001 - Volume 1 Legislation and Applications

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AgVolume 1 Introduction to MORAG

Version: 3 Current at: 01/04/06 Page i of i

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1. WHAT IS MORAG? .............................................................................................. 1

2. HOW IS MORAG USED? ..................................................................................... 1

Revision history............................................................................................................ 3


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Version: Draft 3 Revision date: 25/01/05 This printing: 21/04/2006 Page 2 of 2


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Version: 3 Current at: 01/04/06 Page 1 of 4

1. WHAT IS MORAG?

MORAG is the APVMAs Manual of Requirements and Guidelines. With regard toagricultural and veterinary (agvet) chemicals to be manufactured or used in Australia, itsets out the Australian Governments requirements for:

approval of an active constituent

registration of a product

approval of a label

variation to an active constituent, product or label.

MORAG is published in two versions:

Ag MORAG

VetMORAG.

Each version contains information directly relevant to either agricultural or veterinarychemicals. However, the general principles of each version are identical andapproximately 90 per cent of the text is identical in each version.

MORAG replaces the Ag and Vet Requirements Series which have become redundantsubsequent to amendments to Schedules 6 and 7 of the Agvet Code Regulations, whichcame into force on 1 July 2005.

Each version of MORAG is divided into five volumes as shown in Table 1.

MORAG aims to clearly show what is a requirement and what is a guideline when

making an application to the APVMA for approval of an active constituent, registrationof a product, approval of a label, or a variation to an active constituent, product or label.

2. HOW IS MORAG USED?

An applicant can work through the five volumes to find the answer to the questions:

why does my product require registration?

how do I make an application for registration?

under which application category should the application be made?

what data are required?

what will be the cost and timeframe for evaluation?

what instructions and warnings should appear on the label?

Volumes 2 and 3 are closely linked: Volume 2 shows the category under which anapplication should be made, and Volumes 2 and 3 both give information on datarequirements for an application.

Figure 1 is a map of MORAG which shows how all MORAG volumes work together.

MORAG is located on the APVMA website, from where it can be printed and placed

into binders. It will be continuously under review. When a chapter is changed, theAPVMA will publish a notification on the APVMA website and notify subscribers to


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the APVMAs list server. The revised chapter should be downloaded to replace thesuperseded chapter.

The APVMA welcomes comment and suggestions for revision of MORAG. Comments

and suggestions should be sent to the APVMA at [email protected] .

Table 1: MORAG layout

Volume title Contents Replaces.

Volume 1Legislation andapplications

Introduction to MORAG

Legal background to the NationalRegistration Scheme

Procedures for making applications

Legislative Instruments

Module A of the Agand Vet Manuals

Volume 2Categoryrequirements andguidelines

How to use Volume 2

Individual categories:

1. Application for approval of anew active constituent andregistration of a product

2. Application for approval of anew active constituent andregistration of a product:Modular assessment

310. Application for registration of a

product containing an approvedactive constituent and approvalof the label

1114. Application to vary a product orlabel

1517. Application for approval of anactive constituent

18. Application for variation to anactive constituent

1923. Application for permit

2425. Other applications

Ag and Vet Manuals

Permit guidelines

Volume 3Data requirementsand guidelines

Module levels for modular categories

Data requirements andguidelines Parts 1 to 10

Ag and VetRequirementsParts 1 to 10

Volume 4Specific productguidelines

Specific product guidelines on theAPVMA website

Existing specificguidelines on theAPVMA website

Volume 5Labelling

Ag and Vet Labelling Codes

Label approval process

Ag and Vet LabellingCodes


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Revision history

Revision date Description of revision

1 July 2005 First edition

1 October 2005 Second edition

Legislative Instruments added to Table 1, Volume 1 contents.

1 April 2006 Third edition

no changes.


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Version: 3 Current at: 01/04/06

Figure 1: MORAG map

MORAG MAP

Application

decision trees

Fixed

Categories

Modular

Categories

Modules

1 - 12

Data Parts

1 Overview

2 Chemistry

3 Toxicology

4 Metabolism &kinetics

5 Residues & Trade

6 OH&S

7 Environment

8 Efficacy & Safety

9 Non-food trade

10 Special dataDescription of

category :

definition

requirements

Outline of data

requirements by

application type

Detailed data

requirements

Data requirementsDetermination of application categoryBackground information

Legislation

and Application

Processes

Volume 1 Volume 2 Volume 3

Decision Trees


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AgVolume 1 Legal background to the National Registration Scheme

Version: 3 Current at: 01/04/06 Page i of i

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1. INTRODUCTION................................................................................................... 1

2. WHY AGRICULTURAL AND VETERINARY CHEMICAL PRODUCTSREQUIRE REGISTRATION.................................................................................. 2

3. THE NATIONAL REGISTRATION SCHEME FOR AGRICULTURAL ANDVETERINARY CHEMICALS................................................................................. 3

4. THE ROLE OF THE APVMA................................................................................ 3

5. OTHER GOVERNMENT AGENCIES INVOLVED IN THE REGISTRATIONPROCESS............................................................................................................. 4

6. OTHER MATTERS IN THE AGRICULTURAL AND VETERINARYCHEMICALS LEGISLATION................................................................................ 6

6.1. Definition of an agricultural chemical product.......................................... 6

6.1.1. Inclusions................................................................................... 7

6.1.2. Exclusions ................................................................................. 7

6.2. Definition of a veterinary chemical product.............................................. 8

6.2.1. Inclusions................................................................................... 9

6.2.2. Exclusions ................................................................................. 9

6.3. Legislation covering active constituents .................................................. 9

6.3.1. Agricultural active constituents.................................................. 9

6.3.2. Veterinary active constituents.................................................. 10

6.4. Conditions of Approval and Registration ............................................... 10

6.5. Notification of new Information to the APVMA....................................... 11

6.6. Confidential Commercial Information .................................................... 11

6.7. Reconsideration and review of certain decisions of the APVMA........... 12

6.8. Legislation covering the manufacture of veterinary chemicalproducts................................................................................................. 13

6.9. Public consultation................................................................................. 13

7. DATA PROTECTION PROVISIONS OF THE AGVET CODE............................ 14

7.1. Data protection ...................................................................................... 14

7.1.1. Some qualifications ................................................................. 14

7.1.2. Exceptions allowing use of protected data .............................. 15

7.1.3. What is required in applications for data protection?............... 19

7.2. Early disclosure ..................................................................................... 19

7.3. Summaries of advice............................................................................. 20

7.4. Miscellaneous provisions....................................................................... 21


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Version: 3 Current at: 01/04/06 Page ii of ii

Appendix A: Protection periods for application data............................................. 22

Revision history.......................................................................................................... 24


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1. INTRODUCTION

The gross value of Australias annual farm production now exceeds $30 billion. Themajority of primary producers rely on the supply of pesticides and veterinary medicines

to protect their crops and livestock from pests and disease.

Because of the potential risks from the incorrect use of pesticides and veterinarymedicines, Australian governments have, for many years, had a key role in theregulation of pesticides and veterinary medicines to ensure they work as claimed andare safe to humans, targeted animals and plants, and the general environment.

Regulatory controls over pesticides and veterinary medicines currently require:

all active constituents for agricultural and veterinary chemical products to beapproved by the Australian Pesticides and Veterinary Medicines Authority(APVMA)

! the particular source identity of the manufacturing plant used to make anactive constituent for an agricultural or veterinary chemical product is anessential part of this approval;

all agricultural and veterinary chemical products to be registered by the APVMAprior to their distribution, sale or use in Australia;

all agricultural and veterinary chemical products being sold in Australia to have alabel approved by the APVMA attached to their containers; and

manufacturers of veterinary chemical products in Australia to be licensed by theAPVMA.

The APVMA may also issue a permit to individuals, organizations or corporationsallowing them (or others) to use a particular agricultural or veterinary chemical productin a limited way (such as for minor uses, emergency uses and experimental purposes)when that product is either not registered or the proposed use of a registered product iscontrary to the use instructions and directions on the approved label of the product.

With the assistance of the States and Territories, the national regulator additionally has arole to monitor and enforce compliance with the regulatory controls governing thesupply of agricultural and veterinary chemicals in Australia.

This chapter outlines the legislative provisions under which the APVMA performs itsfunctions and exercises its powers in regard to the regulation of pesticides andveterinary medicines.


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2. WHY AGRICULTURAL AND VETERINARYCHEMICAL PRODUCTS REQUIRE REGISTRATION

There are now over 7000 different pesticide and veterinary medicine products in theAustralian marketplace. With such a wide choice of chemical products available,Australian producers need to know that the products they use will not only work as theyshould, but will not be harmful.

Under the existing national controls for agricultural and veterinary chemicals it is aserious offence for any person to import an agricultural or veterinary chemical productinto Australia or to distribute or sell a chemical product in any State or Territory inAustralia, if that product has not been registered by the APVMA for that State/Territory.It is also a serious offence for any person to sell a chemical product which does not havea label, approved by the APVMA, attached to its container.

In order to avoid the severe penalties for breaching these provisions, chemicalmanufacturers and/or distributors wishing to supply an agricultural or veterinarychemical product in any State or Territory in Australia should apply to the APVMA forregistration of that chemical product and for approval of the proposed label for theproduct.

If the APVMA decides to grant the application for registration, and for approval of theproposed label, it must register the product by entering certain information about thatproduct in the Register of Agricultural and Veterinary Chemical Products, and approvethe label for the product. Upon registering a chemical product, the APVMA will issue anotice of registration and label approval to the applicant.

Once a product has been registered and its label approved, it can then be legallydistributed, sold and used in all Australian States and Territories in which the producthas been registered for use and which are described on the product label.

If a registrant subsequently wants to vary any of the particulars of registration asentered in the Register or to make any variation to the approved label for the chemicalproduct including additional claims made about the product then he or she wouldagain be in breach of the regulatory controls over agricultural and veterinary chemicalproducts unless he or she further applies to the APVMA seeking approval for thevariation to the registration or a variation to the approved label for the chemical product.Note however that Permit 6868 allows certain variations to be made to labels withoutthe need for application to the APVMA. Permit 6868 may be seen on the APVMA

website at http://permits.apvma.gov.au/PER6868.PDF .

Registration ensures that users have access to products that are correctly packaged andlabelled with all necessary limitations, precautions and directions for use. Registrationof agricultural or veterinary chemical products also provides a stamp of security thatthose products have been scientifically assessed to ensure that, when used as directed bythe label, they pose no unacceptable risk to human health, worker safety theenvironment or trade and that the products work effectively.

Registration also helps to ensure that unacceptable residues from the chemicals used inagriculture do not appear in food for human or animal consumption in Australia or inAustralias export markets.


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3. THE NATIONAL REGISTRATION SCHEME FORAGRICULTURAL AND VETERINARY CHEMICALS

In 1991, the Commonwealth, States and Territories of Australia agreed to establish aNational Registration Scheme for agricultural and veterinary chemicals (NRS) settingout a new regulatory framework for the management of pesticides and veterinarymedicines in Australia to replace Australias fragmented regulatory structure. TheScheme was designed to provide for the uniform regulation and control of themanufacture and supply of pesticides and veterinary medicines and to streamline theprocess of registering agricultural and veterinary chemical products.

The NRS is a partnership between the Commonwealth and the State/Territorygovernments.

The APVMA is an independent statutory authority of the Australian Government thatwas established in 1993 to undertake the Commonwealths regulatory responsibilitiesunder the NRS. The APVMA is responsible for the regulation of the manufacture ofagricultural and veterinary chemicals throughout Australia and for their control up toand including the point of retail sale. This includes responsibilities for the registration ofpesticides and veterinary medicines and for quality assurance and compliance of themduring their manufacture, distribution and sale. The APVMA also manages a number ofprograms that monitor the ongoing safety and performance of registered pesticides andveterinary medicines

The States and Territories have retained responsibility for control over the use ofagricultural and veterinary chemicals after their retail sale.

4. THE ROLE OF THE APVMA

The APVMA operates in accordance with its governing legislation principally theAgricultural and Veterinary Chemicals (Administration) Act 1992 and the Agriculturaland Veterinary Chemicals Code (the Agvet Code) scheduled to theAgricultural andVeterinary Chemicals Code Act 1994. There are also regulations under the Agvet CodeAct and the Administration Act which are known as theAgricultural and VeterinaryChemicals Code Regulations 1995 (the Agvet Regulations) and theAgricultural andVeterinary Chemicals (Administration) Regulations 1995. Furthermore, because theAPVMA has to fully recover its costs, there is also a separate suite of legislation

covering these cost recovery arrangements.The Administration Act establishes the APVMA1 and confers powers and functions onit, including to facilitate a consistent national approach to the assessment and control of

1Note: The Administration Act originally established the national regulator with the name of theNational Registration Authority for Agricultural and Veterinary Chemicals (NRA). In changing the nameof the NRA to the APVMA in June 2004, the Administration Act (section 6) formally continued the NRAin existence but with its new name. In so doing, all the previous approvals and registrations issued, orother decisions made, by the NRA thereby remain valid.

The Agvet Code also authorises the APVMA, with assistance from the States and Territories, to

undertake a national program of compliance and surveillance of agricultural and veterinary chemicalsduring their manufacture, distribution and retail sale. The Agvet Code provides for severe penaltiesagainst any person who distributes or sells an unregistered agvet chemical product, or manufacturers or


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chemicals and the assessment of the suitability for sale of active constituents forchemical products, chemical products and labels for chemical products.

The Agvet Code details the operational provisions under which the APVMA functions.

Under the Agvet Code the APVMA has responsibility to ensure that agvet chemicalproducts registered for use in Australia are suitably formulated and properly labelledand, when used according to instructions are:

safe to the host, the user, consumers and the environment;

efficacious (that is, the product does the job it claims it shall do); and

not unduly prejudicial to trade.

5. OTHER GOVERNMENT AGENCIES INVOLVED IN

THE REGISTRATION PROCESSIn considering whether to grant an application for registration of an agricultural orveterinary chemical product, the APVMA must be satisfied that the product will be safeand effective and that its label is suitable. As part of making this broad assessment inrelation to a chemical product, the APVMA conducts a number of separate evaluations,including chemistry and manufacture; toxicology, metabolism and kinetics; residues andtrade; occupational health and safety; and environment.

The APVMA uses the services of a number of Australian and State governmentagencies as advisers to help with some of these evaluations of applications forregistration of agricultural and veterinary chemical products. These include:

the Office of Chemical Safety (OCS) of the Commonwealth Department of Healthand Ageingwhich:

! evaluates and reports on toxicology and metabolism studies; proposes firstaid and safety directions; determines poison schedule classifications2; andestablishes acceptable daily intakes (ADIs) and acute reference doses(ARfD); and

! evaluates the occupational health and safety aspects of an application andrecommends safety directions and occupational controls on use and adviseson a Material Safety Data Sheet (MSDS);

sells a chemical product which fails to meet registered specifications, or sells a chemical product that doesnot have an approved label attached to its container.

Another function that the APVMA is authorised to perform is to issue export or free sale certificatesunder section 69D of the Administration Act to registrants or distributors to facilitate the export fromAustralia of registered agricultural and veterinary chemical products (or unregistered export onlyproducts manufactured in Australia) to countries that require such certificates. Further information onexport certificates may be found at http://www.apvma.gov.au/registration/certificates.shtml

2Note: The determination of poison schedule classification for an agricultural or veterinary chemicalproduct by OCS is authorised separately under the Therapeutic Goods Act 1989 administered by the

Therapeutics Goods Administration (TGA) of the Commonwealth Department of Health and Ageing. Inmaking its assessment of a chemical product, the APVMA is required to consider the poison scheduleclassification determined by a separate law of the relevant jurisdiction.


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the Commonwealth Department of the Environment and Heritage (DEH) whichevaluates environmental data and recommends appropriate use controls andinstructions for the product that will protect the environment; and

State and Territory departments responsible for agricultural and primary industrieswhich evaluate and reports on efficacy and target crop or animal safety data fornew agricultural chemicals and new uses of registered products. In some cases theAPVMA contracts this work out to other agencies such as universities, the CSIROor to other experts.


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6. OTHER MATTERS IN THE AGRICULTURAL ANDVETERINARY CHEMICALS LEGISLATION

It is not possible in this Manual to provide a detailed summary of every matter in theAgvet Code or Agvet Regulations or in the Administration Act or AdministrationRegulations that may be of relevance to a particular application for registration of apesticide or veterinary medicine or approval of a product label. However, the followingrepresents a brief outline of some of the more important matters in the legislationpertaining to applications for registration or approval of labels.

6.1. Definition of an agricultural chemical product

Section 4 of the Agvet Code provides an exhaustive definition of an agriculturalchemical product. In addition to substances included in the definition of an agricultural

chemical product, the definition specifically provides that an agricultural chemicalproduct includes certain other substances as prescribed in the Agvet Regulations andexcludes certain other substances as prescribed.

The definition is as follows:

(1) This section defines what is meant by an agricultural chemical product for thepurposes of this Code.

(2) Subject to subsections (3) and (4), an agricultural chemical product is a substanceor mixture of substances that is represented, imported, manufactured, supplied orused as a means of directly or indirectly:

(a) destroying, stupefying, repelling, inhibiting the feeding of, or preventinginfestation 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 naturaldevelopment, 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 substancesdeclared 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 bean agricultural chemical product.


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6.1.1. Inclusions

Regulation 7 of the Agvet Regulations provides that this definition of an agriculturalchemical product additionally includes:

dairy cleansers for on-farm use;

any substance used in conjunction with an agricultural chemical product to identify areastreated with that product; and

insect repellents for use on humans.

6.1.2. Exclusions

The following substances specified in Schedule 3 of the Agvet Code Regulations areexcluded from the definition of an agricultural chemical by being declared bysubregulation 7(2) not to be agricultural chemical products:

Any mould inhibitor for use in the manufacture of paper, glue, plywood, carpets, or anysurface coating (including paint), if:

(a) the mould inhibitor is incorporated into the product during manufacture as part of themanufacturing process; and

(b) the manufactured product is not claimed to have any effect as a pesticide

Any fungicide, bactericide or deodorant for use in footwear and clothing

Any soil ameliorant, conditioner or fertiliser if the product is not claimed to have any effectas a regulator of plant growth

Any invertebrate pest management lure based on food and not containing any active

constituent, and any vertebrate pest management lure

Any disinfectant, mould inhibitor, air freshener or sanitiser sold by retailers, or presented orpromoted primarily through retailers, to consumers for domestic use, except any sanitiser foruse in swimming pools or spa water

Cyanuric acid for use in swimming pools as a chlorine stabiliser

Any cut flower preservative

Any hay inoculant, silage inoculant or legume inoculant, if the product is based on bacteriaor enzymes, or both

Any predatory insect, predatory mite or macroscopic parasiteThe nematodeDeladenus siricidicola for the control ofSirex species wood wasps in pineplantations

Any industrial biocide used in the manufacture of paper pulp

Any head lice or body lice treatment for human beings


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6.2. Definition of a veterinary chemical product

Similar to the approach taken in the Agvet Code for defining an agricultural chemicalproduct, Section 5 of the Agvet Code provides an exhaustive definition of a veterinary

chemical product. In addition to substances included in the definition of an veterinarychemical product, the definition specifically provides that a veterinary chemical productincludes certain other substances as prescribed in the Agvet Regulations and excludescertain other substances as prescribed.

The definition is as follows:

(1) This section defines what is meant by a veterinary chemical product for thepurposes of this Code.

(2) Subject to subsections (3) and (4), a veterinary chemical product is a substance ormixture 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 theanimal 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 orreproductive 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 aveterinary 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 theperson preparing the substance or mixture of substances, of his or herprofession 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 aveterinary chemical product.


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6.2.1. Inclusions

Regulation 8 of the Agvet Regulations provides that this definition of a veterinarychemical product additionally includes:

allergenic substances supplied or used for administration to an animal by any means, orfor consumption by an animal;

medicated blocks or licks;

enzymes supplied or used for administration to an animal by any means, or forconsumption by an animal;

stockfood non-active constituents except stockfood non-active constituents excluded fromthis class by an order under section 7 of the Act;

direct-fed microbial products;

sheep branding substances.

The order referred to in the fourth dot point above is set out in the Veterinary ChemicalProducts (Excluded Stockfood Non-Active Constituents) Order.

6.2.2. Exclusions

Several substances are excluded from the definition of a veterinary chemical by beingdeclared by subregulation 8(2) not to be veterinary chemical products. Thesesubstances include certain stockfoods, medicated stockfoods and stockfoodsupplements; certain premixes and medicated premixes; certain blocks and licks; andcolour intensifiers for aviary birds.

For a full description of the particular stockfoods, medicated stockfoods and stockfoodsupplements; premixes and medicated premixes; and blocks and licks excluded from thedefinition of a veterinary chemical by subregulation 8(2) see subregulations 8(3), (4),(5), (6) and (7) of the Agvet Regulations.

6.3. Legislation covering active constituents

Approval from the APVMA is required for every active constituent used in theformulation of agricultural or veterinary chemical products intended for distribution,sale or use in Australia. This applies regardless of whether the product is formulated inAustralia or overseas.

It is an offence (under section 69B of the Administration Act) to import into Australia,an active constituent that is not approved without prior written consent from theAPVMA.

6.3.1. Agricultural active constituents

All manufacturing sources of active constituents for use in agricultural chemicalproducts must be approved by the APVMA. New sources of approved activeconstituents must be equivalent to, and are assessed against, the first approval of thatactive constituent.


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6.3.2. Veterinary active constituents

All active constituents for use in veterinary chemical products must be approved by theAPVMA. If the active constituent is subject to a monograph in the British

Pharmacopoeia,British Pharmacopoeia (Vet), European Pharmacopoeia or UnitedStates Pharmacopeia, that standard will be applied. Where such a standard does notexist manufacturers specifications may be applied.

6.4. Conditions of Approval and Registration

In approving an active constituent for a chemical product, or in registering a chemicalproduct, or in approving a label for containers for a chemical product the APVMA mayimpose conditions as it thinks are appropriate: section 23 of the Agvet Code.

One condition of registration that the APVMA may impose on an agricultural or

veterinary chemical product is that the chemical product is supplied only in a containerof a kind prescribed in the Agvet Regulations. For this purpose, regulation 18 of theAgvet Regulations provides that a container for a chemical product must

(a) be impervious to, and incapable of chemical reaction with, its contents whenunder conditions of temperature and pressure that are likely to beencountered in normal service;

(b) have sufficient strength and impermeability to prevent leakage of its contentsduring handling, transport and storage under normal handling conditions;

(c) if it is intended to be opened more than once be able to be securely andreadily closed and reclosed;

(d) have sufficient excess capacity to prevent it from breaking if its contentsexpand during handling, transport or storage; and

(e) enable all or any part of its contents to be removed or discharged in such away that, with the exercise of no more than reasonable care, the contentscannot

(i) harm any person; or

(ii) have an unintended effect that is harmful to the environment

It is now usual for the APVMA to impose a condition of registration on an agricultural

or veterinary chemical product to the effect that the chemical product can be suppliedonly in a container of a kind prescribed in regulation 18 of the Agvet Regulations.

Section 36 of the Agvet Code further provides that a breach of a condition is groundsupon which the APVMA may suspend or cancel the approval or registration.


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6.5. Notification of new Information to the APVMA

Section 160A of the Agvet Code requires applicants for active constituent approval,product registration (or listed registration), a permit, or a manufacturing licence to

notify the APVMA, as soon as practicable, if they become aware of any relevantinformation in relation to the active constituent or chemical product after theirapplication has been lodged with the APVMA.

Relevant information is a defined term that includes any information that contradictsthe information given to the APVMA in the application, or shows that the use of theactive constituent or chemical product would be unsafe or ineffective, or would havehad to be given to the APVMA in connection with the application if the applicant wasaware of the information when the application was made.

An applicant that is an Australian corporation is taken to be aware of information ifthe overseas parent of that Australian corporation is aware of that information.

Similarly, section 161 requires active constituent approval holders, product registrants,or permit holders to notify the APVMA, as soon as practicable, if they become of anyrelevant information in relation to the active constituent or chemical product after theactive constituent approval is given, the product is registered or the permit is issued.

6.6. Confidential Commercial Information

Section 162 of the Agvet Code prohibits the APVMA (or any member of its staff) fromdisclosing confidential commercial information. Confidential commercialinformation in relation to an active constituent or a chemical product is exhaustively

defined in the Agvet Code but essentially it includes a trade secret relating to the activeconstituent or chemical product or other information about them that is of value thatwould be destroyed or diminished if disclosed; or information that if disclosed couldunreasonably affect the owner of the information in an adverse manner.

Although it needs to be considered on a case-by-case basis, the APVMA accepts thatmost information and data sent to the APVMA as part of an application for approval ofan active constituent, the registration of a chemical product, the approval of a productlabel, a permit, or for a manufacturing licence would be confidential commercialinformation that may not be disclosed.

The actual documents that are sent to the APVMA as apart of an application do, by

section 169 of the Agvet Code, become the property of the APVMA.

Quite separate to the concept of information being confidential commercial informationsome information associated with applications to the APVMA attracts data protection see Section 7 of this Part of the Manual.


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6.7. Reconsideration and review of certain decisions of theAPVMA

The Agvet Code provides that, in relation to an application made to the APVMA for

approval of an active constituent, registration of a chemical product or approval of alabel, for a permit, or for a manufacturing licence (or for a variation of any of thesethings) the applicant can seek to have certain decisions of the APVMA reconsidered. Afull description of the type of decisions for which a reconsideration can be sought isdetailed in section 167 of the Agvet Code but, in general terms, they include a decisionto reject an application under section 11A or a decision to refuse an application or toimpose conditions of approval or registration.

In reconsidering an earlier decision the APVMA is legally obliged to reconsider itsoriginal decision and either confirm, vary or set aside that decision and make a newdecision in substitution.

A reconsideration is taken to be a fresh decision on the relevant matter and thus must bemade by a person in the APVMA other than the person who made the original decision.At the present time, only the Chief Executive Officer of the APVMA has beendelegated the authority to reconsider an earlier decision of the APVMA.

Applications for a reconsideration must be made in writing to the General Counsel ofthe APVMA.

An applicant who is not satisfied with the APVMAs original or reconsidered decisionsalso has a right to have some decisions of the APVMA independently reviewed by theAdministrative Appeals Tribunal (AAT) subject to theAdministrative Appeals Tribunal

Act 1975. The AAT is a completely independent body which can review certain

APVMA decisions on their merits and, where the Tribunal decides it is necessary,substitute its own decision. An application for review by the AAT must be in writing,accompanied by the required filing fee, addressed to the AAT at GPO Box 9955 in anycapital city and should be lodged within 28 days of receiving the notice of the decisionby the APVMA.


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6.8. Legislation covering the manufacture of veterinarychemical products

The effect of Section 121 of the Agvet Code is to require manufacturers of veterinary

chemical products in Australia to be licensed by the APVMA.

Australian manufacturers must show that they comply with the APVMAsManufacturing Principles and the Australian Code of Good Manufacturing Practice(GMP) for Veterinary Preparations and/or Australian Code of Good ManufacturingPractice for Homemixed Feeds, Feed-Milling Industry and Stock-Food Premixes as maybe appropriate before the APVMA will license them.

Applicants who wish to register veterinary chemical products manufactured overseasmust provide acceptable evidence that the manufacturer complies with GMP standardscomparable to those applying in Australia. Acceptable evidence consists of:

documentation from a recognised regulatory authority that supports compliancewith an equivalent level of GMP to the relevant Australian Code; or

audit of the overseas plant by an APVMA-authorised auditor or by an auditoracceptable to the APVMA.

There is no requirement for manufacturers of agricultural chemical products to belicensed.

More detailed information on the APVMAs Manufacturers Licensing Scheme isavailable by contacting the APVMA on (02) 6272 3409.

6.9. Public consultationThe Agvet Code (sections 12 and 13) requires the APVMA to publish a general noticein the APVMA Gazette about new active constituents being considered for approval andchemical products containing new active constituents being considered for registration.In the notice the APVMA is to invite written comment from the public on specificgrounds on whether the application for approval of the active constituent or registrationof the chemical product should be granted.

Additionally, if the product is to be used on a food-producing species, a Public ReleaseSummary (PRS) of the information provided in the application for registration isprepared and the public and relevant industry bodies are notified that the PRS is

available on request.

Where trade issues have to be assessed in the registration of a new chemical product theAPVMA publishes a Trade Advice Notice (TAN) in the Gazette seeking publiccomment, on trade grounds only, as to whether the application for registration of theproduct should be granted.

This public consultation process allows members of the public and relevant industrybodies to have an opportunity to raise matters of concern about human andenvironmental safety and, where relevant, trade. The APVMA must take into accountany submissions received in response to public consultation notices before it makes adecision as to whether or not to grant an application for approval of an active

constituent or an application for registration of a chemical product.


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7. DATA PROTECTION PROVISIONS OF THE AGVETCODE

Amendments to the Agvet Code which came into force on 1 January 2005 regulate theway in which the APVMA uses scientific information provided as part of applications.

The amendments introduced three major changes to the manner in which the APVMAuses the information provided with certain applications:

Data protection: New limitations on how the APVMA can use information inmaking certain decisions

Early disclosure: Publishing application summaries once an application has beenaccepted for assessment

Summaries of advice: Publishing the advice provided by other governmentdepartments and agencies, and other specialists the APVMA consults, in relationto applications which are approved.

7.1. Data protection

The provisions relate only to information provided with applications for activeconstituents, products and labels. They do not have any impact on information providedfor chemical reviews undertaken by the APVMA.

Where applicants provide information with an application, the APVMA will berestricted from using it for certain decisions without the permission of the authorisingparty. Essentially, the data protection provisions apply to the following four situations:

screening

evaluation

after-application approval (ie new active constituent, product or label in themarket)

s.161 data.

7.1.1. Some qualifications

Pre-approval protection (screening and evaluation)

While an application for an active constituent or product is in screening or is beingevaluated, the APVMA will be restricted from using that information for anotherapplication relating to an active constituent or product (but not to a permit) as well asany chemical reviews currently in progress.


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After-application approval (or market protection)

Once an application has been granted, all information that the APVMA relied on toapprove the application will become protected data. This protection means that the

APVMA will be limited from using that information to make a decision on anotherapplication (except for a permit) or a chemical review without the consent of theauthorising party (or when one of the other exceptions apply, see paragraph 7.1.2below).

The length of protection depends on the purpose of the application. Appendix Aprovides details of the protection periods for application data and extending the periodof protection.

7.1.2. Exceptions allowing use of protected data

The APVMA can use protected data when making a decision on an application or

chemical review if one of the following conditions is met (see Figure 1 for graphicrepresentation).

Consent for use

The APVMA can use protected data when a consent for use has been provided by theauthorising party for those data. The consent remains valid even if it is withdrawn orwas fraudulently provided. Any disputes as to the validity of a consent will be a matterfor the parties. However, it is a criminal offence to make a false statement to theAPVMA.

Public interest

The APVMA can use protected data when it is in the public interest to do so. Publicinterest can include a range of things but will include when the data indicates an unduerisk to human health or the environment. The APVMA currently has similar powers inrelation to chemical reviews. Data owners will receive a notice indicating theAPVMAs intention to use the information in the public interest and the data owner hasthe right to seek a review of that decision in the Administrative Appeals Tribunal(AAT). There is no right of review where the APVMA considers it is necessary to usethe data due to an imminent risk to health or the environment.

Unfavourable to another application

The APVMA can use protected data when considering another application involving anactive constituent, product or label where the APVMA considers that the datademonstrates the second application is unable to meet requirements with respect tosafety to people or the environment, or the product is ineffective.

Identical information

The APVMA can use protected data when there is identical information available thatare not protected (ie publicly available information). Information that are declared to bepublicly available will not receive protection. There are, however, penalties for makinga false declaration to the APVMA.


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Ineligible applications

The APVMA is not limited from using data provided with one of the following types ofapplication, as they are ineligible for data protection:

an application for an active constituent which at some time in the past had beenapproved (either by the APVMA or a State/Territory government) or had been anactive constituent in a registered product (either by the APVMA or aState/Territory government). If the active constituent had already existedpreviously in Australia then it cannot be considered a new active constituent (andgain protection), but is a previously endorsed active constituent

an application to vary the particulars of an active constituent approval.Information provided with an application to vary the particulars or conditions ofan approval does not gain protection

an application for registration of a companion animal product where that product

does not contain a new active constituent (ie includes a previously endorsed activeconstituent). Companion animal products are products for use on, or to beadministered to, non-food-producing animals and any food-producing animalsdefined by the Agvet Code Regulations. Horses are companion animals

an application to vary the registration of a companion animal product

an application to approve a label of a companion animal product where thatproduct does not contain a new active constituent

an application to vary a label of a companion animal product.


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Figure 1. Situations where the APVMA is not limited from using protectedinformation

APVMA becomesaware of protecteddata unfavourable toanother application

Do the data indicate anundue hazard to peopleor the environment, orthat the product isineffective?

Appropriatedecision ismade

There is no need

to use the data

Applicationreferencesprotected data

Has consentfor use been

provided?

Data are used inthe assessmentprocess

Yes

Applicant receives arequirements letter or theapplication is rejected

APVMA intends touse protected datawhen in the public

interest

Is theassociatedrisk imminent?

Make decisionimmediately.Authorising party

receives notice but doesnot include appeal rights

Authorising party receives notice includingappeal rights and APVMA waits 28 days beforemaking relevant decision

No

Situation 1: Consent for use

Situation 2: Public interest

Yes

No

Situation 3: Unfavourable toanother application

Yes

No


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Figure 1 (continued)

5.

Applicant referencespublicly availableinformation

Is the information listedas public domain?

Applicant mustprovide copy

Applicantprovidesinformationwithapplication

Noprotection isprovided

Information iseligible for protection

Situation 4: Identical information

Appropriatedecision ismade

Yes

No

Situation 5: Ineligible applications

Yes

No

Does the information fall into one ofthe following categories?

1. Owner/authorising party markedas Public or

2. provided in an application for:

a. an active constituent whichhas been previously approved

b. an active constituent whichhas been present in aregistered product

c. variation of an approved activeconstituent

d. registration of a companionanimal product (not including anew active constituent)

e. approval of a label for a

companion animal productf. variation of registration or

label approval for acompanion animal product.


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7.1.3. What is required in applications for data protection?

Application requirements relating to data protection fall into two types:

requirements when providing data

requirements when referencing data.

The following is a general description of what is required. For further details please seethe APVMA website Data Protection Application Requirements pagehttp://www.apvma.gov.au/registration/DP_appreqs.shtml

Requirements when providing information

When providing new data with an application, applicants are required to complete a datalist, setting out all data provided. The APVMA has created two templates for applicantsuse (with instructions on how to complete them). Please see the APVMA website Data

Protection Application Requirements pagehttp://www.apvma.gov.au/registration/DP_appreqs.shtml for full details.

Both hardcopy and electronic versions are required.

The APVMA will use this information to generate application summaries and toproduce the required documentation for assessment.

New requirements when referencing information

For applications that need to reference information held by the APVMA in order tosatisfy the APVMAs full data requirements, applicants will need to consider:

Do my reference products/active constituents have associated protected data?

If so, do I have the necessary consent for use from the authorising party?

To assist applicants, the APVMA intends to provide (via the website):

a means of discerning what active constituents and products have associatedprotected data, what that data is and who the authorising party is

a consent for use letter template to ensure appropriate consent is provided.

7.2. Early disclosure

For most applications, the APVMA is required to publish a summary of applicationshortly after the application has been accepted for assessment. Early disclosureincreases the transparency of the process. It also eliminates the previous requirementthat the APVMA must not publicly acknowledge whether a certain application has beenmade.

One benefit to applicants of this change is that other government authorities with whichthe APVMA deals, such as Food Standards Australia New Zealand (FSANZ) and theOffice of the Gene Technology Regulator (OGTR), will be able to disclose the existenceof the application, thus allowing other related regulatory actions to occur at the sametime.

The type of applications to which early disclosure applies include those for new activeconstituents, products and labels and applications involving variation to products and


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labels, where the variation involves a change to the use, supply or disposal of theproduct.

The summary will include details specified in the Agvet Code Regulations (see

http://www.apvma.gov.au/about_us/AgVetChemCode95Reg.rtf). The Regulationsrequire different application summaries depending on the type of application. They willinclude different combinations of the following details:

applicant name

application number

active constituent name and number

product name and number

application purpose and description of active constituent or product use

a list of data provided with the application and required by the APVMA (asdiscussed in data protection requirements above)

the relevant reference active constituent and/or product names and numbers.

What will be required of applicants in regard to early disclosure?

To allow the APVMA to publish application summaries for early disclosure asefficiently as possible, applicants will be required to provide the information in thespecified format.

7.3. Summaries of adviceWhere the APVMA has granted an application involving an active constituent, productor label and the APVMA has relied on advice provided by another government body ora person contracted by the APVMA, the APVMA must publish a summary of thatadvice.

The summary will include details specified by the Agvet Code Regulations. TheRegulations require the same details as for application summaries, plus:

a summary of the assessment undertaken to provide the advice

a list of the information relied on in providing the advice.

Confidential Commercial Information (CCI) will not be included in the summary ofadvice.

What will be required of applicants in regard to summaries of advice?

To allow the APVMA to publish summaries of advice as efficiently as possible,applicants will be required to declare what data they consider to be CCI.

In addition to application summaries, advice reports, minus any CCI, will also bepublicly available. Although reports and summaries will be written in accordance withthe CCI guideline and will not contain any agreed CCI, applicants should check theadvice reports and summaries to satisfy themselves.


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7.4. Miscellaneous provisions

The amendments to the Agvet Code in the US Free Trade Agreement ImplementationAct 2004 include additional matters relevant to the APVMA that are of importance to

industry. For the sake of restricting this manual to matters that the APVMA is likely toencounter, these additional matters have not been discussed in any detail. The APVMAwill, however, ensure that the requirements of the US Free Trade Agreement Act aremet and will discuss them with industry as required. They involve matters such as:

other rules regarding the public interest exception

APVMA requirements on disclosure of protected information

liability of persons to bring suit if disclosed information is subsequently used bythe APVMA for an unauthorised purpose

decisions that are appealable to the AAT.


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Appendix A: Protection periods for application data

Data provided with this type of application. .will receive this

number of yearsprotection*

1 Application to approve a new active constituent (ieone never previously approved or present as an activeconstituent in a registered product)

8

2 Application to register a product containing a newactive constituent as described in item 1 above, wherethe application for the product had passed screening(ie been accepted for evaluation) before the activeconstituent in item 1 had been approved

8

3 Application to register an agricultural chemicalproduct other than as described in 2 above

5

4 Application to register a veterinary chemical productother than as described in 2 above (food/fibre-producing animals only)

3

5 Application to vary an agricultural chemical productand/or label

5

6 Application to vary a veterinary chemical productand/or label

3

*The protection period starts from the day the application is granted.

Extending the protection period distinct uses

It is possible to extend the protection period for certain data when the followingconditions are met. For data that receive eight years protection (ie items 1 and 2 of theabove table), the protection period will be extended by one year for each five distinctuses that meet the following requirements:

the distinct use is on an approved label of a product as described in item 2 of thetable

the application to include the distinct use on a label for the extension product wasaccepted for evaluation before the end of the sixth year of protection of the dataassociated with the new active constituent

all five distinct uses are specified in the relevant Agvet Code Regulation by thetime the application including the fifth use is granted. Regulation 22A of theAgvet Code Regulations(http://www.apvma.gov.au/about_us/AgVetChemCode95Reg.rtf) determines whatis a distinct use by requiring that:

" the use is a non-major use as listed in the table attached to the Regulations(essentially minor crops and minor animal species); and


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" data have been provided specifically on that non-major use (ie the applicantis not extrapolating from data provided on other uses to satisfy APVMArequirements for the distinct use); and

" the data were required for the type of application involved and were reliedon by the APVMA to grant the application including the distinct use on the

label; and

" the use is specified on the label. Note that if the use is a food or non-foodcrop, then the use can be specified on the label via either the crop or theassociated crop group as specified in the Regulations.

Importantly, the period of protection cannot exceed 11 years.

Section 161 data (notification of new information to the APVMA)

Section 161 of the Agvet Code requires that when a registrant, approval holder or aperson acting on their behalf becomes aware of any new information that is relevant tothe approved active constituent or registered product, and the information is also new tothe APVMA, they must give that information to the APVMA.

If s.161 information is provided for a product (whose application for registration wasmade after 1 January 2005), the APVMA is limited from using the information for thepurpose of making a decision on another persons application involving an activeconstituent, product or label or a decision in a review for:

a period of five years if the product is an agricultural chemical product

a period of three years if the product is a veterinary chemical product.

The protection period starts from the day the information was received.


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Revision history

Revision date Description of revision

1 July 2005 First edition

1 October 2005 Second edition

extensive revision of complete document.

1 April 2006 Third edition

updated link to Agvet Code Regulations.


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AgVolume 1 Procedures for making an application

Version: 3 Current at: 01/04/06 Page i of ii

PPrroocceedduurreess ffoorrmmaakkiinngg aann aapppplliiccaattiioonn ffoorr::

aapppprroovvaall,, oorrvvaarriiaattiioonn ooffaapppprroovvaall,, ooffaaccttiivvee ccoonnssttiittuueennttss

rreeggiissttrraattiioonn,, oorrvvaarriiaattiioonn ooffrreeggiissttrraattiioonn,,

ooffcchheemmiiccaall pprroodduuccttss

aapppprroovvaall,, oorrvvaarriiaattiioonn ooffaapppprroovvaall,, ooff

llaabbeellss

CCoonntteennttss

1. INTRODUCTION................................................................................................... 1

2. TYPES OF REGISTRATION ................................................................................ 1

3. WHO CAN MAKE AN APPLICATION?................................................................ 3

3.1. Approved persons ...................................................................................3

3.1.1. Defining an approved person .................................................... 3

3.1.2. An Australian applicant or registrant can appoint adifferent approved person.......................................................... 4

3.1.3. An overseas applicant and registrant must appoint anapproved person........................................................................ 4

3.1.4. Letter of authority.......................................................................4

4. REQUIREMENTS FOR MAKING AN APPLICATION..........................................5

4.1. Documentation which must be submitted with an application ................. 5

4.2. Where to send applications ..................................................................... 7

4.3. How an application can be altered .......................................................... 7

4.4. How an application can be withdrawn ..................................................... 8

4.5. How to format an application................................................................... 85. PROCESSING APPLICATIONS.........................................................................12

5.1. The screening process .......................................................................... 12

5.1.1. Administrative screening .........................................................13

5.1.2. Technical or agency screening ................................................ 14

5.2. After screening ......................................................................................14

5.3. Applications which do not pass screening.............................................15

5.3.1. Applications which have defects that can reasonably berectified .................................................................................... 15

5.3.2. Treating applications as having been withdrawn..................... 16

5.3.3. Applications which have defects that cannot reasonablybe rectified: rejection of the application ...................................16


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Version: 3 Current at: 01/04/06 Page ii of ii

5.4. The evaluation process .........................................................................17

5.4.1. Assigning applications ............................................................. 17

5.4.2. Changes to applications during evaluation..............................18

5.4.3. Timeframes for assessment .................................................... 185.4.4. Clock time and elapsed time..................................................18

5.4.5. Public consultation................................................................... 19

5.5. The obligation to notify the APVMA of any relevant newinformation relating to a pending application......................................... 20

5.6. Granting an application.......................................................................... 20

5.6.1. Conditions of registration......................................................... 20

5.6.2. Conditions of label approval .................................................... 20

5.7. Refusing an application ......................................................................... 20

5.8. Reconsideration and appeal of an APVMA decision .............................21

5.9. The registrants obligations after an application is granted ................... 215.9.1. New information.......................................................................21

5.9.2. Renewal of registration and payment of levies........................21

5.9.3. Changes to currently-registered products or labels.................22

5.9.4. Changes to registration records including company details ....22

5.10. Certificates of export.............................................................................. 24

5.10.1. Who can apply for a certificate of export? ............................... 24

5.10.2. What type of information may be required for a certificateof export?................................................................................. 25

5.10.3. What are the timeframes for certificates of export?.................26

5.10.4. Fees for certificates of export ..................................................26

Revision history.......................................................................................................... 27


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1. INTRODUCTION

Under theAgricultural and Veterinary Chemicals Code Act 1994 (the Agvet Code) theAustralian Government, through the APVMA, regulates the manufacture, supply and

sale of agricultural and veterinary (agvet) chemical products in Australia.

For a description of the legislation governing the regulation of these chemicals, seeChapter 2 of this volume, Legal background to the National Registration Scheme.

The APVMA has the responsibility to ensure that agvet chemicals registered for use inAustralia are:

safe to the host, the user, general public and the environment

efficacious, that is, they do the job they are supposed to do

suitably formulated and properly labelled

not unduly prejudicial to trade when used according to instructions.

The APVMA achieves these outcomes by:

evaluating active constituents, products and their labels

reviewing existing chemicals where potential risks to safety or performance havebeen identified

issuing permits for emergency uses, minor uses or for research purposes

issuing licences to manufacturers of veterinary chemical products

with assistance from the States and Territories, conducting a national program of

compliance and surveillance up to and including the point of retail sale.

This chapter outlines the procedures for applying to the APVMA for registration orapproval of an agricultural or veterinary chemical or product. Detailed guidance on thecategory under which an application must be made, and data requirements for anapplication are set out in Volume 2, Category requirements and guidelines, and Volume3,Data requirements and guidelines.

2. TYPES OF REGISTRATION

There are three tiers of regulation for agvet chemical products, according to the level of

risk posed by the products and the appropriate management framework. Apart from thenormal registration requirements, two tiers of regulation known as listed registration andreserved from registration are available for those agvet chemical products which areconsidered to be of a lower risk.

1. Registered chemical products

These are products which are subject to the normal requirements of registration. Theseare defined under s.4 and s.5 of the Agvet Code, ie agvet chemical products which:

destroy, repel or prevent infestation of plant pests

modify the physiology of plants prevent, diagnose, cure or alleviate animal disease


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modify the physiology of an animal.

2. Listed registered chemical products

These are lower risk agricultural or veterinary chemical products which do not warrantthe rigorous, individualised assessment process that applies to registered chemical

products, particularly given the known risks associated with their use. These productscan be given listed registration against a Standard, provided that:

the APVMA has submitted a Standard to the Minister declaring it is satisfied thatthe use of the product or class of products in accordance with the Standard would

be safe, effective and not a trade risk

the Minister has approved the Standard that the APVMA proposes to apply to thatproduct or class of products

the chemical or class of chemicals has subsequently been included in a Scheduleof Listable Chemical Products in the Agvet Code Regulations.

3. Reserved chemical products

Agricultural or veterinary chemical products or classes of products can be reserved fromregistration subject to Conditions, provided that:

the APVMA has submitted Conditions to the Minister declaring it is satisfied thatthe use of the product or class of products in accordance with the Conditionswould be safe, effective and not a trade risk

the Minister has approved the Conditions that the APVMA proposes to apply to

reservation of that chemical product

the chemical or class of chemicals has subsequently been included in a Scheduleof Reserved Chemical Products in the Agvet Code Regulations.

This is a very simple system of regulating minimal risk products. The effect is tovirtually exclude reserved products from regulatory controls. Such products areexcluded from the offence provisions of the Agvet Code provided they comply with theConditions set out in the Regulations, eg it is not an offence to possess and/or supply areserved chemical product, even though it is not registered.


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3. WHO CAN MAKE AN APPLICATION?

Any individual person or a body corporate may apply to the APVMA for:

approval of an active constituent for a proposed or existing chemical product

registration, or listed registration of a new agricultural or veterinary chemicalproduct

approval of a label.

If the applicant is a body corporate they must provide an ACN or an overseas equivalentnumber as appropriate.

In relation to an existing approval or an existing registration (regular or listed), theregistrant or approval holder (interested person) can submit further applications thatrelate to the approval or registration that they hold. The registrant or approval holdermay apply to the APVMA to vary:

a label

relevant particulars or conditions of the approval or registration.

3.1. Approved persons

For legal and administrative purposes the APVMA must identify the person with whomit should deal in relation to an application and any requirements relating to thatapplication, and to whom it should issue the notice of registration or approval. TheAPVMA also must identify the person with whom it should deal in relation to post-

registration activities such as registration renewal, cancellations or suspensions, orreconsiderations of registrations or approval.

For the purpose of such dealings the Agvet Code refers to an approved person. Theapproved person does not have to be an individual it can be a body corporate.However the approved person must be a person residing in Australia or a bodycorporate incorporated in Australia.

3.1.1. Defining an approved person

An Australian applicant or registrant can be an approved person. The Australianapplicant or registrant can therefore be responsible for lodging an application, varying

an application, submitting new relevant information and/or withdrawing the application.

Where the Australian applicant or registrant elects to also be an approved person inrelation to receiving letters and/or notices from the APVMA, the APVMA will write tothe applicant in relation to the screening of an application, the notice of registrationand/or approval or the refusal of an application. Similarly, where the Australianregistrant elects to also be an approved person in relation to post-registration activitiesthe APVMA will write to and issue notices to the registrant.


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3.1.2. An Australian applicant or registrant can appoint a differentapproved person

An Australian applicant or registrant can notify the APVMA in writing of the

appointment of a different person residing in Australia or a body corporate incorporatedin Australia to act as the approved person in relation to an application and/or to be the

point of contact for the APVMA in relation to an application. In this case the APVMAwill deal with the appointed approved person.

The Australian registrant can also elect to appoint a different approved person inrelation to post-registration activities. In this case the APVMA will write to and issuenotices related to post-registration activities to the different approved person.

The Australian applicant or registrant can withdraw the appointment of an approvedperson at any time by writing to the APVMA, and can also vary the authority of anapproved person. When an Australian applicant or registrant elects to vary the

responsibilities of an approved person or appoint a different approved person a letter ofauthority is required.

3.1.3. An overseas applicant and registrant must appoint an approvedperson

Overseas applicants and registrants must appoint an Australian person/body corporate asthe approved person when lodging an application, varying an application, submittingnew relevant information or withdrawing an application. Similarly, overseas applicantsmust appoint an Australian person/body corporate as the approved person to whom theAPVMA should write in relation to the screening of an application, the notice of

registration and/or approval or refusal of an application.It is open to the overseas registrant, but not mandatory, to appoint an approved person inrelation to post-registration activities such as cancellations, suspensions orreconsiderations of registrations or approval. If the overseas registrant elects not toappoint an approved person for these post-registration activities the APVMA will writeto and issue notices to the overseas registrant.

3.1.4. Letter of authority

A letter of authority is required when an overseas applicant or registrant appoints aperson residing in Australia, or a body corporate incorporated in Australia, to be an

approved person. A letter of authority should include whichever one or more of theregulatory activities are to apply. If all activities are to apply then the letter of authorityshould state for the purpose of all regulatory activities associated with this applicationand for the purposes of all regulatory activities following registration and/or approvalor words to that effect. If a different approved person is appointed for any one or moreof the regulatory activities, a separate letter for each different approved person must besupplied.


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4. REQUIREMENTS FOR MAKING AN APPLICATION

A complete application must:

include the appropriate and fully completed application form signed by anapproved person

include all the information that the APVMA requires (see Volumes 2 and 3 of thismanual, or the relevant Standard)

be accompanied by the appropriate fee.

An application will not be accepted by the APVMA unless it is complete.

4.1. Documentation which must be submitted with anapplication

An application can range from just a completed application form to a multi-volumedossier containing detailed scientific reports and scientifically based arguments. As aminimum, an application must include the following documents and information:

Application Form and Application Overview

In many cases, an application will require an application overview. The applicationform and application overview (see Part 1 Application Overview in Volume 3 Datarequirements and guidelines) are combined into a single document. The documentrelevant to each application type is available on the APVMA website.

The Application Form and Overview must contain the signature of the approved person.Any whiteout or corrections must be initialled. A single unbound copy of thecombined document must be provided to the APVMA.

Formulation details

Generally, the complete formulation details are submitted with the application.However, if the applicant/approved person is obtaining the formulation from anothersource and does not have access to the information, the onus is on the applicant orapproved person to ensure that the formulator provides the full formulation details to theAPVMA. The provider of the formulation details must ensure that the informationadequately identifies the application that the information relates to (ie reference the

applicants name, the product name and product number if known).Where the formulation details are confidential commercial information (CCI) theformulator and applicant / approved person must clearly state this in theapplication/related information. Unless otherwise advised, the APVMA will assume thata formulation provided directly by a formulator to the APVMA is information which isCCI to the formulator.


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Fees

The appropriate application fee must be submitted with the application before it can beaccepted. The application fee is determined by the application category, or from the

total of modules if the application falls into a modular category. The applicationcategory or relevant modules can be determined from Volume 2 and Volume 3.

Applicants should submit the complete fee with their initial application. If an applicantis unsure as to the correct fee, a minimum preliminary assessment (screening) fee of$460 must be submitted, or the entire fee if less than this amount. The APVMA willrequest the balance after screening once a determination has been made as to whetherthe application is accepted. If an applicant submits and excess amount, the APVMA will

provide a refund of the excess amount.

The APVMA is able to accept payment only by cheque. Cheques should be madepayable to the Australian Pesticides and Veterinary Medicines Authority.

Formulators declaration

If the proposed new product is a repack of a registered product and so application willbe made under Category 8, a formulators declaration is required as detailed inVolume 2, Category 8. The declaration must be on the formulators company letterheadand must contain the name and the title of the person signing the declaration. Wheremore than one formulator is involved in manufacture of a product, each formulator must

provide a declaration covering the manufacturing steps they perform.

Labels

Ten copies of marketed product labels (MPL) must be supplied before an application forregistration, or variation to registration or label approval, can be finalised. For mostapplications, applicants should submit two copies of a draft label in text form with theinitial application. Once the draft text label has been assessed, the APVMA will requestthe submission of ten MPLs. Further details may be found in the individual categorychapters in Volume 2 and in Volume 5 Labelling.

Data

Each application category has different data requirements. Applications must includerelevant data, or scientific argument not to provide certain data.

The APVMAs data requirements for each type of application are outlined in Volumes 2

and 3 of this manual.

When an application is first submitted to the APVMA, any accompanying data (DataParts 2 to 10) must be bound.

Where applications require submission of different data parts (eg chemistry andefficacyandresidues), each data part must be submitted as separate volumes . Different data

parts must not be combined within the same bound volume.

A single copy of each volume of bound data should be submitted in the first instance.The APVMA will request further copies once the application has passed technicalscreening.


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4.2. Where to send applications

All applications must be in hard copy and mailed to:

Application Management and EnquiriesAustralian Pesticides & Veterinary Medicines AuthorityPO Box E240KINGSTON ACT 2604

or delivered to:

Application Management and EnquiriesAustralian Pesticides & Veterinary Medicines AuthorityGround FloorJohn Curtin House22 Brisbane Avenue

BARTON ACT 2600

All correspondence between the APVMA and an approved person must be dated andinclude:

the product name or the proposed product name

the APVMA file number and application number (if known)

the name and position and contact details of the person signing thecorrespondence.

4.3. How an application can be altered

For any application an approved person may authorise the APVMA to alter aspects ofthat application. The request to alter an application must be in writing.

An approved person may give the APVMA additional or different information at anytime after an application has been made, and before it has passed screening andtherefore been formally accepted by the APVMA.


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4.4. How an application can be withdrawn

An approved person may voluntarily withdraw an application at any stage by submittinga written request:

when an application is voluntarily withdrawn before the evaluation process hascommenced, the $460 screening fee will be retained by the APVMA and the

balance of the application fee will be refunded to the applicant.

if the application has passed screening and evaluation has commenced, all or partof the fee may be retained by the APVMA.

4.5. How to format an application

Language

All applications and accompanying data submitted to the APVMA must be in English.If an applicant wishes to submit material in another language, they must supply anauthorised English translation, and clearly identify it as such. The APVMA may requestthe original foreign language paper.

Confidential commercial information

In the performance of their duties, APVMA staff will be required to use confidentialcommercial information submitted by applicants. Confidential commercialinformation is defined in the Agvet Code as follows:

Confidential commercial information, in relation to an application for a proposed

or existing chemical product, or in relation to a chemical product or a constituent ofa chemical product, means:

a trade secret relating to the constituent or product; or

any other information r

Date post:	05-Apr-2018
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001 - Volume 1 Legislation and Applications

Documents