subsection (5) applies, also
give brief particulars of the reasons for the variation of the conditions of
the listed registration.
(7) Section 168 provides for additional matters to be included in a
notice to which subsection (5) applies.
(8) Section 56ZE provides for the suspension or cancellation of the
listed registration if the NRA is not satisfied that the conditions of the
listed registration can be varied as mentioned in subsection (5).
56ZA
Notice of proposed suspension or cancellation to be given to co-ordinators
The NRA must not suspend or cancel a listed registration unless:
(a) it has given notice of the proposed suspension or cancellation to each
co-ordinator designated for a jurisdiction; and
(b) a period of 10 working days, or any other period that the NRA thinks
adequate in a particular case, has elapsed since the notice was given.
56ZB Suspension or cancellation of listed registration for breach of
condition
If there is a contravention of a condition of the listed registration of a
chemical product, the NRA may suspend or cancel the listed registration.
56ZC
Suspension of listed registration for failing to give information, or results
of trials or experiments, to NRA
(1) If:
(a) at the end of the period stated in a notice given to a person under
subsection 56X(2), the NRA is satisfied that the interested person or
an approved person is aware of information relevant to the
reconsideration but the information has not been given to the NRA; or
(b) at the end of the period stated in a notice given to a person under
subsection 56Y(1), the NRA is satisfied that the interested person has
not conducted, or caused to be conducted, the trials or experiments or
has not given the results of the trials or experiments to the NRA;
the NRA may suspend the listed registration.
(3) Subject to subsection (4), the NRA must revoke a suspension imposed
under paragraph (1)(b) when it has received the results of the trials or
experiments.
(4) If the information or the results of the trials or experiments are not
given to the NRA within a period after the suspension takes place that the NRA
thinks reasonable, the NRA may cancel the listed registration.
56ZD
Suspension of listed registration for failing to give information, report or
sample to NRA
(1) If the interested person in relation to a registered listed chemical
product, or an approved person, fails to comply with a requirement contained
in a notice under section 159 or with section 160A or 161, the NRA
may suspend the listed registration.
(2) Subject to subsection (3), the NRA must revoke a suspension imposed
under subsection (1) if it is satisfied that the relevant information,
report or sample has been given to it.
(3) If the information, report or sample is not given to the NRA within a
reasonable period after the suspension takes place, the NRA may cancel the
listed registration.
56ZE Suspension or cancellation of listed registration
following reconsideration
If, in the course of reconsidering the listed registration of a chemical
product, the NRA is not satisfied that the relevant particulars or the
conditions of the listed registration can be varied in such a way that the
prescribed requirements for continued listed registration will be complied
with, the NRA may suspend or cancel the listed registration.
56ZF Suspension
or cancellation of listed registration for non-compliance with criteria
(1) The NRA may suspend or cancel the listed registration of a chemical
product if it appears to the NRA that, having regard to the matters referred
to in subsection 56E(2), the continued use of, or any other dealing with, the
product in accordance with instructions contained in the established standard:
(a) may be an undue hazard to the safety of people exposed to it during
its handling or people using anything containing its residues; or
(b) may be likely to have an effect that is harmful to human beings; or
(c) may be likely to have an unintended effect that is harmful to animals,
plants or things or to the environment; or
(d) may unduly prejudice trade or commerce between Australia and places
outside Australia.
(2) The NRA may suspend or cancel the listed registration of a chemical
product if it appears to the NRA that, having regard to the matters referred
to in subsection 56E(3), the continued use of the product in accordance with
the instructions contained in the standard may not be effective according to
criteria determined by the NRA for the product.
(1) If:
(a) the interested person in relation to a listed registration, or an
approved person, gives to the NRA a written notice:
(i) requesting the NRA to cancel the listed registration; and
(ii) stating the reasons for the request; and
(b) the NRA is satisfied that there are no valid reasons why it should not
agree to the request; the NRA must cancel the listed registration.
(1) A suspension of a listed registration must be for a stated period.
(2) A listed registration is taken for the purposes of this Code other than
section 75 not to be in force during any period in which it is suspended.
(3) A listed registration may be cancelled even though it is suspended.
(1) Suspension or cancellation of a listed registration is made by entering in
the Register of Chemical Products:
(a) the fact that the listed registration has been suspended or cancelled;
and
(b) in respect of a suspensionthe period of the suspension; and
(c) the date on which the entry is made.
(2) Subject to subsection (4), if the NRA suspends or cancels a listed
registration, it must, as soon as practicable, give written notice of the
suspension or cancellation to the interested person, or an approved person,
and to any other person to whom, in its opinion, such a notice should be
given.
(3) A notice given to a person under subsection (2) must:
(a) tell the person of the suspension or cancellation; and
(b) contain the following matters:
(i) brief reasons for the suspension or cancellation;
(ii) instructions for possessing, having custody of, using or otherwise
dealing with the product;
(iii) a warning of the consequences if the person fails to comply with the
instructions, including a statement of any period after which it will
be an offence against this Code to possess or have custody of the
product with the intention of supply, or to supply the product;
(iv) any other warnings or explanations in relation to the product that the
NRA thinks desirable;
excluding any matters that the NRA thinks it unnecessary for the notice to
contain.
(4) Subsection (2) does not require notice of the cancellation under
section 56ZG of a listed registration to be given to the person who
requested the cancellation.
(5) Section 168 provides for additional matters to be included in a
notice given under subsection (2).
(6) After a notice of the suspension or cancellation of the listed
registration of a chemical product is given to a person under this section,
the interested person is taken to have been issued with a permit to possess,
have custody of, use or otherwise deal with the product in accordance with the
instructions contained in the notice until:
(a) 2 years after the day of the suspension or cancellation; or
(b) the NRA revokes the suspension or cancellation; or
(c) the NRA, by notice published in the Gazette , declares that this
subsection ceases to apply in respect of the product; whichever
first occurs.
(a) a notice of the suspension or cancellation of the listed registration
of a chemical product is given to a person under this section; and
(b) the person has possession or custody of the product with the intention
of supply; the person may only possess, have custody of or otherwise
deal with the product if the possession, custody or dealing is in
accordance with the instructions contained in the notice.
56ZJ How suspension or
cancellation of listed registration is revoked
(1) Suspension or cancellation of a listed registration is revoked by entering
in the Register of Chemical Products:
(a) the fact that the suspension or cancellation has been revoked; and
(b) the date on which the entry is made.
(2) If the NRA revokes the suspension or cancellation of a listed
registration, it must, as soon as practicable, give written notice of the
revocation to the interested person or an approved person, and to any other
person to whom, in its opinion, such a notice should be given.
(3) If the cancellation of a listed registration is revoked, the cancellation
is taken never to have occurred.
(1) The listed registration of a chemical product ends at the end of
30 June next following the day on which the listed registration was
granted or renewed, or last renewed, as the case may be.
(2) This section has effect subject to:
(a) any condition of a kind referred to in subsection 56O(3) to which a
listed registration is subject; and
(b) subsection 56ZH(2) (which relates to suspension of a listed
registration); and
(c) the following provisions of this Division.
56ZL Application for
renewal of listed registration of chemical product
(1) The interested person may apply for the renewal, or further renewal, as
the case may be, of the listed registration of a chemical product.
(2) Subject to subsection (3), the application must be made not later
than one month, or a shorter period that the NRA permits, before the listed
registration ends.
(3) In circumstances that are prescribed by the regulations and upon payment
of the prescribed fee (if any), the NRA may accept a late application if the
application is made on or before a date that the NRA determines.
56ZM How
application for renewal of listed registration is to be made
(1) The application must:
(a) be in writing in or to the effect of the approved form; and
(b) contain, or be accompanied by, the information that the NRA requires;
and
(c) be signed by an approved person; and
(d) be accompanied by the prescribed fee (if any); and
(e) be lodged with the NRA.
(2) The NRA may, with the written consent of an approved person, alter the
application.
(3) At any time after an application has been made and before it has been
determined, the applicant may withdraw the application by giving to the NRA
written notice of the withdrawal signed by an approved person.
(4) Subject to subsection (5), the NRA must grant the application:
(a) if the application was made in accordance with subsection
56ZL(2)before the listed registration ends; or
(b) if the application was made in accordance with subsection
56ZL(3)within one month after the application was made; and
must give written notice to an approved person of the renewal and the
period of the renewal.
(6) If the application was made in accordance with subsection 56ZL(2) and the
NRA fails to grant the application before the listed registration ends, the
listed registration continues in force until:
(a) the NRA grants the application; or
(b) if the NRA decides to refuse to grant the application because of
non-payment of an amount as mentioned in subsection (5)the
NRA gives written notice of its decision to the applicant.
(7) If the NRA accepts a late application under subsection 56ZL(3) and grants
the application, the listed registration continues in force, or is taken to
have continued in force, as the case may be, until the application is or was
granted.
The renewal of the listed registration of a chemical product:
(a) is granted by entering in the Register of Chemical Products a
statement that the listed registration has been renewed and the date
on which the renewed listed registration ends; and
(b) takes effect, or is to be regarded as having taken effect, as the case
may be, at the beginning of the day immediately following the day on
which the previous listed registration ends or ended.
Division 9Publication of notices and certain other
instruments by NRA
56ZO Publication of notice of listed registration
of chemical product
(1) If the NRA grants listed registration in respect of a chemical product, it
must, as soon as practicable after the listed registration, cause notice of
the listed registration to be published in accordance with
subsection (2), unless the NRA thinks it unnecessary, in the
circumstances, to publish such a notice.
(2) The notice:
(a) is to be published in the Gazette and in any other manner that the NRA
thinks appropriate; and
(b) must state that the product has been granted listed registration, and
state the date of the listed registration; and
(c) must contain a brief statement of the conditions of the listed
registration that directly regulate the use of the product.
56ZP
Publication of notice of variations of listed registration of chemical
product
(1) If the NRA varies any of the relevant particulars of the listed
registration of a chemical product or any of the conditions of such a listed
registration, it must, as soon as practicable after the variation, cause
notice of the variation to be published in the Gazette and in any other manner
that it thinks appropriate, unless the NRA thinks it unnecessary, in the
circumstances, to do so.
(2) The notice must:
(a) state that the relevant particulars or conditions have been varied and
state the date of the variation; and
(b) contain a brief statement of the nature of, and reasons for, the
variation.
56ZQ Publication of notice of end of listed registration
of chemical product
(1) If the listed registration of a chemical product ends and is not renewed,
the NRA must, as soon as practicable, cause to be published in the Gazette ,
and in any other manner that it thinks appropriate, a notice:
(a) stating that the listed registration has ended; and
(b) containing instructions for possessing, having custody of, using or
otherwise dealing with the product; and
(c) containing a warning of the consequences if a person fails to comply
with the instructions, including a statement of any period after which
it will be an offence against this Code to possess or have custody of
the product with the intention of supply, or to supply the product;
and
(d) containing any other warnings or explanations in relation to the
product that the NRA thinks desirable; and
(e) setting out the date on which the listed registration ended; and
(f) containing any other information that the NRA thinks appropriate;
unless the NRA thinks that, in the circumstances, it is unnecessary to
publish such a notice.
(a) 2 years after the day on which the registration ends; or
(b) the NRA, by notice published in the Gazette , declares that this
subsection ceases to apply in respect of the product; whichever
first occurs.
(a) a notice stating that the listed registration of a chemical product
has ended has been published under this section; and
(b) a person has possession or custody of the product with the intention
of supply; the person may only possess, have custody of or otherwise
deal with the product if the possession, custody or dealing is in
accordance with the instructions contained in the notice.
(6) If a notice stating that the listed registration of a chemical product has
ended is published under this section, the NRA must cause a copy of the notice
to be given to any person who, in the opinion of the NRA, should be given
notice of the ending of the listed registration and of the instructions,
warnings and explanations contained in the notice.
56ZR Publication of notice
of suspension or cancellation of listed registration
(1) If the NRA suspends or cancels the listed registration of a chemical
product, it must, as soon as practicable, cause to be published in the Gazette
, and in any other manner that it thinks appropriate, notice of the suspension
or cancellation containing any information that it thinks relevant.
(2) If the reason, or one of the reasons, for the suspension or cancellation
was that the continued use of the product:
(a) might be an undue hazard to the safety of people exposed to it during
its handling or people using anything containing its residues; or
(b) might be likely to have an effect that is harmful to human beings; or
(c) might be likely to have an unintended effect that is harmful to
animals, plants or things or to the environment; or
(d) might not be effective according to criteria determined by the NRA for
the product; the notice must contain the following:
(f) instructions for possessing, having custody of, using or otherwise
dealing with the product;
(g) a warning of the consequences if a person fails to comply with the
instructions, including a statement of any period after which it will
be an offence against this Code to possess or have custody of the
product with the intention of supply, or to supply the product;
(h) any other warnings or explanations in relation to the product that the
NRA thinks desirable.
(3) If, after the publication under this section of a notice of the suspension
or cancellation of a listed registration, a person possesses, has custody of,
uses or otherwise deals with the product in accordance with the instructions
contained in the notice, the person is taken to have been issued with a permit
to possess, have custody of, use or otherwise deal with the product in
accordance with those instructions until:
(a) 2 years after the day of the suspension or cancellation; or
(b) the NRA revokes the suspension or cancellation; or
(c) the NRA, by notice published in the Gazette , declares that this
subsection ceases to apply in respect of the product; whichever
first occurs.
(a) a notice of the suspension or cancellation of the listed registration
of a chemical product, has been published under this section; and
(b) a person has possession or custody of the product with the intention
of supply; the person may only possess, have custody of or otherwise
deal with the product if the possession, custody or dealing is in
accordance with the instructions contained in the notice.
(7) If the NRA causes a notice of the suspension or cancellation of the listed
registration of a chemical product to be published under this section, the NRA
must cause a copy of the notice to be given to any person who, in the opinion
of the NRA, should be given notice of the suspension or cancellation and of
the instructions, warnings and explanations contained in the notice.
56ZS
Notice of revocation of suspension or cancellation to be published
If the NRA revokes the suspension or cancellation of the listed registration
of a chemical product, it must, as soon as practicable, cause to be published
in the Gazette , and in any other manner that it thinks appropriate, notice of
the revocation containing any information that it thinks relevant.
56ZT
Publication of instrument varying established standard for listable chemical
product
If, after a copy of an instrument varying the established standard for a
listable chemical product is published in the Gazette under section 56G,
a person possesses, has custody of, uses or otherwise deals with part of any
stock of the product that complies with the standard that was established for
the product immediately before the variation, the person is taken to have been
issued with a permit to possess, have custody of, use or otherwise deal with
that part of the stock of the product in accordance with the instructions
contained in the standard as in force immediately before the variation until:
(a) 2 years after the day of the publication of the notice; or
(b) the NRA, by notice published in the Gazette , declares that this
section ceases to apply in respect of the product; whichever first
occurs.
(1) Subject to subsection (2), the regulations may contain a schedule
specifying chemical products, or classes of chemical products, that are
reserved chemical products for the purposes of this Code.
(2) The schedule cannot specify a chemical product that is, or a class of
chemical products that includes, a restricted chemical product.
(3) Regulations containing a schedule mentioned in subsection (1) must
state the conditions to which the possession, having custody of, use of, or
other dealing with, each chemical product, or each chemical product included
in a class of chemical products, specified in the schedule is subject.
(4) Before the Governor-General makes a regulation for the purposes of this
section:
(a) the reservation of the product, or class of products, must have been
recommended to the Minister by the NRA; and
(b) the NRA must have given to the Minister:
(i) written particulars of the product or class of products; and
(ii) a draft of the conditions to which the NRA proposes the product, or
products in the class, should be subject; and
(c) the NRA must have given to the Minister a written explanation as to
why the NRA is satisfied that use of the product, or use of the
products in the class, in accordance with the proposed conditions:
(i) would not be an undue hazard to the safety of people exposed to it
during its handling or people using anything containing its residues;
and
(ii) would not be likely to have an effect that is harmful to human beings;
and
(iii) would not be likely to have an unintended effect that is harmful to
animals, plants or things or to the environment; and
(iv) would not unduly prejudice trade or commerce between Australia and
places outside Australia; and
(v) would be effective according to criteria determined by the NRA for the
product; and
(d) the NRA must have given to the Minister a written statement
identifying the consultations held by, and setting out the advice
given to, the NRA in relation to the proposed reservation of the
products or class of products.
107 The Schedule (subsection 59(1) of
the Agvet Code)
109 The Schedule (paragraph 72(2)(c) of the Agvet
Code)
110 The
Schedule (subsections 75(1) and (3) of the Agvet Code)
(ii) the period beginning on the day when the product ceased, or last
ceased, to be so registered, granted listed registration, or reserved,
and ending on the day when the supply takes place is not longer than a
period that the NRA has determined in relation to the product for the
purposes of this subparagraph;
(iii) the supply is a supply of part of a stock of the product that was in
the person's possession or custody immediately before the product
ceased, or last ceased, to be so registered, granted listed
registration, or reserved;
113 The Schedule (subparagraph
78(1)(c)(vi) of the Agvet Code)
A person may only supply, or cause or permit to be supplied, a registered
listed chemical product whose listed registration is subject to conditions if:
(a) the supply is in accordance with those conditions; or
(b) the supply is authorised by a permit.
(1) A person may only supply, or cause or permit to be supplied, a reserved
chemical product if:
(a) the supply is in accordance with the conditions specified in
regulations made for the purposes of section 56ZU that relate to
the product; or
(b) the supply is authorised by a permit.
(a) the label attached to the container is identical (except for
particulars relating to the batch number, date of manufacture or
expiry date of the product) to the approved label for containers for
the product; or
(b) the supply is authorised by a permit.
(a) the label attached to the container is identical (except for
particulars relating to the batch number, date of manufacture or
expiry date of the product) to a label (the earlier approved label )
that was an approved label for containers for the product at a time
before the supply takes place; and
(b) the NRA has determined that this subsection is to apply in respect of
the earlier approved label; and
(c) the supply takes place not later than 2 years (or such shorter or
longer period as the NRA allows) after the earlier approved label
ceased to be the approved label for containers for the product.
120
The Schedule (after section 83 of the Agvet Code)
(1) A person must not supply, or cause or permit to be supplied, a substance
or mixture of substances in a container to which is attached a label
containing a name of a registered listed chemical product if:
(a) the constituents of the substance or mixture differ by more than the
prescribed extent from the constituents of the registered listed
chemical product that were shown in the particulars of the registered
listed chemical product contained in the Register of Chemical
Products; or
(b) the concentration of the constituents of the substance or mixture
differ by more than the prescribed extent from the concentration of
the constituents of the registered listed chemical product that was
shown in those particulars; or
(c) the composition or purity of any constituent of the substance or
mixture differs by more than the prescribed extent from the
composition or purity of the corresponding constituent of the
registered listed chemical product that was shown in those
particulars.
A person may only supply, or cause or permit to be supplied, a substance or
mixture of substances in a container to which is attached a label containing
the name of a registered listed chemical product if:
(a) the substance or mixture conforms to the established standard for the
product; or
(b) the supply is authorised by a permit.
chemical product does not include a reserved chemical product.
132 The Schedule (paragraph
97(4)(b) of the Agvet Code)
(a) a chemical product (other than a reserved chemical product) is not
registered, and has not been granted listed registration, under the
Agvet Code of this jurisdiction; or
(b) the NRA is reconsidering:
(i) the registration of a chemical product under Division 4 of
Part 2 of that Code; or
(ii) the listed registration of a chemical product under Division 6 of
Part 2A of that Code; the NRA may give written notice to any
person (the notified person ) who has, or has had, possession or
custody of stocks of the product, or of a particular batch of the
product, in this jurisdiction, requiring the notified person to do any
one or more of the things mentioned in subsection (2).
(i) may be an undue hazard to the safety of people exposed to it during
its handling or people using anything containing its residues; or
(ii) may be likely to have an effect that is harmful to human beings; or
(iii) may be likely to have an unintended effect that is harmful to
animals, plants or things or to the environment; or
(iv) may unduly prejudice trade or commerce between Australia and places
outside Australia; or
(v) may not be effective according to criteria that the NRA has determined
for the product; or
138 The Schedule (after paragraph 102(1)(b) of
the Agvet Code)
139 The Schedule (after paragraph 102(1)(c) of
the Agvet Code)
140 The Schedule
(after paragraph 102(1)(d) of the Agvet Code)
141 The Schedule (subsection 103(1)
of the Agvet Code)
(a) that labels attached to the containers of stocks of a registered
chemical product, or of a particular batch of a registered chemical
product, differ from the approved label kept in, or in conjunction
with, the relevant NRA file in relation to the product; or
(b) that labels attached to the containers of stocks of a registered
listed chemical product, or of a particular batch of a registered
listed chemical product, differ from the label required by the
relevant standard for the product; the NRA may give written notice
to any person (the notified person ) who has, or has had, possession
or custody of any of those stocks or of that batch in this
jurisdiction requiring the person to do any one or more of the things
mentioned in subsection (2).
(a) if someone wants to conduct a trial or experiment in relation to a
constituent that is not an approved constituent, or in relation to a
chemical product that is not a registered chemical product, a
registered listed chemical product or a reserved chemical product, in
order to decide whether to make an application for approval,
registration or listed registration; or
(b) if someone wants to use a registered chemical product in a way that is
not authorised by the approved label for containers for the product;
or
(c) if someone wants to use a registered listed chemical product in a way
that is not authorised by the labels for containers for the product as
required by the standard approved for the product.
144 The Schedule
(section 109 of the Agvet Code, paragraph (a) of the
definition of permit)
145 The Schedule (paragraph 111(1)(b) of
the Agvet Code)
(i) the NRA has given a copy of the application and documents referred to
in paragraph (a) to a co-ordinator; and
(ii) the co-ordinator requests any additional information for the purpose
of enabling him or her to make a recommendation to the NRA about the
application; then, unless the NRA has reasonable grounds for
refusing the request:
(iv) when the NRA receives the additional information, it must, as soon as
practicable, give the information to the co-ordinator; and
146 The
Schedule (paragraph 112(2)(b) of the Agvet Code)
149 The Schedule (at the end of
subsection 122(1) of the Agvet Code)
150 The Schedule (subsection 122(2) of the Agvet Code)
154 The Schedule (section 145 of
the Agvet Code)
(a) gives information (whether orally or in writing) that the person knows
to be false or misleading in a material particular; or
(b) produces a document that the person knows to be false or misleading in
a material particular without:
(i) indicating to the person to whom the document is produced that it is
false or misleading and the respect in which it is false or
misleading; and
(ii) providing correct information to that person if the person producing
the document is in possession of, or can reasonably acquire, the
correct information.
(2) The penalty for an offence against subsection (1) is a fine not
exceeding 300 penalty units.
(3) A person commits an offence if, for the purposes of, or in connection
with, the consideration by the NRA, in the course of the performance of any of
its functions or the exercise of any of its powers under this Code, of any
matters other than matters referred to in subsection (1), the person:
(a) gives information (whether orally or in writing) that the person knows
to be false or misleading in a material particular; or
(b) produces a document that the person knows to be false or misleading in
a material particular without:
(i) indicating to the person to whom the document is produced that it is
false or misleading and the respect in which it is false or
misleading; and
(ii) providing correct information to that person if the person producing
the document is in possession of, or can reasonably acquire, the
correct information.
(4) The penalty for an offence against subsection (3) is a fine not
exceeding 60 penalty units.
155 The Schedule (subsection 149(1) of the Agvet
Code)
(a) under or for the purposes of this Code or an eligible law of this
jurisdiction; and
(b) before a court or tribunal of this jurisdiction or an authority or
person having power to require the production of documents or the
answering of questions in this jurisdiction; other than a proceeding
for an offence that is directly punishable by imprisonment.
(a) an application under this Code in relation to:
(i) an active constituent for a proposed or existing chemical product; or
(ii) a chemical product; or
(iii) a label for containers for a chemical product; or
(b) an application under this Code in relation to a permit in respect of:
(i) an active constituent for a proposed or existing chemical product; or
(ii) a chemical product; or
(c) reconsidering the approval of an active constituent for a proposed or
existing chemical product, the registration of a chemical product, the
approval of a label for containers for a chemical product or the
listed registration of a chemical product; or
(d) deciding whether to suspend or cancel:
(i) an approval of an active constituent for a proposed or existing
chemical product; or
(ii) the registration of a chemical product; or
(iii) the approval of a label for containers for a chemical product; or
(iv) the listed registration of a chemical product; or
(v) a permit in respect of an active constituent for a proposed or
existing chemical product or in respect of a chemical product; the
NRA or another prescribed authority may, by written notice given to
the interested person or an approved person, require the interested
person, or the applicant for or holder of the relevant permit, within
a reasonable period stated in the notice, or within a further period
that the NRA allows, to do any one or more of the following:
163 The Schedule (paragraph 160(c) of the Agvet Code)
(1) This section applies if:
(a) an application has been lodged with the NRA for:
(i) approval of an active constituent for a proposed or existing chemical
product; or
(ii) registration of a chemical product; or
(iii) listed registration of a chemical product; or
(iv) a permit in respect of such an active constituent or in respect of a
chemical product; or
(v) a licence in respect of the manufacture of a chemical product; and
(b) the NRA has not determined the application; and
(c) an appropriate person becomes aware of any relevant information in
relation to the constituent, or in relation to the product or any of
its constituents.
(2) The appropriate person must, as soon as practicable after the person
becomes aware of the information, give the information to the NRA.
(a) in the case of an application referred to in
subparagraph (1)(a)(i), (ii) or (iii)the person would be an
interested person in relation to the constituent or product if the
application were granted; or
(b) in any other casethe person who made the application.
(4) Information is relevant information if it:
(a) contradicts any information given to the NRA under this Code; or
(b) shows that the use of, or any other dealing with, the constituent or
chemical product in accordance with the proposed instructions for its
use or for such a dealing contained in the application, or shows that
the use of, or any other dealing with, the chemical product in
accordance with the instructions for its use or for such a dealing
contained in an established standard:
(i) may be an undue hazard to the safety of people exposed to it during
its handling or people using anything containing its residues; or
(ii) may be likely to have an effect that is harmful to human beings; or
(iii) may be likely to have an unintended effect that is harmful to
animals, plants or things or to the environment; or
(c) shows that the use of the chemical product in accordance with the
proposed instructions for its use contained in the application, or in
accordance with the instructions for its use contained in an
established standard, may be ineffective according to criteria
determined by the NRA for the product; or
(d) would have had to be given to the NRA in connection with the
application if the applicant had been aware of the information when
the application was made.
(5) A corporation is taken to be aware of any information if a related
corporation is aware of that information.
(6) The question whether 2 corporations are related to each other is to be
determined in the same way as that question would be determined under the
Corporations Act 2001 .
(7) Any information that a person has to give to the NRA under this section
must be given in writing signed by an approved person.
165 The Schedule
(paragraph 161(1)(a) of the Agvet Code)
(2B) The question whether 2 corporations are related to each other is to be
determined in the same way as that question would be determined under the
Corporations Act 2001 .
169 The Schedule (subparagraph 162(3)(a)(ii) of the
Agvet Code)
172 The Schedule (after subsection 162(13) of
the Agvet Code)
(a) an active constituent for a proposed or existing chemical product; or
(b) a chemical product; or
(c) any of the constituents of a chemical product; or
(d) a label for containers for a chemical product; includes a reference
to information about any substance or thing that was at any time such
an active constituent, such a chemical product, such a constituent of
a chemical product or such a label, as the case may be.
(ab) a decision under section 11A to defer consideration of an
application for approval of an active constituent for a proposed or
existing chemical product, for registration of a chemical product or
for approval of a label for containers for a chemical product, or to
treat such an application as having been withdrawn;
(ac) a decision under section 11A to reject an application for
approval of an active constituent for a proposed or existing chemical
product, for registration of a chemical product or for approval of a
label for containers for a chemical product;
(ad) a decision under subparagraph 11A(3)(a)(iii) refusing to extend a
period;
174 The Schedule (after paragraph 167(1)(f) of the Agvet
Code)
(fb) a decision under Division 4 of Part 2A to grant listed
registration of a chemical product subject to particular conditions;
(fc) a decision under Division 5 of Part 2A to refuse an
application to vary the relevant particulars of the listed
registration of a chemical product;
(fd) a decision under Division 5 of Part 2A to refuse an
application to vary the conditions of the listed registration of a
chemical product;
(fe) a decision under Division 5 of Part 2A to vary the
conditions of the listed registration of a chemical product;
(ff) a decision under Division 7 of Part 2A to suspend or cancel
the listed registration of a chemical product;
175 The Schedule
(paragraph 167(1)(g) of the Agvet Code)
177 The Schedule
(subsection 178(2) of the Agvet Code)
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