Agricultural and Veterinary Chemicals
Code
Part 1—Preliminary
1
Object of Code
The object of this Code is to make
provision for and in relation to:
(a) the evaluation, approval, and
control of the supply, of active constituents for proposed or existing
agricultural chemical products or veterinary chemical products; and
(b) the evaluation, registration, and
control of the manufacture and supply, of agricultural chemical products and
veterinary chemical products.
2
Relationship of Code to other laws
(1) This Code excludes the operation of any
other laws of this jurisdiction that are inconsistent with this Code.
(2) A law of this jurisdiction is not taken
to be inconsistent with this Code if it can operate concurrently with this
Code.
(3) A law of this jurisdiction enacted, or an
instrument made under a law of this jurisdiction, after the commencement of
this Code is not to be interpreted as amending or repealing, or otherwise
altering the effect of, this Code unless that law, or the law under which that
instrument was made, as the case may be, so provides expressly.
3
Definitions
(1) In this Code, unless the contrary
intention appears:
acknowledge an application made under section 10
or 27 has the meaning given in the table:
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Acknowledgment of an
application
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If:
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The application is
acknowledged when:
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1
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The APVMA gives notice under subsection 11A(2) (applying
of its own force or because of section 28A) that the application has
passed a preliminary assessment and will be given a full evaluation in due
course
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The APVMA gives the notice
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2
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The APVMA is satisfied that defects in the application
have been rectified as required by a notice given under paragraph 11A(3)(a)
(applying of its own force or because of section 28A)
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The APVMA becomes satisfied
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3
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The APVMA starts to consider the application after
deferring the consideration under subparagraph 11A(3)(b)(i) (applying of its
own force or because of section 28A)
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The APVMA starts to consider the application
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active constituent, in relation to a proposed
or existing agricultural chemical product or veterinary chemical product, means
the substance that is, or one of the substances that together are, primarily
responsible for the biological or other effect identifying the product as an
agricultural chemical product or a veterinary chemical product, as the case may
be.
adequate, in relation to instructions on a
label for containers for a chemical product, means adequate to ensure, as far
as reasonably practicable, that the use of the product in accordance with the
instructions:
(a) 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 not be likely to have an
effect that is harmful to human beings; and
(c) 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.
agricultural chemical product has the meaning
given by section 4.
animal means any animal (other than a human
being), whether vertebrate or not, and whether a food‑producing species
or not, and includes:
(a) mammals, birds, bees, reptiles,
amphibians, fish, crustaceans and molluscs; and
(b) the semen, ova or embryo of an
animal (other than a human being) or any other substance or thing directly
relevant to the reproduction of an animal (other than a human being); and
(c) any other prescribed form of
animal life, whether prescribed by reference to a species or in any other way.
approval means:
(a) in relation to an active
constituent for a proposed or existing chemical product—an approval of the
constituent under Part 2 of the Agvet Code of this jurisdiction that is in
force; or
(b) in relation to a label for
containers for a chemical product—an approval of the label under Part 2 of
the Agvet Code of this jurisdiction that is in force; or
(c) when the expression is used
without reference to such a constituent or label—an approval referred to in
either paragraph (a) or (b).
approved analyst means a person appointed
under subsection 69G(1) of the Agricultural and Veterinary Chemicals
(Administration) Act 1992 to be an approved analyst for the purposes of
this Code.
approved form means a form approved by the
APVMA or prescribed by the regulations.
approved label, in relation to a container,
means a label approved under Part 2 of the Agvet Code of this jurisdiction
for the container.
approved person means:
(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:
(i) if that person is an
individual residing, or a body corporate incorporated, in Australia—that
person; or
(ii) in any case—an individual
residing in Australia who, or a body corporate incorporated in Australia which,
that person has 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 APVMA 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 licence—an
individual residing in Australia who, or a body corporate incorporated in
Australia which, that person has authorised to receive the notice on that
person’s behalf.
APVMA means the Australian Pesticides and
Veterinary Medicines Authority continued in existence by section 6 of the Agricultural
and Veterinary Chemicals (Administration) Act 1992.
Australia includes any external Territories
that are participating Territories.
authorising party for information means a
person who would be entitled to bring an action for breach of an obligation of
confidence if the information were disclosed by someone else to the APVMA for
the purposes of this Code without the person’s permission.
chemical product means an agricultural
chemical product or a veterinary chemical product, or both.
Chief Executive Officer, in relation to the
APVMA, includes a person acting as the Chief Executive Officer of the APVMA.
claim includes any statement.
companion animal product means a veterinary
chemical product solely for administration or application to animals that:
(a) are not food‑producing
species; and
(b) are not prescribed by the
regulations.
confidential
commercial information, in relation to an active constituent for a
proposed or existing chemical product, or in relation to a chemical product or
a constituent of a chemical product, means:
(a) a trade secret relating to the
constituent or product; or
(b) any other information relating to the
constituent or product that has a commercial value that would be, or could
reasonably be expected to be, destroyed or diminished if the information were
disclosed; or
(c) information (other than trade
secrets to which paragraph (a) applies or information to which paragraph (b)
applies) that:
(i) concerns the lawful
commercial or financial affairs of a person, organisation or undertaking; and
(ii) relates to the
manufacture, distribution or supply of the constituent or product; and
(iii) if it were disclosed,
could unreasonably affect the person, organisation or undertaking in an adverse
manner;
but does not include:
(d) the making of an application for a
permit for the use of an active constituent for a proposed or existing chemical
product or for the use of a chemical product, if the use of the product
proposed in the application is:
(i) a minor use; or
(ii) an emergency use; or
(e) any prescribed information
relating to the making of an application for a permit, as mentioned in
paragraph (d).
constituent, in relation to a chemical
product, means any constituent of the product, whether an active constituent or
not.
container includes anything by which or in
which a chemical product is, or is to be, covered, enclosed, contained or
packaged, but does not include a container (such as a shipping container) in
which other containers of chemical products are, or are to be, placed for the
purpose of being transported.
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.
co‑ordinator, in relation to a
jurisdiction, means a person designated:
(a) if the jurisdiction is a State—by
a Minister of the State; or
(b) if the jurisdiction is the
participating Territories:
(i) if the Australian
Capital Territory is the only participating Territory—by a Minister of the Australian
Capital Territory; or
(ii) if there is more than
one participating Territory—jointly by a Minister of the Commonwealth and a Minister
of the Australian Capital Territory;
to perform the functions of a co‑ordinator under
this Code.
corresponding previous law means a previous
law of this jurisdiction that corresponds wholly or partly to this Code, to the
extent that it so corresponds.
criteria includes standards.
date‑controlled chemical product means
a chemical product declared by the regulations to be a date‑controlled
chemical product.
date of manufacture, in relation to a
chemical product, means the date on which formulation of the product was
completed.
deal with, in relation to an active
constituent for a proposed or existing chemical product, or in relation to a
chemical product, includes supply or otherwise dispose of the constituent or
product.
director, in relation to a body corporate
incorporated for a public purpose by a law of the Commonwealth, of a State or
of a Territory, means:
(a) a constituent member of the body;
or
(b) if the body does not have any
members—a member of the board or other group of persons responsible for the
administration or management of the affairs of the body.
distinguishing number includes a
distinguishing number together with one or more letters or symbols, or both.
document includes a book or other record.
eligible law, in relation to a jurisdiction,
means a law, or a provision of a law, of that jurisdiction that is declared by
a law of that jurisdiction to be an eligible law for the purposes of this Code.
emergency use has the same meaning as in the
regulations.
environment includes all aspects of the
surroundings of human beings, whether affecting them as individuals or in their
social groupings.
established standard for a listable chemical
product means a standard established for the product under Division 3 of
Part 2A.
excluded organism means an organism that is
declared by the regulations to be an excluded organism.
expiry date, in relation to the contents of a
container, means the month and year after which the contents should not be
used.
fee includes a fee that is a tax.
file includes a file of information stored or
recorded by means of a computer.
food‑producing species means an animal
that produces food for human consumption or is used as food for human beings,
and includes:
(a) any buffalo, cattle, deer, fish
(other than ornamental fish), goat, kangaroo, pig, poultry, rabbit, sheep, bee,
crustacean or mollusc; or
(b) any animal declared by the
regulations to be a food‑producing species.
give information includes make a statement.
handling includes transportation, storage,
processing, use or disposal.
holder, in relation to a permit or licence,
means the person to whom the permit or licence was issued.
inspector
means:
(a) a person appointed as an inspector
for the purposes of this Code under subsection 69F(1) of the Agricultural
and Veterinary Chemicals (Administration) Act 1992; or
(b) a person to whom an authorisation
referred to in subsection 69F(2) of that Act applies for the purposes of this
Code.
instruction includes direction, caution,
warning or recommendation.
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:
(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
(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 APVMA 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 person—the 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 corporate—a successor in law of the body corporate.
jurisdiction
means:
(a) a State; or
(b) the participating Territories.
label includes tag, leaflet, brand, stamp,
mark, stencil or written statement.
licence means a licence under Part 8.
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.
manufacturing principles means principles
that the APVMA has determined under section 23 of the Agricultural and
Veterinary Chemicals Act 1994 to be principles to be observed in the
manufacture of chemical products.
material safety data sheet, in relation to a
chemical product, means a written statement:
(a) which:
(i) identifies the
product; and
(ii) states the health
hazards that could be caused by the product; and
(iii) states the manner of
handling the product in a way that minimises hazards; and
(iv) states the procedures
to be adopted in the event of an emergency involving the product; and
(v) contains information
about the chemical and physical properties of the product other than
confidential commercial information; and
(vi) contains
information in relation to the product of a kind prescribed for the purposes of
paragraph (f) of the definition of Material Safety Data Sheet in
section 5 of the Industrial Chemicals (Notification and Assessment) Act
1989; and
(b) which, if there is a note known as
a Guidance Note for Completion of a Material Safety Data Sheet published by the
National Occupational Health and Safety Commission, is prepared in accordance
with that note.
Maximum Residue Limits Standard means the
Maximum Residue Limits Standard, made under the Food Standards Australia
New Zealand Act 1991, as in force from time to time, or any
standard in force in substitution for that standard.
member of the staff, in relation to the
APVMA, has the same meaning as in the Agricultural and Veterinary Chemicals
(Administration) Act 1992.
minor use has the same meaning as in the
regulations.
occupier, in relation to any premises or a
part of any premises, means the person in occupation, charge or control of the
premises or of that part of the premises, as the case may be.
ordinary office hours means the hours when
the office of the APVMA is open to members of the public.
participating Territory has the same meaning
as in the Agricultural and Veterinary Chemicals Act 1994.
penalty unit has the same meaning as in
section 4AA of the Crimes Act 1914.
permit means a permit under Part 7.
pest means:
(a) in
relation to an animal, plant or thing—any animal, plant or other biological
entity that injuriously affects the physical condition, worth or utility of the
first‑mentioned animal or plant or of that thing; or
(b) in relation to a place—an animal,
plant or other biological entity that injuriously affects the use or enjoyment
of that place.
place of residence, in relation to a body
corporate that is incorporated in Australia, means its registered office in Australia.
plant means any vegetation or fungus and
includes a seed or cutting of a plant, or any other part or product of a plant.
premises includes any place (whether enclosed
or built on or not), including a place situated under ground or under water,
and, in particular, includes:
(a) a building, aircraft, vehicle or
vessel; and
(b) any structure, whether a fixed
structure, or a moveable structure such as a tent, and whether on land or the
bed of any waters or floating on any waters; and
(c) a part of premises (including a
part of premises of a kind referred to in paragraph (a) or (b)).
prescribed means prescribed by the Agvet Code
of this jurisdiction or by the regulations.
previously endorsed active constituent for a
chemical product at a particular time means a substance that:
(a) before that time, had been
approved or registered (however described) under a law of the Commonwealth or a
State or Territory as an active constituent for a chemical product; or
(b) was an active constituent for a
chemical product that, before that time, had been approved or registered
(however described) under a law of the Commonwealth or a State or Territory as
a chemical product;
whether or not the approval or registration was a result
of an application by a particular person.
previous registering authority means a
registering authority under a corresponding previous law.
primary active constituent has the meaning
given in section 59.
primary applicant means:
(a) in relation to a primary active
constituent—the interested person by whom, or on whose behalf, protected
information was given to the APVMA in respect of the constituent; or
(b) in relation to a primary chemical
product—the interested person by whom, or on whose behalf, protected
information was given to the APVMA in respect of the product.
primary chemical product has the meaning
given in section 59.
prohibited chemical product means a chemical
product that is declared by the regulations to be a prohibited chemical
product.
protected active constituent means an
approved active constituent for a proposed or existing chemical product, being
an active constituent to which both of the following paragraphs apply:
(a) the constituent is or includes an
invention in respect of which letters patent were granted under the Patents
Act 1952 or the Patents Act 1990;
(b) the term of the letters patent
(including any extension of that term) has ended, or will end, during the
protection period that applies to protected information about that constituent.
protected chemical
product means a registered chemical product to which both of the
following paragraphs apply:
(a) the product is or includes an
invention in respect of which letters patent were granted under the Patents
Act 1952 or the Patents Act 1990;
(b) the term of the letters patent
(including any extension of that term) has ended, or will end during the
protection period that applies to protected information about that product;
but does not include a chemical product in respect of which
the instructions on the approved label, or each of the approved labels, state
that the product should be used only in relation to a particular class of
animals that are not a food‑producing species.
protected commodity means:
(a) any substance or thing of a kind
used, or capable of being used, as food or drink by human beings; or
(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.
protected information, in relation to an
active constituent for a proposed or existing chemical product or in relation
to a chemical product, means information that has been obtained because of
trials or laboratory experiments and relates to the interaction between the
constituent or product, as the case may be, and:
(a) the environment; or
(b) living organisms or naturally
occurring populations in ecosystems, including human beings;
but does not include information obtained only for the
purpose of assessing the performance of the constituent or product in respect
of its proposed use.
protection period, in relation to protected
information of a particular kind, means:
(a) if a period is stated in, or
worked out in accordance with, the regulations in relation to information of
that kind for the purposes of Part 3—the period so stated or worked out;
or
(b) otherwise—7 years.
published literature, in relation to a
particular matter, means all documents that relate to that matter and are
accessible to the public.
recall notice means a notice issued under
section 101, 102 or 103.
Record of Approved Active Constituents means
the Record of Approved Active Constituents for Chemical Products kept under
section 17.
Record of Permits means the Record of Permits
kept under section 113.
re‑entry period, in relation to the use
of a chemical product in a particular place (including a use of the product in
relation to a crop or pasture in that place), means the period after that use
during which it is unsafe for a person to enter the place without wearing
appropriate protective clothing or equipment, or both.
Register of Chemical Products means the
Register of Agricultural and Veterinary Chemical Products kept under section 18.
registered chemical product means a chemical
product registered under Part 2 of the Agvet Code of this jurisdiction.
registered listed chemical product means a
listable chemical product that has been granted listed registration.
registration means registration of a chemical
product that is in force under Part 2 of the Agvet Code of this
jurisdiction.
regulations means the Agvet Regulations of
this jurisdiction.
relevant particulars
means:
(a) in relation to the approval of an
active constituent for a proposed or existing chemical product—the
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
(b) in relation to the registration of
a chemical product—the 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 product—the 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 product—the information required to be
recorded in the relevant APVMA file by paragraph 21(2)(c);
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 26A(4)(a) or 29(1)(h), subsection
34(5), section 34A, paragraph 56U(1)(e) or subsection 56Z(5).
repealed Act means the Agricultural and
Veterinary Chemicals Act 1988.
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:
(a) subject to paragraph (b), any
remains, persisting in or on a protected commodity, of:
(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 APVMA has published a
notice in the Gazette for the purposes of this paragraph that applies to
the active constituent or chemical product—only 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.
restricted chemical product means a chemical
product declared by regulations made for the purposes of section 93 to be
a restricted chemical product.
sample includes specimen.
secondary active constituent has the meaning
given in section 59.
secondary applicant,
in relation to a secondary chemical product, means:
(a) if the APVMA is considering an
application for the registration of that product—the person who made the
application; or
(b) if the APVMA has reconsidered or
is reconsidering the registration of that product:
(i) subject to subparagraphs (ii),
(iii) and (iv), the person (the original applicant) who applied
for the registration or, in the case of a product whose registration has been
renewed, applied for the renewal, or the last renewal, as the case may be, of
the registration; or
(ii) subject to subparagraphs (iii)
and (iv), if the original applicant has entered into a contract with another
person in relation to the product under which, or as a result of which, the
other person will or may apply to the APVMA to have the other person’s name
entered in the relevant particulars in relation to the product, or to have a
label approved in relation to containers for the product, and 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
(iii) if the person who,
apart from this subparagraph, would be the secondary applicant because of subparagraph (i)
or (ii) was an individual who has died or is an individual whose affairs are
being lawfully administered by another person—the legal personal representative
of the individual or the person administering his or her affairs, as the case
may be; or
(iv) if the person who,
apart from this subparagraph, would be the secondary applicant because of subparagraph (i)
or (ii) was a body corporate—a successor in law of the body corporate.
secondary applicant, in relation to a
secondary active constituent for a proposed or existing chemical product,
means:
(a) if the APVMA is considering an
application for the approval of that constituent—the person who made the
application; or
(b) if the APVMA has reconsidered or
is reconsidering the approval of that constituent:
(i) subject to subparagraphs (ii),
(iii) and (iv), the person (the original applicant) who applied
for the approval; or
(ii) subject to subparagraphs (iii)
and (iv), if the original applicant has entered into a contract with another
person in relation to the constituent under which, or as a result of which, the
other person will or may apply to the APVMA to have the other person’s name
entered in the relevant particulars in relation to the constituent and the
other person’s name is entered in those particulars on the application of the
other person—the other person; or
(iii) if the person who,
apart from this subparagraph, would be the secondary applicant because of subparagraph (i)
or (ii) was an individual who has died or is an individual whose affairs are
being lawfully administered by another person—the legal personal representative
of the individual or the person administering his or her affairs, as the case
may be; or
(iv) if the person who,
apart from this subparagraph, would be the secondary applicant because of subparagraph (i)
or (ii) was a body corporate—a successor in law of the body corporate.
secondary chemical product has the meaning
given in section 59.
State includes the Northern Territory.
substance includes:
(a) any gas, liquid, mixture or
compound of gases, or mixture or compound of liquids; and
(b) an organism or part of an
organism, including a genetically manipulated organism or part of a genetically
manipulated organism; and
(c) material that is produced from an
organism; and
(d) matter whose production involves
the use of an organism;
but does not include an excluded organism or part of an
excluded organism, or material that is produced from, or matter whose
production involves the use of, an excluded organism.
supply includes do, or cause or permit the
doing of, any of the following:
(a) sell;
(b) expose for sale;
(c) send or deliver for sale or on
sale;
(d) dispose of under a hire purchase
agreement;
(e) exchange;
(f) give;
(g) offer to do an act that would be a
supply (including an act referred to in any of the above paragraphs);
and, for example, includes supply under a contract for
work or labour that also involves the supply of any thing.
Territory does not include the Northern
Territory;
thing, except
where used as an object of the verb “to do”, includes:
(a) an animal; and
(b) information; and
(c) a document; and
(d) a substance.
this Code means the Agvet Code of this
jurisdiction and includes the Agvet Regulations of this jurisdiction.
variations includes additions, omissions,
substitutions and modifications.
veterinary chemical product has the meaning
given by section 5.
veterinary surgeon means a person who is
registered as a veterinary surgeon under the law of a State or Territory.
withholding period, in relation to the use of
a chemical product, means the minimum period that needs to elapse between:
(a) the last use of the product in
relation to a crop, pasture or animal; and
(b) the harvesting or cutting of, or
the grazing of animals on, the crop or pasture, the shearing or slaughtering of
the animal, or the collection of milk or eggs from the animal for human
consumption, as the case may be;
in order to ensure that the product’s residues fall to or below
the maximum limit that the APVMA permits.
working day means a day other than a
Saturday, a Sunday or a day that is a public holiday in the place where the
office of the APVMA is situated.
(2) A regulation that prescribes information
for the purposes of paragraph (e) of the definition of confidential
commercial information is a legislative instrument.
4
Definition of agricultural chemical product
(1) This section defines what is meant by an
agricultural chemical product for the purposes of this Code.
(2) Subject to subsections (3) and (4),
an agricultural chemical product is a substance or mixture of substances that
is represented, imported, manufactured, supplied or used as a means of directly
or indirectly:
(a) destroying, stupefying, repelling,
inhibiting the feeding of, or preventing infestation by or attacks of, any pest
in relation to a plant, a place or a thing; or
(b) destroying a plant; or
(c) modifying the physiology of a
plant or pest so as to alter its natural development, productivity, quality or
reproductive capacity; or
(d) modifying an effect of another
agricultural chemical product; or
(e) attracting a pest for the purpose
of destroying it.
(3) An agricultural chemical product includes
a substance or mixture of substances declared by the regulations to be an
agricultural chemical product.
(4) An agricultural chemical product does not
include:
(a) a veterinary chemical product; or
(b) a substance or mixture of
substances declared by the regulations not to be an agricultural chemical
product.
5
Definition of veterinary chemical product
(1) This section defines what is meant by an
veterinary chemical product for the purposes of this Code.
(2) Subject to subsections (3) and (4),
a veterinary chemical product is a substance or mixture of substances that is
represented as being suitable for, or is manufactured, supplied or used for,
administration or application to an animal by any means, or consumption by an
animal, as a way of directly or indirectly:
(a) preventing, diagnosing, curing or
alleviating a disease or condition in the animal or an infestation of the
animal by a pest; or
(b) curing or alleviating an injury
suffered by the animal; or
(c) modifying the physiology of the
animal:
(i) so as to alter its
natural development, productivity, quality or reproductive capacity; or
(ii) so as to make it more
manageable; or
(d) modifying the effect of another
veterinary chemical product.
(3) A
veterinary chemical product includes:
(a) a vitamin, a mineral substance, or
an additive, if, and only if, the vitamin, substance or additive is used for a
purpose mentioned in paragraph (2)(a), (b), (c) or (d); and
(b) a substance or mixture of
substances declared by the regulations to be a veterinary chemical product.
(4) A veterinary chemical product does not
include:
(a) a substance or mixture of
substances that is:
(i) prepared by a
pharmacist in accordance with the instructions of a veterinary surgeon; or
(ii) prepared by a
veterinary surgeon;
in the course of the practice,
by the person preparing the substance or mixture of substances, of his or her
profession as permitted by or under a law of this jurisdiction; or
(b) a substance or mixture of
substances declared by the regulations not to be a veterinary chemical product.
6 Determinations,
approvals, exemptions etc. by APVMA
(1) If a provision of this Code refers to a
determination made, approval or exemption given or other thing done by the
APVMA and there is no other provision of this Code expressly authorising the
APVMA to make such a determination, give such an approval or exemption or do
such a thing, the APVMA is authorised by this section to make such a
determination, give such an approval or exemption or do such a thing either
unconditionally or subject to conditions.
(2) The APVMA may at any time vary or revoke
a determination made, approval or exemption given, or other thing done, by it
under subsection (1).
7
Possession or custody of constituent or product
A reference in this Code to doing
anything in respect of an active constituent for a proposed or existing
chemical product, or in respect of a chemical product, includes a reference to
having possession or custody of the constituent or product.
8
Labels attached to containers
(1) For the purposes of this Code, a label is
attached to a container if the label is securely attached or affixed to,
appears on, or is included with, the container.
(2) For the purposes of this Code but without
limiting the generality of subsection (1):
(a) writing appearing on a container
is taken to have been written on a label attached to the container; and
(b) a reference to a label attached to
a container includes a reference to writing appearing on the container; and
(c) a reference to attaching a label
to a container includes a reference to putting writing on the container.
8A
Application of the Criminal Code
Chapter 2 (other than Part 2.5)
of the Criminal Code applies to all offences against this Code.
Note: Chapter 2 of the Criminal Code
sets out the general principles of criminal responsibility.
Part 2—Approvals and registration
Division 1—Preliminary
9
Explanation of Part
(1) This Part contains provisions relating
to:
(a) the approval of active
constituents for proposed or existing chemical products; and
(b) the registration of chemical
products; and
(c) the approval of labels for
containers for chemical products.
(2) Division 2 deals with the giving of
approvals and the granting of registrations.
(2A) Division 2A deals with applications to
vary a relevant particular if the relevant particular is of a kind set out in a
legislative instrument made by the APVMA for the purposes of section 26A.
(3) Division 3 deals with applications
to vary approvals or registrations or to vary the conditions of any approvals
or registrations.
(4) Division 4 provides for the APVMA to
reconsider approvals and registrations for the purpose of deciding whether or
not they should remain in force.
(5) Division 5 sets out the
circumstances in which the APVMA may suspend or cancel approvals or
registrations.
(6) Division 6 states how long approvals
and registrations are to continue in force and makes provision for their
renewal.
(7) Division 7 provides for the APVMA to
publish notices telling the public of actions that it has taken under this
Part.
Division 2—Granting or refusing approvals and registrations
10
Applications that may be made
A person may apply to the APVMA:
(a) for approval of an active
constituent for a proposed or existing chemical product; or
(b) for registration of a chemical
product; or
(c) for approval of a label for
containers for a chemical product.
11 How
application 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, any
information that the APVMA requires; and
(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
(c) be signed by an approved person;
and
(d) be accompanied by:
(i) if only part of the
prescribed fee is required to be paid at the time of making the application—the
amount required to be paid; or
(ii) otherwise—the whole of
the prescribed fee (if any); and
(e) be lodged with the APVMA.
(2) The APVMA 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 APVMA information
additional to or varying information previously given to the APVMA; and
(b) may withdraw the application by
giving to the APVMA written notice of the withdrawal signed by an approved
person.
11A
Preliminary assessment of application
(1) The APVMA 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).
(2) If it appears to the APVMA from the
preliminary assessment that the application complies with subsection 11(1), the
APVMA 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 APVMA 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 APVMA 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 APVMA
allows; and
(b) if the defects are not rectified
to the satisfaction of the APVMA within the period referred to in subparagraph (a)(iii),
the APVMA 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 APVMA 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 APVMA 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
APVMA 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.
11B
APVMA to publish summary of application
(1) As soon as practicable after an
application is acknowledged, the APVMA must cause to be published a summary of
the application.
(2) The summary must include the details
relating to the application that are prescribed by the regulations (if any).
12
APVMA 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 APVMA 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
APVMA’s evaluation of the constituent with regard to the matters mentioned in
paragraph 14(3)(e);
(iv) any other matters that
the APVMA 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 APVMA 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 APVMA is required to take into
account in deciding whether to approve the constituent.
(2) The APVMA must take into account any
submissions made in accordance with an invitation contained in the notice
published under subsection (1).
13
APVMA to publish notice before deciding whether to register chemical product
containing new active constituent
(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 APVMA
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
APVMA’s evaluation of the product with regard to the matters mentioned in
paragraphs 14(3)(e) and (f);
(iv) any other matters that
the APVMA 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 APVMA 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 APVMA is required to take into account in
deciding whether to register the product.
(2) The APVMA must take into account any
submissions made in accordance with an invitation contained in the notice
published under subsection (1).
13A
Notifying Food Standards Australia New Zealand
(1) If it is likely that a chemical product
in relation to which an application for registration is made would, if used, be
present in foods (as defined for the purposes of the Food Standards
Australia New Zealand Act 1991) at a level that is not already permitted
under the Maximum Residue Limits Standard, the APVMA must notify Food Standards
Australia New Zealand of the application.
(2) The notice must:
(a) be in writing; and
(b) set out:
(i) particulars of the
product and its active constituents other than confidential commercial
information; and
(ii) any other matters that
the APVMA thinks appropriate; and
(c) be given to Food Standards
Australia New Zealand at least 30 working days before notice of the application
and public invitation for submissions is published in the Gazette under
section 13 or otherwise.
14
Grant or refusal of application
(1) The APVMA must grant an application made
under section 10 if it is satisfied of all the matters referred to in subsection (3).
(2) If the APVMA is not satisfied as
mentioned in subsection (1), it must refuse the application.
(3) The matters referred to in subsection (1)
are the following:
(a) that the applicant has complied
with subsection 11(1);
(b) that any requirement made under
section 157 or 159 has been complied with;
(c) that, if necessary, section 158
has been complied with;
(ca) 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 constituent, product or label, as the
case may be, have been complied with;
(e) if the application is for approval
of an active constituent or registration of a chemical product—that the use of
the constituent or product in accordance with the instructions for its use that
the APVMA has approved or approves:
(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;
(f) if the application is for
registration of a chemical product—that the use of the product in accordance
with the instructions for its use that the APVMA has approved or approves would
be effective according to criteria determined by the APVMA for the product;
(g) if the application is for approval
of a label for containers for a chemical product—that the label will 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;
(h) that the fee (if any) prescribed
in respect of the approval or 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 APVMA in respect of the product under
this Code or any other law in force in this or any other jurisdiction, have
been paid.
(4) In satisfying itself for the purposes of subsection (1)
whether the use of an active constituent in accordance with the instructions for
its use that the APVMA has approved or approves would be an undue hazard as
mentioned in subparagraph (3)(e)(i), or would be likely to have an effect
that is harmful as mentioned in subparagraph (3)(e)(ii) or (iii), the
APVMA may have regard to such matters as it thinks relevant but must have
regard to the following:
(a) the toxicity of the constituent
and its residues in relation to relevant organisms and ecosystems, including
human beings;
(b) the method by which the
constituent is, or is proposed to be, manufactured;
(c) the extent to which the
constituent will contain impurities;
(d) whether an analysis of the
chemical composition of the constituent has been carried out and, if so, the
results of the analysis;
(e) any other matters prescribed by the
regulations.
(5) In satisfying itself for the purposes of subsection (1)
whether the use of a chemical product in accordance with the instructions for
its use that the APVMA has approved or approves would be an undue hazard as
mentioned in subparagraph (3)(e)(i), or would be likely to have an effect
that is harmful as mentioned in subparagraph (3)(e)(ii) or (iii), the
APVMA 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 in 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
APVMA 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.
(6) In satisfying itself for the purposes of subsection (1)
whether the use of a chemical product in accordance with the instructions for
its use that the APVMA has approved or approves would be effective as mentioned
in paragraph (3)(f), the APVMA 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.
(7) This section has effect subject to
sections 14A and 15.
14A
Approval of active constituents for which information is not readily available
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 APVMA 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 APVMA to be
appropriate; and
(b) the APVMA 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 APVMA may decide to approve the constituent, whether
or not an application has been made for the approval.
14B
APVMA not to use information for registration of new agricultural chemical
product to approve a similar product after disclosure
(1) This section applies if:
(a) information was given to the APVMA
in connection with an application made after the commencement of this section
for registration of an agricultural chemical product (the first product)
containing an active constituent that was not a previously endorsed active
constituent at the time of registration of the first product; and
(b) the information related to the
first product or the active constituent and a matter that:
(i) is described in
paragraph 14(3)(e) (except subparagraph 14(3)(e)(iv)) or paragraph 14(3)(f); or
(ii) is prescribed by the
regulations; and
(c) the information was disclosed:
(i) by the Commonwealth, a
State or a Territory; or
(ii) by an authority of the
Commonwealth, a State or a Territory (including the APVMA); or
(iii) by anyone acting on
behalf of the Commonwealth, a State, a Territory or an authority of the
Commonwealth, a State or a Territory; and
(d) the information was not publicly
available before the disclosure; and
(e) as a result of the disclosure, the
interested person, or an approved person, for an application for registration
of an agricultural chemical product (the second product) that is
the same as, or similar to, the first product, seeks to have the APVMA use the
information in granting the application.
(2) For 10 years after the first day on which
the first product was registered, the APVMA must not use the information to
grant the application for registration of the second product if:
(a) the registration of the second
product would be commercially unfair; and
(b) the authorising party for the
information does not consent to the use.
(3) The use of information in contravention
of subsection (2) for granting the application for registration of the
second product does not affect the validity of the grant or of the registration
of the second product.
(4) An action or proceeding does not lie
against any of the following for any loss directly or indirectly sustained
because of the use of information in contravention of subsection (2):
(a) the Commonwealth;
(b) the APVMA;
(c) a person who is or has been:
(i) a director of the
APVMA; or
(ii) the Chief Executive
Officer of the APVMA; or
(iii) a delegate of the
APVMA; or
(iv) a member of the staff
of the APVMA.
(5) This section has effect in addition to
Division 4A.
15
Restriction on power of APVMA to grant applications
(1) Subject to subsection (2), the APVMA
must not:
(a) grant an application for
registration of a chemical product unless:
(i) the APVMA also grants
or has granted an application for approval of each active constituent for the
product; and
(ii) the APVMA also grants
an application for approval of a label for containers for the product; or
(b) grant an application for approval
of a label for containers for a chemical product unless it also grants or has
granted an application for registration of the product.
(2) Subparagraph (1)(a)(i) does not
apply in relation to an active constituent that is exempted by the APVMA from
the operation of that subparagraph.
16
Multiple approvals or registrations
(1) The approval of an active constituent for
a proposed or existing chemical product does not preclude the approval of the
same constituent on the application of another person.
(2) The registration of a chemical product on
the application of a person does not preclude the registration on the application
of another person of another chemical product that has the same or similar
constituents.
(3) The approval of a label for containers
for a chemical product does not preclude the approval of another label or other
labels for containers for that product.
17
APVMA must keep a Record of Approved Active Constituents for Chemical Products
(1) For the purposes of this Code, the APVMA
must keep a record to be known as the Record of Approved Active Constituents
for Chemical Products.
(2) The Record may be kept at a place and in
a form that the APVMA determines, and may be kept by electronic means.
(3) The Record is to be kept in 3 parts as
follows:
(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.
(4) The APVMA must permit any person to inspect
any part of the Record that does not contain confidential commercial
information at any time during ordinary office hours on a working day.
(5) If a person applies to the APVMA for a
copy of, or extract from, a part of the Record that does not contain confidential
commercial information and pays the prescribed fee (if any), the APVMA must
give the copy or extract to that person.
18
APVMA must keep a Register of Agricultural and Veterinary Chemical Products
(1) For the purposes of this Code, the APVMA must
keep a register to be known as the Register of Agricultural and Veterinary
Chemical Products.
(2) The Register may be kept at a place and
in a form that the APVMA determines, and may be kept by electronic means.
(3) The Register is to be kept in 2 parts,
one containing confidential commercial information and the other containing
other information.
(4) The APVMA must permit any person to
inspect any part of the Register that does not contain confidential commercial
information at any time during ordinary office hours on a working day.
(5) If a person applies to the APVMA for a
copy of, or extract from, a part of the Register that does not contain
confidential commercial information and pays the prescribed fee (if any), the
APVMA must give the copy or extract to that person.
19 How
approval of active constituent is effected
(1) If the APVMA decides to approve an active
constituent for a proposed or existing chemical product, it must give a
distinguishing number to, and approve, the constituent in accordance with subsection (2),
either unconditionally or subject to conditions as mentioned in section 23.
(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.
20 How
registration of chemical product is effected
(1) If the APVMA decides to register a
chemical product, it must give a distinguishing number to, and register, the
product in accordance with subsection (2), either unconditionally or
subject to conditions as mentioned in section 23.
(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.
21 How
approval of label is effected
(1) If the APVMA decides to approve a label
for containers for a chemical product, the APVMA 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 23A.
(2) Approval of a label takes place by:
(a) determining the particulars,
prescribed by the regulations, that are appropriate to be contained on the
label; and
(b) giving a distinguishing number to
the label; and
(c) recording the following
information in the relevant APVMA file:
(i) the distinguishing
number;
(ii) the adequate
instructions and any particulars that are to be contained on the label; and
(d) recording any conditions imposed
on the approval by the APVMA under subsection 23A(2) in the relevant APVMA
file.
22
Date of approval or registration
(1) The date of approval of an active
constituent for a proposed or existing chemical product, of registration of a
chemical product or of approval of a label for containers for a chemical
product is the date on which the relevant particulars are entered in the Record
of Approved Active Constituents or in the Register of Chemical Products or are
recorded in the relevant APVMA file, as the case may be.
(2) If:
(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 APVMA file, as the case may
be.
23
Conditions of approval or registration—active constituents and chemical
products
(1) The conditions of the approval of an
active constituent for a proposed or existing chemical product or the
registration of a chemical product are the conditions that the APVMA thinks
appropriate.
(2) Without limiting subsection (1),
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) Approval of an active constituent for a
proposed or existing chemical product or the registration of a chemical product
may be granted on the condition that the approval or registration remains in
force only for a stated period that is not more than one year.
(4) If the approval or registration is
subject to a condition referred to in subsection (3) and the conditions of
approval or 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 APVMA 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.
23A
Conditions of approval—labels
(1) The approval of a label for containers
for a chemical product is subject to:
(a) the conditions prescribed by the
regulations (whether or not the conditions are prescribed at the time the label
is approved); and
(b) any conditions imposed on the
approval by the APVMA under subsection (2).
(2) At the time of approving a label for containers
for a chemical product, the APVMA may impose conditions, as the APVMA considers
appropriate, on the approval.
(3) The conditions prescribed by the
regulations may be expressed to apply in relation to:
(a) a label for containers for a
particular chemical product; or
(b) a label for containers for a class
of chemical products; or
(c) a label for containers for all
chemical products.
(4) Approval of a label for containers for a
chemical product may be granted on the condition that the approval remains in
force for a particular period. The period may not be more than one year.
(5) If:
(a) the approval is subject to a
condition referred to in subsection (4); and
(b) the conditions of approval 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 APVMA 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.
24
Notice of approval or registration
(1) If 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 is granted:
(a) the APVMA must give to an approved
person written notice of the approval or registration; and
(b) if the application related to
registration of a chemical product—the APVMA 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 approving a constituent, registering a
product, or approving a label, subject to conditions.
25
Notice of refusal of application
(1) If an application for approval of an
active constituent for a proposed or existing chemical product, registration of
a chemical product or approval of a label for containers for a chemical product
is refused, the APVMA 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.
26
Notice of incorrectly recorded or registered particulars
(1) If a person:
(a) is the interested person in
relation to an approved active constituent for a proposed or existing chemical
product, a registered chemical product or an approved label for containers for
a 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 Record of Approved
Active Constituents or in the Register of Chemical Products or recorded in the
relevant APVMA file in relation to the constituent, product or label is not
correct in a material respect;
the person must, as soon as practicable, give to the APVMA
a written notice, signed by an approved person, identifying the incorrect
particular or condition and informing the APVMA of the correct particular or
condition.
Penalty: 60 penalty units.
(1A) An offence
under subsection (1) is an offence of strict liability.
Note: For strict liability, see section 6.1 of
the Criminal Code.
(2) If the APVMA is satisfied that the
particular or condition entered in the Record or Register, or recorded in the
APVMA file, in relation to the constituent, product or label is not correct,
the APVMA must change the entry or record accordingly.
Division 2A—Changes in certain relevant particulars
26A
Applying for a change in certain relevant particulars
(1) An interested person in relation to:
(a) an approved active constituent for
a proposed or existing chemical product; or
(b) a registered chemical product; or
(c) an approved label for containers;
may apply to the APVMA for variation of a relevant
particular of the approval or registration if the relevant particular is of a
kind set out in a legislative instrument made by the APVMA for the purposes of
this section.
(2) An application must:
(a) be signed by an approved person;
and
(b) be accompanied by the prescribed
fee (if any); and
(c) be lodged with the APVMA.
(3) Subsection (4) applies if:
(a) in the case of an application that
relates to an active constituent or registration of a chemical product—the
APVMA is satisfied that, if those particulars were varied in accordance with
the application, the continued use of, or any other dealing with, the
constituent or product in accordance with the instructions for its use or for
such a dealing:
(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; or
(b) in the case of an application that
relates to a label for containers for a chemical product—the APVMA is satisfied
that, if those particulars were varied in accordance with the application, the
use of the product in accordance with the instructions for its use would be
effective according to criteria determined by the APVMA for the product.
(4) If the APVMA is satisfied, as mentioned
in subsection (3), the APVMA must:
(a) both:
(i) vary the relevant
particulars; and
(ii) record in the relevant
APVMA file the relevant particulars as varied and the date on which the record
is made; and
(b) give the interested person a
written notice that states that the relevant particulars have been varied.
(5) If the APVMA is not satisfied, as
mentioned in subsection (3), the APVMA must give the interested person a
written notice that:
(a) states that the relevant particulars
have not been varied; and
(b) sets out the reasons why the
relevant particulars have not been varied; and
(c) states that the interested person
may apply to have the relevant particulars varied under Division 3 of this
Part.
Division 3—Application for variation of relevant particulars, or of
conditions, of approval or registration
27 Who
may apply
The interested person in relation to:
(a) an approved active constituent for
a proposed or existing chemical product; or
(b) a registered chemical product; or
(c) an approved label for containers;
may apply to the APVMA for variation of the relevant
particulars of the approval or registration, or variation of the conditions of
the approval or registration.
28 How
application 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 APVMA 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 APVMA.
(1A) If an application is made under this
Division and an application has previously been made for the same variation
under Division 2A, the APVMA must set off the fee paid for the previous
application against the fee payable (if any) under paragraph (1)(d).
(2) The APVMA 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 APVMA written notice of the withdrawal signed by
an approved person.
28A
Preliminary assessment of application
Section 11A
applies to an application lodged under section 28 and compliance with
subsection 28(1) in the same way as it applies to an application lodged under
section 11 and compliance with subsection 11(1).
28B
APVMA to publish summary of application
(1) As soon as practicable after an
application is acknowledged, the APVMA must cause to be published a summary of
the application, unless satisfied that the variation applied for does not
relate to use of or dealing with a proposed or existing chemical product.
(2) The summary must include the details
relating to the application that are prescribed by the regulations (if any).
29
Grant or refusal of application
(1) If the APVMA is satisfied of the
following:
(a) that subsection 28(1) has been
complied with;
(b) that any requirement made under
section 157 or 159 has been complied with;
(c) that, if necessary, section 158
has been complied with;
(ca) that, if necessary, paragraph
8A(2)(b) 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 of
an approval or registration or of the conditions of an approval or registration
have been complied with;
(e) if the application relates to a
constituent or a product—that, if those particulars or conditions were varied
in accordance with the application, the continued use of, or any other dealing
with, the constituent or product in accordance with the instructions for its
use or for such a dealing that the APVMA proposes to approve:
(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;
(f) if the application relates to a
product—that, if those particulars or conditions were varied in accordance with
the application, the use of the product in accordance with the instructions for
its use that the APVMA proposes to approve would be effective according to
criteria determined by the APVMA for the product;
(g) if the application relates to a
label—that the label would contain adequate instructions relating to the
matters referred to in paragraph 14(3)(g);
it must:
(h) grant the application and vary
those particulars or conditions:
(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 product—by 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 label—by
recording in the relevant APVMA file the relevant particulars as varied and the
date on which the record is made; or
(iii) if the application was
for a variation of the conditions of approval of a label—by recording in the
file the conditions as varied; or
(i) 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 paragraph (1)(e)
or (f), the APVMA must have regard to the matters referred to in subsection
14(4), (5) or (6), as the case requires.
(3) If the APVMA is not satisfied as
mentioned in subsection (1), it must refuse the application.
(4) If the application is refused, the APVMA
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.
(5) Section 168 provides for additional
matters to be included in a notice under subsection (4).
Division 4—Reconsideration of approval or registration
30
APVMA may invite the public to propose approved active constituents or
registered chemical products for reconsideration
(1) The APVMA may cause to be published in
the Gazette, and in any other manner it thinks appropriate, notices
inviting persons to propose active constituents for proposed or existing
chemical products, or to propose chemical products, whose approval or
registration the APVMA might reconsider.
(2) A notice under subsection (1) must
state the criteria that are to be taken into account by the APVMA in
reconsidering the approval or 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.
31
APVMA may reconsider approval or registration
(1) The APVMA may at any time, in accordance
with this Division, reconsider:
(a) the approval of an active
constituent for a proposed or existing chemical product; or
(b) the registration of a chemical
product; or
(c) the approval of a label for
containers for a chemical product.
32
APVMA may give notice of proposed reconsideration
(1) Before reconsidering the approval of an
active constituent for a proposed or existing chemical product, the
registration of a chemical product or the approval of a label for containers
for a chemical product, the APVMA 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 APVMA proposes to
reconsider the approval or registration and setting out the relevant
particulars of the approval of the constituent or label or of the registration
of the product; and
(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
(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 publication of the notice, a written submission to the APVMA
as to whether the approval or registration complies with the prescribed
requirements for continued approval or registration.
(2) The APVMA must give written notice to the
interested person in relation to the constituent, product or label or 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 APVMA:
(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 APVMA 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).
Penalty: 120 penalty units.
(3A) An offence under subsection (3) is an
offence of strict liability.
Note: For strict liability, see section 6.1 of
the Criminal 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 APVMA 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 APVMA complies with the request.
(5) The APVMA 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).
33
APVMA may require trials or laboratory experiments to be conducted
(1) The APVMA may, by written notice given to
the interested person in relation to an active constituent for a proposed or
existing chemical product, or in relation to a 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 constituent or
product, as the case may be, that the APVMA thinks necessary for the purposes
of its reconsideration of the approval of the constituent or the registration
of the product; and
(b) to give the results of the trials
or experiments to the APVMA.
(2) A person must comply with a requirement
made of the person under subsection (1).
Penalty: 120 penalty units.
(2A) An offence under subsection (2) is an
offence of strict liability.
Note: For strict liability, see section 6.1 of
the Criminal Code.
(3) 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 APVMA under section 42 to cancel the approval
of the constituent or the registration of the product, as the case may be, and
the APVMA complies with the request.
(4) This section does not affect the APVMA’s
powers under section 159.
34
Reconsideration by APVMA of continued approval or registration
(1) If the APVMA is satisfied that, provided
that the conditions to which an approval or registration is currently subject
are complied with:
(a) if the reconsideration relates to
an approval of a constituent or registration of a product—the continued use of,
or any other dealing with, the constituent or product in accordance with the
instructions for its use or for such a dealing that the APVMA has approved:
(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
(b) if the reconsideration relates to
registration of a product—the continued use of the product in accordance with
the instructions for its use that the APVMA has approved would be effective
according to criteria determined by the APVMA for the product; and
(c) if the reconsideration relates to
an approval of a label:
(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
(d) any other prescribed requirements
for continued approval or registration would be complied with; and
(da) that, if necessary, paragraph
8A(2)(c) of the Agricultural and Veterinary Chemicals (Administration) Act
1992 has been complied with;
the APVMA must as soon as practicable:
(e) give written notice to the
interested person or to an approved person stating that it affirms the approval
or registration on the conditions to which the approval or registration is
currently subject and giving brief particulars of the reasons for its decision;
and
(f) if it caused a notice to be
published under subsection 32(1) in relation to its proposed reconsideration of
the approval or registration—cause to be published, in the same way as the
first‑mentioned notice, a notice stating that it has affirmed the
approval or registration on the conditions to which the approval or registration
is currently subject.
(2) In satisfying itself as mentioned in paragraph (1)(a)
or (b), the APVMA must have regard to the matters referred to in subsection
14(4), (5) or (6), as the case requires.
(3) If the APVMA is not satisfied as mentioned
in subsection (1), subsections (4) to (6) apply.
(4) The APVMA must give written notice to the
interested person or to an approved person stating that the APVMA is not so
satisfied.
(5) If the APVMA 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:
(a) the APVMA 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 product—by 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 label—by recording in
the relevant APVMA file the relevant particulars as varied and the date on
which the record is made; or
(iii) if the variation
relates to the conditions of the approval of a label—by recording in the
relevant APVMA file particulars of the variation and the date on which the
record is made; and
(b) the APVMA 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 APVMA may only vary a condition of the
approval of a label that was imposed under subsection 23A(2).
(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 APVMA 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.
(6) A notice given under subsection (4)
must give brief particulars of the reasons for the APVMA’s decision and, if subsection (5)
applies, also give brief particulars of the reasons for the variation of the
conditions of the approval or registration.
(7) Section 168 provides for additional
matters to be included in a notice to which subsection (5) applies.
(8) Section 40 provides for the
suspension or cancellation of the approval or registration if the APVMA is not
satisfied that the conditions of the approval or registration can be varied as
mentioned in subsection (5).
34A
Reconsideration of approval of label without notice in certain circumstances
(1) The APVMA 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
APVMA considers that the particulars do not contain adequate instructions in
relation to a matter, the APVMA must:
(a) both:
(i) vary the relevant
particulars; and
(ii) record in the relevant
APVMA file the relevant particulars as varied and the date on which the record
is made; 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.
(5) Sections 30 to 34 do not apply to a
reconsideration under this section.
Division 4A—Limits on use of information
Subdivision A—Preliminary
34B
Explanation of Division
(1) This Division limits for a period the use
the APVMA can make of information given to it:
(a) in connection with an application
under section 10 or 27 relating to:
(i) approval of an active
constituent for a chemical product; or
(ii) registration of a chemical
product; or
(iii) approval of a label
for a container for a chemical product; or
(b) under section 161 in
connection with a registered chemical product.
(2) During the period, the APVMA cannot use
the information for granting another application, or for a reconsideration of
an approval or registration, unless:
(a) the APVMA is given a written
statement made by a person who can authorise the use of the information
consenting to the use; or
(b) certain other conditions are met.
(3) The object of limiting use of the
information in this way is to encourage innovation by making it easier for a
person who made an investment in finding out the information to get a return on
that investment.
Subdivision B—Limits on use of information
34C
APVMA must not use some information during some periods for some purposes
(1) During the period described in an item of
the table, the APVMA must not use information described in the item for a
purpose described in the item.
|
Limits on use of
information
|
|
|
The APVMA must not use
this information:
|
During this period:
|
For this purpose:
|
|
1
|
Information that the applicant or an approved person gives
the APVMA:
(a) in connection with an application under section 10
or 27; and
(b) before the APVMA makes a preliminary assessment under
section 11A or 28A of the application
|
The period:
(a) starting when the information is given; and
(b) ending when the APVMA makes the preliminary assessment
|
Making a decision under section 14, 29 or 34 (except
a decision on the application)
|
|
2
|
Information that the applicant or an approved person gives
the APVMA:
(a) in connection with an application under section 10
or 27; and
(b) as required by the APVMA or section 160A
|
The period:
(a) starting when the APVMA makes a preliminary assessment
under section 11A or 28A of the application; and
(b) ending when the APVMA treats the application as having
been withdrawn or grants or refuses the application
|
Making a decision under section 14, 29 or 34 (except
a decision on the application)
|
|
3
|
Information that:
(a) was given to the APVMA by the applicant or an approved
person in connection with an application under section 10 or 27; and
(b) was given as required by the APVMA or section 160A;
and
(c) was relied on by the APVMA to grant the application
|
The relevant period described in section 34F
|
Making a decision under section 14, 29 or 34
|
|
4
|
Information that the interested person for a registered
chemical product gives the APVMA under section 161 in connection with
the product
|
The period:
(a) starting when the person gives the APVMA the information;
and
(b) ending 5 years later if the product is an agricultural
chemical product or 3 years later if the product is a veterinary chemical
product
|
Making a decision under section 14, 29 or 34
|
Note 1: Section 34D sets out exceptions to this
subsection.
Note 2: Section 161 may require an interested
person for an approved active constituent to give the APVMA information in
connection with the constituent, even though this table does not deal with that
requirement.
(2) This section applies only to information
given to the APVMA:
(a) in connection with an application
made after the commencement of this section; or
(b) under section 161 in
connection with a chemical product that was registered as a result of an
application made after the commencement of this section.
(3) The use of information in contravention
of subsection (1) for making a decision does not affect the validity of
the decision.
(4) An action or proceeding does not lie
against any of the following for any loss directly or indirectly sustained
because of the use of information in contravention of subsection (1):
(a) the Commonwealth;
(b) the APVMA;
(c) a person who is or has been:
(i) a director of the
APVMA; or
(ii) the Chief Executive
Officer of the APVMA; or
(iii) a delegate of the
APVMA; or
(iv) a member of the staff
of the APVMA.
Subdivision C—Exceptions to limits on use of information
34D
Exceptions
(1) Section 34C does not prevent the
APVMA from using information for making a decision:
(a) under section 14 or 29 about
an application; or
(b) under section 34 about a
reconsideration of an approval or registration;
if a condition in subsection (2), (3), (4), (5) or
(6) of this section is met.
Evidence of consent for use
(2) One condition is that the applicant, an
approved person or the interested person for the approval or registration gives
the APVMA a written statement by the authorising party of that party’s consent
to the APVMA using the information for making the decision. This condition is
met even if the authorising party:
(a) later states that it has not
consented; or
(b) withdraws the consent (whether
before or after the APVMA is given the statement of consent).
Note: Chapter 7 of the Criminal Code
creates offences relating to false and misleading statements and forgery.
Use in the public interest
(3) Another condition is that the APVMA is
satisfied, having regard to the criteria (if any) prescribed by the
regulations, that the use of the information is in the public interest.
Note: Section 34E sets out other rules that are
relevant to the exception based on this condition.
Information does not favour the applicant or interested
person
(4) Another condition is that:
(a) the decision relates to:
(i) a proposed or existing
approval of an active constituent for a proposed or existing chemical product;
or
(ii) a proposed or existing
registration of a proposed or existing chemical product; and
(b) the information meets a condition
in paragraph 160A(4)(b) or (c) or 161(2)(b) or (c) (which are about showing
that use or dealing with the product may have adverse effects or that the
product may be ineffective), whether or not the information was given to the
APVMA under section 160A or 161.
Identical information whose use is not limited
(5) Another condition is that the APVMA is
satisfied that there is identical information, or information to the same
effect, whose use is not prevented by section 14B or 34C or Part 3.
Information given to APVMA in connection with certain
applications
(6) Another condition is that the application
mentioned in subsection 34C(1) was one of the following:
(a) an application for approval, as an
active constituent for a chemical product, of a substance that was a previously
endorsed active constituent on the commencement of this Division;
(b) an application for the variation
of the relevant particulars or conditions of the approval of an active
constituent for a chemical product;
(c) an application for the
registration of a companion animal product each active constituent for which
was a previously endorsed active constituent at the time of the preliminary
assessment of the application under section 11A;
(d) an application for variation of
the relevant particulars or conditions of the registration of a companion animal
product;
(e) an application for the approval of
a label for a container for a companion animal product each active constituent
of which was a previously endorsed active constituent at the time of the
preliminary assessment of the application under section 11A;
(f) an application for variation of
the relevant particulars or conditions of the approval of a label for a
container for a companion animal product.
34E
Further rules about public interest exception
(1) This section applies if the APVMA is satisfied
under subsection 34D(3) that it is in the public interest to use information
that section 34C would otherwise prohibit the APVMA from using for making
a decision:
(a) under section 14 or 29 about
an application; or
(b) under section 34 about a reconsideration
of an approval or registration.
(2) As soon as practicable after becoming
satisfied, the APVMA must give written notice of its satisfaction to:
(a) the applicant, an approved person
or the interested person for the approval or registration; and
(b) the person whom the APVMA believes
is the authorising party for the information.
(3) Section 168 provides for additional
matters to be included in the notice.
(4) The APVMA must not make the decision
using the information before the end of 28 days after the day on which the
notice is given.
(5) However, subsections (3) and (4) do
not apply if:
(a) the APVMA believes it is necessary
to make the decision before the end of 28 days after the notice is given, to
prevent imminent risk to public health or occupational health or safety; and
(b) states that belief in the notice.
Subdivision D—Period of limit on use of information
34F
Period of limit on future use of information relied on in granting application
(1) Subsection 34C(1) prohibits the APVMA
from using, during the period described in an item of the following table,
information that:
(a) was given to the APVMA by the
applicant or an approved person in connection with an application described in
the item; and
(b) was given as required by the APVMA
or section 160A; and
(c) was relied on by the APVMA to
grant the application.
The period starts when the application was granted.
|
Period for which the
APVMA must not use the information
|
|
|
Application
|
Period
|
|
1
|
Application made under section 10 for approval of an
active constituent (for a proposed or existing chemical product) that was not
a previously endorsed active constituent on the commencement of this Division
|
8 years
|
|
2
|
Application made under section 10 for:
(a) registration of a chemical product at least one of whose
active constituents was not a previously endorsed active constituent when the
application was acknowledged; or
(b) approval of a label for a container for a chemical
product at least one of whose active constituents was not a previously
endorsed active constituent when the application was acknowledged
|
8 years
|
|
3
|
Application (except one covered by item 2) made under
section 10 for:
(a) registration of an agricultural chemical product; or
(b) approval of a label for a container for an agricultural
chemical product
|
5 years
|
|
4
|
Application (except one covered by item 2) made under
section 10 for:
(a) registration of a veterinary chemical product; or
(b) approval of a label for a container for a veterinary
chemical product
|
3 years
|
|
5
|
Application made under section 27 for variation of
the relevant particulars or conditions of:
(a) the registration of an agricultural chemical product; or
(b) the approval of a label for a container for an
agricultural chemical product
|
5 years
|
|
6
|
Application made under section 27 for variation of
the relevant particulars or conditions of:
(a) the registration of a veterinary chemical product; or
(b) the approval of a label for a container for a veterinary
chemical product
|
3 years
|
Note 1: This section has effect for the purposes of
item 3 of the table in subsection 34C(1) (and not for any of the other
items in that table).
Note 2: This section is not relevant to information if
section 34D provides an exception to the prohibition in subsection 34C(1)
on the APVMA using the information.
Extension of 8‑year limits
(2) The period mentioned in item 1 or 2
of the table in subsection (1) in relation to:
(a) an application for an approval of
an active constituent (a key constituent); or
(b) an application for registration of
a chemical product containing an active constituent (also a key
constituent) that had not been approved when the application was
acknowledged; or
(c) an application for approval of a
label for a container for a chemical product containing an active constituent
(also a key constituent) that had not been approved when the
application was acknowledged;
is extended by 1 year for each 5 distinct uses that meet
the requirements in subsections (3), (4) and (5).
(3) The first requirement is that the uses
are uses of a chemical product (an extension product) for which
the following conditions are met:
(a) the key constituent is an active
constituent for the product;
(b) the product was registered as a
result of an application that:
(i) was made by the
applicant mentioned in subsection (1); and
(ii) was acknowledged
before the approval of the key constituent.
(4) The second requirement is that each of
the uses is included in an approved label for a container for an extension
product as a result of an application that:
(a) is for:
(i) the approval of the
label; or
(ii) the variation of the
relevant particulars or conditions of approval of the label; and
(b) was made by the applicant
mentioned in subsection (1) or by the interested person in relation to the
approval of the key constituent; and
(c) was acknowledged before the end of
6 years after the date of the approval of the key constituent as a result of an
application by the applicant mentioned in subsection (1).
(5) The third requirement is that all 5 of
the uses are prescribed by the regulations at the latest time an application
described in subsection (4) is granted.
(6) However, the period mentioned in item 1
or 2 of the table in subsection (1) cannot be extended so that it exceeds
11 years.
Subdivision E—Ancillary provisions
34G
Identifying information relied on in advice APVMA relied on
(1) This section has effect if:
(a) the APVMA made a decision under
subsection 14(1) or 29(1) to grant an application made after the commencement
of this section; and
(b) in making the decision, the APVMA
relied on advice given by a person, body or Government the APVMA consulted
under section 8 or 8A of the Agricultural and Veterinary Chemicals
(Administration) Act 1992.
(2) The APVMA must cause to be published a
summary of the advice.
(3) The summary must:
(a) identify the information that the
person, body or Government relied on in giving the advice; and
(b) include the matters (if any)
prescribed by the regulations.
Division 5—Suspension or cancellation of approval or registration
35
Notice of proposed suspension or cancellation to be given to co‑ordinators
The APVMA must not suspend or cancel an
approval or 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 APVMA thinks adequate in a particular case, has
elapsed since the notice was given.
36
Suspension or cancellation of approval or registration for breach of condition
If there is a contravention of a
condition of the approval of an active constituent for a proposed or existing
chemical product, the registration of a chemical product or the approval of a
label for containers for a chemical product, the APVMA may suspend or cancel
the approval or registration.
37
Suspension of approval or registration for failing to give information, or
results of trials or experiments, to APVMA
(1) If:
(a) at the end of the period stated in
a notice given to a person under subsection 32(2), the APVMA 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 APVMA; or
(b) at the end of the period stated in
a notice given to a person under subsection 33(1), the APVMA 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
APVMA;
the APVMA may suspend the approval or registration.
(2) Subject to subsection (4), the APVMA
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.
(3) Subject to subsection (4), the APVMA
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 APVMA within a period after the
suspension takes place that the APVMA thinks reasonable, the APVMA may cancel
the approval or registration.
38
Suspension of approval or registration for failing to give information, report
or sample to APVMA
(1) If the interested person in relation to
an approved active constituent for a proposed or existing chemical product, or
in relation to a chemical product, or an approved person fails, without
reasonable excuse, to comply with a requirement contained in a notice under
section 159 or with section 160A or 161, the APVMA may suspend the
approval or registration.
(2) Subject to subsection (3), the APVMA
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 APVMA within a reasonable period after the suspension takes
place, the APVMA may cancel the approval or registration.
39
Suspension of approval or registration if compensation for use of protected
information cannot be arbitrated
(1) If:
(a) the primary applicant in relation
to a primary active constituent and the secondary applicant in relation to a
secondary active constituent or a secondary chemical product were parties to an
arbitration under Division 3 of Part 3 as to the terms of
compensation; and
(b) the arbitrator gives notice to the
APVMA under section 68 in respect of the failure of each party to the
arbitration to make a fresh proposal as to the terms of the compensation or to
make a fresh proposal as to those terms that the arbitrator thinks reasonable;
the APVMA may suspend the approval of the primary active
constituent or may suspend the approval of the secondary active constituent or
the registration of the secondary chemical product, as the case may be, or may
do both of those things.
(2) If:
(a) the primary applicant in relation
to a primary chemical product and the secondary applicant in relation to a
secondary chemical product were parties to an arbitration under Division 3
of Part 3 as to the terms of compensation; and
(b) the arbitrator gives notice to the
APVMA under section 68 in respect of the failure of each party to the
arbitration to make a fresh proposal as to the terms of the compensation or to
make a fresh proposal as to those terms that the arbitrator thinks reasonable;
the APVMA may suspend the registration of either or both
of those products.
40
Suspension or cancellation of approval or registration following
reconsideration of continued approval or registration
(1) If, in the course of reconsidering the
approval of an active constituent for a proposed or existing chemical product,
the registration of a chemical product or the approval of a label for
containers for a chemical product, the APVMA is not satisfied that the relevant
particulars or the conditions of the approval or registration can be varied in
such a way that the prescribed requirements for continued approval or
registration will be complied with, the APVMA may suspend or cancel the approval
or registration.
(2) If, in the course of reconsidering the
approval of a label for containers for a chemical product:
(a) the APVMA 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
satisfy the APVMA that a label, including the particulars as proposed to be
varied by the APVMA, will be attached to the containers for the chemical
product;
the APVMA may suspend or cancel the approval.
41
Suspension or cancellation of approval or registration for non‑compliance
with criteria for registration or approval
(1) The APVMA may suspend or cancel the approval
of an active constituent for a proposed or existing chemical product, or the
registration of a chemical product, if it appears to the APVMA that, having
regard to the matters referred to in subsection 14(4) or (5), as the case
requires, the continued use of, or any other dealing with, the constituent or
product in accordance with the instructions for its use or for such a dealing
that the APVMA has approved:
(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 APVMA may suspend or cancel the
registration of a chemical product if it appears to the APVMA that, having
regard to the matters referred to in subsection 14(6), the continued use of the
product in accordance with the instructions for its use that the APVMA has
approved may not be effective according to criteria determined by the APVMA for
the product.
(3) If it appears to the APVMA that any of
the instructions on an approved label for containers for a chemical product
that relates to a matter referred to in paragraph 14(3)(g) may no longer be
adequate, the APVMA may suspend or cancel the approval.
(4) If:
(a) the APVMA 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
satisfy the APVMA that a label, including the particulars as proposed to be
varied by the APVMA, will be attached to the containers for the chemical
product;
the APVMA may suspend or cancel the approval of the label.
42
Cancellation of approval or registration at request of interested person
(1) If:
(a) the interested person in relation
to an approval or registration or an approved person gives to the APVMA a
written notice:
(i) requesting the APVMA
to cancel the approval or registration; and
(ii) stating the reasons
for the request; and
(b) the APVMA is satisfied that there
are no valid reasons why it should not agree to the request;
the APVMA must cancel the approval or registration.
(2) The APVMA must give written notice of its
decision on a request under subsection (1) to the person or persons who
made the request.
43
Effect of suspension of approval or registration
(1) A suspension of an approval or
registration must be for a stated period.
(2) An approval or registration is taken for
the purposes of this Code other than sections 74 and 75 not to be in force
during any period in which it is suspended.
(3) An approval or registration may be
cancelled even though it is suspended.
44
Inter‑related suspensions and cancellations
(1) If the APVMA suspends or cancels the only
approval, or all the approvals, of an active constituent for a proposed or
existing chemical product, it must also suspend or cancel any registration of
that product.
(2) If the APVMA suspends or cancels the
registration of a chemical product, it may also suspend or cancel, as the case
may be, any approval relating to a label for containers for the product.
(3) If the APVMA suspends or cancels the
approval of the only approved label, or all the approved labels, for containers
for a chemical product, it may also suspend or cancel, as the case may be, the
registration of the product.
45 How
approval or registration is suspended or cancelled
(1) Suspension or cancellation of an approval
or registration is made by entering in the relevant Record or Register or
recording in the relevant file:
(a) the fact that the approval or
registration has been suspended or cancelled; and
(b) in respect of a suspension—the
period of the suspension; and
(c) the date on which the entry or
record is made.
45A
Notice of suspension or cancellation
(1) Subject to subsection (3), if the
APVMA 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.
(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 product—must
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 APVMA thinks
desirable;
excluding any matters that the
APVMA 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 APVMA revokes the suspension
or cancellation; or
(c) the APVMA, by notice published in
the Gazette, declares that this subsection ceases to apply in respect of
the constituent or product;
whichever first occurs.
(6) Subject to subsection (8), if:
(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.
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.
Note: For strict liability, see
section 6.1 of the Criminal Code.
(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.
46 How
suspension or cancellation is revoked
(1) Suspension or cancellation of an approval
or registration is revoked by entering in the relevant Record or Register or
recording in the relevant file:
(a) the fact that the suspension or
cancellation has been revoked; and
(b) the date on which the entry is
made.
(2) If the APVMA revokes the suspension or
cancellation of an approval or 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 an approval or
registration is revoked, the cancellation is taken never to have occurred.
Division 6—Duration and renewal of approval or registration
47
Period of approval or registration
(1) The approval of an active constituent for
a proposed or existing chemical product continues in force unless it is
cancelled.
(2) Subject to subsection (3), the
registration of a chemical product ends at the end of 30 June next
following the day on which the registration was granted or renewed, or last
renewed, as the case may be.
(3) The registration of a chemical product
that is taken to have been effected by subsection 172(2) or paragraph 174(1)(a)
or 176(1)(c) ends at the end of 3 months after the commencement of this Code unless
the registration is renewed.
(4) The approval of a label for containers
for a chemical product ends when the registration of the product ends.
(4A) If:
(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.
(5) This section has effect subject to:
(a) any condition of a kind referred
to in:
(i) subsection 23(3) to
which an approval or registration is subject; or
(ii) subsection 23A(4) to
which an approval of a label for containers for a chemical product is subject;
and
(b) subsection 43(2), which relates to
suspension of an approval or registration; and
(c) the following provisions of this
Division.
48
Application for renewal of registration of chemical product
(1) The interested person may apply for the
renewal, or further renewal, as the case may be, of the 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
APVMA permits, before the registration ends.
(3) In circumstances that are prescribed by
the regulations and upon payment of the prescribed fee (if any), the APVMA may
accept a late application if the application is made on or before a date that
the APVMA determines.
49 How
application for renewal of 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 APVMA 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 APVMA.
(2) The APVMA 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 APVMA written notice of the withdrawal signed by an approved
person.
(4) Subject to subsection (5), the APVMA
must grant the application:
(a) if the application was made in
accordance with subsection 48(2)—before the registration ends; or
(b) if the application was made in
accordance with subsection 48(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.
(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 APVMA in respect of the product under any law in force
in any jurisdiction has not been paid, the APVMA may refuse to grant the
application for renewal.
(6) If the application was made in accordance
with subsection 48(2) and the APVMA fails to grant the application before the
registration ends, the registration continues in force until:
(a) the APVMA grants the application;
or
(b) if the APVMA decides to refuse to
grant the application because of non‑payment of an amount as mentioned in
subsection (5)—the APVMA gives written notice of its decision to an
approved person.
(7) If the APVMA accepts a late application
under subsection 48(3) and grants the application, the registration continues
in force, or is taken to have continued in force, as the case may be, until the
application is or was granted.
50
Renewal of registration of chemical product
The renewal of registration of a
chemical product:
(a) is granted by entering in the
Register of Chemical Products a statement that the registration has been
renewed and the date on which the renewed 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 registration ends or ended.
51
Renewal of approval of label
If the registration of a chemical
product is renewed:
(a) any approval of a label for
containers for the product is, by this section, also renewed; and
(b) the renewal of that approval 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
registration of the product ends or ended; and
(c) the APVMA must record in the
relevant file a statement that the approval of the label has been renewed and
the date on which the renewed approval ends.
Division 7—Publication of notices by APVMA
52
Publication of notice of approval of active constituent or registration of
chemical product
(1) If the APVMA approves an active
constituent for a proposed or existing chemical product, it must, as soon as
practicable after the approval, cause notice of the approval to be published in
accordance with subsection (3).
(2) If the APVMA registers a chemical
product, it must, as soon as practicable after the registration, cause notice
of the registration to be published in accordance with subsection (3),
unless the APVMA thinks it unnecessary, in the circumstances, to publish such a
notice.
(3) The notice:
(a) is to be published in the Gazette
and in any other manner that the APVMA thinks appropriate; and
(b) must state that the constituent
has been approved or the product has been registered, as the case may be, and
state the date of the approval or registration; and
(c) must contain a brief statement of
the conditions of the approval or registration that directly regulate the use
of the constituent or product, as the case may be.
53
Publication of notice of variations of approval of active constituent or
registration of chemical product
(1) If the APVMA varies any of the relevant
particulars of an approval of an active constituent for a proposed or existing
chemical product or of the registration of a chemical product or any of the
conditions of such an approval or registration, the APVMA must, unless it
thinks that, in the circumstances, it is unnecessary to do so, cause notice of
the variation to be published in the Gazette and in any other manner
that it thinks appropriate.
(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.
54
Publication of notice of end of registration of chemical product
(1) If the registration of a chemical product
ends and is not renewed, the APVMA 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 registration has
ended; and
(b) setting out the date on which the
registration ended; and
(ba) containing instructions for
possessing, having custody of, using or otherwise dealing with the product; and
(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 APVMA thinks desirable; and
(c) containing any other information
that the APVMA thinks appropriate;
unless the APVMA thinks that, in the circumstances it is
it unnecessary to publish such a notice.
(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:
(a) 2 years after the day on which the
registration ended; or
(b) the APVMA, by notice published in
the Gazette, declares that this subsection ceases to apply in respect of
the product;
whichever first occurs.
(3) Subject to subsection (5), if:
(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.
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.
Note: For strict liability, see
section 6.1 of the Criminal Code.
(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.
(6) If a notice stating that the registration
of a chemical product has ended is published under this section, the APVMA
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 APVMA, should be given
notice of the ending of the registration and of the instructions, warnings and
explanations contained in the notice.
55
Publication of notice of suspension or cancellation of approval or registration
(1) If the APVMA suspends or cancels the
approval of an active constituent for a proposed or existing chemical product,
the registration of a chemical product or the approval of a label for
containers for 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:
(a) that the continued use of, or
other dealing with, the constituent or product:
(i) might be an undue
hazard to the safety of people exposed to it during its handling or people
using anything containing its residues; or
(ii) might be likely to
have an effect that is harmful to human beings; or
(iii) might be likely to
have an unintended effect that is harmful to animals, plants or things or to
the environment; or
(b) that the continued use of the
product might not be effective according to criteria determined by the APVMA
for the product; or
(c) that an instruction on a label for
containers for the product might no longer be adequate;
the notice must contain the following:
(d) a statement to that effect;
(e) instructions for possessing,
having custody of, using or otherwise dealing with the constituent or product;
(f) 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 have possession
or custody of the constituent or product with the intention of supply, or to
supply the constituent or product;
(g) any other warnings or explanations
in relation to the constituent or product that the APVMA thinks desirable.
(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:
(a) 2 years after the day of the
suspension or cancellation; or
(b) the
APVMA revokes the suspension or cancellation; or
(c) the APVMA, 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.
(4) Subject to subsection (5), if:
(a) a notice of the suspension or
cancellation of the approval of an active constituent for a proposed or
existing chemical product, the registration of a chemical product or the
approval of a label for containers for a chemical product has been published
under this section; and
(b) a
person has possession or custody of that constituent or product with the
intention of supply;
the person must not
possess, have custody of or otherwise deal with the constituent or product
except in accordance with the instructions contained in the notice.
Penalty: 300 penalty units.
(5) Subsection (4) does not apply to a
possession, custody or dealing with a constituent or product if the constituent
was an approved active constituent, the product was a registered chemical
product, or the label on the product was an approved label, when the
possession, custody or dealing took place because of its having been approved
or registered again after its previous approval or registration had been
cancelled.
(6) It is a defence to a prosecution of a
person for an offence against subsection (4) if the person proves that,
when the person possessed, had custody of or dealt with the constituent or
product, the person did not know, and could not reasonably be expected to have
known, of the existence of the notice or that the possession, custody or
dealing was not in accordance with the instructions contained in the notice.
(6A) In paragraph (4)(a), strict liability
applies to the physical element of circumstance, that the publishing of the
notice was under this section.
Note: For strict liability, see section 6.1 of
the Criminal Code.
(7) If the
APVMA causes a notice of the suspension or cancellation of the registration of
a chemical product to be published under this section, the APVMA must:
(a) as soon as practicable cause a
copy of the notice to be given to each person who is an interested person for
the product to which the notice relates or an approved person; and
(b) cause a copy of the notice to be
given to any other person who, in the opinion of the APVMA, should be given
notice of the suspension or cancellation and of the instructions, warnings and
explanations contained in the notice.
(8) If the APVMA causes a notice of the
suspension or cancellation of the approval of a label for containers for a
chemical product to be published under this section, the APVMA must:
(a) as soon as practicable cause a
copy of the notice to be given to the interested person in relation to the
chemical product or an approved person; and
(b) cause a copy of the notice to be
given to any other person who, in the opinion of the APVMA, should be given
notice of the suspension or cancellation and of the instructions, warnings and
explanations contained in the notice.
56
Notice of revocation of suspension or cancellation to be published
If the APVMA revokes the suspension or
cancellation of the approval of an active constituent for a proposed or existing
chemical product, the registration of a chemical product or the approval of a
label for containers for 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.
Part 2A—Listable chemical products
Division 1—Preliminary
56A
Explanation of Part
(1) This Part contains provisions relating
to:
(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 APVMA 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 APVMA 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 APVMA to
publish notices telling the public of actions that it has taken under this
Part.
56B
Exclusion of restricted chemical products
This Part does not apply to chemical
products that are restricted chemical products.
Division 2—Schedule of listable chemical products
56C
Regulations may contain schedule of listable 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 APVMA; and
(b) the APVMA 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 APVMA 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 APVMA 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 APVMA 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
APVMA 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 APVMA 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 APVMA 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 APVMA to
publish a notice under subsection (3), the APVMA 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 3—Establishing standards for listable chemical products
56D
APVMA to prepare standards
(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 APVMA 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 APVMA 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 APVMA 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 APVMA 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 APVMA
of the reasons for the decision; and
(b) the APVMA 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 APVMA must cause a copy of the standard
established for a listable chemical product to be published in the Gazette.
56E
Matters to be taken into account in preparing a standard
(1) The APVMA must not submit a standard for
a chemical product to the Minister for approval unless the APVMA 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 APVMA 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 APVMA 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
APVMA 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 APVMA 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.
56F
Variation or revocation of standards
(1) The APVMA 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 APVMA may, by writing, with the
approval of the Minister, revoke the standard established for a listable chemical
product.
(4) The APVMA 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.
56G
Date of effect of standards
(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.
56H
Standards to be disallowable
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 4—Application for registration of listable chemical products
56I
Application
A person may apply to the APVMA for a
chemical product:
(a) that is a listable chemical
product; and
(b) for which there is an established
standard;
to be granted listed registration.
56J
How application 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, any
information that the APVMA 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 APVMA.
(2) The APVMA 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 APVMA information
additional to or varying information previously given to the APVMA; and
(b) may withdraw the application by
giving to the APVMA a written notice of the withdrawal signed by an approved
person.
56K
Grant or refusal of application
(1) The APVMA 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 APVMA 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 APVMA 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.
(3) If the APVMA is not satisfied as
mentioned in subsection (1) it must refuse the application.
56L
Multiple listed registrations
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.
56M
How listed registration of chemical product is effected
(1) If the APVMA 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.
56N
Date of 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;
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.
56O
Conditions of listed registration
(1) The conditions of the listed registration
of a chemical product are the conditions that the APVMA thinks appropriate.
(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 APVMA 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.
56P
Notice of listed registration
(1) If an application for listed registration
of a chemical product is granted, the APVMA:
(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.
56Q
Notice of refusal of application
(1) If an application for listed registration
of a chemical product is refused, the APVMA 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.
56R
Notice of incorrectly registered particulars
(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 APVMA
a written notice, signed by an approved person, identifying the incorrect
particular or condition and informing the APVMA of the correct particular or condition.
Penalty: 60 penalty units.
(2) If the APVMA is satisfied that the
particular or condition entered in the Register of Chemical Products in
relation to the product is not correct, the APVMA must change the entry
accordingly.
Division 5—Application for variation of relevant particulars, or of
conditions, of listed registration
56S
Who may apply
The interested person in relation to a
registered listed chemical product may apply to the APVMA for variation of the
relevant particulars, or variation of the conditions, of the listed
registration.
56T
How application 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 APVMA 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 APVMA.
(2) The APVMA 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 APVMA written notice of the withdrawal signed by
an approved person.
56U
Grant or refusal of application
(1) If the APVMA 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 APVMA 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 APVMA 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:
(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
(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 APVMA 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 APVMA must have regard to the matters referred to in subsection 56E(3).
(4) If the APVMA is not satisfied as
mentioned in subsection (1), it must refuse the application.
(5) If the application is refused, the APVMA
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).
Division 6—Reconsideration of listed registration
56V
APVMA may invite the public to propose registered listed chemical products for
reconsideration
(1) The APVMA 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
APVMA might reconsider.
(2) A notice under subsection (1) must
state the criteria that are to be taken into account by the APVMA 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.
56W
APVMA may reconsider listed registration
The APVMA may at any time, in accordance
with this Division, reconsider the listed registration of a chemical product.
56X
APVMA may give notice of proposed reconsideration
(1) Before reconsidering the listed
registration of a chemical product, the APVMA 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 APVMA 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 APVMA
as to whether the listed registration complies with the prescribed requirements
for continued listed registration.
(2) The APVMA 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 APVMA:
(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 APVMA 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).
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).
Note: For strict liability, see
section 6.1 of the Criminal Code.
(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 APVMA under section 56ZG to cancel the listed
registration of the product and the APVMA complies with the request.
(6) The APVMA 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).
56Y
APVMA may require trials or laboratory experiments to be conducted
(1) The APVMA 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
APVMA 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 APVMA.
(2) A person must comply with a requirement
made of the person under subsection (1).
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).
Note: For strict liability, see
section 6.1 of the Criminal Code.
(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 APVMA under section 56ZG to cancel the listed
registration of the product and the APVMA complies with the request.
(5) This section does not affect the APVMA’s
powers under section 159.
56Z
Reconsideration by APVMA of continued listed registration
(1) If the APVMA 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 APVMA for the product; and
(d) any other prescribed requirements
for the continued listed registration would be complied with;
the APVMA must as soon as practicable:
(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
(f) if it caused a notice to be
published under subsection 56X(1) in relation to its proposed reconsideration
of the listed registration—cause 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 APVMA must have regard to the matters referred to in
subsection 56E(2).
(3) If the APVMA is not satisfied as
mentioned in subsection (1), subsections (4) to (6) apply.
(4) The APVMA must give written notice to the
interested person or to an approved person stating that the APVMA is not so
satisfied.
(5) If the APVMA 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 APVMA 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 APVMA must:
(i) state in the notice
referred to in subsection (4) that, although the APVMA 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 APVMA’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 APVMA is not
satisfied that the conditions of the listed registration can be varied as
mentioned in subsection (5).
Division 7—Suspension or cancellation of listed registration
56ZA
Notice of proposed suspension or cancellation to be given to co‑ordinators
The APVMA 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 APVMA 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 APVMA may
suspend or cancel the listed registration.
56ZC
Suspension of listed registration for failing to give information, or results
of trials or experiments, to APVMA
(1) If:
(a) at the end of the period stated in
a notice given to a person under subsection 56X(2), the APVMA 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 APVMA; or
(b) at the end of the period stated in
a notice given to a person under subsection 56Y(1), the APVMA 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
APVMA;
the APVMA may suspend the listed registration.
(2) Subject to subsection (4), the APVMA
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.
(3) Subject to subsection (4), the APVMA
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 APVMA within a period after the
suspension takes place that the APVMA thinks reasonable, the APVMA may cancel
the listed registration.
56ZD
Suspension of listed registration for failing to give information, report or
sample to APVMA
(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 APVMA may suspend the listed registration.
(2) Subject to subsection (3), the APVMA
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 APVMA within a reasonable period after the suspension takes
place, the APVMA 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 APVMA 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 APVMA may suspend or cancel the listed
registration.
56ZF
Suspension or cancellation of listed registration for non‑compliance with
criteria
(1) The APVMA may suspend or cancel the
listed registration of a chemical product if it appears to the APVMA 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 APVMA may suspend or cancel the
listed registration of a chemical product if it appears to the APVMA 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 APVMA for
the product.
56ZG
Cancellation of listed registration on request
(1) If:
(a) the interested person in relation
to a listed registration, or an approved person, gives to the APVMA a written
notice:
(i) requesting the APVMA
to cancel the listed registration; and
(ii) stating the reasons
for the request; and
(b) the APVMA is satisfied that there
are no valid reasons why it should not agree to the request;
the APVMA must cancel the listed registration.
(2) The APVMA must give written notice of its
decision on a request under subsection (1) to the person or persons who
made the request.
56ZH
Effect of suspension of 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.
56ZI
How listed registration is suspended or cancelled
(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 suspension—the
period of the suspension; and
(c) the date on which the entry is
made.
(2) Subject to subsection (4), if the
APVMA 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 APVMA thinks desirable;
excluding any matters that the
APVMA 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 APVMA revokes the suspension
or cancellation; or
(c) the APVMA, by notice published in
the Gazette, declares that this subsection ceases to apply in respect of
the product;
whichever first occurs.
(7) Subject to subsection (9), if:
(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.
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.
Note: For strict liability, see
section 6.1 of the Criminal Code.
(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.
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 APVMA 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.
Division 8—Duration and renewal of listed registration
56ZK
Period of listed registration
(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
APVMA 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 APVMA may
accept a late application if the application is made on or before a date that
the APVMA 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 APVMA 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 APVMA.
(2) The APVMA 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 APVMA written notice of the withdrawal signed by
an approved person.
(4) Subject to subsection (5), the APVMA
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.
(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 APVMA in respect of the product under any law in force
in any jurisdiction has not been paid, the APVMA may refuse to grant the
application for renewal.
(6) If the application was made in accordance
with subsection 56ZL(2) and the APVMA fails to grant the application before the
listed registration ends, the listed registration continues in force until:
(a) the APVMA grants the application;
or
(b) if the APVMA decides to refuse to
grant the application because of non‑payment of an amount as mentioned in
subsection (5)—the APVMA gives written notice of its decision to the
applicant.
(7) If the APVMA 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.
56ZN
Renewal of listed registration of chemical product
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 9—Publication of notices and certain other instruments by APVMA
56ZO
Publication of notice of listed registration of chemical product
(1) If the APVMA 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 APVMA 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 APVMA 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 APVMA 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 APVMA 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 APVMA 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 APVMA thinks desirable; and
(e) setting out the date on which the
listed registration ended; and
(f) containing any other information
that the APVMA thinks appropriate;
unless the APVMA thinks that, in the circumstances, it is
unnecessary to publish such a notice.
(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:
(a) 2 years after the day on which the
registration ends; or
(b) the APVMA, by notice published in
the Gazette, declares that this subsection ceases to apply in respect of
the product;
whichever first occurs.
(3) Subject to subsection (5), if:
(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.
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.
Note: For strict liability, see
section 6.1 of the Criminal Code.
(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.
(6) If a notice stating that the listed
registration of a chemical product has ended is published under this section,
the APVMA must cause a copy of the notice to be given to any person who, in the
opinion of the APVMA, 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 APVMA 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 APVMA for the product;
the notice must contain the following:
(e) a statement to that effect;
(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 APVMA 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 APVMA revokes the suspension
or cancellation; or
(c) the APVMA, by notice published in
the Gazette, declares that this subsection ceases to apply in respect of
the product;
whichever first occurs.
(4) Subject to subsection (6), if:
(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.
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.
Note: For strict liability, see
section 6.1 of the Criminal Code.
(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.
(7) If the APVMA causes a notice of the
suspension or cancellation of the listed registration of a chemical product to
be published under this section, the APVMA must cause a copy of the notice to
be given to any person who, in the opinion of the APVMA, 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 APVMA 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 APVMA, by notice published in
the Gazette, declares that this section ceases to apply in respect of
the product;
whichever first occurs.
Part 2B—Reserved chemical products
56ZU
Regulations may contain schedule of reserved chemical products
(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 APVMA; and
(b) the APVMA 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 APVMA proposes the product, or products in the class, should be
subject; and
(c) the APVMA must have given to the
Minister a written explanation as to why the APVMA 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 APVMA for the product; and
(d) the APVMA must have given to the
Minister a written statement identifying the consultations held by, and setting
out the advice given to, the APVMA in relation to the proposed reservation of
the products or class of products.
Part 3—Compensation for provider of certain information in respect
of continued registration of certain chemical products
Division 1—Preliminary
57
Explanation of Part
(1) This Part contains provisions that
entitle a person who has provided protected information to the APVMA in
relation to a protected active constituent or in relation to a protected
chemical product, in compliance with a requirement made of the person by the
APVMA, to receive compensation from anyone else who wishes the information to
be used by the APVMA in connection with an application for the approval, or
continued approval, of another active constituent or the registration, or
continued registration, of another chemical product.
(2) Compensation is not payable in respect of
the information unless:
(a) the protected active constituent
or the protected chemical product is or includes a patentable invention and the
term of the patent has ended or is about to end; and
(b) the information was obtained from
trials or laboratory experiments and relates to the interaction between the
constituent or product and:
(i) the environment; or
(ii) living organisms or
naturally occurring populations in ecosystems, including human beings;
and is not information that was obtained merely for the
purpose of assessing the performance of the constituent or product.
(3) Compensation is not payable in respect of
information if the constituent or product is for use only in relation to a
species of animals that is not a food‑producing species.
(4) The parties concerned are invited to
negotiate the terms of the compensation and provision is made for the
appointment of a mediator if the parties are unable to agree and for the terms
to be arbitrated if the mediation is unsuccessful. If an arbitration takes
place, the arbitrator is to base his or her decision on whichever of the
proposals put forward by the parties is considered by the arbitrator to be the
most reasonable assessment of the proportion of the cost of producing the
information that it is fair for the party wishing to use it to pay to the party
who provided it.
Division 2—Right to compensation
58
Right of APVMA to use information
(1) Except as provided in section 14B,
Division 4A of Part 2 and this Part, the APVMA may use information
obtained by it from any source for the purpose of performing any of its
functions or exercising any of its powers under this Code.
(2) This Part does not affect the operation
of section 169.
59
Right of originator of protected information to compensation for its use in
relation to other applications
(1) Subject to subsections (1A) and (2),
if, in compliance with a requirement that the APVMA:
(a) has made under paragraph 32(2)(b)
or section 33; or
(b) has made under section 159
for the purposes of paragraph 159(1)(c) or (d);
protected information has been given to the APVMA in
relation to:
(c) a protected active constituent for
a proposed or existing chemical product (the primary active constituent);
or
(d) a protected chemical product (the primary
chemical product);
the APVMA must not use the information in determining
whether to approve, or to continue the approval of, another active constituent
for a proposed or existing chemical product (the secondary active
constituent), or whether to register, or to continue the registration
of, another chemical product (the secondary chemical product).
(1A) Subsection (1) does not apply if the
information is the same as information previously given to the APVMA otherwise
than in compliance with a requirement referred to in that subsection.
(2) Subsection (1) does not apply if:
(a) the primary applicant and the
secondary applicant:
(i) have agreed as to the
terms of the compensation to be paid by the secondary applicant to the primary
applicant for the information to be used in relation to the secondary active
constituent or the secondary chemical product, as the case may be; and
(ii) have notified the
APVMA in writing that they have so agreed and of the terms of the compensation;
or
(b) an arbitrator that the APVMA has
appointed has determined the compensation to be so paid and the secondary
applicant has given notice to the primary applicant and to the APVMA stating
that the secondary applicant agrees to comply with the determination; or
(c) the protection period has elapsed
since that information was given to the APVMA; or
(d) the APVMA is satisfied, having
regard to such criteria (if any) as are prescribed, that it is in the public
interest for the information to be so used.
(3) If the APVMA decides to use the
information under paragraph (2)(d), the APVMA:
(a) must give written notice of its
decision to the primary applicant and the secondary applicant; and
(b) must not make a determination
using the information before the end of 28 days after the day on which the
notice is given.
(4) Section 168 provides for additional
matters to be included in a notice given under paragraph (3)(a).
(5) Without affecting the duty of the APVMA
to comply with subsection (1):
(a) the validity of any approval, or
continued approval, of the secondary active constituent or the validity of any
registration, or continued registration, of the secondary chemical product is
not affected by a contravention by the APVMA of that subsection or by the
failure of the secondary applicant to comply with the agreement or
determination; and
(b) no action or other proceeding lies
against the Commonwealth, the APVMA, or a person who is or has been a delegate
of the APVMA, a director of the APVMA, the Chief Executive Officer of the
APVMA, or a member of the staff of the APVMA, for any loss directly or
indirectly sustained because of such a contravention or failure.
60
APVMA to notify applicants
(1) This
section applies if:
(a) the APVMA is unable to complete
its consideration of:
(i) the approval or
continued approval of an active constituent for a proposed or existing chemical
product; or
(ii) the registration or
continued registration of a secondary chemical product;
under this Code unless it uses
protected information; and
(b) paragraph 59(2)(c) does not permit
the APVMA to use the information.
(2) The APVMA must give to the secondary
applicant written notice:
(a) stating that the APVMA’s
consideration of:
(i) the approval or continued
approval of the secondary active constituent; or
(ii) the registration or
continued registration of the secondary chemical product;
cannot be completed unless the
APVMA uses the information; and
(b) stating that the APVMA is
precluded from using the information except in circumstances prescribed by
paragraph 59(2)(a), (b) or (d) and setting out those circumstances; and
(c) requesting the secondary applicant
to tell the APVMA, within a reasonable period stated in the notice, whether the
secondary applicant wants the APVMA to take further action in respect of the
information under this section.
(3) If the secondary applicant tells the
APVMA that it wants the APVMA to take further action in respect of the
information under this section, the APVMA must give to the primary applicant or
each primary applicant and to the secondary applicant written notice:
(a) containing:
(i) in respect of the
notice to a primary applicant—the prescribed information about the secondary
applicant and about the secondary active constituent or the secondary chemical
product, as the case may be; or
(ii) in respect of the
notice to the secondary applicant—the prescribed information about the primary
applicant and about the primary active constituent or the primary chemical product,
or about each primary applicant and about each primary active constituent or
primary chemical product, as the case may be; and
(b) stating that the APVMA’s
consideration of the approval or continued approval of the secondary active
constituent, or of the registration or continued registration of the secondary
chemical product, cannot be completed unless the APVMA uses protected
information given by a primary applicant but the APVMA is precluded from using
that information except in circumstances prescribed by paragraph 59(2)(a), (b)
or (d) and setting out those circumstances; and
(c) inviting the primary applicant or
each primary applicant, and the secondary applicant, within a period stated in
the notice, to negotiate as to the terms of the compensation to be paid by the
secondary applicant to that primary applicant for the use of that information
and to give written notice to the APVMA of the results of the negotiation; and
(d) telling them that, if they are
unable to agree as to the terms of the compensation:
(i) a mediator will be
appointed to try to help them to reach agreement; and
(ii) if the mediation is
not successful, an arbitrator will be appointed to determine those terms in
accordance with any reasonable proposals made in the course of the negotiations
(including negotiations during the period of the mediation); and
(iii) if the arbitrator
finds that no reasonable proposals were made, the APVMA may suspend the
approval of the primary active constituent or the registration of the primary
chemical product (as the case may be), or the approval of the secondary active
constituent or the registration of the secondary chemical product (as the case
may be), or both; and
(e) telling them of the obligations
imposed on the primary applicant or each primary applicant under section 61.
61
Primary applicant to notify secondary applicant
(1) As soon as practicable after a primary
applicant receives a notice under section 60, the primary applicant must
give written notice to the secondary applicant setting out the following:
(a) the amount of the cost incurred by
the primary applicant in obtaining the protected information excluding any part
of that cost that relates to information that was obtained from a Government or
public authority, whether in Australia or elsewhere, or was otherwise publicly
available;
(b) particulars of the amounts
included in that cost as mentioned in subsection 69(3);
(c) when the protected information was
obtained by the primary applicant;
(d) when the APVMA required the
primary applicant to give the protected information to the APVMA;
(e) any
other information required by the regulations.
Penalty: 300 penalty units.
(2) An offence under subsection (1) is
an offence of strict liability.
Note: For strict liability, see section 6.1 of
the Criminal Code.
Division 3—Mediation or arbitration as to terms of compensation
62
Application of Division
(1) This Division applies if:
(a) there is only one primary
applicant and the primary applicant is unable to agree with the secondary
applicant as to the terms of the compensation to be paid by the secondary
applicant to the primary applicant; or
(b) there are 2 or more primary
applicants and none of them is able to agree with the secondary applicant as to
the terms of the compensation to be paid by the secondary applicant to the
primary applicant concerned;
and the secondary applicant has notified the APVMA in
writing of the failure to reach agreement.
(2) If the secondary applicant tells the
APVMA at any time during the course of any negotiations, mediation or
arbitration under this Division that the secondary applicant no longer wants
any further action to be taken under this Division for the purposes of the
secondary application, this Division ceases to apply in relation to that
application.
63
Mediation
(1) The APVMA must appoint a person as a
mediator to try to help the parties to the negotiations to reach agreement as
to the terms of the compensation.
(2) The mediation ceases:
(a) if the parties reach agreement as
to those terms; or
(b) the mediator or either party to
the mediation tells the APVMA that the mediation has not been successful; or
(c) 14 days have elapsed since the
appointment of the mediator.
(3) If, before the mediation ceases, the
person appointed as the mediator:
(a) dies; or
(b) becomes incapable of performing,
or continuing to perform, his or her functions; or
(c) resigns his or her appointment; or
(d) for any other reason refuses or
fails to perform, or to complete the performance of, his or her functions as
required by this section;
the APVMA may appoint another person as mediator in place
of the first‑mentioned person.
(4) If another mediator is appointed under subsection (3),
the period of 14 days referred to in paragraph (2)(c) is taken to have
begun from the appointment of the first mediator but that period does not
include any period after the occurrence of an event referred to in subsection (3)
and before the appointment of the other mediator.
64
Appointment of arbitrator
(1) If the mediation has ceased without the
parties having reached agreement as to the terms of the compensation, the APVMA
must appoint a person as an arbitrator to determine those terms in accordance
with any reasonable proposals that were made in the course of the negotiations
(including negotiations during the period of the mediation).
(2) If, before the functions of an arbitrator
appointed under this section (including this subsection) are fully performed,
the person appointed as the arbitrator:
(a) dies; or
(b) becomes incapable of performing,
or continuing to perform, his or her functions; or
(c) resigns his or her appointment; or
(d) for any other reason refuses or
fails to perform, or to complete the performance of, his or her functions as
required by this section;
the APVMA may appoint another person as arbitrator in
place of the first‑mentioned person.
65
Determination of compensation on the basis of proposals made during
negotiations
(1) The arbitrator must consider the
proposals as to the terms of the compensation that were made by the parties to
the negotiations or each of the negotiations.
(2) If a party to any negotiations made a
proposal as to the terms of the compensation that the arbitrator considers to
be reasonable and the other party failed to make any proposal as to those terms
or failed to make a proposal that the arbitrator considers to be reasonable,
the arbitrator must determine those terms in accordance with the first‑mentioned
proposal.
(3) If each party to any negotiations made
proposals as to the terms of the compensation that the arbitrator considers to
be reasonable, the arbitrator must determine those terms in accordance with
whichever of those proposals the arbitrator considers to be the most
reasonable.
66
Arbitrator may require fresh proposals
If each party to any negotiations failed
to make any proposal as to the terms of the compensation or failed to make a
proposal as to those terms that the arbitrator considers to be reasonable, the
arbitrator must give written notice to each of them requiring them to make
fresh proposals to the arbitrator as to the terms of the compensation.
67
Determination on basis of fresh proposals
(1) If a party to an arbitration makes a
fresh proposal as to the terms of the compensation that the arbitrator
considers to be reasonable and the other party fails to make any fresh proposal
as to those terms or fails to make a fresh proposal that the arbitrator
considers to be reasonable, the arbitrator must determine those terms in
accordance with the first‑mentioned proposal.
(2) If each party to an arbitration makes
fresh proposals as to the terms of the compensation that the arbitrator
considers to be reasonable, the arbitrator must determine those terms in
accordance with whichever of those proposals the arbitrator considers to be the
most reasonable.
68
What happens if fresh proposals are not made or are inadequate
If each party to an arbitration fails,
within a reasonable period, to make a fresh proposal as to the terms of the
compensation or to make a fresh proposal as to those terms that the arbitrator
considers to be reasonable, the arbitrator must give written notice of the
failure to the APVMA and, upon the giving of the notice, section 39
permits the APVMA to suspend the registration of the primary product or any of
the primary products or of the secondary product, or both or all of them.
69
What constitutes a reasonable proposal for compensation
(1) A proposal as to the terms of the
compensation is taken to be reasonable if, and only if, the arbitrator is
satisfied that:
(a) it provides for an amount or
amounts to be paid by the secondary applicant to a primary applicant; and
(b) the amount or amounts represent a
fair proportion of:
(i) the amount of the cost
incurred by that primary applicant in obtaining the protected information
excluding any part of that cost that relates to information that was obtained
from a Government or public authority, whether in Australia or elsewhere, or
was otherwise publicly available; or
(ii) if the protected
information was obtained by that primary applicant before the APVMA required
that applicant to give that information to the APVMA—a lesser amount than the
amount worked out under subparagraph (i) that is appropriate having regard
to the period between the time when that information was so obtained and the
time when it was given to the APVMA.
(2) The question as to what is a fair
proportion of an amount referred to in subparagraph (1)(b)(i) or (ii) is
to be determined by the arbitrator having regard to any matters that are
prescribed by the regulations and any other matters that he or she considers
appropriate.
(3) For the purposes of subsection (1),
the amount of the cost incurred by a primary applicant in obtaining protected
information comprises:
(a) all relevant costs incurred by
that primary applicant in obtaining that information (taking into account the
practices generally engaged in by persons conducting tests or laboratory
experiments of the kinds used to obtain information of the kind concerned) and
including, without limiting the above:
(i) the direct and
indirect costs of planning, conducting, and analysing the results of, tests and
laboratory experiments and giving the information to the APVMA; and
(ii) the cost of repeating,
or redoing with modifications, tests or laboratory experiments if it was
appropriate to repeat or redo them; and
(iii) if the tests or
laboratory experiments were conducted by the use of equipment of that primary
applicant—depreciation on that equipment; and
(iv) any other prescribed
costs; and
(b) a reasonable rate of interest on
the amount worked out under paragraph (a).
(4) The reference in paragraph (3)(a) to
all relevant costs incurred by a primary applicant includes, if the primary
applicant is a body corporate, an appropriate portion of any relevant costs
incurred by another body corporate that is related to the primary applicant.
(5) The question whether 2 bodies corporate
are related to each other is to be determined in the same way as for the
purposes of the Corporations Act 2001.
70
Effect and enforcement of determination by arbitrator
(1) If the arbitrator makes a determination
or determinations as to the terms of the compensation to be paid by the
secondary applicant to a primary applicant or primary applicants, the following
provisions apply.
(2) The
arbitrator must:
(a) send the determination, or each
determination, to the APVMA; and
(b) give to the primary applicant and
secondary applicant to whom a determination relates a copy of the determination
certified by the arbitrator to be a true copy.
(3) If there is only one such determination
and the secondary applicant gives written notice to the primary applicant
stating that the secondary applicant agrees to comply with the determination,
the secondary applicant is liable to pay compensation to the primary applicant
in accordance with the determination.
(4) If there are 2 or more such
determinations and the secondary applicant gives written notice to the primary
applicant to whom one of those determinations relates stating that the
secondary applicant agrees to comply with that determination, the secondary
applicant is liable to pay compensation to that primary applicant in accordance
with that determination.
(5) If the secondary applicant to whom a determination
relates gives notice under subsection (3) or (4) to the primary applicant
to whom that determination relates, that secondary applicant must give a copy
of the notice to the APVMA.
Penalty: 10 penalty units.
(5A) Subsection (5) does not apply if the
secondary applicant has a reasonable excuse.
Note: The defendant bears an evidential burden in
relation to the matter in subsection (5A). See subsection 13.3(3) of the Criminal
Code.
(5B) An offence under subsection (5) is an
offence of strict liability.
Note: For strict liability, see section 6.1 of
the Criminal Code.
(6) If a primary applicant to whom a
determination by the arbitrator relates receives a notice under subsection (3)
or (4) by the secondary applicant to whom that determination relates, that
primary applicant may lodge a copy of the determination certified by the
arbitrator, together with the notice, with a court having jurisdiction to the
extent of the total amount of compensation payable under the determination and,
when the determination and application have been so lodged, the determination
may be enforced as a final judgment of that court.
71
Regulations to govern conduct of arbitration
(1) The regulations may make rules governing
the conduct of an arbitration under this section.
(2) The regulations may provide that rules so
made apply to the exclusion of any law of this jurisdiction relating to the
conduct of commercial arbitrations.
Part 4—Control of chemical products
Division 1—Preliminary
72
Explanation of Part
(1) This Part regulates the supply of active
constituents for chemical products and the supply of chemical products.
(2) The Part restricts:
(a) the possession of unapproved
constituents and unregistered products for the purpose of supplying them; and
(b) the supply of unapproved
constituents or unregistered products; and
(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.
(3) Section 73 contains special
provisions relating to the application of this Part to veterinary surgeons.
(4) Division 2 contains provisions
relating to active constituents or chemical products generally.
(5) Division 3 contains special
provisions relating to the manufacture and supply of date‑controlled
chemical products.
(6) Division 4 relates to the supply of
certain restricted chemical products.
73
Part not to apply to veterinary surgeons acting under other laws
(1) This Part does not apply to a veterinary
surgeon, or a person acting under the instructions of a veterinary surgeon, in
respect of any thing done or omitted to be done by him or her if the doing of,
or the omitting to do, that thing is permitted by or under a law of this
jurisdiction other than the Agvet Code of this jurisdiction.
(2) Nothing in this Part affects the
application to a veterinary surgeon of any other law of this jurisdiction.
Division 2—Control generally
74
Possession or custody of unapproved active constituents with the intention of
supply
(1) A person must not at any time (the relevant
time) have in the person’s possession or custody with the intention of
supply a substance that is likely to be used as an active constituent for a
chemical product unless:
(a) the substance is an approved
active constituent for a proposed or existing chemical product; or
(b) the substance is exempted by the
APVMA from the operation of this section; or
(c) the possession or custody is
authorised by a permit; or
(d) all the following subparagraphs
apply:
(i) the constituent had,
at a time or times before the relevant time, been approved under this Code or a
corresponding previous law;
(ii) the period beginning
on the day when the constituent ceased, or last ceased, to be so approved and
ending at the relevant time is not longer than a period that the APVMA has
determined in relation to the constituent for the purposes of this
subparagraph;
(iii) if the approval of the
constituent was subject to conditions—the possession or custody is in
accordance with those conditions.
Penalty: 200 penalty units.
Note: The defendant bears an evidential burden in
relation to the matters in paragraphs (1)(a) to (d). See subsection
13.3(3) of the Criminal Code.
(2) The APVMA may, on its own initiative or
on the application of a person, extend a period determined by it under subparagraph (1)(d)(ii)
for a further period or periods determined by it.
(3) It is a defence to a prosecution of a
person for an offence against subsection (1) if the person proves that at
the relevant time the person did not know, and could not reasonably be expected
to have known, that the substance was not an approved active constituent.
Note: The defendant bears a legal burden in relation
to the matter in subsection (3). See section 13.4 of the Criminal
Code.
(4) If an application is made to the APVMA
under subsection (2), the APVMA must give to the applicant written notice
of its decision on the application.
(5) Section 168 provides for additional
matters to be included in a notice given under subsection (4).
75
Possession or custody of chemical products, other than registered, registered
listed or reserved products, with the intention of supply
(1) A person must not at any time (the relevant
time) have in the person’s possession or custody with the intention of
supply a chemical product that is not a registered chemical product, a
registered listed chemical product or a reserved chemical product unless:
(a) the possession or custody is
authorised by a permit; or
(b) the product is exempted by the
APVMA from the operation of this section; or
(c) all the following subparagraphs
apply:
(i) the product had, at a
time or times before the relevant time, been registered under this Code or a
corresponding previous law;
(ii) the period beginning
on the day when the product ceased, or last ceased, to be so registered and
ending at the relevant time is not longer than a period that the APVMA has
determined in relation to the product for the purposes of this subparagraph;
(iii) a recall notice has
not been issued in respect of the product;
(iv) if the registration of
the product was subject to conditions—the possession or custody is in
accordance with those conditions.
Penalty: 200 penalty units.
Note: The defendant bears an evidential burden in
relation to the matters in paragraphs (1)(a) to (c). See subsection
13.3(3) of the Criminal Code.
(2) The APVMA may, on its own initiative or
on the application of a person, extend a period determined by it under subparagraph (1)(c)(ii)
for a further period or periods determined by it.
(3) It is a defence to a prosecution of a
person for an offence against subsection (1) if the person proves that at
the relevant time the person did not know, and could not reasonably be expected
to have known, that the chemical product was not a registered chemical product,
a registered listed chemical product or a reserved chemical product.
Note: The defendant bears a legal burden in relation
to the matter in subsection (3). See section 13.4 of the Criminal
Code.
(4) If an application is made to the APVMA
under subsection (2), the APVMA must give to the applicant written notice
of its decision on the application.
(5) Section 168 provides for additional
matters to be included in a notice given under subsection (4).
76
Supply of unapproved active constituents
(1) A person must not supply, or cause or
permit to be supplied, an active constituent for a proposed or existing
chemical product that is not an approved active constituent unless:
(a) the constituent is exempted by the
APVMA from the operation of this section; or
(b) the supply is authorised by a
permit; or
(c) all the following subparagraphs
apply:
(i) the constituent had,
at a time or times before the supply takes place, been approved under this Code
or a corresponding previous law;
(ii) the period beginning
on the day when the constituent ceased, or last ceased, to be so approved and
ending on the day when the supply takes place is not longer than a period that
the APVMA has determined in relation to the constituent for the purposes of
this subparagraph;
(iii) the supply is a supply
of part of a stock of the constituent that was in the person’s possession or
custody immediately before the product so ceased, or last ceased, to be
approved;
(iv) if the approval of the
constituent was subject to conditions—the supply is in accordance with those
conditions.
Penalty: 300 penalty units.
Note: The defendant bears an evidential burden in
relation to the matters in paragraphs (1)(a) to (c). See subsection
13.3(3) of the Criminal Code.
(2) The APVMA may, on its own initiative or
on the application of a person, extend a period determined by it under subparagraph (1)(c)(ii)
for a further period or periods determined by it.
(3) It is a defence to a prosecution of a
person for an offence against subsection (1) if the person proves that,
when the person supplied the constituent, or caused or permitted the
constituent to be supplied, as the case may be, the person did not know, and
could not reasonably be expected to have known, that the active constituent was
not an approved active constituent.
Note: The defendant bears a legal burden in relation
to the matter in subsection (3). See section 13.4 of the Criminal
Code.
(4) If an application is made to the APVMA
under subsection (2), the APVMA must give to the applicant written notice
of its decision on the application.
(5) Section 168 provides for additional
matters to be included in a notice given under subsection (4).
77
Supply of approved active constituents in contravention of conditions of
approval
(1) A person must not supply, or cause or
permit to be supplied, an approved active constituent for a proposed or
existing chemical product whose approval is subject to conditions unless the
supply is in accordance with those conditions or is authorised by a permit.
Penalty: 300 penalty units.
Note: The defendant bears an evidential burden in
relation to establishing that the supply is in accordance with the conditions
or is authorised by a permit. See subsection 13.3(3) of the Criminal Code.
(2) It is a defence to a prosecution of a
person for an offence against subsection (1) if the person proves that,
when the person supplied the constituent, or caused or permitted the
constituent to be supplied, as the case may be, the person did not know, and
could not reasonably be expected to have known, that the approval of the
constituent was subject to the conditions referred to in that subsection.
Note: The defendant bears a legal burden in relation
to the matter in subsection (2). See section 13.4 of the Criminal
Code.
78
Supply of chemical products that are not registered products, registered listed
products or reserved products
(1) A person must not supply, or cause or
permit to be supplied, a chemical product that is not a registered chemical
product, a registered listed chemical product or a reserved chemical product
unless:
(a) the supply is authorised by a
permit; or
(b) the product is exempted by the
APVMA from the operation of this section; or
(c) all the following subparagraphs
apply:
(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;
(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 APVMA 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;
(iv) a recall notice has not
been given in respect of the product;
(v) the person is not the
person who imported the product into, or manufactured the product in, Australia;
(vi) if the registration or
listed registration of the product was subject to conditions—the supply is in
accordance with those conditions.
Penalty: 300 penalty units.
Note: The defendant bears an evidential burden in
relation to the matters in paragraphs (1)(a) to (c). See subsection
13.3(3) of the Criminal Code.
(2) The APVMA may, on its own initiative or
on the application of a person, extend a period determined by it under subparagraph (1)(c)(ii)
for a further period or periods determined by it.
(3) It is a defence to a prosecution of a
person for an offence against subsection (1) if the person proves that,
when the chemical product was supplied, or caused or permitted to be supplied,
as the case may be, the person did not know, and could not reasonably be
expected to have known, that the product was not a registered chemical product,
a registered listed chemical product or a reserved chemical product.
Note: The defendant bears a legal burden in relation
to the matter in subsection (3). See section 13.4 of the Criminal
Code.
(4) If an application is made to the APVMA
under subsection (2), the APVMA must give to the applicant written notice
of its decision on the application.
(5) Section 168 provides for additional
matters to be included in a notice given under subsection (4).
79
Supply of registered chemical products in contravention of conditions of
registration
(1) A person must not supply, or cause or
permit to be supplied, a registered chemical product whose registration is
subject to conditions unless the supply is in accordance with those conditions
or is authorised by a permit.
Penalty: 300 penalty units.
Note: The defendant bears an evidential burden in
relation to establishing that the supply is in accordance with the conditions
or is authorised by a permit. See subsection 13.3(3) of the Criminal Code.
(2) It is a defence to a prosecution of a
person for an offence against subsection (1) if the person proves that,
when the chemical product was supplied, or caused or permitted to be supplied,
as the case may be, the person did not know, and could not reasonably be
expected to have known, that the registration of the product was subject to the
conditions referred to in that subsection.
Note: The defendant bears a legal burden in relation
to the matter in subsection (2). See section 13.4 of the Criminal
Code.
79A
Supply of registered listed chemical products in contravention of conditions of
listed registration
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.
Penalty: 300 penalty units.
79B
Supply of reserved chemical products contrary to conditions specified in the
regulations
(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.
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.
Note: For strict liability, see
section 6.1 of the Criminal Code.
80
Supply of chemical products without a label
(1) A person must not supply, or cause or
permit to be supplied, a chemical product in a container that does not have a
label attached to it unless the supply is authorised by a permit.
Penalty: 300 penalty units.
Note: The defendant bears an evidential burden in
relation to establishing that the supply is authorised by a permit. See
subsection 13.3(3) of the Criminal Code.
(2) It is a defence to a prosecution of a
person for an offence against subsection (1) if the person proves that,
when the chemical product was supplied, or caused or permitted to be supplied,
as the case may be, in the container, the person did not know, and could not
reasonably be expected to have known, that the container did not have a label
attached to it.
Note: The defendant bears a legal burden in relation
to the matter in subsection (2). See section 13.4 of the Criminal
Code.
81
Supply of registered chemical products with unapproved label
(1) A person may only supply, or cause or
permit to be supplied, a registered chemical product in a container if:
(a) the label attached to the
container:
(i) states the relevant
particulars; and
(ii) does not contain
information that is contrary to the relevant particulars; or
(b) the supply is authorised by a
permit.
Penalty: 300 penalty units.
(2) It is a defence to a prosecution of a
person for an offence against subsection (1) if the person proves that,
when the chemical product was supplied, or caused or permitted to be supplied,
as the case may be, in the container, the person did not know, and could not
reasonably be expected to have known, that the label attached to the container:
(a) did not state the relevant
particulars; or
(b) contained information contrary to
the relevant particulars.
Note: The defendant bears a legal burden in relation
to the matter in subsection (2). See section 13.4 of the Criminal
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:
(a) the label attached to the
container states the relevant particulars that were required to be stated on 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 APVMA 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 APVMA allows) after the
earlier approved label ceased to be the approved label for containers for the
product.
82
Supply of chemical products in containers opened by inspector
(1) A person
must not supply, or cause or permit to be supplied, a chemical product in a
container that has been opened by an inspector under paragraph 131(1)(f).
Penalty: 300 penalty units.
(1A) Subsection (1) does not apply if the
person had the written consent of an inspector to engage in the conduct concerned.
Note: The defendant bears an evidential burden in
relation to the matter in subsection (1A). See subsection 13.3(3) of the Criminal
Code.
(2) It is a defence to a prosecution of a
person for an offence against subsection (1) if the person proves that,
when the chemical product was supplied, or caused or permitted to be supplied,
as the case may be, in the container, the person did not know, and could not
reasonably be expected to have known, that the container had been opened by an
inspector.
Note: The defendant bears a legal burden in relation
to the matter in subsection (2). See section 13.4 of the Criminal
Code.
(3) In subsection (1), strict liability
applies to the physical element of circumstance, that, in opening the
container, the inspector was acting under paragraph 131(1)(f).
Note: For strict liability, see section 6.1 of
the Criminal Code.
83
Supply of substances whose constituents differ from constituents of registered
chemical product
(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 chemical product
if:
(a) the constituents of the substance
or mixture differ by more than the prescribed extent from the constituents of
the registered chemical product that were shown in the particulars of the
registered chemical product contained in the Register of Chemical Products; or
(b) the concentration of the
constituents of the substance or mixture differs by more than the prescribed
extent from the concentration of the constituents of the registered 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 chemical product that was shown in those particulars.
Penalty: 300 penalty units.
(2) Subsection (1) does not apply if the
person has a reasonable excuse.
Note: The defendant bears an evidential burden in
relation to the matter in subsection (2). See subsection 13.3(3) of the Criminal
Code.
83A
Supply of substances whose constituents differ from constituents of registered
listed chemical product
(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.
Penalty: 300 penalty units.
(2) Subsection (1) does not apply if the
person has a reasonable excuse.
Note: The defendant bears an evidential burden in
relation to the matter in subsection (2). See subsection 13.3(3) of the Criminal
Code.
84
Claims inconsistent with labels
(1) A person must not make any claim, or
cause or permit any claim to be made, in respect of:
(a) a registered chemical product or
registered listed chemical product; or
(b) a chemical product that contains a
registered chemical product or registered listed chemical product;
that is inconsistent with any of the instructions on any
approved label for containers for the registered chemical product or
inconsistent with any instruction required by an established standard for the
registered listed chemical product to be included on a label for a container
for the registered listed chemical product, as the case may be.
Penalty: 300 penalty units.
(2) Subsection (1) does not apply to:
(a) a claim that is exempted by the
APVMA from the operation of this section; or
(b) a claim made in a notice published
under section 55; or
(c) a claim that is permitted to be
made under any other law of this jurisdiction.
(3) Subsection (1) does not apply to the
extent that the person is authorised by a permit to engage in the conduct
concerned.
Note: The defendant bears an evidential burden in
relation to the matter in subsection (3). See subsection 13.3(3) of the Criminal
Code.
(4) Subsection (1) does not apply if the
person has a reasonable excuse.
Note: The defendant bears an evidential burden in
relation to the matter in subsection (4). See subsection 13.3(3) of the Criminal
Code.
85
Modification of warning prohibited
(1) A person must not, in connection with the
supply of a chemical product, make a claim, or cause or permit a claim to be
made, in respect of the product that is inconsistent with the expiry date
required by the regulations to be contained on a label attached to a container
of the product.
Penalty: 300 penalty units.
(2) Subsection (1) does not apply to a
claim made in a notice published under section 55.
(3) Subsection (1) does not apply to the
extent that the person is authorised by a permit to engage in the conduct
concerned.
Note: The defendant bears an evidential burden in
relation to the matter in subsection (3). See subsection 13.3(3) of the Criminal
Code.
(4) Subsection (1) does not apply if the
person has a reasonable excuse.
Note: The defendant bears an evidential burden in
relation to the matter in subsection (4). See subsection 13.3(3) of the Criminal
Code.
(5) In subsection (1), strict liability
applies to the physical element of circumstance, that it is the regulations
that require an expiry date to be contained on a label attached to a container
of the product.
Note: For strict liability, see section 6.1 of
the Criminal Code.
86
Labels not to be detached etc.
(1) A person commits an offence if:
(a) either:
(i) a label attached to a
container of a chemical product contains any relevant particular identical to
any relevant particular contained on an approved label for containers for the
product; or
(ii) a label attached to a
container of a chemical product contains any relevant particular identical to
any matter required by an established standard for the product to be included
on a label for containers for the product; and
(b) the
person:
(i) detaches
or otherwise removes the label; or
(ii) alters, defaces,
obliterates or destroys the relevant particular; or
(iii) attaches another label
to, or endorses anything upon, the container that in either case has the effect
of expressly or impliedly negating, varying, or in any way detracting from,
qualifying or minimising the purport or effect of, the relevant particular.
Penalty: 300 penalty units.
(2) A person commits an offence if:
(a) either:
(i) a label attached to a
container of a chemical product contains any relevant particular identical to
any relevant particular contained on an approved label for containers for the
product; or
(ii) a label attached to a
container of a chemical product contains any relevant particular identical to
any matter required by an established standard for the product to be included
on a label for containers for the product; and
(b) the person causes or permits:
(i) the label to be
detached or otherwise removed; or
(ii) the relevant particular
contained on the label to be altered, defaced, obliterated or destroyed; or
(iii) another label to be
attached to the container that has the effect of expressly or impliedly
negating, varying, or in any way detracting from, qualifying or minimising the
purport or effect of, the relevant particular; or
(iv) anything to be endorsed
upon the container that has the effect of expressly or impliedly negating,
varying, or in any way detracting from, qualifying or minimising the purport or
effect of, the relevant particular.
Penalty: 300 penalty units.
(3) Subparagraphs (1)(b)(ii) and
(2)(b)(ii) do not apply to an alteration, defacing, obliteration or destruction
of a relevant particular that is done by the destruction or disposal of the
chemical product without otherwise contravening this Code.
(4) Subsections (1) and (2) do not apply
if the person has a reasonable excuse.
Note: The defendant bears an evidential burden in
relation to the matter in subsection (4). See subsection 13.3(3) of the Criminal
Code.
87
Chemical product to conform to standard
(1) This section applies to a chemical
product (other than a listable chemical product) if:
(a) a standard is prescribed in
respect of the product or in respect of a constituent contained in the product;
and
(b) the product is prescribed for the
purposes of this section.
(2) A person must not supply the product, or
cause or permit the product to be supplied, unless:
(a) if a standard is prescribed in
respect of the product—the product conforms to the standard; or
(b) if a standard is prescribed in
respect of a constituent contained in the product—the constituent contained in
the product conforms to the standard.
Penalty: 300 penalty units.
(3) Subsection (2) does not apply to the
extent that the conduct is authorised by a permit.
Note: The defendant bears an evidential burden in
relation to the matter in subsection (3). See subsection 13.3(3) of the Criminal
Code.
(4) Subsection (2) does not apply if the
person has a reasonable excuse.
Note: The defendant bears an evidential burden in
relation to the matter in subsection (4). See subsection 13.3(3) of the Criminal
Code.
87A
Supply of registered listed chemical product that does not conform to
established standard
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.
Penalty: 300 penalty units.
88
Certain notices not to be published
(1) In this section:
chemical product does not include a reserved
chemical product.
notice includes a circular and an
advertisement.
publish, means publish by any means,
including in a newspaper or periodical, by broadcasting or televising, in a
cinematograph film or in a video recording.
(2) A person must not publish, or cause or
permit to be published, a notice that offers to sell, or invites the making of
offers to buy:
(a) an active constituent for a
proposed or existing chemical product if the constituent is not an approved
active constituent; or
(b) a chemical product that is neither
a registered chemical product nor a registered listed chemical product;
unless:
(c) an application has been made for
approval of the constituent or registration or listed registration of the
product, as the case may be; and
(d) the notice states:
(i) that the constituent
is not an approved active constituent or the product is neither a registered
chemical product nor a registered listed chemical product, as the case may be;
and
(ii) that such an
application has been made.
Penalty: 30 penalty units.
Note: The defendant bears an evidential burden in
relation to the matters in paragraphs (2)(c) and (d). See subsection
13.3(3) of the Criminal Code.
(3) It is a defence to a prosecution of a
person for an offence against subsection (2) if the defendant proves that,
when the notice was published, or caused or permitted to be published, as the
case may be, the defendant did not know, and could not reasonably be expected
to have known, that:
(a) if paragraph (2)(a)
applies—the constituent was not an approved active constituent; or
(b) if paragraph (2)(b)
applies—the product was neither a registered chemical product nor a registered
listed chemical product.
Note: The defendant bears a legal burden in relation
to the matter in subsection (3). See section 13.4 of the Criminal
Code.
89
Certain statements prohibited
(1) A person must not do, or cause or permit
to be done, any of the following:
(a) publish or communicate any false
or misleading information about a chemical product;
(b) expressly or impliedly claim that
the APVMA recommends the use of a chemical product;
(c) expressly or impliedly claim that
the APVMA guarantees, warrants or assures the safety or efficacy of a chemical
product;
(d) expressly or impliedly claim that
the use of a chemical product is recommended:
(i) by the Commonwealth, a
State or a Territory; or
(ii) by an authority of the
Commonwealth, a State or a Territory; or
(iii) by an officer or
employee of, or of an authority of, the Commonwealth, a State or a Territory;
(e) expressly or impliedly make a
claim (however the claim is stated), without any qualification, or with a
qualification that, in the APVMA’s opinion, is unjustified, to the effect that
a chemical product is natural, organic, safe, harmless, non‑toxic, non‑poisonous,
non‑injurious or environment‑friendly;
(f) expressly or impliedly claim that
a chemical product has particular qualities if those qualities are prescribed
by the regulations for the purposes of this paragraph.
Penalty: 30 penalty units.
(2) Paragraph (1)(d)
does not apply:
(a) to an officer or employee of, or
of an authority of, the Commonwealth, a State or a Territory when, in the
course of his or her employment as such an officer or employee, he or she
expressly or impliedly claims that a chemical product is recommended; or
(b) to a prescribed person when, in prescribed
circumstances, the person expressly or impliedly claims that a chemical product
is recommended.
(3) Subsection (1) does not prevent a
person from making statements about a chemical product in circumstances
prescribed by the regulations or from reporting statements so made.
(4) Paragraph (1)(b) or (c) does not
apply in relation to a claim as to a recommendation, guarantee, warrant or
assurance by the APVMA if a document issued to the public by the APVMA contains
such a recommendation, guarantee, warrant or assurance and the APVMA did not,
before the claim was made, publicly withdraw or revoke the recommendation,
guarantee, warrant or assurance.
(5) Paragraph (1)(d) does not apply in
relation to a claim as to a recommendation by, or by an authority of, the
Commonwealth, a State or a Territory, or by an officer or employee of the
Commonwealth, a State, a Territory or such an authority, if a document issued
to the public by the Commonwealth, the State, the Territory or the authority,
as the case may be, contains such a recommendation and the Commonwealth, State,
Territory or authority did not, before the claim was made, publicly withdraw or
revoke the recommendation.
(6) Subsection (1) does not apply if the
person has a reasonable excuse.
Note: The defendant bears an evidential burden in
relation to the matter in subsection (6). See subsection 13.3(3) of the Criminal
Code.
(7) In paragraph (1)(f), strict
liability applies to the physical element of circumstance, that the particular
qualities concerned were prescribed by the regulations for the purposes of that
paragraph.
Note: For strict liability, see section 6.1 of
the Criminal Code.
Division 3—Date‑controlled chemical products
89A
Exclusion of certain chemical products
This Division does not apply to a
chemical product that is a listable chemical product or is a reserved chemical
product.
90
Manufacture or import of date‑controlled chemical product
(1) A person who manufactures or imports a
date‑controlled chemical product must:
(a) as soon as practicable make a
record in or to the effect of the approved form and in the prescribed manner
containing the date of manufacture, or the date of manufacture and import, as
the case may be, of the product and any other particulars that are required by
the regulations to be inserted in the record; and
(b) keep that record for at least the
period prescribed by the regulations for keeping it.
Penalty: 120 penalty units.
(2) Subsection (1) does not apply if the
person has a reasonable excuse.
Note: The defendant bears an evidential burden in
relation to the matter in subsection (2). See subsection 13.3(3) of the Criminal
Code.
(3) In subsection (1), strict liability
applies to the physical element of circumstance, that the relevant matter is
prescribed by the regulations.
Note: For strict liability, see section 6.1 of
the Criminal Code.
91
Supply of date‑controlled chemical product
(1) A person must not supply, or cause or
permit to be supplied, a date‑controlled chemical product in a container
that does not have attached to it an approved label containing:
(a) matter that the APVMA has approved
as sufficient to enable the APVMA to identify the date of manufacture of the
product; and
(b) the expiry date required to be
contained on the label as a condition of the registration of the product.
(1A) Subsection (1) does not apply to the
extent that the person’s conduct is otherwise authorised by a permit.
Note: The defendant bears an evidential burden in
relation to the matter in subsection (1A). See subsection 13.3(3) of the Criminal
Code.
(1B) Subsection (1) does not apply if the
person has a reasonable excuse.
Note: The defendant bears an evidential burden in
relation to the matter in subsection (1B). See subsection 13.3(3) of the Criminal
Code.
(1C) In subsection (1), strict liability
applies to the physical elements of circumstance, that:
(a) the APVMA has not approved the
relevant matter as mentioned in paragraph (1)(a); and
(b) an expiry date was required to be
contained on the label as a condition of the registration of the product.
Note: For strict liability, see section 6.1 of
the Criminal Code.
(2) If the container of a date‑controlled
chemical product has attached to it a label containing an expiry date, a person
must not, after that date, supply, or cause or permit to be supplied, the
product that is in the container unless:
(a) the person is authorised to do so
by a permit; or
(b) the person does so on a date that,
despite the date on the label, is earlier than the date that is required to be
contained on the label as a condition of the registration of the product.
Penalty: 120 penalty units.
(3) Subsection (2) does not apply if the
person has a reasonable excuse.
Note: The defendant bears an evidential burden in
relation to the matter in subsection (3). See subsection 13.3(3) of the Criminal
Code.
92
Abuse of warning on label prohibited
(1) If a label attached to a container of a
chemical product contains any matter (the approved matter) that
is, or has been, required to be contained on the label by or under subsection
91(1), a person must not do, or cause or permit to be done, any of the
following:
(a) detach or otherwise remove the
label;
(b) alter, deface, obliterate or
destroy the approved matter;
(c) attach another label to, or endorse
anything upon, the container that in either case has the effect of negating,
varying, or in any way detracting from, qualifying or minimising the purport or
effect of, the approved matter.
(2) Paragraph (1)(b) does not apply to
an alteration, defacing, obliteration or destruction of matter that is done by
the destruction or disposal of the chemical product without otherwise
contravening this Code.
Penalty: 120 penalty units.
(3) Subsection (1) does not apply if the
person has a reasonable excuse.
Note: The defendant bears an evidential burden in
relation to the matter in subsection (3). See subsection 13.3(3) of the Criminal
Code.
Division 4—Restricted chemical products
93
Restricted chemical product
(1) Subject to subsection (2), the
regulations may declare a chemical product to be a restricted chemical product.
(2) A chemical product may not be declared by
the regulations to be a restricted chemical product unless the APVMA has
certified in writing that it is in the public interest for the product to be so
declared.
(3) In deciding whether to give a certificate
in relation to a chemical product under subsection (2), the APVMA must
have regard to the following:
(a) whether the product may have an
effect that is harmful to human beings;
(b) whether the product may have any
unintended effect that is harmful to any animal, plant or thing or to the
environment;
(c) whether any special knowledge,
skill or qualification is required in the preparation or handling of the
product;
(d) whether any special equipment is
required to use the product with safety.
94
Restricted chemical products may be supplied only to authorised persons
(1) A person must not supply a restricted
chemical product, or cause or permit a restricted chemical product to be
supplied, to a person who is not authorised to use the product under another
law of this jurisdiction.
Penalty: 120 penalty units.
(2) Subsection (1) does not apply if the
person has a reasonable excuse.
Note: The defendant bears an evidential burden in
relation to the matter in subsection (2). See subsection 13.3(3) of the Criminal
Code.
95
Labels for restricted chemical products
(1) A person
must not supply a restricted chemical product, or cause or permit a restricted
chemical product to be supplied, unless the label attached to the container for
the product contains the words “RESTRICTED CHEMICAL PRODUCT—ONLY TO BE SUPPLIED
TO OR USED BY AN AUTHORISED PERSON”.
Penalty: 120 penalty units.
(2) Subsection (1) does not apply if the
person has a reasonable excuse.
Note: The defendant bears an evidential burden in
relation to the matter in subsection (2). See subsection 13.3(3) of the Criminal
Code.
Part 5—Analysis
96
Explanation of Part
This Part sets out the procedure by
which samples or substances are to be analysed and states how evidence of the
results of the analysis may be given in proceedings under this Code.
97
Analysis by approved analysts
(1) An inspector may give a portion of a
sample taken under paragraph 131(1)(c) or 132(1)(d) to an approved analyst for
analysis.
(2) If an analysis has been made by, or under
the personal supervision of, an approved analyst in respect of a sample given
for analysis under this Code, the analyst must give to the APVMA a certificate
in or to the effect of the approved form in respect of the analysis.
Penalty: 10 penalty units.
(2A) An offence under subsection (2) is an
offence of strict liability.
Note: For strict liability, see section 6.1 of
the Criminal Code.
(3) The APVMA must, if asked to do so by an
inspector, give to the inspector a copy of a certificate given under subsection (2).
(4) The APVMA must, upon receipt of the
prescribed fee (if any), give a copy of a certificate given to it under subsection (2)
to a person who appears to it to be:
(a) the owner of the substance from
which the sample analysed was taken or the person in whose possession or
custody, or under whose control, the substance was when the sample was taken;
or
(b) an applicant for approval of that
substance as an active constituent or for registration or listed registration
of that substance as a chemical product.
(5) If a person referred to in paragraph (4)(a)
or (b) so requests, the APVMA must give to the person a portion of the sample
that is sufficient to enable the person to have a further analysis made.
(6) A person must not, for trade purposes or
for advertisement, use a certificate given under subsection (2) or any
matter contained in it.
Penalty: 60 penalty units.
(6A) Subsection (6) does not apply if the
person has a reasonable excuse.
Note: The defendant bears an evidential burden in
relation to the matter in subsection (6A). See subsection 13.3(3) of the Criminal
Code.
(6B) An offence under subsection (6) is an
offence of strict liability.
Note: For strict liability, see section 6.1 of
the Criminal Code.
(7) This section applies in respect of a
substance seized under section 131 or 132 in the same way as it applies in
respect of a sample of a substance taken under paragraph 131(1)(c) or 132(1)(d)
and references in this section to a sample or to a substance from which a
sample was taken include references to a substance so seized.
98
Evidence of results of analysis
(1) Subject to subsection (3), in any
proceedings under this Code, a certificate of an approved analyst in or to the
effect of the approved form stating, in respect of a sample of a substance in
relation to which the offence is alleged to have been committed, any of the
following:
(a) that the analyst signing the
certificate is an approved analyst;
(b) when and from whom the sample of
the substance was received;
(c) what, if any, labels or other
means of identifying the sample of the substance accompanied it when it was
received;
(d) what container or containers the
sample of the substance was contained in when it was received;
(e) a description of the sample of the
substance received;
(f) when the sample of the substance,
or a portion of it, was analysed;
(g) a description of the method of
analysis;
(h) the results of the analysis;
(i) how
the sample of the substance was dealt with after handling by the analyst,
including details of:
(i) the quantity kept; and
(ii) the name of the
person, if any, to whom any quantity so kept was given; and
(iii) measures taken to
secure any quantity so kept;
is admissible as prima facie evidence of the
matters stated in the certificate and, if the certificate states the results of
the analysis, of the correctness of those results.
(2) Unless the contrary is proved, a document
purporting to be a certificate under subsection (1) is taken to be such a
certificate and to have been duly given.
(3) A
certificate must not be admitted in evidence under subsection (1) in
proceedings for an offence unless:
(a) the person charged with the
offence or a barrister or solicitor who has appeared for the person in those
proceedings has, at least 14 days before the certificate is sought to be so
admitted, been given a copy of the certificate together with reasonable notice
of the intention to produce the certificate as evidence in the proceedings; or
(b) reasonable efforts were made to
give the copy and notice as required by paragraph (a) but those efforts
were unsuccessful.
(4) Subject to subsection (5), if, under
subsection (1), a certificate of an analyst is admitted in evidence in a proceeding
for an offence, the person charged with the offence may require the analyst to
be called as a witness for the prosecution and the analyst may be cross‑examined
as if he or she had given evidence of the matters stated in the certificate.
(5) Subsection (4) does not entitle a
person to require an analyst to be called as a witness for the prosecution
unless:
(a) the prosecutor has been given at
least 4 days’ notice of the person’s intention to require the analyst to be so
called; or
(b) the court, by order, allows the
person to require the analyst to be so called.
(6) This
section applies in respect of a substance seized under section 131 or 132
in the same way as it applies in respect of a sample of a substance taken under
paragraph 131(1)(c) or 132(1)(d) and references in this section to a sample or
to a substance from which a sample was taken include references to a substance
so seized.
99
Analysis of chemical products
(1) If a person has possession or custody of
a substance or mixture of substances that is intended for supply as a chemical
product under a particular name, the following provisions apply.
(2) If a chemical product having that name is
registered under Division 2 of Part 2, or has been granted listed
registration under Division 4 of Part 2A, and the APVMA, on the
advice of an inspector, reasonably suspects that:
(a) the constituents of the substance
or mixture differ by more than the prescribed extent from the constituents
stated in relation to the chemical product in the Register of Chemical
Products; or
(b) the concentration of the
constituents of the substance or mixture differs by more than the prescribed
extent from the concentration of the constituents stated in relation to the
chemical product in the Register of Chemical Products; or
(c) the composition or purity of a
constituent of the substance or mixture differs by more than the prescribed
extent from the composition or purity of that constituent stated in relation to
the chemical product in the Register of Chemical Products;
the APVMA may, by written notice given to the person,
require the person to have the substance or mixture analysed to find out its
constituents, their concentration and the composition and purity of each of
them.
(3) If the APVMA, on the advice of an
inspector, reasonably suspects that the substance or mixture does not comply
with any prescribed standard, established standard or other prescribed
requirement, the APVMA may, by written notice given to the person, require the
person to have the substance or mixture analysed to find out whether it
complies with any prescribed standard, established standard or other prescribed
requirement.
(4) Without limiting subsections (2) and
(3), a notice given to a person under either of those subsections may require
any one or more of the following:
(a) that samples of the substance or
mixture are taken:
(i) under the supervision
of an inspector; or
(ii) in the manner stated
in the notice;
(b) that the analysis is carried out:
(i) under the supervision
of an approved analyst; or
(ii) in the manner stated
in the notice;
(c) that the analysis is carried out
at a prescribed laboratory;
(d) that the analysis is carried out
within a period stated in the notice;
(e) that the analysis is carried out
at the expense of the person.
(5) A person to whom a notice is given under subsection (2)
or (3) must not fail:
(a) to comply with the notice; and
(b) to
give the analyst’s certificate to the APVMA not later than 5 working days after
the person received that certificate.
Penalty: 120 penalty units.
(5A) Subsection (5) does not apply if the
person has a reasonable excuse.
Note: The defendant bears an evidential burden in
relation to the matter in subsection (5A). See subsection 13.3(3) of the Criminal
Code.
(5B) An offence under subsection (5) is an
offence of strict liability.
Note: For strict liability, see section 6.1 of
the Criminal Code.
(6) The APVMA may cause to be published in a
manner that it thinks appropriate:
(a) the name, and the address of the
place of business, of:
(i) the person who had
possession or custody of the substance or mixture; and
(ii) if the substance or
mixture is intended for supply as a chemical product and the person referred to
in subparagraph (i) is not the interested person in relation to the
product—the interested person; and
(b) the result of the analysis of the
substance or mixture.
(7) If a requirement made under this section
is inconsistent with an earlier requirement made under this section, the
earlier requirement is, to the extent of the inconsistency, of no effect.
(8) Section 168 provides for additional
matters to be included in a notice given under subsection (2) or (3).
Part 6—Recall notices
100
Explanation of Part
This Part sets out various circumstances
in which the APVMA may issue recall notices requiring persons who have, or have
had, stocks of chemical products in their possession to stop supplying the
products and to take action in relation to the products as directed by the
APVMA. The power of the APVMA to issue recall notices is in addition to powers
conferred on the Australian Competition and Consumer Commission under the Trade
Practices Act 1974.
101
Recall of products that are not registered and do not have listed registration
or whose registration or listed registration is being reconsidered
(1) If:
(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 APVMA 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 APVMA 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).
(2) The things that the notified person may
be required to do under subsection (1) are as follows:
(a) not to supply, or to stop
supplying, the product, or that batch, in this jurisdiction either immediately
or within a stated period;
(b) to take any action stated in the
notice that the notified person is reasonably capable of taking to recover
stocks of the product or of that batch from any other person in this
jurisdiction:
(i) to whom the product or
that batch has been supplied by the notified person; or
(ii) who has possession or
custody of any such stocks directly or indirectly because of a supply by the
notified person;
(c) if the product is not registered
and has not been granted listed registration—to destroy, as stated in the
notice, stocks of the product or of that batch in the possession or custody of,
or recovered by, the notified person in this jurisdiction or to deal with them
as stated in the notice;
(d) to report to the APVMA within a
stated period on the action taken by the notified person under the notice.
(3) Section 168 provides for additional
matters to be included in a notice under subsection (1).
102
Recall of products in certain circumstances
(1) If it appears to the APVMA that:
(a) having regard to the matters
referred to in subsection 14(5) or (6), as the case requires, the continued use
of a registered chemical product in accordance with the instructions on an
approved label for containers for the product:
(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 APVMA has determined for the product; or
(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:
(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 APVMA has determined for the product; or
(b) the constituents of stocks of a
registered chemical product or of a particular batch of a registered chemical
product differ by more than the prescribed extent from the constituents stated
in relation to the product in the Register of Chemical Products; or
(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
(c) the concentration of the
constituents of stocks of a registered chemical product or of a particular
batch of a registered chemical 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
(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
(d) the composition or purity of any
constituent of stocks of a registered chemical product or of a particular batch
of a registered chemical product differs by more than the prescribed extent
from the composition or purity of that constituent stated in relation to the
product in the Register of Chemical Products;
(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
the APVMA may give written notice to any person (the notified
person) who has, or has had, possession or custody in this jurisdiction
of any of the stocks or of the batch, or of stocks or a batch of the product in
containers to which the label is attached, as the case may be, requiring the
notified person to do any one or more of the things mentioned in subsection (2).
(2) The things that the notified person may
be required to do under subsection (1) are as follows:
(a) not to supply, or to stop
supplying, any of those stocks or of that batch, either immediately or within a
stated period;
(b) to take any action stated in the
notice that the notified person is reasonably capable of taking to recover
stocks of the product or of that batch from any other person in this
jurisdiction:
(i) to whom the product or
that batch has been supplied by the notified person; or
(ii) who has possession or
custody of any such stocks directly or indirectly because of a supply by the
notified person;
(c) to take any action that is stated
in the notice, or that the notified person thinks necessary, to prevent or
reduce any harmful effects that may have resulted from the use of the product;
(d) to destroy, as stated in the
notice, any of those stocks or any of that batch in the possession or custody
of, or recovered by, the notified person in this jurisdiction or to deal with
them as stated in the notice;
(e) to report to the APVMA within a
stated period on the action taken by the notified person under the notice.
(3) Section 168 provides for additional
matters to be included in a notice under subsection (1).
103
Recall of products with labels that are not approved or are not authorised by
an established standard
(1) If it appears to the APVMA:
(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 for 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 APVMA 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).
(2) The things that the notified person may
be required to do under subsection (1) are as follows:
(a) not to supply, or to stop
supplying, any of those stocks or of that batch, either immediately or within a
stated period;
(b) to take any action stated in the
notice that the notified person is reasonably capable of taking to recover
stocks of the product or of that batch from any other person in this
jurisdiction:
(i) to whom the product or
that batch has been supplied by the notified person; or
(ii) who has possession or
custody of any such stocks directly or indirectly because of a supply by the
notified person;
(c) to attach labels to the containers
that are the same as the approved label for the product or the label required
by the established standard for the product, as the case may be or to destroy
any of those stocks or of that batch in the possession or custody of, or
recovered by, the notified person or to deal with them as stated in the notice;
(d) to report to the APVMA within a
stated period on the action taken by the notified person under the notice.
(3) Section 168 provides for additional
matters to be included in a notice under subsection (1).
104
Notice of recall to be published
(1) If the APVMA issues a recall notice, it
must, as soon as practicable, cause notices of the issue of the recall notice
to be published in the Gazette and in any other manner that it thinks
appropriate.
(2) Each notice must contain a brief
statement of the matters to which the recall notice relates.
105
Non‑compliance with recall notice
(1) A person to whom a recall notice is given
must not fail to comply with the notice.
Penalty: 120 penalty units.
(2) Subsection (1) does not apply if the
person has a reasonable excuse.
Note: The defendant bears an evidential burden in
relation to the matter in subsection (2). See subsection 13.3(3) of the Criminal
Code.
(3) An offence under subsection (1) is
an offence of strict liability.
Note: For strict liability, see section 6.1 of
the Criminal Code.
106
Recall under Trade Practices Act
Section 65R of the Trade
Practices Act 1974 imposes obligations on certain persons who voluntarily
recall chemical products.
107
Inconsistent requirements
If a requirement made under section 101,
102 or 103 is inconsistent with an earlier requirement made under any of those
sections, the earlier requirement is, to the extent of the inconsistency, of no
effect.
Part 7—Permits
108
Explanation of Part
(1) This Part sets up a system under which a
person who wants to do something in respect of an active constituent for a
proposed or existing chemical product, or in respect of a chemical product,
that would otherwise be prohibited by this Code or another law of this
jurisdiction may obtain a permit in respect of the doing of the thing. The
permit does not have any practical operation unless a law of this jurisdiction
permits the thing to be done by the holder of such a permit.
(2) Examples of circumstances in which a
permit could be sought are:
(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.
109
Definition of permit
In this Part:
permit means a permit, in respect of an
active constituent for a proposed or existing chemical product, or in respect
of a chemical product, to do or omit to do any thing stated in the permit the
doing of which, or the omission to do which, would, apart from the permit, be:
(a) an offence against section 74,
75, 76, 77, 78, 79, 79A, 79B, 80, 81, 84, 85, 87, 87A or 91; or
(b) an offence against an eligible law
of this jurisdiction.
110
How application is made
(1) Any person may apply to the APVMA, on
behalf of that person, a class of persons or persons generally, for a permit in
respect of an active constituent for a proposed or existing chemical product or
in respect of a chemical product.
(2) 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 APVMA requires; and
(c) be signed by an approved person;
and
(d) be accompanied by the prescribed
fee (if any).
(3) The APVMA may, with the written consent
of the applicant, alter the application.
(4) 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 APVMA written notice of the withdrawal signed by
an approved person.
111
Functions of co‑ordinators
(1) If there is a co‑ordinator
designated for this or another jurisdiction:
(a) the APVMA must, unless it thinks
it inappropriate to do so, give the co‑ordinator a copy of the
application and of any accompanying documents; and
(b) if:
(i) the APVMA 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 APVMA about the application;
then, unless the APVMA has reasonable grounds for refusing
the request:
(iii) the APVMA must, by
written notice given to the applicant, require the applicant to give the
additional information to the APVMA; and
(iv) when the APVMA receives
the additional information, it must, as soon as practicable, give the
information to the co‑ordinator; and
(c) when the co‑ordinator is
satisfied that he or she has sufficient information to enable a recommendation
to be made about the application, the co‑ordinator may give to the APVMA
a recommendation as to whether the application should be granted.
(2) Any information given by a person to a co‑ordinator
because of a requirement made under subsection (1) must be in writing and
be signed by an approved person.
112
APVMA may grant or refuse application
(1) The APVMA must consider the application
and take into account any recommendations made by a co‑ordinator.
(2) The APVMA must grant the application if
it is satisfied of the following:
(a) that, having regard to criteria
determined by it, the applicant is a suitable person to hold the permit applied
for;
(b) that the applicant has complied
with subsection 110(2) and any requirement made by a co‑ordinator to the
APVMA under paragraph 111(1)(b);
(c) that any requirement made under
section 157 or 159 has been complied with;
(d) that, if necessary, section 158
has been complied with;
(e) that any requirements prescribed
by the regulations in relation to such an application have been complied with;
(f) that, having regard to the
matters referred to in subsection 14(4) or (5), as the case requires, the use
of, or any other dealing with, the constituent or product as proposed in the
application for the permit:
(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;
(g) that, having regard to the matters
referred to in subsection 14(6), the use of the product as proposed in the
application for the permit would be effective according to criteria that the
APVMA has determined for the product;
(h) that any requirements prescribed
by the regulations in relation to the issue of such a permit have been complied
with;
(i) if an application has not been
made for approval of the constituent or registration or listed registration of
the product or such an application has not been determined—that there are
reasonable grounds for the application not having been made or for issuing the
permit pending determination of the application, as the case may be.
(3) If the APVMA is not satisfied as
mentioned in subsection (2), it must refuse the application.
(4) If the APVMA refuses the application, it
must:
(a) give written notice of the refusal
to the applicant and to each co‑ordinator to whom a copy of the
application was given; and
(b) include in the notice brief
particulars of the reasons for the refusal.
(5) Section 168 provides for additional
matters to be included in a notice of refusal of an application for a permit.
113
Record of Permits
(1) For the purposes of this Code, the APVMA
must keep a record, in a form determined by it, to be known as the Record of
Permits.
(2) The Record of Permits is to be kept in 2
parts as provided by subsections (3) and (4).
(3) One part is to contain:
(a) information about permits the
making of applications for which is confidential commercial information; and
(b) confidential commercial
information about other permits.
(4) The other part is to contain information
about the other permits referred to in paragraph (3)(b) that is not
confidential commercial information.
(5) The APVMA must permit any person to
inspect the part of the Record of Permits referred to in subsection (4) at
any time during ordinary office hours on a working day.
(6) Subject to subsection (7), if a
person asks for a copy of a permit other than a permit to which paragraph (3)(a)
applies and pays the prescribed fee (if any), the APVMA must give the person a
copy of the permit.
(7) If a permit referred to in subsection (6)
contains confidential commercial information, the APVMA must delete that
information from the copy given under that subsection.
114
Issue of permit
(1) The APVMA may, on its own initiative or
on an application made under section 110, issue a permit to a person.
(1A) Before issuing a permit, the APVMA must be
satisfied that, if necessary, paragraph 8A(2)(d) of the Agricultural and
Veterinary Chemicals (Administration) Act 1992 has been complied with.
(2) When issuing a permit, the APVMA must
give a distinguishing number to the permit.
(3) The permit may be unconditional or
subject to any conditions that the APVMA thinks appropriate.
(4) The permit must:
(a) contain the distinguishing number
given to the permit; and
(b) state whether it applies to persons
generally and, if not, state the persons or class of persons to whom it
applies, other than persons to whom it applies because of subsection 116(3);
and
(c) state the active constituent or
chemical product in respect of which it is issued; and
(d) state the things authorised by the
permit to be done or omitted to be done; and
(e) state any conditions of the
permit.
(5) As soon as practicable after a permit is
issued, the APVMA must:
(a) place a copy of the permit in the
Record of Permits; and
(b) if there is a co‑ordinator
designated for this or another jurisdiction, tell the co‑ordinator that
the permit has been issued and tell him or her of any conditions to which the
permit is subject; and
(c) in prescribed circumstances, tell
a prescribed authority that the permit has been issued.
115
Duration of permit
(1) Subject to this section, a permit is in
force until it is surrendered under section 117 or the APVMA cancels it
under section 119.
(2) Subject to subsection (3), a permit
may be expressed to be in force only for a period stated in the permit.
(3) The holder of a permit to which subsection (2)
applies may apply in writing to the APVMA for an extension or extensions of the
permit and, if such an application is made and the prescribed fee (if any) is
paid, the APVMA may extend the permit for a further period that it thinks
appropriate.
(4) This section has effect subject to
subsection 118(6).
(5) If an application is made to the APVMA
under subsection (3), the APVMA must give to the applicant written notice
of its decision on the application.
(6) Section 168 provides for additional
matters to be included in a notice refusing to extend a permit.
116
Effect of permit
(1) If, while a permit in respect of an
active constituent for a proposed or existing chemical product, or in respect
of a chemical product, is in force:
(a) a person to whom the permit
applies who, in accordance with the conditions (if any) stated in the permit,
does or omits to do any thing in respect of the constituent or product that the
permit states may be done or omitted to be done; and
(b) a provision of this Code or of an
eligible law of this jurisdiction prohibits the doing of, or the omitting to
do, that thing unless authorised by a permit;
the person does not commit an offence against that
provision.
(2) The persons to whom a permit applies are:
(a) if the permit states that it
applies to persons generally—any person; or
(b) otherwise—the person or each
person named, or included in a class of persons stated, in the permit.
(3) If a permit names a person or states a
class of persons as mentioned in paragraph (2)(b), the permit also applies
to:
(a) any qualified employee of the
person, or of a person in the class, acting in the course of his or her
employment; and
(b) if a person, or a person in the
class, is a body corporate—any qualified person acting in his or her capacity
as a director of the body corporate.
(4) In this section:
qualified means qualified under another law
of this jurisdiction in relation to the things authorised by the permit to be
done or omitted to be done.
117
Surrender of permit
(1) The holder of a permit may surrender it
by giving to the APVMA a written notice, signed by an approved person, stating
that the holder surrenders the permit.
(2) The surrender of a permit takes effect
when the APVMA receives the notice of surrender.
(3) If there is a co‑ordinator
designated for this or another jurisdiction, the APVMA must, as soon as
practicable, tell the co‑ordinator that the permit has been surrendered.
118
Suspension of permit
(1) The APVMA, by written notice given to the
holder of a permit, may suspend the permit if it appears to the APVMA that:
(a) having regard to the matters
referred to in subsection 14(4) or (5), as the case requires, the continued use
of, or any other dealing with, an active constituent for a proposed or existing
chemical product, or a chemical product, in accordance with the permit:
(i) may be an undue hazard
to the safety of people exposed to the constituent or product during its
handling or people using anything containing its residues; or
(ii) may have an effect
that is harmful to human beings; or
(iii) may 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) is inappropriate for
any other reason; or
(b) having regard to the matters
referred to in subsection 14(6), the continued use of a chemical product in
accordance with the permit may not be effective according to criteria that the
APVMA has determined for the product.
(2) If the holder of a permit fails, without
reasonable excuse, to comply with a requirement contained in a notice under
section 159 or with section 161, the APVMA may, by written notice
given to the holder of the permit, suspend the permit.
(3) The APVMA may, for any reason that it
thinks sufficient, suspend a permit that is taken by section 181 to have
been issued under section 114.
(4) A suspension of a permit under subsection (1),
(2) or (3) must be for a stated period.
(5) If the holder of a permit is proceeded
against for an offence against, or has failed to comply with a lawful direction
or requirement of an inspector given under, the Agvet Code of this or another
jurisdiction, the APVMA may, by written notice given to the holder of the
permit, suspend the permit until the proceeding has been disposed of or the
direction or requirement has been complied with, as the case may be.
(6) A permit is not in force during any
period in which it is suspended.
(7) A notice of suspension of a permit must
include brief particulars of the reasons for the suspension.
(8) Section 168 provides for additional
matters to be included in a notice of suspension of a permit.
(9) If a permit is suspended, the APVMA may,
by written notice given to the holder of the permit, revoke the suspension.
(10) If:
(a) the APVMA suspends, or revokes the
suspension of, a permit; and
(b) there is a co‑ordinator
designated for this or another jurisdiction;
the APVMA must, as soon as practicable, tell the co‑ordinator
of the suspension or revocation.
119
Cancellation of permit
(1) The APVMA,
by written notice given to the holder of a permit, may cancel the permit if it
appears to the APVMA that:
(a) having regard to the matters
referred to in subsection 14(4) or (5), as the case requires, the continued use
of, or any other dealing with, an active constituent for a proposed or existing
chemical product, or a chemical product, in accordance with the permit:
(i) may be an undue hazard
to the safety of people exposed to the constituent or product during its
handling or people using anything containing its residues; or
(ii) may have an effect
that is harmful to human beings; or
(iii) may 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) is inappropriate for
any other reason; or
(b) having regard to the matters
referred to in subsection 14(6), the continued use of a chemical product in
accordance with the permit may not be effective according to criteria that the
APVMA has determined for the product.
(2) If a permit is suspended under subsection
118(2) and the information, report or sample referred to in section 159 or
161 is not given within a reasonable period after the suspension takes place,
the APVMA may cancel the permit.
(3) The APVMA may, for any reason that it
thinks sufficient, cancel a permit that is taken by section 181 to have
been issued under section 114.
(4) The APVMA may, by written notice given to
the holder of a permit, cancel the permit if the holder:
(a) has been convicted of an offence
against the Agvet Code of this or another jurisdiction, or an offence against
another law of this or another jurisdiction relating to chemical products or to
active constituents for proposed or existing chemical products; or
(b) contravenes a condition of the
permit.
(5) A permit may be cancelled even though it
is suspended.
(6) If information about the holder of a
permit comes to the APVMA’s knowledge and it is of the opinion that, if it had
been in possession of the information before it issued the permit, it would
have refused to issue the permit, it may, by written notice given to the
holder, cancel the permit.
(7) A notice of cancellation of a permit must
include brief particulars of the reasons for the cancellation.
(8) Section 168 provides for additional
matters to be included in a notice of cancellation of a permit.
(9) If a permit is cancelled, the APVMA may,
by written notice to the person who held the permit, revoke the cancellation.
(10) If the cancellation of a permit is
revoked, the cancellation is taken never to have occurred.
(11) If:
(a) a permit is cancelled or the
cancellation of a permit is revoked; and
(b) there
is a co‑ordinator designated for this or another jurisdiction;
the APVMA must, as soon as practicable, tell the co‑ordinator
of the cancellation or revocation.
Part 8—Manufacture of chemical products
120
Explanation of Part
(1) This Part:
(a) prohibits the manufacture of
certain chemical products; and
(b) provides for the licensing of
manufacturers of other chemical products.
(2) A licensee is required by this Part to
comply with manufacturing principles determined by the APVMA, which may include
codes of good manufacturing practice.
(3) Section 121 does not come into force
until a date to be prescribed by regulations that is not later than 12 months
after the date of commencement of this Code.
120A
Exclusion of certain chemical products
This Part does not apply to chemical
products that are listable chemical products or are reserved chemical products.
121
Offences relating to manufacture and licences
(1) Subject to subsection (2), this
section applies on and after a date to be prescribed by the regulations for the
purposes of this Part.
(2) If this section does not apply under subsection (1)
before the end of the period of 12 months after the date of commencement of
this Code, it applies on and after the first day after the end of that period.
(3) A person must not carry out a step in the
manufacture of a prohibited chemical product at premises in this jurisdiction.
Penalty: 240 penalty units.
(4) A person
must not carry out a step in the manufacture of chemical products at premises
in this jurisdiction unless:
(a) under the regulations, the
products are exempt products or the person is an exempt person in relation to
the manufacture of the products; or
(b) the person is the holder of a
licence that is in force that authorises the carrying out of that step in
relation to the products at those premises; or
(c) both the following subparagraphs
apply:
(i) the person was engaged
in the manufacture of the products at those premises at the commencement of
this Code;
(ii) before this section
began to apply the person applied for a licence authorising the carrying out of
that step in relation to the products at those premises but the APVMA has not
dealt with the application.
Penalty: 240 penalty units.
(5) A person who is the holder of a licence
must not contravene a condition of the licence.
Penalty for a contravention of this subsection: 120 penalty
units.
(6) Subsections (3), (4) and (5) do not
apply if the person has a reasonable excuse.
Note: The defendant bears an evidential burden in
relation to the matter in subsection (6). See subsection 13.3(3) of the Criminal
Code.
(7) An offence under subsection (3), (4)
or (5) is an offence of strict liability.
Note: For strict liability, see section 6.1 of
the Criminal Code.
122
Application for licence
(1) An application for a licence 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 APVMA 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 APVMA.
(2) The APVMA may, in relation to an
application for a licence, by written notice given to an approved person,
require the applicant:
(a) to give to the APVMA, within a
reasonable time stated in the notice, the further information concerning the
application that is mentioned in the notice; or
(b) to allow an inspector, or another
person authorised in writing by the APVMA, at any reasonable time set out in
the notice, to inspect the premises, equipment, processes and facilities that
are proposed to be used in the manufacture of the chemical products, or to
inspect other goods on those premises.
123
Issue of licence
(1) If a person has made an application to
carry out steps in the manufacture of chemical products (other than prohibited
chemical products) at particular premises and complied with section 122,
the APVMA must issue to the person a licence to carry out those steps at those
premises unless:
(a) the APVMA is satisfied that:
(i) the person will be
unable to comply with the manufacturing principles; or
(ii) the premises are not
satisfactory for the manufacture of the products; or
(b) a licence previously issued to the
person was cancelled except at the request of the person; or
(c) the person:
(i) has been convicted of
an offence against the Agvet Code of this or another jurisdiction, or an
offence against another law of this or another jurisdiction relating to
chemical products; or
(ii) has failed on more
than 2 occasions in any 12 months to observe any one or more of the
manufacturing principles in connection with the manufacture of chemical
products, whether the failures related to the same manufacturing principle or
to different manufacturing principles.
(2) Despite paragraph (1)(b) or (c), the
APVMA may issue a licence to a person to whom, apart from this subsection, it
could not issue a licence because of that paragraph if, in the opinion of the
APVMA, special circumstances make it appropriate to do so.
(3) A licence is subject to conditions as
mentioned in section 126.
(4) The licence must state:
(a) the person to whom it is issued;
and
(b) the products to which it relates;
and
(c) any conditions (other than
conditions referred to in subsection 126(4)) to which the licence is subject
when it is issued.
(5) If the APVMA issues a licence, the APVMA
must cause particulars of the licence to be published in the Gazette,
and in any other manner that it thinks appropriate, as soon as is practicable
after the licence is issued.
124
Refusal of application
(1) If the APVMA refuses an application for a
licence, it must:
(a) give written notice of the refusal
to an approved person; 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 of refusal of an application for a licence.
125
Period of licence
(1) A licence comes into force on the day
stated in the licence and, subject to subsection (2), remains in force
until it is cancelled.
(2) A licence is not in force during any
period in which it is suspended.
126
Conditions of licences
(1) The conditions to which a licence may be
subject are:
(a) the conditions that the APVMA
imposes for the purpose of ensuring that the holder of the licence manufactures
the chemical products in accordance with the manufacturing principles and any
standards that apply to the products; and
(b) any other conditions relating to
the manufacture of the products that the APVMA thinks appropriate to impose.
(2) The APVMA may, by written notice given to
the holder of a licence, impose new conditions on the licence or vary or remove
existing conditions.
(3) The imposition or variation of a
condition under subsection (2) takes effect:
(a) if the notice states that the
action is necessary to prevent imminent risk to public health or occupational
health or safety, or imminent risk of impact on trade or commerce between
Australia and places outside Australia—on the day on which the notice is given
to the person; or
(b) otherwise—on a day stated for the
purpose in the notice that is not earlier than 28 days after the notice is
given to the person.
(4) In addition to any conditions imposed in
accordance with subsection (1) or (2), each licence is, except as
otherwise stated in the licence, subject to the conditions that the holder of
the licence will:
(a) ensure that the chemical products
conform to any standard that applies to them; and
(b) comply with any other conditions
prescribed by the regulations for the purposes of this section.
(5) Section 168 provides for additional
matters to be included in a notice imposing a new condition on a licence or
varying an existing condition.
127
Suspension and cancellation of licences
(1) Subject to subsection (2), the APVMA
may, in relation to a licence, by written notice given to an approved person,
suspend the licence for a period stated in the notice, or cancel the licence,
if:
(a) the holder has been convicted of
an offence against the Agvet Code of this or another jurisdiction, or an
offence against another law of this or another jurisdiction in relation to
chemical products or active constituents for proposed or existing chemical
products; or
(b) the holder has contravened a
condition of the licence; or
(c) the holder has failed on more than
2 occasions in any 12 months to comply with any one or more of the
manufacturing principles in connection with the manufacture of chemical
products, whether the failures related to the same manufacturing principle or
to different manufacturing principles; or
(d) the holder has asked in writing
that the licence be suspended or cancelled, as the case may be; or
(e) the holder ceases to carry on the
business of manufacturing the chemical products to which the licence relates;
or
(f) a prescribed fee in connection
with the licence has not been paid.
(2) If the APVMA proposes to suspend or
cancel a licence except when asked to do so by the holder of the licence, the
APVMA must, unless it thinks that failure to suspend or cancel the licence
immediately would create an imminent risk to public health or occupational
health or safety, or an imminent risk of impact on trade or commerce between
Australia and places outside Australia:
(a) by written notice given to an
approved person, set out the action that the APVMA proposes to take and the
reasons for the proposed action; and
(b) except if the proposed action is
to be taken because of a failure to pay a prescribed fee—give the holder an
opportunity to make, within a reasonable time stated in the notice, written
submissions to the APVMA in relation to the proposed action.
(3) If the holder makes written submissions
in accordance with paragraph (2)(b), the APVMA is not to make a decision
relating to the suspension or cancellation of the licence before taking the
submissions into account.
(4) A licence may be cancelled even though it
is suspended.
(5) A notice suspending or cancelling a
licence must include brief particulars of the reasons for the suspension or
cancellation.
(6) Section 168 provides for additional
matters to be included in a notice suspending or cancelling a licence.
(7) If a licence is suspended or cancelled,
the APVMA may, by written notice given to the holder of the licence, revoke the
suspension or cancellation.
(8) If the APVMA suspends or cancels, or
revokes the suspension or cancellation of, a licence, the APVMA must cause
particulars of the suspension, cancellation or revocation to be published in
the Gazette, and in any other manner that it thinks appropriate, as soon
as is practicable after the suspension, cancellation or revocation takes place.
(9) If the cancellation of a licence is
revoked, the cancellation is taken never to have occurred.
128
Publication of list of manufacturers etc.
The APVMA may, from time to time and in
a manner determined by it, publish a list of the holders of licences, the
chemical products to which the licences relate, the steps of manufacture that
the licences authorise and the addresses of the premises to which the licences
relate.
Part 9—Enforcement
Division 1—Preliminary
129
Explanation of Part
(1) This Part contains provisions for the
enforcement of this Code.
(2) Division 2 empowers any person to
seek an injunction to enforce compliance with this Code.
(3) Division 3 contains provisions
authorising inspectors to monitor compliance with this Code and, if
contraventions are suspected to have occurred, to obtain search warrants.
Inspectors are, or may be, given powers to enter and search premises and seize
things. They may also require the giving of information or the production of
documents.
(4) Division 4 contains various
ancillary provisions.
Division 2—Injunctions
130
Injunctions
(1) If a person has engaged, or is proposing
to engage, in any conduct that was or would be an offence against this Code, a
court of competent jurisdiction may, on the application of any person, grant an
injunction restraining the first‑mentioned person from engaging in the
conduct and, if in the court’s opinion it is desirable to do so, requiring that
person to do a particular thing.
(2) If in the opinion of the court it is
desirable to do so, the court may grant an interim injunction pending
determination of an application under subsection (1).
(3) The court may discharge or vary an
injunction granted under subsection (1) or (2).
(4) The power of the court to grant an
injunction restraining a person from engaging in conduct may be exercised:
(a) whether or not it appears to the
court that the person intends to engage again, or to continue to engage, in
conduct of that kind; and
(b) whether or not the person has
previously engaged in conduct of that kind; and
(c) whether or not the conduct
involves a serious and immediate risk of:
(i) an effect that is
harmful to human beings; or
(ii) an unintended effect
that is harmful to animals, plants or things or to the environment.
(5) The power of the court to grant an
injunction requiring a person to do a particular thing may be exercised:
(a) whether or not it appears to the
court that the person intends to refuse or fail again, or to continue to refuse
or fail, to do that thing; and
(b) whether or not the person has
previously refused or failed to do that thing; and
(c) whether or not there is a serious
and immediate risk of:
(i) an effect that is
harmful to human beings; or
(ii) an unintended effect
that is harmful to animals, plants or things or to the environment;
if the person refuses or fails
to do that thing.
Division 3—Powers of entry, search and seizure
131
Searches to monitor compliance with Code
(1) Subject to this section, to the extent
that it is reasonably necessary to do so for the purpose of finding out whether
this Code has been complied with, an inspector, with any necessary help, may
enter, at any time during ordinary working hours on any day, any premises that
the inspector has reasonable cause to believe are premises at which active
constituents for proposed or existing chemical products, or chemical products,
or records relating to any such constituents or products, are kept and may do
any one or more of the following:
(a) search the premises and any thing
found at the premises;
(b) inspect and take photographs
(including video recordings), or make sketches, of the premises or any thing at
the premises;
(c) take and keep samples of any thing
at the premises;
(d) inspect any document kept at the
premises;
(e) seize any thing at the premises if
the inspector believes on reasonable grounds that it is necessary to seize the
thing in order to prevent its concealment, loss or destruction or to protect
the health of the public or of any person;
(f) open any container at the
premises for the purpose of inspecting, or taking a sample of, its contents
provided that the container is resealed after the inspection is made or the
sample is taken;
(g) if a thing is seized under paragraph (e),
direct the occupier of the premises or the owner of that thing to keep it at
the premises, or at other premises under the control of the occupier or owner
that will, in the opinion of the inspector, cause least danger to the health of
the public or of any person;
(h) give any other directions for, or
with respect to, the detention of a thing that has been seized under paragraph (e);
(i) destroy or make harmless, or give
directions for the destruction or making harmless of, a chemical product at the
premises.
(2) An
inspector may not:
(a) under paragraph (1)(c)—take
samples of a thing; or
(b) under paragraph (1)(e)—seize
a thing;
that appears to the inspector to be in the possession or
custody of a person unless the inspector makes out and tenders to the person a
receipt in or to the effect of the approved form for the sample taken or thing
seized.
(3) An inspector may not, under subsection (1),
enter premises that are a residence unless the occupier of the premises has
consented to the entry.
(4) An inspector may not exercise any powers
under subsection (1) in relation to premises if:
(a) the occupier of the premises has
required the inspector to produce his or her identity card for inspection by
the occupier; and
(b) the inspector fails to comply with
the requirement.
(5) The powers conferred on an inspector
under paragraph (1)(i) may not be exercised unless:
(a) the APVMA believes on reasonable
grounds that it is necessary in the interest of the health of the public or of
any person for those powers to be exercised and authorises the inspector
concerned to do so; or
(b) the owner of the chemical product
concerned authorises the inspector to exercise those powers in respect of the
product.
(6) If a direction given by an inspector
under this section is inconsistent with an earlier direction given by an
inspector under this section, the earlier direction is, to the extent of the
inconsistency, of no effect.
(7) If a direction given by an inspector
under this section is inconsistent with a requirement that the APVMA has made
under section 99, 101, 102 or 103, the direction is, to the extent of the
inconsistency, of no effect.
(8) A person must not refuse or fail to
comply with the direction given by an inspector under this section.
Penalty: 30 penalty units.
(9) Subsection (8) does not apply if the
person has a reasonable excuse.
Note: The defendant bears an evidential burden in
relation to the matter in subsection (9). See subsection 13.3(3) of the Criminal
Code.
(10) An offence under subsection (8) is an
offence of strict liability.
Note: For strict liability, see section 6.1 of
the Criminal Code.
132
Offence‑related searches and seizures
(1) If an inspector has reasonable grounds
for suspecting that there may be at any premises a particular thing that may be
evidence of the commission of an offence against this Code, the inspector, with
any necessary help, may:
(a) with the consent of the occupier
of the premises; or
(b) under a warrant issued under
section 133;
enter the premises and:
(c) search the premises for the thing;
and
(d) if the thing is found, take photographs
(including video recordings) of the premises or thing, take samples of the
thing, seize the thing or undertake more than one of those activities; and
(e) give any directions for, or with
respect to, the detention of a thing that has been seized under paragraph (d).
(2) If, in the course of searching, under a
warrant issued under section 133, for a particular thing in relation to a
particular offence, an inspector finds a thing that the inspector believes, on
reasonable grounds, to be:
(a) a thing that may be evidence of
the commission of the offence, although not the thing stated in the warrant; or
(b) a thing that may be evidence of
the commission of another offence against this Code or an offence against the
Agvet Code of another jurisdiction;
and the inspector believes, on reasonable grounds, that it
is necessary to seize that thing in order to prevent its concealment, loss or
destruction, or its use in committing, continuing or repeating the offence or
the other offence, the warrant is taken to authorise the inspector to seize
that thing.
(3) If an inspector seizes a thing under paragraph (1)(d)
and the inspector is authorised by the APVMA to exercise powers under this
subsection, the inspector may do any one or more of the following:
(a) if the seizure related to a
substance and the inspector suspects that there has been a contravention of
this Code in respect of any of its constituents, or in respect of the
concentration, composition or purity of any of its active
constituents—supervise the reformulation of the substance so that there is no
such contravention;
(b) if the seizure related to a
substance and its container and the inspector suspects that there has been a
contravention of this Code in respect of the container—supervise the placing of
the substance in a container in respect of which there is no such
contravention;
(c) if the seizure related to a
substance and its container and the inspector suspects that there has been a
contravention of this Code in respect of the label attached to the
container—supervise the attaching to the container of a label in respect of
which there is no such contravention.
133
Offence‑related warrants
(1) An inspector may apply to a magistrate
for a warrant under this section in relation to particular premises.
(2) Subject to subsection (3), a
magistrate may issue the warrant in accordance with the prescribed form if he
or she is satisfied, by information on oath, that there are reasonable grounds
for suspecting that there is, or may be within the next 72 hours, at the
premises a particular thing that may be evidence of the commission of an
offence against this Code.
(3) A magistrate must not issue a warrant
under subsection (2) unless the informant or some other person has given
to the magistrate, either orally or by affidavit, any further information that
the magistrate requires about the grounds on which the issue of the warrant is
being sought.
(4) The warrant must:
(a) state the nature of the offence;
and
(b) state the purpose for which the warrant
is issued; and
(c) authorise an inspector named in
the warrant, with any help, and using any force, that is necessary and
reasonable, to enter the premises and exercise the powers referred to in
paragraphs 132(1)(c), (d) and (e) in respect of the thing; and
(d) state whether entry is authorised
to be made at any time of the day or night or during stated hours of the day or
night; and
(e) state a day, not later than 7 days
after the day of issue of the warrant, upon which the warrant ceases to have effect.
134
Announcement before entry
(1) An inspector who is authorised to enter
premises under a warrant issued under section 133 or a person helping such
an inspector must, before any person enters the premises under the warrant:
(a) announce that he or she is
authorised by the warrant to enter the premises; and
(b) give any person at the premises an
opportunity to allow entry to the premises.
(2) The inspector or a person helping the
inspector does not have to comply with subsection (1) if he or she
believes on reasonable grounds that immediate entry to the premises is required
to ensure:
(a) the safety of a person (including
the inspector and any person helping the inspector); or
(b) that the effective execution of
the warrant is not frustrated.
135
Details of warrant to be given to occupier
(1) If a warrant under section 133 in
relation to premises is being executed and the occupier of the premises or
another person who apparently represents the occupier is present at the
premises, the inspector or a person helping the inspector must make a copy of
the warrant available to that person.
(2) The inspector must identify himself or
herself to the person at the premises.
(3) The copy of the warrant referred to in subsection (1)
need not include the signature of the magistrate who issued the warrant.
136
Use of equipment to examine or process things
(1) An inspector who enters premises under
section 131 or 132 or a person helping the inspector may bring to the
premises any equipment reasonably necessary for the examination or processing
of things found at the premises in order to determine whether they are things
that may be seized under that section.
(2) If:
(a) it is not practicable to examine
or process the things at the premises; or
(b) the occupier of the premises
consents in writing;
the things may be moved to another place so that the
examination or processing can be carried out in order to determine whether they
are things that may be seized under section 131 or 132, as the case may
be.
(3) If things containing electronically
stored information are moved to another place for the purpose of examination or
processing under subsection (2), the inspector must, if it is practicable
to do so:
(a) tell the occupier the address of
the place and the time at which the examination or processing will be carried
out; and
(b) allow the occupier or a
representative of the occupier to be present during the examination or
processing.
(4) The inspector or a person helping the
inspector may operate equipment already at the premises to carry out the
examination or processing of a thing found at the premises in order to
determine whether it is a thing that may be seized under section 131 or
132, as the case may be, if the inspector or person helping believes on
reasonable grounds that:
(a) the equipment is suitable for the
examination or processing; and
(b) the examination or processing can
be carried out without damage to the equipment or the thing.
137
Use of electronic equipment at premises
(1) Subject to subsection (4), if a
thing found at premises that an inspector has entered under section 131 or
132 is or includes records of information in a written or electronic form, the
inspector or a person helping the inspector may operate, or the inspector may require
the occupier or an employee of the occupier who is present to operate,
equipment at the premises to see whether:
(a) the equipment; or
(b) a disk, tape or other storage
device that:
(i) is at the premises;
and
(ii) can be used with, or
is associated with, the equipment;
contains records that are relevant to determining whether
this Code has been complied with.
(2) If the inspector or a person helping the
inspector, after equipment at the premises is operated, finds that the
equipment contains records of that kind or that a disk, tape or other storage
device at the premises contains records of that kind, he or she may:
(a) seize the equipment or the disk,
tape or other storage device; or
(b) if the records can, by using
facilities at the premises, be put in documentary form—operate the facilities
to put the records in that form and seize the documents so produced; or
(c) if the records can be transferred
to a disk, tape or other storage device that:
(i) is brought to the
premises; or
(ii) is at the premises and
whose use for the purpose has been agreed to in writing by the occupier of the
premises;
operate the equipment or other
facilities to copy the records to the storage device and remove the storage
device from the premises.
(3) An inspector or person helping an
inspector may seize equipment under paragraph (2)(a) only if:
(a) it is not practicable to put the
relevant records in documentary form as mentioned in paragraph (2)(b) or
to copy the records as mentioned in paragraph (2)(c); or
(b) possession by the occupier of the
equipment could be an offence.
(4) An inspector or a person helping an
inspector must not operate equipment for the purpose mentioned in subsection (1)
unless the inspector or person helping believes on reasonable grounds that the
operation of the equipment can be carried out without damage to the equipment.
138
Compensation for damage to electronic equipment
(1) If:
(a) equipment is damaged because of
being operated as mentioned in section 136 or 137; and
(b) the damage was caused by:
(i) insufficient care
being exercised in selecting the person who was to operate the equipment; or
(ii) insufficient care
being exercised by the person operating the equipment;
the APVMA must pay compensation for the damage to the
owner of the equipment.
(2) In determining the amount of compensation
payable, regard is to be had to whether the occupier of the premises and the
employees and agents of the occupier, if they were available at the time, had
provided any warning or guidance as to the operation of the equipment that was
appropriate in the circumstances.
139
Copies of seized things to be given
(1) Subject to subsection (2), if an
inspector who has entered premises under section 131 or 132 seizes:
(a) a document, film, computer file or
other thing that can be readily copied; or
(b) a storage device the information
in which can be readily copied;
the inspector must, if asked to do so by the occupier of
the premises or another person who apparently represents the occupier and is
present when the seizure takes place, give a copy of the thing or the
information to that person as soon as practicable after the seizure.
(2) Subsection (1)
does not apply if:
(a) the thing that has been seized was
seized under paragraph 137(2)(b) or (c); or
(b) possession by the occupier of the
document, film, computer file, thing or information could be an offence.
140
Return of things that are seized
(1) If an inspector seizes a thing under
section 131 or 132, the inspector must take reasonable steps to return it
if the reason for its seizure no longer exists.
(2) If the thing has not been returned before
the end of 60 days after its seizure, the inspector must take reasonable steps
to return it unless:
(a) proceedings in which the thing may
be used in evidence were begun before the end of the 60 days and the
proceedings (including an appeal to a court in relation to the proceedings)
have not been completed; or
(b) the inspector may keep the thing
because of an order under section 141; or
(c) the inspector is authorised by
this Code or by an order of a court to keep, destroy or dispose of the thing.
(3) If the thing has to be returned, it must
be returned to the person from whom it was seized or, if that person is not
entitled to possess it, to the owner.
(4) If there is a dispute as to the ownership
of the thing, the inspector may keep the thing until the dispute is resolved.
(5) This section has effect subject to
sections 141 and 150.
141
Court of summary jurisdiction may permit a thing to be kept
(1) If:
(a) before the end of 60 days after an
inspector seizes a thing under section 131 or 132; or
(b) before the end of a period
previously stated in an order of a court under this section in respect of a
thing seized by an inspector as mentioned in paragraph (a);
proceedings in which the thing may be used in evidence
have not been brought, the inspector may apply to a court of summary
jurisdiction for an order that he or she may keep the thing for a further
period.
(2) If the court is satisfied that it is
necessary for the inspector to continue to keep the thing:
(a) for the purposes of an
investigation as to whether an offence has been committed; or
(b) to enable evidence of an offence
to be secured for the purposes of a prosecution;
the court may order that the inspector may keep the thing
for a period stated in the order.
(3) If the court thinks that notice of the
application should be given to any person, it may require such a notice to be
given before it hears the application.
142 Certain
expenses to be recoverable by APVMA
(1) Any expense incurred by the APVMA under
paragraph 131(1)(i) in respect of the destruction or making harmless of a
chemical product is a debt due to the APVMA by the owner of the product.
(2) Any expense incurred by the APVMA under
subsection 132(3) in supervising:
(a) the reformulation of a substance;
or
(b) the placing of a substance in a
container; or
(c) the attaching of a label to a
container;
is a debt due to the APVMA:
(d) if paragraph (a) or (b) applies—by
the owner of the substance; or
(e) if paragraph (c) applies—by
the owner of the substance in the container.
(3) Any expense incurred by the APVMA under
paragraph 140(2)(c) in destroying or disposing of a thing is a debt due to the
APVMA by the owner of the thing.
(4) Any expense incurred by the APVMA under
section 140 in returning a thing to a person is a debt due to the APVMA by
the person.
(5) Any expense incurred by the APVMA under
section 150 in disposing of a thing that has been forfeited to the APVMA
is a debt due to the APVMA by the person whose property the thing was before it
was forfeited.
(6) The APVMA may recover a debt due by a
person under this section by action against the person.
143
Warrants may be granted by telephone in urgent circumstances
(1) If, because of circumstances of urgency,
an inspector considers it necessary to do so, the inspector may apply for a
warrant under subsection 133(1), by telephone, in accordance with this section.
(2) Before so applying, an inspector must
prepare an information of a kind referred to in subsection 133(2) that sets out
the grounds on which the issue of the warrant is being sought, but the
inspector may, if it is necessary to do so, apply before the information has
been sworn.
(3) If a magistrate to whom an application
under subsection (1) is made is satisfied:
(a) after having considered the terms
of the information prepared in accordance with subsection (2); and
(b) after having received any further
information that the magistrate requires about the grounds on which the issue
of the warrant is being sought;
that there are reasonable grounds for issuing the warrant,
the magistrate must complete and sign such a search warrant as the magistrate
would have issued under section 133 if the application had been made in
accordance with that section.
(4) If a magistrate signs a warrant under subsection (3):
(a) the magistrate must notify the
inspector of the terms of the warrant and the date on which and the time at
which it was signed, and write on it the reasons for the granting of the
warrant; and
(b) the inspector must complete a form
of warrant in the terms notified to the inspector by the magistrate and write
on it the name of the magistrate and the date on which and the time at which
the warrant was signed.
(5) If an inspector completes a form of
warrant in accordance with subsection (4), the inspector must, not later
than the day after the day on which the warrant ended or was executed,
whichever is the earlier, send to the magistrate who signed the warrant the
form of warrant completed by the inspector and the information duly sworn in
connection with the warrant.
(6) Upon
receiving the documents referred to in subsection (5), the magistrate must
attach to them the warrant signed by the magistrate and deal with the documents
in the manner in which the magistrate would have dealt with the information if
the application for the warrant had been made in accordance with section 133.
(7) A form of warrant duly completed by an
inspector in accordance with subsection (4) is, if it is in accordance
with the terms of the warrant signed by the magistrate, authority for any
entry, search, seizure or direction that the warrant so signed authorises.
(8) If it is material, in any proceedings, for
a court to be satisfied that an entry, search, seizure or direction was
authorised in accordance with this section, and the warrant signed by a
magistrate in accordance with this section authorising the entry, search,
seizure or direction is not produced in evidence, the court must assume, unless
the contrary is proved, that the entry, search, seizure or direction was not
authorised by such a warrant.
144
Power of inspector to require information or documents
(1) Subject to subsection (2), an
inspector who has entered premises under this Division may, to the extent that
it is reasonably necessary for the purpose of finding out whether this Code has
been complied with, require a person to give information to the inspector and
to produce any documents referred to by the inspector.
(2) An inspector is not entitled to make a
requirement of a person under subsection (1) unless the inspector produces
his or her identity card for inspection by the person.
(3) A person must not refuse or fail to
comply with a requirement made under subsection (1).
Penalty: 30 penalty units.
(4) Subsection (3) does not apply if the
person has a reasonable excuse.
Note: The defendant bears an evidential burden in
relation to the matter in subsection (4). See subsection 13.3(3) of the Criminal
Code.
(5) An offence under subsection (3) is
an offence of strict liability.
Note: For strict liability, see section 6.1 of
the Criminal Code.
145
False or misleading information or document
(1) A person commits an offence if, for the
purposes of, or in connection with, the consideration by the APVMA, 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:
(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 APVMA, 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.
Division 4—Miscellaneous enforcement provisions
146
Self‑incrimination to be a reasonable excuse for non‑compliance
with requirement
It is a reasonable excuse for a person
to refuse or fail to give information, produce a document or do any other thing
that the person is required to do by or under this Code that the information,
the production of the document or the doing of that other thing would tend to
incriminate the person.
147
Time for bringing prosecutions
A prosecution for an offence against
this Code may be begun at any time within 2 years after the commission of the
offence.
148
Copying of documents
If an inspector inspects a document
under section 131 or seizes a document under section 131 or 132 or a
person produces a document to an inspector in accordance with a requirement
under subsection 144(1), the inspector may make copies of, or take extracts
from, the document.
149
Evidential certificates
(1) This section has effect for the purposes
of any proceeding:
(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.
(2) A certificate that states a matter
referred to in subsection (3) is evidence of that matter if it is signed
by the Chief Executive Officer of the APVMA, or by a member of the staff of the
APVMA whom the APVMA has authorised to give certificates under this section.
(3) The matters that may be stated in a
certificate referred to in subsection (2) are as follows:
(a) that a substance referred to in
the certificate was, or was not, at a particular time, or during a particular
period, an active constituent, or an approved active constituent, for a
proposed or existing chemical product;
(b) that a chemical product referred
to in the certificate was, or was not, at a particular time, or during a
particular period, a chemical product, a registered chemical product or a
registered listed chemical product;
(c) that a label referred to in the
certificate was, or was not, at a particular time, or during a particular
period, an approved label for containers for a chemical product or a label for
containers for a chemical product that is required by an established standard
for the product;
(d) that a permit or exemption
referred to in the certificate was in force at a particular time or during a
particular period;
(e) that an approval, registration,
permit or exemption referred to in the certificate was suspended at a
particular time or during a particular period;
(f) that an approval, registration,
permit or exemption referred to in the certificate is, or was at a particular
time or during a particular period, subject to a stated condition;
(g) that the matter appearing on an
approved label or on a label for containers for a chemical product that is
required by an established standard for the product, or in a permit, referred
to in the certificate is identical to matter set out in, or in a writing
annexed to, the certificate;
(h) that a person named in the
certificate was an inspector at a particular time or during a particular
period;
(i) that a document referred to in
the certificate that purports to be a copy of, or an extract from, a record,
register or file kept under this Code is a true copy or extract, as the case
may be;
(j) that a notice, direction or
requirement referred to in the certificate was given at a particular time to a
particular person under this Code;
(k) that the APVMA had not received by
a particular time an application, statement, report or other document, or any
sample or other thing, referred to in the certificate that was required or
permitted to be made or given to the APVMA by a person under this Code;
(l) that a document referred to in
the certificate is, or was at a particular time or during a particular period,
a standard, rule, code, specification or method of a particular association,
body or institution;
(m) that a licence referred to in the
certificate was in force at a particular time or during a particular period;
(n) that a licence referred to in the
certificate was suspended at a particular time or during a particular period;
(o) that a licence referred to in the
certificate is, or was at a particular time or during a particular period,
subject to a stated condition;
(p) that a particular statement
contained in a document referred to in the certificate is, or was at a
particular time or during a particular period, a manufacturing principle that
the APVMA has determined.
(4) Unless the contrary is proved, a document
purporting to be a certificate referred to in subsection (2) is taken to
be such a certificate and to have been duly given.
(5) Unless the contrary is proved, evidence
that a label attached to a sealed container contained any matter at any time in
a manner prescribed or required by this Code in relation to a chemical product
is also evidence that the product was in the container at that time.
150
Forfeiture
(1) If a person is convicted of an offence
against this Code in respect of a thing that the court finds to be the property
of that person, the court may order all or any part of the thing to be
forfeited to the APVMA.
(2) If the court makes an order under subsection (1)
in respect of, or in respect of part of, a thing, the thing, or that part of
the thing, as the case may be, becomes the property of the APVMA and, subject
to section 162, may be dealt with or disposed of in any manner that the
APVMA thinks appropriate.
151
Conduct by directors, servants and agents
(1) Subject to subsection (2), in
proceedings against a body corporate for an offence against this Code:
(a) any conduct engaged in by a
director, servant or agent of the body corporate within the actual or apparent
scope of his or her employment or within his or her actual or apparent
authority is taken to have been engaged in also by the body corporate; and
(b) it is taken to be established that
conduct (the relevant conduct) was engaged in by the body
corporate intentionally, knowingly or recklessly if it is proved:
(i) that the directors of
the body corporate intentionally, knowingly or recklessly engaged in the
relevant conduct or expressly, tacitly or impliedly authorised or permitted the
relevant conduct to be engaged in; or
(ii) that a servant or
agent of the body corporate with duties of such responsibility that his or her
conduct may fairly be assumed to represent the policy of the body corporate
intentionally, knowingly or recklessly engaged in the relevant conduct or
expressly, tacitly or impliedly authorised or permitted the relevant conduct to
be engaged in.
(2) Subparagraph (1)(b)(ii) does not
apply if the body corporate proves that it exercised due diligence to prevent
the relevant conduct.
(3) Subject to subsection (4), in
proceedings against an individual for an offence against this Code:
(a) any conduct engaged in by a
servant or agent of the individual within the actual or apparent scope of his
or her employment or within his or her actual or apparent authority is taken to
have been engaged in also by the individual; and
(b) it is taken to be established that
conduct (the relevant conduct) was engaged in by the individual
intentionally, knowingly or recklessly if it is proved that a servant or agent
of the individual with duties of such responsibility that his or her conduct
may fairly be assumed to represent the policy of the individual intentionally,
knowingly or recklessly engaged in the relevant conduct or expressly, tacitly
or impliedly authorised or permitted the relevant conduct to be engaged in.
(4) Paragraph (3)(b) does not apply if
the individual proves that he or she exercised due diligence to prevent the
relevant conduct.
(5) If:
(a) an individual is convicted of an
offence against this Code; and
(b) the individual would not have been
convicted of the offence if subsections (3) and (4) had not been enacted;
the individual is not liable to be punished by
imprisonment for the offence.
(6) A reference in this section to engaging
in conduct includes a reference to failing or refusing to engage in conduct.
152
Liability of persons acting on behalf of non‑residents
(1) If:
(a) a person does any thing in this
jurisdiction on behalf of another person who is not a resident of, and does not
carry on business in, Australia; and
(b) the doing of that thing is an
offence against this Code;
this Code has effect, in addition to the effect that it
has apart from this subsection, as if the first‑mentioned person did that
thing on that person’s own account and not on behalf of the other person.
(2) If:
(a) a person who is not a resident of,
and does not carry on business in, Australia fails to do a thing in this
jurisdiction in relation to:
(i) an active constituent
for a proposed or existing chemical product in respect of which that person is
the interested person; or
(ii) a chemical product in
respect of which that person is the interested person; and
(b) the failure of that person to do
that thing is an offence against this Code;
the approved person who signed the application for the
approval of the constituent or the registration or listed registration, or the
renewal of the registration or listed registration, of the product is taken to
have been under the same liability under this Code as the first‑mentioned
person to do that thing and, if the thing is not done by the approved person,
is punishable accordingly.
(3) For an offence that arises because of subsection (2),
strict liability applies to paragraphs (2)(a) and (b).
Note: For strict liability, see section 6.1 of
the Criminal Code.
Part 10—Miscellaneous
153
Explanation of Part
This Part contains miscellaneous
provisions (other than enforcement provisions) that relate generally to other
provisions of this Code. Most provisions that affect only a particular part of
this Code are contained in that Part.
154
Recognition of things done under corresponding laws
(1) In this Code, unless the contrary
intention appears, a reference to any thing done by or in relation to the APVMA
is a reference to such a thing done under or for the purposes of the Agvet Code
of this jurisdiction or of another jurisdiction.
(2) In this Code, unless the contrary
intention appears, a reference to any thing done by or in relation to a court
is a reference to such a thing done under or for the purposes of the Agvet Code
of this jurisdiction or of another jurisdiction.
155
Discharge of obligations under this Code
(1) Except as expressly provided in this
Code, any thing done, whether within Australia or elsewhere, which, if it had
been done under or for the purposes of this Code, would have discharged an
obligation under this Code, discharges that obligation.
(2) Subject to subsection (3), any thing
that has to be done under this Code may, for the purposes of this Code, be done
anywhere in Australia, whether within or outside this jurisdiction.
(3) Subsection (2) does not affect the
operation of any provision of this Code that:
(a) expressly requires a particular
thing to be done within this jurisdiction; or
(b) expressly or by implication
permits a particular thing to be done outside Australia.
156
The making of single applications or the giving of single notices under the
Agvet Codes of all jurisdictions
(1) This section
facilitates the administration, on a national basis, of the Agvet Codes of all
jurisdictions by permitting the making of a single application, or the giving
or publication of a single notice, under the Agvet Codes of all jurisdictions.
(2) If an application is expressed to be made
under the Agvet Codes (rather than under the Agvet Code of a particular jurisdiction),
it has effect as an application under the relevant provision of the Agvet Code
of this jurisdiction in addition to any effect that it may have under the Agvet
Code of any other jurisdiction.
(3) If a notice is expressed to be given or
published by the APVMA under the Agvet Codes (rather than under the Agvet Code
of a particular jurisdiction), it has effect as a notice given or published
under the relevant provision of the Agvet Code of this jurisdiction in addition
to any effect that it may have under the Agvet Code of any other jurisdiction.
157
Samples to be given for analysis
(1) If the APVMA so requires, a person who
makes an application under this Code must:
(a) if the application relates to an
active constituent or active constituents for a proposed or existing chemical
product—give a sample of that constituent or of each of those constituents; or
(b) if the application relates to a
chemical product—give a sample of any constituent of the product or a sample of
the product, or both;
to the APVMA or to a body named by the APVMA, for the
purpose of analysis by an approved analyst.
(2) The sample
must:
(a) be of a quantity; and
(b) be taken on a day; and
(c) be taken in a manner; and
(d) be
taken from a batch;
that the APVMA has directed.
(3) The applicant must pay to the APVMA the
amount that the APVMA notifies the applicant in writing to be the cost of the
analysis referred to in subsection (1), including the cost of packaging
and transporting the sample or samples for analysis.
159 APVMA
or other authority may require, or require additional, information, report or
sample in certain circumstances
(1) For the purposes of:
(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 APVMA 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 APVMA allows, to do any one or more of the following:
(e) give to the APVMA or that
prescribed authority, as the case may be, information, of a kind stated in the
notice, that may be relevant to the application, reconsideration or decision;
(f) carry out a search of published
literature for information about the active constituent, or about the chemical
product or any of its constituents, as the case may be, and give a report to
the APVMA or that prescribed authority on the results of that search;
(g) give to the APVMA or that
prescribed authority, or to another body that the APVMA or that authority has
determined, a sample of the active constituent, or of the chemical product or
any of its constituents, as the case may be, for the purpose of analysis by an
approved analyst.
(1A) The power of the APVMA or another authority
under subsection (1) to require a person to give to the APVMA or to that
authority information, a report or a sample includes a power to require the
person to give to the APVMA 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 APVMA or to that authority under any provision of
this Code other than this section or under a previous application of this
section.
(2) Any information or report that a person
has to give to the APVMA or a prescribed authority under subsection (1)
must be given in writing and be signed by an approved person.
(3) If a person fails, without reasonable
excuse, to comply with a requirement under subsection (1) that was made
for the purposes of an application referred to in paragraph (1)(a) or (b),
the APVMA may:
(a) treat the application as having
been withdrawn; or
(b) suspend further consideration of
the application until the applicant complies with the requirement.
(4) If the APVMA decides in accordance with subsection (3)
to treat an application as having been withdrawn or to suspend further
consideration of an application, it must give written notice of its decision to
the applicant.
(5) Section 168 provides for additional
matters to be included in a notice under subsection (4).
160
Overseas trials or experiments
For the purposes of:
(a) an application under this Code in
relation to an active constituent for a proposed or existing chemical product;
or
(b) an application under this Code in
relation to a chemical product (including an application in relation to a label
for containers for a chemical product); or
(c) reconsidering the approval of an
active constituent for a proposed or existing chemical product, the
registration or listed registration of a chemical product or the approval of a
label for containers for a chemical product; or
(d) deciding whether to suspend or
cancel a permit in respect of an active constituent for a proposed or existing
chemical product or in respect of a chemical product;
the APVMA may take account of the results of any trials or
experiments already carried out in a foreign country in relation to the
constituent, or in relation to the product or any of its constituents, to the
extent that those results are relevant having regard to any matters it thinks
appropriate, including:
(e) any significant differences in the
proposed use of the constituent, or of the product, in Australia and in that
foreign country; or
(f) any different environmental
factors affecting the use of the constituent, or of the product, in Australia
and in that foreign country; or
(g) any significant additional
information relating to the properties of the constituent, or of the product or
of any of its constituents, that has become available since the conduct of
those trials or experiments.
160A
Notification of new information to APVMA in respect of pending application
(1) This section applies if:
(a) an application has been lodged
with the APVMA 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 APVMA 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 APVMA.
Penalty: 300 penalty units.
(3) A person is an appropriate person
in relation to an application referred to in paragraph (1)(a) if:
(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 case—the person who
made the application.
(4) Information is relevant information
if it:
(a) contradicts any information given
to the APVMA 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 APVMA for the product; or
(d) would have had to be given to the
APVMA 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 APVMA under this section must be given in writing signed by an approved
person.
161
Notification of new information to APVMA
(1) If:
(a) the interested person in relation
to an approved active constituent for a proposed or existing chemical product
or in relation to a registered chemical product or a registered listed chemical
product; or
(b) the holder of a permit in relation
to an active constituent for a proposed or existing chemical product or in
relation to a chemical product;
becomes aware of any relevant information in relation to
the constituent or in relation to the product or of any of its constituents,
the person must, as soon as practicable after the person becomes aware of the
information, give that information to the APVMA.
Penalty: 300 penalty units.
(2) Information
is relevant information if it:
(a) contradicts any information given
to the APVMA under this Code; or
(b) shows that the use of, or any
other dealing with, the constituent or the chemical product in accordance with
the instructions for its use or for such a dealing that the APVMA has approved:
(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 product
in accordance with the instructions for its use that the APVMA has approved may
be ineffective according to criteria determined by the APVMA for the product;
or
(d) would have had to be given to the
APVMA in connection with the application for the approval, registration, listed
registration or permit if the applicant had been aware of the information when
the application was made.
(2A) A corporation is taken to be aware of any
information if a related corporation is aware of that information.
(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.
(3) Any information that a person has to give
to the APVMA under this section must be given in writing signed by an approved
person.
162
Disclosure of confidential commercial information
(1) A person who is or has been a director,
the Chief Executive Officer, or a member of the staff, of the APVMA, or is or
has been a consultant to the APVMA, a mediator or arbitrator appointed under
this Code, or a co‑ordinator designated for a jurisdiction, must not
disclose, directly or indirectly, to another person any information about an
active constituent for a proposed or existing chemical product, about a
chemical product or any of its constituents, or about a label for containers
for a chemical product, that:
(a) the person knows to be
confidential commercial information; and
(b) was
acquired by the person in the performance of such functions or duties or the
exercise of such powers.
Penalty: Imprisonment for 2 years.
(1A) Subsection (1) does not apply to the
extent that the person engages in the conduct in the performance of functions
or duties, or the exercise of powers, under this Code.
Note: The defendant bears an evidential burden in
relation to the matter in subsection (1A). See subsection 13.3(3) of the Criminal
Code.
(2) Subsection (1) does not prohibit the
disclosure of information about a constituent or a chemical product to a court
in any proceeding but the court must do all things necessary to prevent
disclosure of that information to any other person except for the purpose of
the proceeding.
(3) Despite subsection (1), a person
(the authorised person) that the APVMA has authorised to act
under this section may:
(a) disclose confidential commercial
information about an active constituent for a proposed or existing chemical
product:
(i) by disclosing a
summary of an assessment of the constituent made by the APVMA or by a
prescribed authority or person; or
(ii) for the purposes of
the APVMA’s reconsideration of the approval of the constituent under Division 4
of Part 2—by disclosing the relevant particulars of the constituent; or
(iii) by disclosing, subject
to the conditions prescribed by the regulations, information about the toxicity
of the constituent and its residues in relation to relevant organisms and
ecosystems, including human beings; or
(b) disclose confidential commercial
information about a chemical product or any of its constituents:
(i) if the product
contains an active constituent that, before the registration or listed
registration of the product, was not contained in a chemical product registered
in this or another jurisdiction under the Agvet Code, or a corresponding
previous law, of the jurisdiction concerned—by disclosing a summary of an
assessment that the APVMA has made of the product; or
(ii) for the purposes of
the APVMA’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 2A—by disclosing the relevant particulars of the product; or
(iii) by disclosing, subject
to any conditions prescribed by the regulations, information about the toxicity
of the product and its residues in relation to relevant organisms and
ecosystems, including human beings; or
(c) disclose confidential commercial
information about an active constituent for a proposed or existing chemical
product, or about a chemical product or any of its constituents, to:
(i) the Commonwealth, a
State or a Territory, or an authority of the Commonwealth, of a State or of a
Territory; or
(ii) a person who is
expressly authorised to obtain the information by the interested person in
relation to the constituent or product; or
(iii) a prescribed authority
or prescribed person; or
(d) subject to subsection (4),
disclose confidential commercial information about an active constituent for a
proposed or existing chemical product, or about a chemical product or any of
its constituents, to:
(i) an overseas authority
having similar functions to the APVMA; or
(ii) a
prescribed international organisation;
if the authorised person thinks
it is reasonable to make the disclosure and the interested person in relation
to the constituent or product has consented to the disclosure or the authorised
person has made reasonable efforts to obtain that consent.
(4) An authorised person must not disclose
information to an authority or organisation under paragraph (3)(d) without
the consent of the interested person unless:
(a) the authorised person has given to
the interested person written notice of the decision to disclose the
information; and
(b) a period of 28 days has elapsed
since the notice was given.
(5) Section 168 provides for additional
matters to be included in a notice given under paragraph (4)(a).
(6) A person who acquires information because
of a disclosure under subsection (3), and any person under the control of
that person, is, in respect of that information, subject to the same
obligations and liabilities under subsection (1) as if that person were a
person performing duties under this Code and had acquired the information in
the performance of those duties.
(7) Despite subsection (1), the
authorised person may permit confidential commercial information about a
constituent or chemical product to be disclosed to a Government, body or
person:
(a) for the purpose of enabling the
Government, body or person to give advice to the APVMA or to another
Government, body or person in accordance with section 8 of the
Agricultural and Veterinary Chemicals (Administration) Act 1992; or
(b) if the person is a co‑ordinator
for a jurisdiction—for the purpose of enabling the co‑ordinator to make a
recommendation to the APVMA in accordance with paragraph 111(1)(c).
Note: The defendant bears an evidential burden in
relation to the matter in subsection (7). See subsection 13.3(3) of the Criminal
Code.
(8) A person who acquires information because
of a disclosure under subsection (7), and any person who is or has been
under the control of that person, must not disclose that information, directly
or indirectly, to any person if the person disclosing the information knows
that the information is confidential commercial information.
Penalty: Imprisonment for 2 years.
(8A) Subsection (8) does not apply to
conduct engaged in with the intention of providing advice to the APVMA in
accordance with section 8 of the Agricultural and Veterinary Chemicals
(Administration) Act 1992 or making a recommendation to the APVMA in
accordance with paragraph 111(1)(c).
Note: The defendant bears an evidential burden in
relation to the matter in subsection (8A). See subsection 13.3(3) of the Criminal
Code.
(8B) In subsection (8), strict liability
applies to the physical element of circumstance, that the disclosure was under subsection (7).
Note: For strict liability, see section 6.1 of
the Criminal Code.
(9) If a person who is or has been a
director, the Chief Executive Officer, or a member of the staff, of the APVMA,
or is or has been a consultant to the APVMA, a mediator or arbitrator appointed
under this Code, or a co‑ordinator designated for a jurisdiction, has
disclosed to another person, except under subsection (3) or (7), any
confidential commercial information about an active constituent for a proposed
or existing chemical product, or about a chemical product or any of its
constituents, that was acquired by the first‑mentioned person in the
performance of functions or duties, or the exercise of powers, under this Code,
the other person, and any person who is or has been under the control of the
other person, must not disclose that information, directly or indirectly, to
any person if the person disclosing the information knows that the information
is confidential commercial information.
Penalty: Imprisonment for 2 years.
(9A) In subsection (9),
strict liability applies to the physical elements of circumstance, that:
(a) the acquisition of the information
by the first‑mentioned person was in the performance of functions or
duties, or the exercise of powers, under this Code; and
(b) the disclosure mentioned first in
that subsection was made other than under subsection (3) or (7).
Note: For strict liability, see section 6.1 of
the Criminal Code.
(10) The powers conferred by subsection (7)
are in addition to, and do not prejudice, the powers conferred by subsection (3).
(11) A notice published under section 52,
53, 54 or 55 must not contain any confidential commercial information about an
active constituent for a proposed or existing chemical product or about a
chemical product or any of its constituents.
(12) This section does not preclude the
institution of an action or other civil proceeding against a person in respect
of the disclosure, or the proposed, threatened or likely disclosure, by that
person of confidential commercial information about an active constituent for a
proposed or existing chemical product, or about a chemical product or any of
its constituents.
(13) A reference in this section to information
about an active constituent for a proposed or existing chemical product, or
about a chemical product, includes a reference to the fact that:
(a) an application has been made for
approval of the constituent or registration of the product; or
(b) an application has been made for a
permit in respect of the constituent or product, if the making of the
application is confidential commercial information.
(13A) A reference in this section to information
about:
(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.
(14) In this section:
court includes a tribunal, authority or
person having power to require the production of documents or the answering of
questions.
disclose, in relation to information, means
give or communicate in any way.
163
Notice to interested person of proposed disclosure of information that is
claimed to be confidential commercial information
(1) If:
(a) a person (the disclosing
person) decides to disclose to another person information about an
active constituent for a proposed or existing chemical product, about a
chemical product or any of its constituents, or about a label for containers
for a chemical product; and
(b) the interested person in relation
to the constituent, product or label has claimed to the APVMA that the
information is confidential commercial information but the disclosing person
does not agree with the claim; and
(c) the disclosure would, if the
information were confidential commercial information, contravene section 162;
the disclosing person:
(d) must give written notice to the
interested person of the decision to disclose the information stating the
reasons why the disclosing person considers that the information is not
confidential commercial information; and
(e) must
not disclose the information until the end of 28 days after the notice is
given.
Penalty: Imprisonment for 2 years.
(2) Section 168 provides for additional
matters to be included in a notice given under subsection (1).
164
Fees
(1) The regulations may prescribe, or prescribe
a method of working out, the fees to be paid in respect of the making of an
application to the APVMA, or the doing of any thing by the APVMA or by an
inspector, under this Code.
(1A) The APVMA may make a legislative
instrument setting out criteria for working out which fee applies under the
regulations in a particular case.
(2) Fees referred to in subsection (1)
are due and payable in the manner and at the time or times that are prescribed.
(4) Two or more fees may be prescribed for
the same matter.
(5) A fee is not payable in respect of the
making of an application to the APVMA, or the doing of any thing by the APVMA
or by an inspector, under a provision of the Agvet Code of this jurisdiction in
relation to an active constituent for a proposed or existing chemical product,
a chemical product, or a label for containers for a chemical product, if a
corresponding fee has been paid in respect of the making of a corresponding
application, or the doing of a corresponding thing, as the case may be, in relation
to the same constituent, product or label, under the corresponding provision of
the Agvet Code of another jurisdiction.
(6) Any fee that the APVMA receives under
this Code is to be paid to the Commonwealth.
(7) If a fee has to be paid in respect of an
application to the APVMA or in respect of the doing of any thing by the APVMA,
the APVMA may refuse to consider the application or do that thing until the fee
is paid.
(8) The APVMA may, on behalf of the
Commonwealth, either on its own initiative or on application by a person, waive
the whole or a part of a fee that would otherwise be payable under this Code,
or remit the whole or a part of a fee that has been paid under this Code:
(a) if the fee is payable or was paid
in respect of an application to the APVMA that is to be or has been withdrawn;
or
(b) in any other circumstances that
are prescribed by the regulations.
(9) If an application is made to the APVMA
under subsection (8), it must give to the applicant written notice of its
decision on the application.
(10) Section 168 provides for additional
matters to be included in a notice given under subsection (9).
165
Period within which APVMA is to determine applications
(1) When an application is made under this
Code to the APVMA, the APVMA must determine the application within a period
stated in, or determined in accordance with, the regulations.
(1A) The APVMA may make a legislative
instrument setting out criteria for working out which period stated in, or
determined in accordance with, the regulations made for the purposes of subsection (1)
applies in a particular case.
(2) In working out the period within which an
application has to be determined, no regard is to be had to:
(a) any period beginning on the day
when the APVMA makes a requirement of the applicant in connection with the
application and ending on the day when the requirement is complied with; and
(b) if the APVMA has, before the
application was made, caused to be published a notice in the Gazette under
subsection 69EP(2) of the Agricultural and Veterinary Chemicals
(Administration) Act 1992 in relation to a hearing that is relevant to the
determination of the application and the hearing did not finish before the
application was made—the period beginning when the application was made and
ending when the hearing finished; and
(c) if the APVMA has, after the
application was made, caused such a notice to be published in the Gazette—the
period beginning when the notice was published and ending when the hearing
finished.
166
Reconsideration of decisions
(1) This section applies if:
(a) a decision (the original
decision) on a particular matter (the relevant matter)
has been made under this Code other than this section on behalf of the APVMA by
a member of the staff of the APVMA; and
(b) a person is entitled to apply
under section 167 to the Administrative Appeals Tribunal for review of the
original decision.
(2) The person may, by writing, request the
APVMA to reconsider the original decision.
(3) If a request is so made, the APVMA must
reconsider the original decision and:
(a) confirm the original decision; or
(b) vary the original decision; or
(c) set aside the original decision;
or
(d) set aside the original decision
and make a new decision in substitution for the original decision.
(4) The APVMA must, as soon as practicable,
give written notice to the person who made the request setting out the APVMA’s
decision on the reconsideration.
(5) The decision on the reconsideration is
taken, for the purposes of this Code other than paragraph (1)(a), to be a
fresh decision on the relevant matter made under the provision of this Code
under which the original decision was made.
(6) Section 168 provides for additional
matters to be included in certain notices given under subsection (4).
167
Review of decisions
(1) An application may be made to the
Administrative Appeals Tribunal for review of the following decisions of the
APVMA:
(aa) a decision under section 11A
that the application does not comply with subsection 11(1);
(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;
(a) a decision under Division 2
of Part 2 to refuse 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;
(b) a decision under Division 2
of Part 2 to approve an active constituent for a proposed or existing
chemical product, to register a chemical product, or to approve a label for
containers for a chemical product, subject to particular conditions;
(baa) a decision under section 26A
to refuse to vary:
(i) relevant particulars
of the approval of an active constituent for a proposed or existing chemical
product; or
(ii) relevant particulars
of the registration of a chemical product; or
(iii) relevant particulars
of the approval of a label for containers for a chemical product;
(ba) a decision under section 28A
that the application does not comply with subsection 28(1);
(bb) a
decision under section 28A:
(i) to defer consideration
of an application to vary the relevant particulars, or the conditions, of an
approval or registration; or
(ii) to treat such an
application as having been withdrawn; or
(iii) to reject such an
application;
(bc) a decision under section 28A
refusing to extend a period;
(c) a decision under Division 3
of Part 2 to refuse an application to vary the relevant particulars of the
approval of an active constituent for a proposed or existing chemical product,
the relevant particulars of the registration of a chemical product or the
relevant particulars of the approval of a label for containers for a chemical
product;
(d) a decision under Division 3
of Part 2 to refuse an application to vary the conditions of the approval
of an active constituent for a proposed or existing chemical product, the
registration of a chemical product, or the approval of a label for containers
for a chemical product;
(e) a decision under Division 4
of Part 2 to vary the conditions of the approval of an active constituent
for a proposed or existing chemical product, the registration of a chemical
product, or the approval of a label for containers for a chemical product;
(ea) a decision (the information
decision) under subsection 34D(3) that the APVMA is satisfied that it
is in the public interest to use information that section 34C would
otherwise prohibit the APVMA from using for making a decision (the substantive
decision):
(a) under section 14
or 29 about an application; or
(b) under section 34
about a reconsideration of an approval or registration;
(f) a decision under Division 5
of Part 2 to suspend or cancel the approval of an active constituent for a
proposed or existing chemical product, the registration of a chemical product
or the approval of a label for containers for a chemical product;
(fa) a decision under Division 4
of Part 2A to refuse an application for listed registration of a chemical
product;
(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;
(g) a decision under subsection 48(3)
or 56ZL(3) refusing to accept a late application;
(h) a decision to use protected
information under paragraph 59(2)(d);
(i) a decision under subsection
74(2), 75(2), 76(2) or 78(2) extending, or refusing to extend, a period;
(ia) a decision under subsection 81(3)
shortening, or extending or refusing to extend, a period;
(j) a decision under section 99
to require the analysis of a substance or mixture of substances;
(k) a decision to issue a recall
notice;
(l) a decision under Part 7 to
refuse an application for a permit;
(m) a decision under Part 7 to
issue a permit subject to particular conditions or for a particular period
only;
(n) a decision under Part 7 to
refuse to extend a permit;
(o) a decision under section 118
to suspend a permit;
(p) a decision under section 119
to cancel a permit;
(q) a decision under Part 8 to
refuse an application for a licence;
(r) a decision under Part 8 to
issue a licence subject to particular conditions referred to in subsection
126(1);
(s) a decision under subsection
126(2) to impose a new condition on a licence or varying an existing condition;
(t) a decision under section 127
to suspend or cancel a licence;
(u) a decision under subsection 159(3)
to treat an application as having been withdrawn or to suspend further
consideration of an application;
(v) a decision to disclose information
to an authority or organisation under paragraph 162(3)(d) without the consent
of the interested person concerned;
(w) a decision to disclose information
under section 163;
(x) a decision under subsection 164(8)
to refuse to waive or remit the whole or a part of a fee.
(2) For the purposes of this section, if an
application made to the APVMA is not determined within the period within which
the APVMA has to determine the application, the APVMA is taken to have made a
decision at the end of that period to refuse the application.
(2A) Despite paragraph (1)(ea), an
application may not be made to the Administrative Appeals Tribunal for review
of the information decision if the APVMA stated in the notice of that decision
given under section 34E that the APVMA believed it was necessary to make
the substantive decision before the end of 28 days after giving the notice, to
prevent imminent risk to public health or occupational health or safety.
(3) This section has effect subject to the Administrative
Appeals Tribunal Act 1975.
(4) In this section:
decision has the same meaning as in the
Administrative Appeals Tribunal Act 1975.
168
Statement to be included in certain notices of decisions
(1) If written notice of the making of a
decision to which section 167 applies, or of the making of a decision
under section 166 which, because of subsection 166(5), is taken to be a
decision to which section 167 applies, is given to a person (other than a
co‑ordinator designated for this or another jurisdiction), that notice
must include a statement to the effect that:
(a) subject to the Administrative
Appeals Tribunal Act 1975, application may be made by or on behalf of a
person whose interests are affected by the decision to the Administrative
Appeals Tribunal for review of the decision to which the notice relates; and
(b) unless subsection 28(4) of that
Act applies, application may be made in accordance with section 28 of that
Act by or on behalf of a person whose interests are affected by the decision
for a statement in writing setting out the findings on material questions of
fact, referring to the evidence or other material on which those findings were
based and giving the reasons for the decision.
(2) Any failure to comply with a requirement
of subsection (1) in relation to a decision does not affect the validity
of the decision.
169
Documents and samples become property of APVMA
When a document or sample is given to
the APVMA for any purpose of this Code, it becomes the property of the APVMA.
170
Provisions relating to offences
(1) Offences against subsections 162(1), (8)
and (9) and subsection 163(1) are indictable offences.
(2) All other offences against this Code are
summary offences.
(3) A provision of this Code relating to
indictable offences or summary offences is taken to refer to bodies corporate
as well as to individuals.
(4) If an
individual is convicted of an indictable offence against this Code, the court
may, if the court thinks it appropriate in all the circumstances of the case,
impose, instead of, or in addition to, a penalty of imprisonment, a monetary
penalty not greater than the number of penalty units worked out using the
formula:
where:
Term of Imprisonment means the number of
months in the maximum term of imprisonment by which the offence is punishable.
(5) If a body corporate is convicted of an
offence against this Code, the court may, if the court thinks fit, impose a
monetary penalty not greater than 5 times the amount of the maximum monetary
penalty that could be imposed by the court on an individual convicted of the
same offence.
170A
Person not to use protected name or protected symbol
(1) A person must not:
(a) use in relation to a business, trade,
profession or occupation; or
(b) use as the name, or as part of the name, of
any firm, body corporate, institution, premises, vehicle, ship or craft
(including aircraft); or
(c) apply, as a trade mark or otherwise, to
goods imported, manufactured, produced, sold, offered for sale or let on hire;
or
(d) use in relation to:
(i) goods or services; or
(ii) the promotion, by any means, of the supply
or use of goods or services;
either:
(e) a protected name, or a name so closely
resembling a protected name as to be likely to be mistaken for it; or
(f) a protected symbol, or a symbol so closely
resembling a protected symbol as to be likely to be mistaken for it.
Penalty: 30 penalty
units.
(2) Subsection (1) does not apply if the
APVMA consents in writing to the use or application of the name or symbol.
Note: The
defendant bears an evidential burden in relation to the matter in subsection (2).
See subsection 13.3(3) of the Criminal Code.
(3) Nothing in subsection (1) affects
rights conferred by law on a person in relation to:
(a) a trade mark that is registered under the Trade
Marks Act 1995; or
(b) a design that is registered under the Designs
Act 2003;
and was so registered immediately before 24 March 2004 in relation to the name or symbol.
(4) Nothing in this section affects the use, or
rights conferred by law relating to the use, of the name or symbol by a person
in a particular manner if, immediately before 24 March 2004, the person:
(a) was using the name or symbol in good faith
in that manner; or
(b) would have been entitled to prevent another
person from passing off, by means of the use of the name of the symbol or a
similar name or symbol, goods or services as the goods or services of the first‑mentioned
person.
(5) In this section:
protected name means:
(a) “APVMA”; or
(b) “Australian Pesticides and Veterinary
Medicines Authority”.
protected symbol means the logo of the APVMA
set out in the regulations.
Part 11—Transitional provisions
171
Explanation of Part
This Part contains provisions that
continue in force, under the Agvet Code of this jurisdiction, certain existing
clearances, registrations, approvals and permits and certain pending
applications, reconsiderations and proceedings.
172
Existing clearance for registration of chemical product
(1) If:
(a) immediately before the
commencement of the Agvet Code of this jurisdiction:
(i) a clearance for
registration that the APVMA granted under section 15 of the repealed Act
in respect of a chemical product was in force; and
(ii) the product was not
registered by a previous registering authority of this jurisdiction; and
(b) a label for containers for the
product becomes approved under that Code;
the following subsections apply.
(2) The product is taken to be registered by
the APVMA under section 20 of that Code when the label becomes approved
and to be so registered subject to the conditions (if any) to which the
clearance was subject.
(3) The person who applied for the clearance
is taken to be the person who applied for the registration.
173
Pending application for clearance for registration of chemical product
If:
(a) before the commencement of the
Agvet Code of this jurisdiction an application for the clearance for
registration of a chemical product was duly made to the APVMA under section 12
of the repealed Act but had not been disposed of by the APVMA; and
(b) the product was not registered
before that commencement by a previous registering authority of this
jurisdiction;
the following paragraphs apply:
(c) the application is taken to be an
application for the registration of the product duly made upon that
commencement to the APVMA under section 10 of that Code;
(d) any sample, particulars of trials
or laboratory experiments or other information given to the APVMA under a
provision of the repealed Act in connection with the application is taken to
have been given to the APVMA under the provision of that Code that corresponds
to that provision of the repealed Act.
174
Existing registration of chemical product
(1) If, immediately before the commencement
of the Agvet Code of this jurisdiction, a chemical product was registered by
the previous registering authority of this jurisdiction and a label in relation
to, or in relation to containers for, that product was also registered or
approved by that authority, the following paragraphs apply:
(a) the product is taken to have been
registered by the APVMA under section 20 of that Code upon that
commencement subject to the conditions (if any) to which its registration by
that previous registering authority was subject;
(b) the person who applied for the
registration of the product by the previous registering authority or, if that
registration was renewed, the person who applied for the renewal or the last
renewal, as the case may be, is taken to be the person who applied for the
registration of the product under that Code;
(c) the label is taken to have been
approved in relation to the product by the APVMA under section 21 of that
Code upon that commencement:
(i) for the containers for
which it was registered or approved by that previous registering authority or,
if it was not registered or approved for containers, for all containers for the
product; and
(ii) subject to the
conditions (if any) to which its registration or approval by that previous
registering authority was subject.
(2) If:
(a) immediately before the
commencement of the Agvet Code of this jurisdiction, the supply of a chemical
product that was not registered by the previous registering authority of this
jurisdiction was permitted in this jurisdiction, either unconditionally or
subject to conditions, because the product was registered by the previous
registering authority of another jurisdiction; and
(b) a label for containers for the
product becomes approved under that Code;
the following paragraphs apply:
(c) if the supply of the product was
permitted unconditionally—the product is taken to be registered by the APVMA
under section 20 of that Code when the label becomes approved;
(d) if its supply was permitted
subject to conditions—the product is taken to be so registered subject to those
conditions;
(e) the person who applied for the
registration of the product by the previous registering authority of the other
jurisdiction or, if that registration was renewed, the person who applied for
the renewal or the last renewal, as the case may be, is taken to be the person
who applied for the registration of the product under that Code.
(3) If, immediately before the commencement
of the Agvet Code of this jurisdiction:
(a) a chemical product was registered
by the previous registering authority of this jurisdiction; but
(b) it was unlawful under the law of
this jurisdiction to supply the product;
the product is taken for the purposes of this section not
to have been so registered immediately before that commencement.
175
Pending application for registration of chemical product
(1) If:
(a) before the commencement of the
Agvet Code of this jurisdiction an application for the registration of a
chemical product was duly made to the previous registering authority of this
jurisdiction but had not been disposed of by that authority; and
(b) subject to subsection (2),
immediately before that commencement the product was registered by a previous
registering authority of another jurisdiction;
the application is taken to be an application for the
registration of the product duly made upon that commencement to the APVMA under
section 10 of that Code.
(2) If the APVMA directs that paragraph (1)(b)
is not to apply in respect of a particular chemical product, subsection (1)
applies in relation to that product as if that paragraph were omitted.
176
Existing registration or approval of label
(1) If, immediately before the commencement
of the Agvet Code of this jurisdiction:
(a) no provision was made by the
corresponding previous law of this jurisdiction for the registration of chemical
products; but
(b) a label in relation to, or in
relation to containers for, a chemical product was registered or approved by
the previous registering authority of this jurisdiction;
then, upon that commencement, the following paragraphs
apply:
(c) the product is taken to have been
registered unconditionally by the APVMA under section 20 of that Code;
(d) the label is taken to have been
approved in relation to the product by the APVMA under section 21 of that
Code:
(i) for the containers for
which it was registered or approved by that previous registering authority or,
if it was not registered or approved for containers, for all containers for the
product; and
(ii) subject to the
conditions (if any) to which its registration or approval by that authority was
subject.
(2) If, immediately before the commencement
of the Agvet Code of this jurisdiction, a label in relation to, or in relation
to containers for, a chemical product was registered or approved by the
previous registering authority of this jurisdiction, the label is taken to have
been approved in relation to the product by the APVMA under section 21 of
that Code upon that commencement:
(a) for the containers for which it
was registered or approved by that previous registering authority or, if it was
not registered or approved for containers, for all containers for the product;
and
(b) subject to the conditions (if any)
to which its registration or approval by that authority was subject.
177
Pending application for registration or approval of label
(1) If:
(a) before the commencement of the
Agvet Code of this jurisdiction, an application for the registration or
approval of a label in relation to, or in relation to containers for, a
chemical product was duly made to the previous registering authority of this
jurisdiction but had not been disposed of by that previous registering
authority; and
(b) immediately before that
commencement:
(i) no provision was made
by the corresponding previous law of this jurisdiction for the registration or
approval of chemical products; and
(ii) the product was
registered by a previous registering authority of another jurisdiction;
the following paragraphs apply:
(c) the application is taken to be an
application for the registration of the product duly made upon that
commencement to the APVMA under section 10 of that Code;
(d) subject to subsection (3),
the application is also taken to be an application for the approval of the
label duly made upon that commencement to the APVMA under that section.
(2) If:
(a) before the commencement of the
Agvet Code of this jurisdiction, an application for the registration or
approval of a label in relation to, or in relation to containers for, a
chemical product was duly made to the previous registering authority of this jurisdiction
but had not been disposed of by that authority; and
(b) subject to subsection (3),
immediately before that commencement the label was registered or approved by a
previous registering authority of another jurisdiction;
the application is taken to be an application for the
approval of the label duly made upon that commencement to the APVMA under
section 10 of that Code.
(3) If the APVMA directs that paragraph (1)(d)
or (2)(b) is not to apply in respect of a particular label, this section
applies in relation to that label as if that paragraph were omitted.
178
Provisions that apply in respect of existing registrations or approvals
(1) If a chemical product is taken by section 172
or 174 or subsection 176(1) of the Agvet Code of this jurisdiction to have been
registered under that Code:
(a) the APVMA may, but does not have
to, do either or both of the following:
(i) give a distinguishing
number to the product;
(ii) enter the relevant
particulars in the Register of Chemical Products; and
(b) paragraph 167(1)(b) of that Code
has effect as if the registration of the product that is taken to be effected
by section 172 or 174 or subsection 176(1) of that Code resulted from a
decision by the APVMA under Division 2 of Part 2 of that Code to
register the product subject to the conditions to which its registration is
taken to be subject by that section.
(2) If a label for containers for a chemical
product is taken by paragraph 174(1)(c) or section 176 of the Agvet Code
of this jurisdiction to have been approved under that Code, the APVMA may, but
does not have to, do either or both of the following:
(a) give a distinguishing number to
the label;
(b) record the relevant particulars in
the relevant APVMA file.
179
Pending application for variation of conditions
If:
(a) before the commencement of the
Agvet Code of this jurisdiction an application for the variation of the
conditions to which a clearance for registration in respect of a chemical
product was subject under the repealed Act was duly made to the APVMA under
section 13 of that Act but had not been disposed of by the APVMA; and
(b) the product is taken by section 172
or 174 of that Code to have been registered by the APVMA subject to those
conditions;
the following paragraphs apply:
(c) the application is taken to be an
application duly made to the APVMA under section 27 of that Code for the
variation of the conditions to which the registration of the product is taken
to be subject because of section 172 or 174 of that Code;
(d) any particulars of trials or
laboratory experiments or other information given to the APVMA under a
provision of the repealed Act in connection with the application are taken to
have been given to the APVMA under the provision of that Code that corresponds
to that provision of the repealed Act.
180
Reconsideration of existing clearances for registration
If:
(a) before the commencement of the
Agvet Code of this jurisdiction, the APVMA had, under section 17 of the
repealed Act, informed the person holding a certificate of clearance for
registration issued in respect of a chemical product that it proposed to
reconsider the grant of the clearance, but the APVMA had not completed its
reconsideration; and
(b) the product is taken by section 172
or 174 of that Code to have been registered by the APVMA subject to conditions;
the following paragraphs apply:
(c) any notice that the APVMA has
given to the person under subsection 17(1) of the repealed Act in respect of
its proposed reconsideration of the clearance is taken to have been a notice of
a proposed reconsideration of the registration that the APVMA has duly given,
with any necessary changes, under subsection 32(2) of that Code as if that Code
had been in force when the notice was given;
(ca) any information (other than
particulars of trials or laboratory experiments) given to the APVMA by the
person to whom the notice was given is taken to have been given by the person
to the APVMA under subsection 32(2) of that Code;
(d) any
particulars of trials or laboratory experiments given to the APVMA by the
person to whom the notice was given is taken to have been given by the person
to the APVMA under section 33 of that Code.
181
Existing permit
(1) If:
(a) immediately before the
commencement of the Agvet Code of this jurisdiction, there was in force a
permit or other instrument issued by the previous registering authority of this
jurisdiction in respect of an active constituent for a proposed or existing
chemical product or in respect of a chemical product; and
(b) the permit or other instrument
authorised persons generally, or a person or class of persons, to do or omit to
do any thing the doing of which, or the omission to do which, after that
commencement would, apart from this section, be an offence against section 74,
75, 76, 77, 78, 79, 80, 81, 84, 85, 87 or 91 of that Code or against an
eligible law of this jurisdiction;
the following subsections apply.
(2) The permit or other instrument, to the
extent that it authorises a person to do or omit to do that thing, is taken to
be a permit that the APVMA has issued under section 114 of that Code upon
that commencement subject to the conditions (if any) to which it was subject
immediately before that commencement.
(3) The person who applied for the permit or
other instrument is taken to be the person who applied for the permit under
that Code.
182
Pending application for permit
If:
(a) before the commencement of the
Agvet Code of this jurisdiction, an application for a permit under a
corresponding previous law in respect of an active constituent for a proposed
or existing chemical product, or in respect of a chemical product, was duly
made to the previous registering authority of this jurisdiction but had not
been disposed of by that authority; and
(b) the application was for a permit
to do or omit to do something which, if such a permit were not granted under
that Code, would be:
(i) an offence against
section 74, 75, 76, 77, 78, 79, 80, 81, 84, 85, 87 or 91 of that Code; or
(ii) an offence against an
eligible law of this jurisdiction;
the application is taken to be an application for such a
permit duly made upon that commencement to the APVMA under section 110 of
that Code.
183
Pending proceedings before Administrative Appeals Tribunal
(1) If, before the commencement of the Agvet
Code of this jurisdiction, an application had been duly made under the repealed
Act to the Administrative Appeals Tribunal for review of a decision by the
APVMA under that Act in respect of a chemical product but the application had
not been disposed of by the Tribunal, the following provisions apply.
(2) If the application to the Tribunal was
made under paragraph 41(1)(b) of the repealed Act for the review of a decision
by the APVMA under section 15 of that Act to refuse an application for clearance
of the product:
(a) the application for clearance of
the product is taken to have been an application made under section 10 of
the Agvet Code of this jurisdiction for registration of the product; and
(b) the APVMA’s decision to refuse the
application for clearance of the product is taken to have been a decision by
the APVMA under Division 2 of Part 2 of that Code to refuse the
application for registration of the product; and
(c) the application to the Tribunal is
taken to have been an application duly made under paragraph 167(1)(a) of that
Code for review of that decision by the APVMA to refuse the application for
registration of the product; and
(d) the Tribunal is to continue to
deal with the application for review accordingly.
(3) If:
(a) the application to the Tribunal
was made under paragraph 41(1)(a) of the repealed Act for the review of a
decision by the APVMA under section 15 of that Act to grant clearance of
the product subject to particular conditions; and
(b) the product is taken by section 172
or 174 of the Agvet Code of this jurisdiction to have been registered by the
APVMA subject to those conditions;
the application is taken to have been an application duly
made under paragraph 167(1)(b) of that Code for review of a decision of the
APVMA under Division 2 of Part 2 of that Code to register the product
subject to those conditions and the Tribunal is to continue to deal with the
application accordingly.
(4) If:
(a) the application to the Tribunal
was made under paragraph 41(1)(c) of the repealed Act for the review of a
decision that the APVMA has made under section 16 of that Act to refuse an
application to vary the conditions to which clearance of the product was
subject; and
(b) the product is taken by section 172
or 174 of the Agvet Code of this jurisdiction to have been registered by the
APVMA subject to those conditions;
the following paragraphs apply:
(c) the application to vary the
conditions of the clearance of the product is taken to have been an application
made under section 27 of that Code for the variation of conditions of the
registration of the product;
(d) the application to the Tribunal is
taken to have been an application duly made under paragraph 167(1)(d) of that
Code for review of a decision by the APVMA under Division 3 of Part 2
of that Code to refuse the application for the variation of conditions of the
registration of the product;
(e) the Tribunal is to deal with the
application for review accordingly.
(5) If:
(a) the application to the Tribunal
was made under paragraph 41(1)(e) of the repealed Act for the review of a
decision that the APVMA made under section 17 of that Act to vary the
conditions to which the clearance of the product was subject; and
(b) the product is taken by section 172
or 174 of the Agvet Code of this jurisdiction to have been registered by the
APVMA subject to those conditions;
the following paragraphs apply:
(c) the product is taken to have had
those conditions varied by the APVMA under subsection 29(1) of that Code;
(d) the application to the Tribunal is
taken to have been an application duly made under paragraph 167(1)(e) of that
Code for review of the decision by the APVMA to vary those conditions;
(e) the Tribunal is to deal with the
application for review accordingly.
184 Existing
notices requiring further information or samples
If, before the commencement of the Agvet
Code of this jurisdiction:
(a) the APVMA duly gave a notice to a
person, under section 14 of the repealed Act, in respect of a chemical
product to which section 173 or 179 of that Code applies; or
(b) a previous registering authority
of this jurisdiction duly gave a notice to a person, under a provision of the
law of this jurisdiction to which section 159 of that Code corresponds, in
respect of a chemical product to which section 174 of that Code applies or
in respect of a label to which section 176 of that Code applies;
and the person had not complied with the notice before
that commencement, the notice is taken to have been a notice duly given to that
person by the APVMA under section 159 of that Code in respect of that
product or label, as the case may be, as if that Code had been in force when
the notice was given.