001 - Volume 1 Legislation and Applications

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Legislation and applications
VOLUME 1 LEGISLATION AND APPLICATIONS CONTENTS

Introduction to MORAG Legal background to the National Registration Scheme Procedures for making an application for:

registration, or variation of registration of products approval, or variation of approval of active constituents approval, or variation of approval of labels
Legislative Instruments
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Introduction to MORAG
Introduction to MORAG Contents

1. 2. WHAT IS MORAG? .............................................................................................. 1 HOW IS MORAG USED? ..................................................................................... 1
Revision history............................................................................................................ 3
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1. WHAT IS MORAG?
MORAG is the APVMAs Manual of Requirements and Guidelines. With regard to agricultural and veterinary (agvet) chemicals to be manufactured or used in Australia, it sets 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. Ag MORAG Vet MORAG.
MORAG is published in two versions:
Each version contains information directly relevant to either agricultural or veterinary chemicals. However, the general principles of each version are identical and approximately 90 per cent of the text is identical in each version. MORAG replaces the Ag and Vet Requirements Series which have become redundant subsequent to amendments to Schedules 6 and 7 of the Agvet Code Regulations, which came 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, registration of 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 an application should be made, and Volumes 2 and 3 both give information on data requirements 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, the APVMA 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 the superseded chapter. The APVMA welcomes comment and suggestions for revision of MORAG. Comments and suggestions should be sent to the APVMA at MORAG_feedback@apvma.gov.au.
Table 1: MORAG layout Volume title Volume 1 Legislation and applications Contents
Introduction to MORAG Legal background to the National Registration Scheme Procedures for making applications Legislative Instruments
Replaces.
Module A of the Ag and Vet Manuals
Volume 2 Category requirements and guidelines
How to use Volume 2 Individual categories: 1. Application for approval of a new active constituent and registration of a product Application for approval of a new active constituent and registration of a product: Modular assessment Application for registration of a product containing an approved active constituent and approval of the label
2.
310.
Ag and Vet Manuals
Permit guidelines
1114. Application to vary a product or label 1517. Application for approval of an active constituent 18. Application for variation to an active constituent
1923. Application for permit 2425. Other applications
Volume 3 Data requirements and guidelines Volume 4 Specific product guidelines Volume 5 Labelling
Module levels for modular categories Data requirements and guidelines Parts 1 to 10 Specific product guidelines on the APVMA website
Ag and Vet Requirements Parts 1 to 10 Existing specific guidelines on the APVMA website Ag and Vet Labelling Codes
Ag and Vet Labelling Codes Label approval process
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Revision history
Revision date Description of revision
1 July 2005 1 October 2005 1 April 2006
First edition Second edition Legislative Instruments added to Table 1, Volume 1 contents. Third edition no changes.
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Figure 1: MORAG map
MORAG MAP
Background information Determination of application category Data requirements Supporting documents
Data Parts 1 2 Fixed Categories 3 4 Legislation and Application Processes Decision Trees Overview Chemistry Toxicology Metabolism & kinetics Residues & Trade OH&S Environment Efficacy & Safety Non-food trade Guidelines Labelling Code
5 6
Application decision trees
Modular Categories
Modules 1 - 12
7 8 9
Description of category : definition requirements
Outline of data requirements by application type
10 Special data
Detailed data requirements
Volume 1
Volume 2
Volume 3
Volume 4
Volume 5
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Legal background to the National Registration Scheme
Legal background to the National Registration Scheme Contents

1. 2. 3. 4. 5. 6. INTRODUCTION ................................................................................................... 1 WHY AGRICULTURAL AND VETERINARY CHEMICAL PRODUCTS REQUIRE REGISTRATION .................................................................................. 2 THE NATIONAL REGISTRATION SCHEME FOR AGRICULTURAL AND VETERINARY CHEMICALS ................................................................................. 3 THE ROLE OF THE APVMA ................................................................................ 3 OTHER GOVERNMENT AGENCIES INVOLVED IN THE REGISTRATION PROCESS ............................................................................................................. 4 OTHER MATTERS IN THE AGRICULTURAL AND VETERINARY CHEMICALS 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 chemical products................................................................................................. 13 6.9. Public consultation................................................................................. 13 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
7.
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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. The majority 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 veterinary medicines, Australian governments have, for many years, had a key role in the regulation of pesticides and veterinary medicines to ensure they work as claimed and are 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 be approved by the Australian Pesticides and Veterinary Medicines Authority (APVMA)
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the particular source identity of the manufacturing plant used to make an active constituent for an agricultural or veterinary chemical product is an essential part of this approval;
all agricultural and veterinary chemical products to be registered by the APVMA prior to their distribution, sale or use in Australia; all agricultural and veterinary chemical products being sold in Australia to have a label approved by the APVMA attached to their containers; and manufacturers of veterinary chemical products in Australia to be licensed by the APVMA.
The APVMA may also issue a permit to individuals, organizations or corporations allowing them (or others) to use a particular agricultural or veterinary chemical product in 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 is contrary 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 a role to monitor and enforce compliance with the regulatory controls governing the supply of agricultural and veterinary chemicals in Australia. This chapter outlines the legislative provisions under which the APVMA performs its functions and exercises its powers in regard to the regulation of pesticides and veterinary medicines.
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2. WHY AGRICULTURAL AND VETERINARY CHEMICAL PRODUCTS REQUIRE REGISTRATION

There are now over 7000 different pesticide and veterinary medicine products in the Australian 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 they should, but will not be harmful. Under the existing national controls for agricultural and veterinary chemicals it is a serious offence for any person to import an agricultural or veterinary chemical product into Australia or to distribute or sell a chemical product in any State or Territory in Australia, 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 have a label, approved by the APVMA, attached to its container. In order to avoid the severe penalties for breaching these provisions, chemical manufacturers and/or distributors wishing to supply an agricultural or veterinary chemical product in any State or Territory in Australia should apply to the APVMA for registration of that chemical product and for approval of the proposed label for the product. If the APVMA decides to grant the application for registration, and for approval of the proposed label, it must register the product by entering certain information about that product in the Register of Agricultural and Veterinary Chemical Products, and approve the label for the product. Upon registering a chemical product, the APVMA will issue a notice of registration and label approval to the applicant. Once a product has been registered and its label approved, it can then be legally distributed, sold and used in all Australian States and Territories in which the product has 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 as entered in the Register or to make any variation to the approved label for the chemical product including additional claims made about the product then he or she would again be in breach of the regulatory controls over agricultural and veterinary chemical products unless he or she further applies to the APVMA seeking approval for the variation 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 without the 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 and labelled with all necessary limitations, precautions and directions for use. Registration of agricultural or veterinary chemical products also provides a stamp of security that those products have been scientifically assessed to ensure that, when used as directed by the label, they pose no unacceptable risk to human health, worker safety the environment or trade and that the products work effectively. Registration also helps to ensure that unacceptable residues from the chemicals used in agriculture do not appear in food for human or animal consumption in Australia or in Australias export markets.
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3. THE NATIONAL REGISTRATION SCHEME FOR AGRICULTURAL AND VETERINARY CHEMICALS

In 1991, the Commonwealth, States and Territories of Australia agreed to establish a National Registration Scheme for agricultural and veterinary chemicals (NRS) setting out a new regulatory framework for the management of pesticides and veterinary medicines in Australia to replace Australias fragmented regulatory structure. The Scheme was designed to provide for the uniform regulation and control of the manufacture and supply of pesticides and veterinary medicines and to streamline the process of registering agricultural and veterinary chemical products. The NRS is a partnership between the Commonwealth and the State/Territory governments. The APVMA is an independent statutory authority of the Australian Government that was established in 1993 to undertake the Commonwealths regulatory responsibilities under the NRS. The APVMA is responsible for the regulation of the manufacture of agricultural and veterinary chemicals throughout Australia and for their control up to and including the point of retail sale. This includes responsibilities for the registration of pesticides and veterinary medicines and for quality assurance and compliance of them during their manufacture, distribution and sale. The APVMA also manages a number of programs that monitor the ongoing safety and performance of registered pesticides and veterinary medicines The States and Territories have retained responsibility for control over the use of agricultural and veterinary chemicals after their retail sale.
4. THE ROLE OF THE APVMA

The APVMA operates in accordance with its governing legislation principally the Agricultural and Veterinary Chemicals (Administration) Act 1992 and the Agricultural and Veterinary Chemicals Code (the Agvet Code) scheduled to the Agricultural and Veterinary Chemicals Code Act 1994. There are also regulations under the Agvet Code Act and the Administration Act which are known as the Agricultural and Veterinary Chemicals Code Regulations 1995 (the Agvet Regulations) and the Agricultural and Veterinary Chemicals (Administration) Regulations 1995. Furthermore, because the APVMA 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 on it, including to facilitate a consistent national approach to the assessment and control of
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Note: The Administration Act originally established the national regulator with the name of the National Registration Authority for Agricultural and Veterinary Chemicals (NRA). In changing the name of the NRA to the APVMA in June 2004, the Administration Act (section 6) formally continued the NRA in existence but with its new name. In so doing, all the previous approvals and registrations issued, or other 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 chemicals during their manufacture, distribution and retail sale. The Agvet Code provides for severe penalties against 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 for chemical 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 chemical products registered for use in Australia are suitably formulated and properly labelled and, 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 PROCESS

In considering whether to grant an application for registration of an agricultural or veterinary chemical product, the APVMA must be satisfied that the product will be safe and effective and that its label is suitable. As part of making this broad assessment in relation to a chemical product, the APVMA conducts a number of separate evaluations, including chemistry and manufacture; toxicology, metabolism and kinetics; residues and trade; occupational health and safety; and environment. The APVMA uses the services of a number of Australian and State government agencies as advisers to help with some of these evaluations of applications for registration of agricultural and veterinary chemical products. These include:
the Office of Chemical Safety (OCS) of the Commonwealth Department of Health and Ageing which:
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evaluates and reports on toxicology and metabolism studies; proposes first aid and safety directions; determines poison schedule classifications2; and establishes acceptable daily intakes (ADIs) and acute reference doses (ARfD); and evaluates the occupational health and safety aspects of an application and recommends safety directions and occupational controls on use and advises on a Material Safety Data Sheet (MSDS);
sells a chemical product which fails to meet registered specifications, or sells a chemical product that does not have an approved label attached to its container. Another function that the APVMA is authorised to perform is to issue export or free sale certificates under section 69D of the Administration Act to registrants or distributors to facilitate the export from Australia of registered agricultural and veterinary chemical products (or unregistered export only products manufactured in Australia) to countries that require such certificates. Further information on export certificates may be found at http://www.apvma.gov.au/registration/certificates.shtml Note: The determination of poison schedule classification for an agricultural or veterinary chemical product 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. In making its assessment of a chemical product, the APVMA is required to consider the poison schedule classification determined by a separate law of the relevant jurisdiction.
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the Commonwealth Department of the Environment and Heritage (DEH) which evaluates environmental data and recommends appropriate use controls and instructions for the product that will protect the environment; and State and Territory departments responsible for agricultural and primary industries which evaluate and reports on efficacy and target crop or animal safety data for new agricultural chemicals and new uses of registered products. In some cases the APVMA contracts this work out to other agencies such as universities, the CSIRO or to other experts.
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6. OTHER MATTERS IN THE AGRICULTURAL AND VETERINARY CHEMICALS LEGISLATION

It is not possible in this Manual to provide a detailed summary of every matter in the Agvet Code or Agvet Regulations or in the Administration Act or Administration Regulations that may be of relevance to a particular application for registration of a pesticide or veterinary medicine or approval of a product label. However, the following represents a brief outline of some of the more important matters in the legislation pertaining 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 agricultural chemical product. In addition to substances included in the definition of an agricultural chemical product, the definition specifically provides that an agricultural chemical product includes certain other substances as prescribed in the Agvet Regulations and excludes certain other substances as prescribed. The definition is as follows:
(1) (2) This section defines what is meant by an agricultural chemical product for the purposes of this Code. 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) (4) An agricultural chemical product includes a substance or mixture of substances declared by the regulations to be an agricultural chemical product. 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.
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6.1.1.
Inclusions
Regulation 7 of the Agvet Regulations provides that this definition of an agricultural chemical product additionally includes:

dairy cleansers for on-farm use; any substance used in conjunction with an agricultural chemical product to identify areas treated 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 are excluded from the definition of an agricultural chemical by being declared by subregulation 7(2) not to be agricultural chemical products:
Any mould inhibitor for use in the manufacture of paper, glue, plywood, carpets, or any surface coating (including paint), if: (a) the mould inhibitor is incorporated into the product during manufacture as part of the manufacturing 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 effect as 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 or promoted primarily through retailers, to consumers for domestic use, except any sanitiser for use 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 bacteria or enzymes, or both Any predatory insect, predatory mite or macroscopic parasite The nematode Deladenus siricidicola for the control of Sirex species wood wasps in pine plantations 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 chemical product, 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 veterinary chemical product, the definition specifically provides that a veterinary chemical product includes certain other substances as prescribed in the Agvet Regulations and excludes certain other substances as prescribed. The definition is as follows:
(1) (2) This section defines what is meant by a veterinary chemical product for the purposes of this Code. 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) (b) (c) preventing, diagnosing, curing or alleviating a disease or condition in the animal or an infestation of the animal by a pest; or curing or alleviating an injury suffered by the animal; or 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) (3) (a) modifying the effect of another veterinary chemical product. 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 a substance or mixture of substances declared by the regulations to be a veterinary chemical product. 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. A veterinary chemical product includes:
(b) (4)
A veterinary chemical product does not include: (a)
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6.2.1.
Inclusions
Regulation 8 of the Agvet Regulations provides that this definition of a veterinary chemical product additionally includes:

allergenic substances supplied or used for administration to an animal by any means, or for consumption by an animal; medicated blocks or licks; enzymes supplied or used for administration to an animal by any means, or for consumption by an animal; stockfood non-active constituents except stockfood non-active constituents excluded from this 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 Chemical Products (Excluded Stockfood Non-Active Constituents) Order.
6.2.2.
Exclusions
Several substances are excluded from the definition of a veterinary chemical by being declared by subregulation 8(2) not to be veterinary chemical products. These substances include certain stockfoods, medicated stockfoods and stockfood supplements; certain premixes and medicated premixes; certain blocks and licks; and colour intensifiers for aviary birds.
For a full description of the particular stockfoods, medicated stockfoods and stockfood supplements; premixes and medicated premixes; and blocks and licks excluded from the definition 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 the formulation of agricultural or veterinary chemical products intended for distribution, sale or use in Australia. This applies regardless of whether the product is formulated in Australia 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 the APVMA. 6.3.1. Agricultural active constituents
All manufacturing sources of active constituents for use in agricultural chemical products must be approved by the APVMA. New sources of approved active constituents must be equivalent to, and are assessed against, the first approval of that active constituent.
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6.3.2.
Veterinary active constituents
All active constituents for use in veterinary chemical products must be approved by the APVMA. If the active constituent is subject to a monograph in the British Pharmacopoeia, British Pharmacopoeia (Vet), European Pharmacopoeia or United States Pharmacopeia, that standard will be applied. Where such a standard does not exist 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 chemical product, or in approving a label for containers for a chemical product the APVMA may impose 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 container of a kind prescribed in the Agvet Regulations. For this purpose, regulation 18 of the Agvet Regulations provides that a container for a chemical product must (a) be impervious to, and incapable of chemical reaction with, its contents when under conditions of temperature and pressure that are likely to be encountered in normal service; have sufficient strength and impermeability to prevent leakage of its contents during handling, transport and storage under normal handling conditions; if it is intended to be opened more than once be able to be securely and readily closed and reclosed; have sufficient excess capacity to prevent it from breaking if its contents expand during handling, transport or storage; and enable all or any part of its contents to be removed or discharged in such a way that, with the exercise of no more than reasonable care, the contents cannot (i) (ii) harm any person; or have an unintended effect that is harmful to the environment
(b) (c) (d) (e)
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 supplied only 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 grounds upon 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 relevant information in relation to the active constituent or chemical product after their application has been lodged with the APVMA. Relevant information is a defined term that includes any information that contradicts the information given to the APVMA in the application, or shows that the use of the active constituent or chemical product would be unsafe or ineffective, or would have had to be given to the APVMA in connection with the application if the applicant was aware of the information when the application was made. An applicant that is an Australian corporation is taken to be aware of information if the 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 any relevant information in relation to the active constituent or chemical product after the active 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) from disclosing confidential commercial information. Confidential commercial information 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 active constituent or chemical product or other information about them that is of value that would be destroyed or diminished if disclosed; or information that if disclosed could unreasonably 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 that most information and data sent to the APVMA as part of an application for approval of an active constituent, the registration of a chemical product, the approval of a product label, a permit, or for a manufacturing licence would be confidential commercial information 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 information some 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 the APVMA
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 a label, for a permit, or for a manufacturing licence (or for a variation of any of these things) the applicant can seek to have certain decisions of the APVMA reconsidered. A full description of the type of decisions for which a reconsideration can be sought is detailed in section 167 of the Agvet Code but, in general terms, they include a decision to reject an application under section 11A or a decision to refuse an application or to impose conditions of approval or registration. In reconsidering an earlier decision the APVMA is legally obliged to reconsider its original decision and either confirm, vary or set aside that decision and make a new decision in substitution. A reconsideration is taken to be a fresh decision on the relevant matter and thus must be made 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 been delegated the authority to reconsider an earlier decision of the APVMA. Applications for a reconsideration must be made in writing to the General Counsel of the APVMA. An applicant who is not satisfied with the APVMAs original or reconsidered decisions also has a right to have some decisions of the APVMA independently reviewed by the Administrative Appeals Tribunal (AAT) subject to the Administrative 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 any capital city and should be lodged within 28 days of receiving the notice of the decision by the APVMA.
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6.8.
Legislation covering the manufacture of veterinary chemical 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 APVMAs Manufacturing Principles and the Australian Code of Good Manufacturing Practice (GMP) for Veterinary Preparations and/or Australian Code of Good Manufacturing Practice for Homemixed Feeds, Feed-Milling Industry and Stock-Food Premixes as may be appropriate before the APVMA will license them. Applicants who wish to register veterinary chemical products manufactured overseas must provide acceptable evidence that the manufacturer complies with GMP standards comparable to those applying in Australia. Acceptable evidence consists of:

documentation from a recognised regulatory authority that supports compliance with an equivalent level of GMP to the relevant Australian Code; or audit of the overseas plant by an APVMA-authorised auditor or by an auditor acceptable to the APVMA.
There is no requirement for manufacturers of agricultural chemical products to be licensed. More detailed information on the APVMAs Manufacturers Licensing Scheme is available by contacting the APVMA on (02) 6272 3409.
6.9.
Public consultation
The Agvet Code (sections 12 and 13) requires the APVMA to publish a general notice in the APVMA Gazette about new active constituents being considered for approval and chemical products containing new active constituents being considered for registration. In the notice the APVMA is to invite written comment from the public on specific grounds on whether the application for approval of the active constituent or registration of the chemical product should be granted. Additionally, if the product is to be used on a food-producing species, a Public Release Summary (PRS) of the information provided in the application for registration is prepared 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 the APVMA publishes a Trade Advice Notice (TAN) in the Gazette seeking public comment, on trade grounds only, as to whether the application for registration of the product should be granted. This public consultation process allows members of the public and relevant industry bodies to have an opportunity to raise matters of concern about human and environmental safety and, where relevant, trade. The APVMA must take into account any submissions received in response to public consultation notices before it makes a decision 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 AGVET CODE

Amendments to the Agvet Code which came into force on 1 January 2005 regulate the way in which the APVMA uses scientific information provided as part of applications. The amendments introduced three major changes to the manner in which the APVMA uses the information provided with certain applications:

Data protection: New limitations on how the APVMA can use information in making certain decisions Early disclosure: Publishing application summaries once an application has been accepted for assessment Summaries of advice: Publishing the advice provided by other government departments and agencies, and other specialists the APVMA consults, in relation to applications which are approved.
7.1.
Data protection
The provisions relate only to information provided with applications for active constituents, products and labels. They do not have any impact on information provided for chemical reviews undertaken by the APVMA. Where applicants provide information with an application, the APVMA will be restricted from using it for certain decisions without the permission of the authorising party. Essentially, the data protection provisions apply to the following four situations:

screening evaluation after-application approval (ie new active constituent, product or label in the market) s.161 data. Some qualifications
7.1.1.
Pre-approval protection (screening and evaluation)
While an application for an active constituent or product is in screening or is being evaluated, the APVMA will be restricted from using that information for another application relating to an active constituent or product (but not to a permit) as well as any 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 to approve the application will become protected data. This protection means that the APVMA will be limited from using that information to make a decision on another application (except for a permit) or a chemical review without the consent of the authorising party (or when one of the other exceptions apply, see paragraph 7.1.2 below). The length of protection depends on the purpose of the application. Appendix A provides details of the protection periods for application data and extending the period of 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 graphic representation).
Consent for use
The APVMA can use protected data when a consent for use has been provided by the authorising party for those data. The consent remains valid even if it is withdrawn or was fraudulently provided. Any disputes as to the validity of a consent will be a matter for the parties. However, it is a criminal offence to make a false statement to the APVMA.
Public interest
The APVMA can use protected data when it is in the public interest to do so. Public interest can include a range of things but will include when the data indicates an undue risk to human health or the environment. The APVMA currently has similar powers in relation to chemical reviews. Data owners will receive a notice indicating the APVMAs intention to use the information in the public interest and the data owner has the 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 use the 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 an active constituent, product or label where the APVMA considers that the data demonstrates the second application is unable to meet requirements with respect to safety to people or the environment, or the product is ineffective.
Identical information
The APVMA can use protected data when there is identical information available that are not protected (ie publicly available information). Information that are declared to be publicly available will not receive protection. There are, however, penalties for making a 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 of application, as they are ineligible for data protection:
an application for an active constituent which at some time in the past had been approved (either by the APVMA or a State/Territory government) or had been an active constituent in a registered product (either by the APVMA or a State/Territory government). If the active constituent had already existed previously in Australia then it cannot be considered a new active constituent (and gain 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 of an 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 active constituent). Companion animal products are products for use on, or to be administered to, non-food-producing animals and any food-producing animals defined 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 that product 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 protected information
Situation 1: Consent for use

Application references protected data Has consent for use been provided? Data are used in the assessment process
Yes
No
Applicant receives a requirements letter or the application is rejected
Situation 2: Public interest
APVMA intends to use protected data when in the public interest
Is the associated risk imminent? No
Yes
Make decision immediately. Authorising party receives notice but does not include appeal rights
Authorising party receives notice including appeal rights and APVMA waits 28 days before making relevant decision
Situation 3: Unfavourable to another application
APVMA becomes aware of protected data unfavourable to another application
Do the data indicate an undue hazard to people or the environment, or that the product is ineffective? No There is no need to use the data
Yes
Appropriate decision is made
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Figure 1 (continued)
Situation 4: Identical information
Applicant references publicly available information
Is the information listed as public domain?
Yes
Appropriate decision is made
No Applicant must provide copy
5. Situation 5: Ineligible applications
Applicant provides information with application
Does the information fall into one of the following categories? 1. Owner/authorising party marked as Public or 2. provided in an application for: a. an active constituent which has been previously approved b. an active constituent which has been present in a registered product c. variation of an approved active constituent d. registration of a companion animal product (not including a new active constituent) e. approval of a label for a companion animal product f. variation of registration or label approval for a companion animal product.
Yes
No protection is provided
No
Information is eligible for protection
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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 see the APVMA website Data Protection Application Requirements page http://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 data list, setting out all data provided. The APVMA has created two templates for applicants use (with instructions on how to complete them). Please see the APVMA website Data Protection Application Requirements page http://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 to produce the required documentation for assessment.
New requirements when referencing information
For applications that need to reference information held by the APVMA in order to satisfy 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? a means of discerning what active constituents and products have associated protected data, what that data is and who the authorising party is a consent for use letter template to ensure appropriate consent is provided.
To assist applicants, the APVMA intends to provide (via the website):

7.2.
Early disclosure
For most applications, the APVMA is required to publish a summary of application shortly after the application has been accepted for assessment. Early disclosure increases the transparency of the process. It also eliminates the previous requirement that the APVMA must not publicly acknowledge whether a certain application has been made. One benefit to applicants of this change is that other government authorities with which the APVMA deals, such as Food Standards Australia New Zealand (FSANZ) and the Office of the Gene Technology Regulator (OGTR), will be able to disclose the existence of the application, thus allowing other related regulatory actions to occur at the same time. The type of applications to which early disclosure applies include those for new active constituents, 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 the product. The summary will include details specified in the Agvet Code Regulations (see http://www.apvma.gov.au/about_us/AgVetChemCode95Reg.rtf). The Regulations require different application summaries depending on the type of application. They will include 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 (as discussed 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 as efficiently as possible, applicants will be required to provide the information in the specified format.
7.3.
Summaries of advice
Where the APVMA has granted an application involving an active constituent, product or label and the APVMA has relied on advice provided by another government body or a person contracted by the APVMA, the APVMA must publish a summary of that advice. The summary will include details specified by the Agvet Code Regulations. The Regulations 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 of advice.
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 be publicly available. Although reports and summaries will be written in accordance with the CCI guideline and will not contain any agreed CCI, applicants should check the advice 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 Implementation Act 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 to encounter, these additional matters have not been discussed in any detail. The APVMA will, however, ensure that the requirements of the US Free Trade Agreement Act are met 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 by the 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 years protection*
Application to approve a new active constituent (ie one never previously approved or present as an active constituent in a registered product) Application to register a product containing a new active constituent as described in item 1 above, where the application for the product had passed screening (ie been accepted for evaluation) before the active constituent in item 1 had been approved Application to register an agricultural chemical product other than as described in 2 above Application to register a veterinary chemical product other than as described in 2 above (food/fibreproducing animals only) Application to vary an agricultural chemical product and/or label Application to vary a veterinary chemical product and/or label
3 4
5 3
5 6
5 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 following conditions are met. For data that receive eight years protection (ie items 1 and 2 of the above table), the protection period will be extended by one year for each five distinct uses that meet the following requirements:

the distinct use is on an approved label of a product as described in item 2 of the table the application to include the distinct use on a label for the extension product was accepted for evaluation before the end of the sixth year of protection of the data associated with the new active constituent all five distinct uses are specified in the relevant Agvet Code Regulation by the time the application including the fifth use is granted. Regulation 22A of the Agvet Code Regulations (http://www.apvma.gov.au/about_us/AgVetChemCode95Reg.rtf) determines what is 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 applicant is not extrapolating from data provided on other uses to satisfy APVMA requirements for the distinct use); and the data were required for the type of application involved and were relied on 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-food crop, then the use can be specified on the label via either the crop or the associated 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 a person acting on their behalf becomes aware of any new information that is relevant to the approved active constituent or registered product, and the information is also new to the APVMA, they must give that information to the APVMA. If s.161 information is provided for a product (whose application for registration was made after 1 January 2005), the APVMA is limited from using the information for the purpose of making a decision on another persons application involving an active constituent, 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
1 July 2005 1 October 2005
First edition Second edition extensive revision of complete document. Third edition updated link to Agvet Code Regulations.
1 April 2006
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Procedures for making an application
Procedures for making an application for: approval, or variation of approval, of active constituents registration, or variation of registration, of chemical products approval, or variation of approval, of labels Contents
1. 2. 3. INTRODUCTION ................................................................................................... 1 TYPES OF REGISTRATION ................................................................................ 1 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 a different approved person.......................................................... 4 3.1.3. An overseas applicant and registrant must appoint an approved person........................................................................ 4 3.1.4. Letter of authority....................................................................... 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 ................................................................... 8 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 be rectified .................................................................................... 15 5.3.2. Treating applications as having been withdrawn ..................... 16 5.3.3. Applications which have defects that cannot reasonably be rectified: rejection of the application ................................... 16
4.
5.
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5.4.
5.5. 5.6.
5.7. 5.8. 5.9.
5.10.
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 .................................................... 18 5.4.4. Clock time and elapsed time .................................................. 18 5.4.5. Public consultation................................................................... 19 The obligation to notify the APVMA of any relevant new information relating to a pending application ......................................... 20 Granting an application.......................................................................... 20 5.6.1. Conditions of registration ......................................................... 20 5.6.2. Conditions of label approval .................................................... 20 Refusing an application ......................................................................... 20 Reconsideration and appeal of an APVMA decision ............................. 21 The registrants obligations after an application is granted ................... 21 5.9.1. 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 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 certificate of 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 the Agricultural and Veterinary Chemicals Code Act 1994 (the Agvet Code) the Australian 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, see Chapter 2 of this volume, Legal background to the National Registration Scheme. The APVMA has the responsibility to ensure that agvet chemicals registered for use in Australia 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 have been 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 or approval of an agricultural or veterinary chemical or product. Detailed guidance on the category under which an application must be made, and data requirements for an application are set out in Volume 2, Category requirements and guidelines, and Volume 3, 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 the normal registration requirements, two tiers of regulation known as listed registration and reserved from registration are available for those agvet chemical products which are considered to be of a lower risk.
1. Registered chemical products
These are products which are subject to the normal requirements of registration. These are 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 warrant the rigorous, individualised assessment process that applies to registered chemical products, particularly given the known risks associated with their use. These products can be given listed registration against a Standard, provided that: the APVMA has submitted a Standard to the Minister declaring it is satisfied that the 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 that product or class of products the chemical or class of chemicals has subsequently been included in a Schedule of Listable Chemical Products in the Agvet Code Regulations.
3. Reserved chemical products
Agricultural or veterinary chemical products or classes of products can be reserved from registration subject to Conditions, provided that: the APVMA has submitted Conditions to the Minister declaring it is satisfied that the use of the product or class of products in accordance with the Conditions would 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 Schedule of Reserved Chemical Products in the Agvet Code Regulations. This is a very simple system of regulating minimal risk products. The effect is to virtually exclude reserved products from regulatory controls. Such products are excluded from the offence provisions of the Agvet Code provided they comply with the Conditions set out in the Regulations, eg it is not an offence to possess and/or supply a reserved 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 chemical product approval of a label. If the applicant is a body corporate they must provide an ACN or an overseas equivalent number as appropriate. In relation to an existing approval or an existing registration (regular or listed), the registrant or approval holder (interested person) can submit further applications that relate to the approval or registration that they hold. The registrant or approval holder may 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 whom it should deal in relation to an application and any requirements relating to that application, and to whom it should issue the notice of registration or approval. The APVMA also must identify the person with whom it should deal in relation to postregistration activities such as registration renewal, cancellations or suspensions, or reconsiderations of registrations or approval. For the purpose of such dealings the Agvet Code refers to an approved person. The approved 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 body corporate incorporated in Australia. 3.1.1. Defining an approved person
An Australian applicant or registrant can be an approved person. The Australian applicant 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 in relation to receiving letters and/or notices from the APVMA, the APVMA will write to the applicant in relation to the screening of an application, the notice of registration and/or approval or the refusal of an application. Similarly, where the Australian registrant elects to also be an approved person in relation to post-registration activities the 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 different approved 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 incorporated in 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 APVMA will deal with the appointed approved person. The Australian registrant can also elect to appoint a different approved person in relation to post-registration activities. In this case the APVMA will write to and issue notices related to post-registration activities to the different approved person. The Australian applicant or registrant can withdraw the appointment of an approved person at any time by writing to the APVMA, and can also vary the authority of an approved person. When an Australian applicant or registrant elects to vary the responsibilities of an approved person or appoint a different approved person a letter of authority is required. 3.1.3. An overseas applicant and registrant must appoint an approved person
Overseas applicants and registrants must appoint an Australian person/body corporate as the approved person when lodging an application, varying an application, submitting new relevant information or withdrawing an application. Similarly, overseas applicants must appoint an Australian person/body corporate as the approved person to whom the APVMA 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 in relation to post-registration activities such as cancellations, suspensions or reconsiderations of registrations or approval. If the overseas registrant elects not to appoint an approved person for these post-registration activities the APVMA will write to 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 a person 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 the regulatory activities are to apply. If all activities are to apply then the letter of authority should state for the purpose of all regulatory activities associated with this application and for the purposes of all regulatory activities following registration and/or approval or words to that effect. If a different approved person is appointed for any one or more of the regulatory activities, a separate letter for each different approved person must be supplied.
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4. REQUIREMENTS FOR MAKING AN APPLICATION

A complete application must: include the appropriate and fully completed application form signed by an approved person include all the information that the APVMA requires (see Volumes 2 and 3 of this manual, 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 an application
An application can range from just a completed application form to a multi-volume dossier containing detailed scientific reports and scientifically based arguments. As a minimum, 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 application form and application overview (see Part 1 Application Overview in Volume 3 Data requirements and guidelines) are combined into a single document. The document relevant 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 the combined 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 another source and does not have access to the information, the onus is on the applicant or approved person to ensure that the formulator provides the full formulation details to the APVMA. The provider of the formulation details must ensure that the information adequately 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) the formulator and applicant / approved person must clearly state this in the application/related information. Unless otherwise advised, the APVMA will assume that a formulation provided directly by a formulator to the APVMA is information which is CCI to the formulator.
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Fees
The appropriate application fee must be submitted with the application before it can be accepted. The application fee is determined by the application category, or from the total of modules if the application falls into a modular category. The application category or relevant modules can be determined from Volume 2 and Volume 3. Applicants should submit the complete fee with their initial application. If an applicant is 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 will request the balance after screening once a determination has been made as to whether the 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 made payable 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 will be made under Category 8, a formulators declaration is required as detailed in Volume 2, Category 8. The declaration must be on the formulators company letterhead and must contain the name and the title of the person signing the declaration. Where more 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 for registration, or variation to registration or label approval, can be finalised. For most applications, applicants should submit two copies of a draft label in text form with the initial application. Once the draft text label has been assessed, the APVMA will request the submission of ten MPLs. Further details may be found in the individual category chapters in Volume 2 and in Volume 5 Labelling.
Data
Each application category has different data requirements. Applications must include relevant 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 (Data Parts 2 to 10) must be bound. Where applications require submission of different data parts (eg chemistry and efficacy and residues), 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 technical screening.
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4.2.
Where to send applications

Application Management and Enquiries Australian Pesticides & Veterinary Medicines Authority PO Box E240 KINGSTON ACT 2604
All applications must be in hard copy and mailed to:
or delivered to: Application Management and Enquiries Australian Pesticides & Veterinary Medicines Authority Ground Floor John Curtin House 22 Brisbane Avenue BARTON ACT 2600 All correspondence between the APVMA and an approved person must be dated and include: 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 the correspondence.
4.3.
How an application can be altered
For any application an approved person may authorise the APVMA to alter aspects of that application. The request to alter an application must be in writing. An approved person may give the APVMA additional or different information at any time after an application has been made, and before it has passed screening and therefore 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 submitting a written request: when an application is voluntarily withdrawn before the evaluation process has commenced, 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 part of the fee may be retained by the APVMA.
4.5.
Language
How to format an application
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 an authorised English translation, and clearly identify it as such. The APVMA may request the original foreign language paper.
Confidential commercial information
In the performance of their duties, APVMA staff will be required to use confidential commercial information submitted by applicants. Confidential commercial information 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 of a chemical product, means: a trade secret relating to the constituent or product; or 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 can information (other than trade secrets to which paragraph (a) applies or information to which paragraph (b) applies) that: concerns the lawful commercial or financial affairs of a person, organisation or undertaking; relates to the manufacture, distribution or supply of the constituent or product; and if it were disclosed, could unreasonably affect the person, organisation or undertaking in an adverse manner.
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The Agvet Code provides certain protection to confidential data submitted to the APVMA. Claims by applicants to the effect that:
information and data submitted contain trade secrets; or contains commercial information which is the property of the applicant; or disclosure of the information or data to the APVMA is on a confidential basis; or no government agency is authorised to disclose the data and information without written permission from the applicant
are acceptable. It is also acceptable for an applicant to claim that the information is to be treated as confidential commercial information for the purposes of the Agvet Code or when subject to any request for disclosure under the Freedom of Information legislation. However, the APVMA expressly disclaims statements (however stated) to the effect that:
the information or data are supplied only for the purposes of enabling the APVMA to evaluate the application for approval/registration of a particular product the subject of the present application or the information or data are not to be used, either directly or indirectly, to approve or register another product without the prior written permission of the applicant.
These types of confidentiality statement purport to establish a claim that by way of data protection is over and above the protection provided by the Agvet Code.
Cover page for bound data
The cover page for bound data must contain certain information to enable reviewers to easily identify and access data. Applicants must label the cover of each volume with the following information: name of the applicant common name of the active constituent and its approval number (if applicable) trade name/distinguishing name of the product APVMA file number (if known) type of application or category volume numbers and total number of volumes in the application part number and a brief statement of the contents date of application.
Table of contents
Data parts that contain more than 10 pages of data must have a table of contents showing the page numbers. Where a part consists of more than one volume, each volume must be clearly identified.
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Presentation
All material submitted must be legible and printed on A4 paper. Applicants may print pages on both sides if legibility is not affected. If printed double sided, the margins must be wide enough to enable the material to be read when bound and/or placed on file. The material must be presented in a systematic order. If the entire data submission contains more than 10 pages of data, applicants must separate the different parts of the application (eg the Chemistry part from the Toxicology part). If a section comprises a series of studies, a concise summary (abstract) must be provided at the front of each study. Within each section, similar studies must be grouped together to facilitate assessment (eg group all acute toxicology studies together). The full name of each study must be listed in the table of contents along with referenced crops/species.
Photocopies and photographs
Applicants must ensure that all photocopies are legible with margins on both sides of the page. The APVMA will return any unreadable, unclear or incomplete copies and ask the applicant to replace them. Any photographs must be of a quality suitable for reproduction. Original prints are preferred. Photocopies of photographs will only be accepted if they are of good quality and clearly illustrate the subject.
References and testimonials
If specific references are cited in an application, applicants must include a legible copy of the whole article with the application. Applicants must indicate which part of the reference is applicable to the application. For generally accepted scientific information, full references will not usually be required. However, in some instances the APVMA may require a copy of a reference. Testimonials and other forms of anecdotal evidence are generally not acceptable, and will normally be disregarded. However, a short summary (less than 250 words) may be provided.
Pagination
Applicants must number the pages of their application systematically so that reviewers can easily and accurately locate data or application parts. Pages may be sequentially numbered from start to finish or, if an application is in several volumes, sequentially numbered within each volume. For example: Part 1: Part 2: Pages 1.1, 1.2, 1.3 and so on Pages 2.1, 2.2, 2.3 and so on
Any system for numbering the pages of an application may be used, if it is consistent throughout the application and is accurately reflected in the table(s) of contents. Applicants do not need to erase page numbers on copies of other documents included in an application, if those page numbers cannot be confused with the page numbers of the application.
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Binding
Data parts must be bound in one or more volumes with durable covers, preferably the same size as the pages. The volumes must be free from damaging projections and each volume must be no more than 5 cm thick. Where applications require submission of different data parts (eg chemistry and efficacy and residues), each data part must be submitted as a separate bound volume/s. Different data parts must not be combined within the same bound volume. Larger applications may need to be broken down into several volumes, with each major part contained in a separate volume. Individual parts, if very large, may need to be broken down into several volumes. For example, the different sections of Part 3 (Toxicology) may need to be presented in separate volumes. Binding that allows volumes to be easily opened for reading and evaluation must be used. Plastic spiral binders and plastic arnos-type fasteners are suitable. Metal arnos-type fasteners and ring binders are not acceptable because they often open during transport. If data are not bound properly there are risks that data could be separated during transport which will not only cause delays but also risks to commercial confidential information going astray. Additionally, the proper binding of data is also a requirement of Australian Archives. If bound data are received in an unacceptable format, they will be returned to the applicant for appropriate binding.
Number of copies required
The number of copies required will depend on how many agencies must evaluate the application. Applicants should initially send one unbound copy of Part 1 (Application Form and Overview) and one bound copy of all other volumes. The APVMA will use the volume(s) for screening purposes. Once the submission has passed screening, the APVMA will advise the applicant of the number of copies of each part required to progress the evaluation.
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5. PROCESSING APPLICATIONS
The APVMA will first screen the application to assess whether the application is a complete application. If all the requirements are met the APVMA will notify the approved person that the application has passed preliminary assessment (screening) and that a full evaluation will proceed. If screening determines that there are defects in the application, but that these defects can reasonably be rectified, the APVMA will notify the approved person of these defects. The APVMA will specify the timeframe within which the defects must be rectified. If the defects are not addressed within the specified period the APVMA may treat the application as having been withdrawn (see paragraph 5.3.1). If the preliminary assessment finds that there are deficiencies in the application that cannot reasonably be rectified the APVMA may reject the application (see paragraph 5.3.3). If the APVMA rejects the application, it will notify the approved person of this decision and give reasons for the decision. A screening fee is retained by the APVMA. Monies paid in excess of the screening fee are repaid to the applicant.
5.1.
The screening process
On receipt, all applications for new products are immediately recorded on a database and given a unique number that becomes, when registration is granted, the National Chemical Registration Information System Database (NCRIS) number. This number remains with the product throughout the life of the product. Each application is also given an Application Tracking System (ATS) number. Over the life of a product several applications to alter registration particulars or labels may be made, and the APVMA uses the ATS number to individually identify each application. Both numbers will be quoted on all correspondence. Please quote both numbers when corresponding with the APVMA. The screening process can have up to three steps: administrative screening technical screening; and agency screening
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5.1.1.
Administrative screening
The APVMA administratively screens applications as soon as they are received. The APVMA also records accompanying bound data and receipts all monies received. At administrative screening, APVMA staff check the following:
Application details
are the applicant details correct? are the approved person details correct? is the application form correctly signed? has a fully completed application form been supplied, including the appropriate formulation details? is the supplied information legible with any corrections initialled by the applicant? if the application is to vary an existing registered product or label, are the registrants details provided on the application form the same as those on the APVMA register? has the applicant provided an electronic and hard copy of the data list? has the applicant submitted a minimum screening fee of $460 (except for Category 13 applications with a nil fee)?
New product details
for new products similar to registered products, has a registered reference product been nominated? for applications to repack a registered product under a new name, has a registered reference product been nominated? Is the formulator of the product the same as the formulator of the reference product? Has a formulators declaration been provided? has the applicant provided two copies of the draft label of the proposed product? if required, has the applicant provided an electronic and hard copy of the data list?
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Variation to existing product details
if the application is to vary an existing registered product or label, is the product name on the application form the same as on the APVMA register? if the application is to vary a label, has the applicant provided a copy of the of the currently approved label showing all deletions struck out and a copy of the proposed new label showing all additions underlined? if required, has the applicant provided an electronic and hard copy of the data list? If an application fails administrative screening, the APVMA will send a letter to the applicant or approved person outlining what is required and the timeframe within which the requirement must be met. Once the requirements are met the application will progress to technical/agency screening. If the requirement is not met within the timeframe and the applicant or approved person has not requested an extension, the APVMA will advise the applicant or approved person that they have a further 28 days to comply with the APVMAs requirements. The letter will also state that after this period the APVMA may proceed to treat the application as having been withdrawn. Once an application passes administrative screening, it progresses to technical or agency screening. 5.1.2. Technical or agency screening
The agricultural, veterinary, and external government agency evaluators meet each week to screen new applications and deal with responses to deficiencies identified when they first screened an application. The evaluators determine whether the application has been made under the correct application category and therefore whether the correct fee has been provided. The evaluators screen the data provided with the application against the data requirements outlined in Volumes 2 and 3 of this manual.
5.2.
After screening
When the application has passed technical and agency screening it is assigned to an evaluator. At this stage, the APVMA may request extra copies of data. An overview of who may be involved in the evaluation is provided in paragraph 5.4. The timeframe for assessment (ie clock time) commences on the day the application passes technical screening, or, if the APVMA requests additional copies of data and/or fees, the date the APVMA receives the data and/or fees.
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5.3.
5.3.1.
Applications which do not pass screening

Applications which have defects that can reasonably be rectified
If an application fails technical and/or agency screening the APVMA will send a deficiency letter to the approved person outlining the defects of the application and how these should be corrected. Generally, a period of two months is given for defects to be corrected. The deficiency letter will contain a contact for general enquiries regarding the registration process and a contact for technical queries regarding the defects outlined in the letter. All correspondence and enquiries must be directed to the relevant contact officer. All enquiries of a technical or regulatory nature must be in writing. Depending on the approved persons response, the APVMA will proceed as follows:
Full response
A full response to a deficiency letter means that the approved person has provided data and/or relevant scientific argument to address each of the identified defects in the application. If the technical and/or agency evaluators determine that the information in the response now means that all the APVMAs requirements have been met, the application will proceed to evaluation. However, the technical and/or agency evaluators may determine that the information in the response is not sufficient to address the APVMAs requirements. In that case the application remains deficient and the APVMA will send a further deficiency letter to the approved person. An application will not pass screening until all defects have been addressed to the satisfaction of the APVMA.
Partial response
A partial response to a deficiency letter means that the approved person has provided data and/or relevant scientific argument to address some but not all of the identified defects. The APVMA will send a letter to the approved person to remind them of all outstanding defects and the time remaining to address them. If no response is received to the reminder letter or the second response is incomplete (ie a further partial response is received) the APVMA will send another letter to the approved person to again remind them of the outstanding defects. The letter will also state that the application may be rejected, or treated as having been withdrawn if the approved person does not provide a satisfactory response.
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5.3.2.
Treating applications as having been withdrawn
If the approved person does not provide a satisfactory response to the deficiency letters described above, the APVMA may treat an application as having been withdrawn. The APVMA will send a letter to the applicant or approved person asking them to show cause why the APVMA should not treat the application as having been withdrawn. If an application is treated as having been withdrawn, the APVMA will retain $460 of the application fee and will refund the remainder. Certain appeal rights are available to applicants if the APVMA proceeds to treat an application as having been withdrawn. If the defects in the application are corrected and the technical and/or agency evaluators determine that the information in the response now means that all the APVMAs requirements have been met, the application will proceed to evaluation.
Request for extension of time
Written requests for extensions of time to address the APVMAs requirements will be accepted from the approved person only. In the request it is important to outline what will be done to rectify each deficiency and the anticipated finish date must be nominated. Requests for extensions will be assessed on individual merit. If the APVMA declines a request for an extension of time, the APVMA will notify the approved person of this decision and give reasons for its decision. Certain rights to appeal this decision apply. 5.3.3. Applications which have defects that cannot reasonably be rectified: rejection of the application
If APVMA decides at screening that there are defects in the application that cannot reasonably be rectified, the APVMA may reject the application. The APVMA will send a letter to the applicant or approved person asking them to show cause why the APVMA should not reject the application. If an application is rejected, the APVMA will retain $460 of the application fee and will refund the remainder. Certain appeal rights are available to applicants if the APVMA rejects an application.
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5.4.
5.4.1.
The evaluation process

Assigning applications
Once an application passes screening, it is assigned to an evaluator. The APVMA will notify the approved person when the application has passed screening, giving the evaluators contact details. From this point, the evaluator is responsible for evaluating, overseeing and answering any queries regarding the application. If an application requires assessment within the APVMA or by external agencies, the appropriate data parts of the application will be sent out as summarised in the following table:
Application part Agencies
Part 1 Part 2 Part 3 Part 4
Application Overview Chemistry and Manufacture Toxicology Metabolism and Toxicokinetics
Evaluator, all relevant agencies and reviewers APVMA Chemistry Section, APVMA GMP Section and all relevant agencies OCS APVMA Residue Section, OCS, DEH APVMA Residue Section, evaluator APVMA Residue Section, evaluator DEH Evaluator and reviewers Evaluator Evaluator, relevant agencies (OGTR, EAGAR)
Part 5A Residues Part 5B Overseas Trade Aspects Part 6 Part 7 Part 8 Part 9 Environment Efficacy and Safety Other Trade Aspects
Occupational Health and Safety OCS (OHS)
Part 10 Special Data Requirements GMP OCS DEH OCS (OHS) OGTR EAGAR
Good manufacturing practice Office of Chemical Safety Department of the Environment and Heritage Office of Chemical Safety (Occupational Health and Safety) Office of the Gene Technology Regulator Expert Advisory Group on Antimicrobial Resistance
If an application does not require external agency assessment, it will be evaluated inhouse by the APVMA. Applications for listed registration will be assessed in-house by the APVMA against the relevant Standard.
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5.4.2.
Changes to applications during evaluation
When a product application involving more than one claim for use proceeds to registration for one or more claim, but not all claims, the applicant may: withdraw the unacceptable claims in which case the APVMA can proceed with the registration and approval of the satisfactory parts of the application withdraw the application. Should the applicant choose to withdraw the application it is open to the applicant to submit additional data later. This will be categorised as a new application with an appropriate fee and timeframe. The APVMA will be able to use the satisfactory parts of the previously-withdrawn application. When an applicant changes the formulation of a yet-to-be-registered product necessitating a substantial amount of re-evaluation, the amended application becomes a new application with a new timeframe and fee. The same product name may still be used. When an application is changed to add target or host species, the application will be regarded as a supplementary application. The fee and timeframe for the supplementary application will depend on the work to be done. 5.4.3. Timeframes for assessment
The timeframes for assessing the different categories of applications are prescribed in Schedules 6 and 7 of the Regulations to the Agvet Code. These schedules may be found in Volume 2 of this manual and in the individual category chapters. 5.4.4. Clock time and elapsed time
The total time taken to finalise an application is the sum of the time taken to complete the steps of: screening data evaluation public consultation for 28 days (if applicable see paragraph 5.4.5) label checking entry of the product details on the register and issue of a Notice of Registration (or amendment of particulars of registration), or issue of a permit as the case may be. The APVMA measures the time taken to process and evaluate an application by clocks which are embedded in the Application Tracking System (ATS). The time taken to assess a particular application is called clock time. The clock does not start until screening is complete, the full application fee has been paid and all the requested data copies have been received. The application is then assigned for evaluation. If an application must be returned to the applicant for any reason, or if additional information is requested, the clock is stopped and not started again until the changes or information required are provided. This means that any requests for additional information will delay the total time taken for the evaluation of
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an application and there may be a considerable difference between clock time and elapsed time. Applicants should note the difference between clock time and elapsed time. The timeframes prescribed in Schedules 6 and 7 of the Regulations to the Agvet Code do not include the one month (30 days) for screening (preliminary assessment) provided in Section 11A of the Agvet Code. The prescribed timeframes also do not include the period when the ATS clock is stopped for any of the following reasons: the APVMA has returned the application to the applicant to correct an administrative or technical defect in the application the APVMA has sent a letter to the applicant to required further data or technical information the applicant may debate the need to provide the additional data or information; nevertheless, the ATS clock remains stopped until the matter is finalised a 28 day period of public consultation is required (see paragraph 5.4.5) the APVMA has requested the applicant to provide marketed product labels (MPLs) to finalise the application. For the reasons outlined above, the elapsed time to finalise an application may be several months longer than the clock time prescribed in Schedules 6 and 7 of the Regulations to the Agvet Code. 5.4.5. Public consultation
For all new products containing new active constituents, the APVMA publishes a notice in the Commonwealth of Australia Agricultural and Veterinary Chemicals Gazette (APVMA Gazette) to announce that the APVMA is considering registering the product. The Gazette notice invites the public and industry bodies to raise matters of concern about human and environmental safety and trade. These comments are considered before the APVMA makes its final decision on whether to register the product. If the product is to be used on a food- or fibre-producing crop or animal species, the APVMA publishes a Public Release Summary of the technical assessment on the APVMA website. The APVMA may also, if it deems it appropriate, publish a Public Release Summary for other uses not involving food- or fibre-producing crops or animal species. A printed version is available from the APVMA. For all new products based on existing active constituents or currently registered products where a new use in food- or fibre-producing crops or animal species is proposed, a Trade Advice Notice is published in the APVMA Gazette and a printed version is available from the APVMA.
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5.5.
The obligation to notify the APVMA of any relevant new information relating to a pending application
Section 160A of the Agvet Code provides that if an application for approval of an active constituent or registration of a chemical product has been lodged with the APVMA and the applicant becomes aware of any relevant information in relation to the active constituent, or in relation to the product or any of its constituents, the applicant must give that information to the APVMA. Relevant information includes information: that contradicts any information given to the APVMA that shows that the use of the constituent or product may be a risk to public health, the environment, plants or animals that shows that the product may not be effective. The information must be given in writing and be signed by an approved person. Applicants should note that a person is taken to be aware of new and relevant information if a related corporation is aware of that information.
5.6.
Granting an application
When all evaluations and assessments of an application have been completed and the APVMA is completely satisfied that the product is safe and effective and that the label contains adequate instructions, the APVMA will grant the application. The APVMA will issue a notice to the approved person to that effect. 5.6.1. Conditions of registration
The APVMA may put conditions on the registration (regular or listed) of a product. If a registrant fails to comply with the conditions, the APVMA may take compliance action. 5.6.2. Conditions of label approval
The APVMA may put conditions on the approval of a label for a product (regular or listed). If a registrant fails to comply with these conditions, the APVMA may take compliance action.
5.7.
Refusing an application
If all evaluations and assessments of an application have been completed and the APVMA is not satisfied that the product is safe and effective and that the label contains adequate instructions, the APVMA may refuse the application. The APVMA will notify the approved person of this decision and give reasons for its decision. Certain appeal rights are available to applicants if the APVMA refuses an application.
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5.8.
Reconsideration and appeal of an APVMA decision
If an applicant is not satisfied with an APVMA decision, an applicant may apply for a reconsideration of that decision. If an applicant requests reconsideration of a decision, the Agvet Code requires the APVMA to reconsider its original decision and to confirm, vary or set aside that decision. The reconsidered decision is a fresh decision and so must be made by a person other than the person who made the original decision. If the APVMA decides to set aside the original decision, it may also substitute a new decision. Seeking a reconsideration does not affect an applicants rights to also apply to the Administrative Appeals Tribunal (AAT) for review of the original decision or fresh decision.
5.9.
The registrants obligations after an application is granted

New information
5.9.1.
The Agvet Code provides that registrants of agvet chemical products must immediately notify the APVMA of new information (eg any reported adverse experience following use of the product or new research) that shows that use of the product in accordance with the approved label may be a hazard, or unsafe, or not effective. The information must be provided to the APVMA in writing and be signed by an approved person. In the case of reserved chemical products, if information indicating there may be adverse effects following a products use becomes available to the manufacturer/supplier or other supplier of the product this information must also be supplied to the APVMA, as it may indicate that the reserved status of the product is inappropriate. The APVMA will consider this information on its merits. Further information on the APVMAs adverse experience reporting program can be found on the APVMA website at www.apvma.gov.au/qa/subpage_qa.shtml Registrants should note that a person is taken to be aware of new and relevant information if a related corporation is aware of that information. 5.9.2. Renewal of registration and payment of levies
Registrants must pay an annual fee to renew registration (or listed registration). The APVMA will notify registrants before their current registration is due to expire. Applications for renewal must be submitted by the due date on the form provided by the APVMA and must be accompanied by the appropriate fee. In most cases, registrants will not need to provide additional product information.
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5.9.3.
Changes to currently-registered products or labels
Registrants must apply for approval of any variation they may wish to make to the registered particulars or conditions of a product such as its formulation, current use pattern or claims. The types of variations that require approval include: changes to shelf life change in formulation changes to withholding periods and/or concomitant amendments to established maximum residue limits amendments to current poison schedule classification variation in rate, timing or frequency of application change in the method of application extension of use to additional crops or animal species. Applications for approval of any variation to the registered conditions of a listed registered product will be considered against the relevant Standard. If the proposed variation takes the product outside the Standard, the product will require registration. Applications for variations to registered products must be made under one of the Categories 1114, whichever is relevant to the application. Details on data requirements for these application categories are provided in Volumes 2 and 3 of this manual. 5.9.4. Changes to registration records including company details
Changes to registration records may include registrant details, company contact details, active constituent approval holder details or approved person details. The APVMA requires the following information: company name street address postal address telephone and fax numbers. Notification of changes to registration records is necessary when: the registrant, approval holder or approved person changes their name address or contact details change products or approvals are sold or transferred to another registrant/approval holder two or more companies amalgamate or a takeover occurs the name of the formulator(s) of the product changes, provided the site and formulation process remain unchanged.
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The registrants responsibilities
The APVMA can alter the record of a registrant or approval holder only with the written consent of the current registrant or approval holder. To notify the APVMA of changes to registration records as outlined above, registrants and active constituent approval holders must submit the changes either on the Changes to Registration Records form or as a letter on company letterhead. The Changes to Registration Records form is available from the APVMA, or on the APVMA website at http://www.apvma.gov.au/forms/KP22_3F4.rtf In addition to a signed Changes to Registration Records form or letter on company letterhead, registrants and approval holders must supply: a list of the full names and product numbers of all registered products and/or active constituents including any previously registered or approved products (eg those stopped or withdrawn) in the case of a takeover, transfer or amalgamation, a letter of agreement from the new registrant or approval holder and a statement identifying the new registrant or approval holders responsibility for stopped and cancelled products or active constituent approval in the case of a change in company name, evidence of the change from the Australian Securities and Investments Commission. It is not necessary to submit amended labels through the Changes to Registration Records process. However, it is the responsibility of the registrant to ensure the marketed product label shows correct contact details. Details on labelling requirements may be found in Volume 5, Labelling.
The APVMAs responsibilities
The APVMA will process the Changes to Registration Records form/letter within 10 working days of receipt. When changes to the registration records are approved a letter of acceptance will be sent to the registrant. Where the proposed changes are not within the scope of the Changes of Registration Records scheme, the APVMA will inform the registrant that an application is required.
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5.10.
Certificates of export
Section 69D of the Agricultural and Veterinary Chemicals (Administration) Act 1992 provides that the APVMA may issue certificates of export. Before accepting exports of a chemical product from Australia, many countries require a certificate from the competent authority that the chemical is authorised for supply and use in Australia. To comply with this importing country requirement, a registrant may request the APVMA to provide a certificate of export for a product.
Standard format
The APVMA provides a number of standard certificates of export which have been designed to satisfy the requirements of the majority of importing countries: Certificate of Export Certificate of Export (Exempt Product) Certificate of Export (Unregistered Product) Certificate of Export (Active Constituent) Certificate of Manufacture (Approved Good Manufacturing Practice (GMP)) Certificate of Manufacture (No GMP for agricultural products only) Certificate of Export and Manufacture (Approved GMP).
Non-standard format
A person may apply for a non-standard certificate of export if an importing country requires this. The applicant must supply the information and form of words which should appear on the certificate. The APVMA will assess the information and form of words, and inform the applicant whether or not the APVMA can certify that the information is correct. A different fee applies for non-standard certificates (see paragraph 5.10.4). 5.10.1. Who can apply for a certificate of export?
Anyone can apply for a certificate of export. However, written approval from the registrant, manufacturer or approval/licence holder is required if commercial-inconfidence information is required on the certificate. Requests for certificates of export will only be accepted in writing and the appropriate fee must accompany the application. For this reason, faxes are not acceptable. Further information on applications for certificates of export may be found on the APVMA website at http://www.apvma.gov.au/registration/certificates.shtml
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5.10.2.
What type of information may be required for a certificate of export?
The APVMA may require any or all of the following depending on the type of certificate requested: the product or active constituent name the registration number of the product or active constituent approval number the interested person (registrants) name and address the name and manufacturing site address of the formulating company if the manufacturing site is to be included on the certificate, a letter of support from the formulator stating the APVMA may include the formulators name and address on the certificate the APVMA manufacturers licence number the active constituents listed on the product label or the full formulation the number of certificates required whether Department of Foreign Affairs and Trade verification is required the appropriate fee (see paragraph 5.10.4). Additional information is required for an unregistered product. Please seek further advice from the APVMA before applying. The APVMA will evaluate certain aspects of the application for a certificate of export for an unregistered or exempt product or if additional/non-standard wording is required on a certificate. If there are any differences between the information supplied by the applicant and the Register of Chemical Products, the APVMA will inform the applicant. The applicant may be required to supply further information before the APVMA will issue a certificate. Occasionally, where the form of words sought on the certificate of export differs from the APVMAs Register of Chemical Products, it will first be necessary to amend the registration of a product. In this case, an application (supported by the appropriate data, if necessary) for variation of registration will be required. This application must be approved and the variation to registration made before the certificate of export can be issued.
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5.10.3.
What are the timeframes for certificates of export?
There are no statutory timeframes for the issue of certificates of export. However, the APVMA will endeavour to meet the following timeframes for processing the different types of certificates of export: 10 working days for: Certificate of Export 20 working days for: Certificate of Export (Exempt Product) Certificate of Export (Unregistered Product) Certificate of Export (Active Constituent) Certificate of Manufacture (Approved GMP) Certificate of Manufacture (No GMP for agricultural products only) Certificate of Export and Manufacture (Approved GMP) These timeframes are based on the assumption that all the required information is supplied, the information is correct in accordance with APVMA records and the appropriate fee accompanies the application. Delays are likely to occur if this is not the case. Please note that a permit is required before a certificate of export can be issued for a product that is not registered. The permit application will also require assessment. The APVMA encourages applicants to plan ahead and allow sufficient time for assessment. Further information on certificates of export may be found on the APVMA website at http://www.apvma.gov.au/registration/certificates.shtml 5.10.4. Fees for certificates of export $115 $210 No fee
Fees are prescribed in the regulations to the Agvet Code: Standard format: Non-standard format: Duplicates of certificates:
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Revision history
1 July 2005 1 October 2005
First edition Second edition requirement for bound data clarified in paragraphs 4.1 and 4.5 paragraph 5.9.4: insert hyperlink to form for Changes to Registration Records. Third edition paragraph 4.1 (data) and 4.5 (binding): added statement that different data parts must be submitted as separate bound volumes paragraph 4.2: changed addressee for submitting applications paragraph 5.3: edited to clarify the treatment of applications that do not pass screening added new paragraphs 5.3.2 and 5.3.3 on treating applications as having been withdrawn, and rejecting applications added new paragraph 5.4.4 to explain the difference between clock time and elapsed time.
1 April 2006
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Agricultural and Veterinary Chemicals Code Instrument No. 1 (Application Fees) 2005
I, Roland Joseph Smith, Chief Executive Officer of the Australian Pesticides and Veterinary Medicines Authority, acting in accordance with my powers under subsection 32(1) of the Agricultural and Veterinary Chemicals (Administration) Act 1992, make this instrument for the purposes of subsection 164(1A) of the Agricultural and Veterinary Chemicals Code (the Agvet Code) scheduled to the Agricultural and Veterinary Chemicals Code Act 1994.
RJ Smith Chief Executive Officer
Dated this Twenty-first day of June 2005
Part 1
1.
Preliminary
Name of Instrument This Instrument is the Agricultural and Veterinary Chemicals Code Instrument No. 1 (Application Fees) 2005.
2.
Commencement This Instrument commences on 1 July 2005.
3.
Object The object of this Instrument is to set out criteria which more fully describe some of the 25 items in Part 2 of Schedule 6 to the Agricultural and Veterinary Chemicals Code Regulations 1995. A more detailed description of the items will allow applicants to work out which fee applies to a particular application. Interpretation (1) Unless the contrary intention appears, an expression used in the Agvet Code Act or the Agvet Regulations and in this Instrument has the same meaning in this Instrument as in the Agvet Code Act or the Agvet Regulations. In this Instrument, unless the contrary intention appears: Category in relation to an application means an item in Column 1 of Part 2 of Schedule 6 of the Agvet Regulations; new active constituent means an active constituent that, at the time an application in respect of that active constituent is lodged with the APVMA, has not been approved; new chemical product means a chemical product that, at the time an application in respect of that chemical product is lodged with the APVMA, has not been registered.
4.
(2)
Part 2
5.
Criteria for Working out which Application Category Applies

A Category 1 application includes only applications for agricultural chemical products for use on food-crops where the new active constituent in the agricultural chemical product is synthetic or is semi-synthetic or is highly purified or is produced by genetic engineering. In the context of a Category 1 application, a full assessment means that to grant the application the APVMA must undertake an assessment of the
Category 1 (application fee $48,860) (1)
(2)
application that is equivalent to the following Schedule 7 modules 1, 2.1, 3.1, 4, 5.1, 6.1, 7.1, 8.1, 11.1, and 12. 6. Category 2 (modular assessment fee) A Category 2 application includes applications for: (a) (b) 7. agricultural chemical products where the active constituent is a commonly used household or industrial chemical with a history of safe use; or veterinary chemical products.
Category 3 (application fee $31,750) In the context of a Category 3 application, a full assessment means that to grant the application the APVMA must undertake an assessment of the application that is equivalent to the following Schedule 7 modules 1, 2.3, 3.3, 4, 5.1, 6.1, 7.1, 8.1, 11.1, and 12.
8.
Category 11 (application fee $14,260) A Category 11 application does not include an application to vary the particulars or conditions of registration where the variation is an extension of use of a chemical product from a non-food-producing use to a food-producing use for the first time for any chemical product containing the active constituent which the chemical product contains.
9.
Category 15 (application fee $23,430) In the context of a Category 15 application, a full assessment means that to grant the application the APVMA must undertake an assessment of the application that is equivalent to either of the following Schedule 7 modules 2.1 and 3.1; or 2.1 and 3.2.
10.
Category 17 (application fee $1,435) A Category 17 application includes an application for a new source of manufacture for the active constituent that is the subject of the application.
11.
Category 18 (application fee $915) Category 18 applies to applications to vary the particulars or conditions of an approved active constituent where a chemistry assessment is the only assessment required. Variations to the particulars or conditions of approval of biological active constituents (which also involve efficacy and safety assessment, at least) are not included in this Category.
12.
Category 20 (application fee $320) In the context of a Category 20 application, a previous assessment would remain valid where the application is for the purposes of extending or renewing the duration of a permit.
13.
Category 25 (modular assessment fee) A Category 25 application includes an application for assessment of a trial protocol.
Part 3
14. Fees
Fees
Subregulation 70(2) of the Agricultural and Veterinary Chemicals Code Regulations 1995 provides that the fee payable in respect of an application of a kind specified in Column 2 of an item in Part 2 of Schedule 6 of the Regulations is the fee (if any) specified for the item in Column 4 of that Schedule.
Note For reference, the fee payable in respect of an application of a particular kind specified in Column 2 of an item in Part 2 of Schedule 6 of the Regulations is included (in brackets) in this Instrument beside that item or Category.
Legal and Governance Program APVMA June 2005
Agricultural and Veterinary Chemicals Code Instrument No. 2 (Modular Assessment Fees) 2005
I, Roland Joseph Smith, Chief Executive Officer of the Australian Pesticides and Veterinary Medicines Authority, acting in accordance with my powers under subsection 32(1) of the Agricultural and Veterinary Chemicals (Administration) Act 1992, make this Instrument for the purposes of subsections 164(1A) and 165(1A) of the Agricultural and Veterinary Chemicals Code (the Agvet Code) scheduled to the Agricultural and Veterinary Chemicals Code Act 1994.
RJ Smith Chief Executive Officer
Dated this Twenty-first day of June 2005
Part 1
1.
Preliminary
Name of Instrument This Instrument is the Agricultural and Veterinary Chemicals Code Instrument No. 2 (Modular Assessment Fees) 2005.
2.
Commencement This Instrument commences on 1 July 2005.
3.
Object The object of this Instrument is to set out criteria which, in circumstances when the modular assessment fee as provided by regulation 71 of the Agvet Regulations is to apply to a particular application made under the Agvet Code, describes which levels and types of modules, as set out in Schedule 7 of the Agvet Regulations, are to apply to the application.
4.
Interpretation (1) Unless the contrary intention appears, an expression used in the Agvet Code Act or the Agvet Regulations and in this Instrument has the same meaning in this Instrument as in the Agvet Code Act or the Agvet Regulations. In this Instrument, unless the contrary intention appears: Acceptable Daily Intake (ADI) means the daily intake of a chemical which, during an entire lifetime, appears to be without appreciable risk to the health of the consumer on the basis of all the known facts at the time. The ADI is expressed in milligrams of the chemical per kilogram of body weight per day (mg/kg/day). Acute Reference Dose (ARfD) means the estimate of the amount of a substance in food or drinking water, that can be ingested in one meal or during one day, without appreciable health risk to the consumer, on the basis of all known facts at the time. The ARfD is expressed in milligrams of the chemical per kilogram of body weight (mg/kg). biological chemical product means an agricultural or veterinary chemical product where the active constituent comprises or is derived from a living organism (plant, animal, micro-organism, etc), with or without modification. biotechnology chemical product is one that is developed by means of one of the following biotechnological processes (a) (b) (c) recombinant DNA technology; controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including transformed mammalian cells; or hybridoma and monoclonal antibody methods.
(2)
Category, in relation to an application, means an item in Column 1 of Schedule 6 of the Agvet Regulations. drug and poison scheduling in relation to a chemical substance means the determination by the National Drugs and Poisons Schedule Committee established by section 52B of the Therapeutic Goods Act 1989 of the schedule to the Poisons Standard in which the name or description of the substance is included. genetically-modified organisms (GMOs) are biotechnology chemical products. immunobiological chemical product means a product which, when administered to the host, provides, induces or changes an immune response to a target chemical or biological entity. Immunobiological products include vaccines, antisera, antibodies and cytokines. NDPSC means the National Drugs and Poisons Schedule Committee established by section 52B of the Therapeutic Goods Act 1989. new active constituent means an active constituent that, at the time an application in respect of that active constituent is lodged with the APVMA, has not been approved in Australia. new chemical product means a chemical product that, at the time an application in respect of that chemical product is lodged with the APVMA, has not been registered in Australia. new source of active constituent means: (a) a new manufacturing source of an approved active constituent for an agricultural chemical product where, at the time an application in respect of that active constituent is lodged with the APVMA, that source has not been approved by the APVMA; or a new manufacturing source of an approved active constituent for a veterinary chemical product that is an ectoparasiticide and for which there is no compendial standard, and where, at the time an application in respect of that active constituent is lodged with the APVMA, that source has not been approved by the APVMA.
(b)
reference product means reference chemical product as defined in section 3B of the Agvet Regulations.
Part 2
5.
Criteria for Working out which Application Module Applies
Module 1 Screening (Fee of $460) This module applies to all modular assessment fee applications (that is, categories 2, 10, 14, 23, 24 and 25) for: (a) (b) (c) (d) (e) (f) (g) (h) approval of an active constituent for agricultural or veterinary chemical products; registration of agricultural or veterinary chemical products; approval of a label for containers for an agricultural or veterinary chemical product; a variation to the particulars or conditions of approval of an active constituent for agricultural or veterinary chemical products; a variation to the particulars or conditions of registration of agricultural or veterinary chemical products; a variation to the particulars or conditions of approval of a label for containers for an agricultural or veterinary chemical product; a permit in relation to agricultural or veterinary chemical products; any other application requiring scientific or technical assessment by the APVMA.
6.
Module 2 Chemistry (1)

Module 2.1 Level 1 Comprehensive Assessment (Fee of $2,960)
(a)
A comprehensive chemistry assessment is required for applications for new agricultural or veterinary chemical products containing a new active constituent which meet any of the following criteria: (i) (ii) (iii) an active constituent manufactured by chemical synthesis; a highly purified and well-characterised active constituent derived from plants or animals; a semi-synthetic active constituent manufactured by the chemical modification of a highly purified and wellcharacterised intermediate derived from plants or animals; a semi-synthetic active constituent manufactured by the chemical modification of an intermediate produced by conventional fermentation; an active constituent produced by conventional fermentation or using recombinant DNA technology (excluding veterinary biologicals described in paragraph 6(2)(a) below);
(iv)
(v)
(vi)
an active constituent produced by transgenic technology (excluding veterinary biologicals described in paragraph 6(2)(a) below); an active constituent that is a growth regulator, antibiotic or polypeptide; or
(vii)
(viii) some animal tissue extracts and some plant extracts/oils. (2)
Module 2.2 Level 2 Reduced Assessment (Fee of $2,025)
(a)
A reduced chemistry assessment is required for applications for agricultural or veterinary chemical products of the following type: (i) (ii) (iii) (iv) new biological products containing a new active constituent except those included in subsection 6(1); new agricultural chemical products containing a new active constituent which is used in household or industrial chemicals; new agricultural chemical products containing a new source of existing active constituent; new ectoparasiticide veterinary chemical products containing a new source of existing active constituent (for which there is no acceptable compendial standard); new veterinary immunobiological chemical products containing a new active constituent; veterinary immunobiological chemical products with a major change to seed strains (including substitution of source or the addition of antigen); new veterinary direct-fed microbial products containing a new active constituent;
(v) (vi)
(vii)
(viii) new veterinary enzyme products containing a new active constituent; (ix) (x) new veterinary herbal products containing a new active constituent; or new agricultural or veterinary chemical products where the active constituent in the chemical product has been previously assessed in an application for a permit in relation to that chemical product
(b)
For the purposes of subparagraph 6(2)(a)(ii) an active constituent used in household and industrial chemicals includes certain solvents, surfactants and oils used to dilute or spread other agricultural chemicals, some disinfectants, and biocides used to control moulds and fungi in agriculture which are commonly-used household or industrial chemicals. If these chemicals are well known, in common use and have a history of safety in the context of use, they qualify for reduced chemistry assessment. 6
(c)
A reduced chemistry assessment is required for applications for a permit in relation to agricultural and veterinary chemical products containing a new active constituent. A reduced chemistry assessment is required for any other application for chemical products with a new active constituent which require a chemistry assessment that is not in subsection 6(1) above. This chemistry assessment is required for applications for new agricultural or veterinary chemical products containing an existing active constituent requiring an assessment of chemistry and manufacture data for the product only. A limited chemistry assessment is required for applications for a variation to the particulars or conditions of registration of agricultural or veterinary chemical products including: (i) (ii) minor formulation changes requiring technical assessment; changes to product specifications with or without a change in manufacturing process; or
(d)
(3)
Module 2.3 Level 3 Assessment (Fee of $935)
(a)
(4)
Module 2.4 Level 4 Limited Assessment (Fee of $180)
(a)
(iii) changes to non-active constituent specifications requiring technical assessment. (b) A limited chemistry assessment is required for applications for a variation to the particulars or conditions of registration of agricultural or veterinary chemical products which meet any of the following criteria: (i) (ii) (iii) (iv) (v) (c) extension of shelf life; extension of in-use shelf life; changes to storage temperature and/or conditions; changes to packaging material (immediate container and/or closure system); or other applications where assessment of stability data may be required.
A limited chemistry assessment is required for all applications for a variation to the particulars or conditions of registration of immunobiological chemical products. A limited chemistry assessment is required for applications for a permit in relation to a variation to the particulars or conditions of registration of agricultural or veterinary chemical products where chemistry assessment is required (for example, an extension of the shelf life of a batch of product).
(d)
(e)
A limited chemistry assessment is required for any other application for chemical products which require a chemistry assessment that is not in subsection 6(1) or 6(2) or paragraph 6(4) (a) to (d) above.
7.
Module 3 Toxicology (not requiring poison schedule classification) (1)

(a)
A comprehensive toxicology assessment is required for applications of the following type: (i) applications for: (A) (B) new agricultural or veterinary chemical products; or a permit in relation to agricultural or veterinary chemical products;
containing a new active constituent and which are for foodproducing use unless included in subsections 7(2) or 7(3) below. (2)
(a)
A reduced toxicology assessment is required for applications of the following type: (i) applications for: (A) (B) new agricultural or veterinary chemical products; or a permit in relation to agricultural or veterinary chemical products;
containing a new active constituent and which are for non-foodproducing use; (ii) applications for: (A) (B) (C) new agricultural or veterinary chemical products; a variation to the particulars or conditions of registration of agricultural or veterinary chemical products; or a permit in relation to agricultural or veterinary chemical products;
containing an existing active constituent and which involve an extension of use from non-food-producing to food-producing use for the first time for any chemical product containing the active constituent which the chemical products contain (so that an ADI, with or without an ARfD, is required); or (iii) applications for a research permit in relation to agricultural or veterinary chemical products which contain a new active constituent and are for food-producing use with restrictions including single season, single use, or specified research personnel. 8
(3)
Module 3.3 Level 3 Limited Assessment (Fee of $2,635)
(a)
A limited toxicology assessment is required for applications of the following type: (i) applications for: (A) (B) new agricultural chemical products; or a permit in relation to agricultural or veterinary chemical products;
containing an existing active constituent and which involve a new formulation or a major change in formulation; (ii) (iii) applications for new biological chemical products containing a new active constituent, adjuvant or excipient; applications for: (A) (B) new agricultural or veterinary chemical products; or a variation to the particulars or conditions of registration of agricultural chemical products;
containing an existing active constituent and which involve an extension of use from commercial use to use by a householder in the home or home garden; (iv) applications involving a change to one or more of the following: (A) (B) (C) (v) label safety directions (hazard statements); label first aid statements; or poison scheduling;
applications for a research permit in relation to agricultural or veterinary chemical products containing a new active constituent and which are for non-food-producing use with restrictions including single season, single use, or specified research personnel applications for: (A) (B) new agricultural or veterinary chemical products; or a permit in relation to agricultural or veterinary chemical products;
(vi)
containing a new active constituent and where an acceptable overseas report or health assessment report has been supplied;. (b) For the purposes of subparagraph 7(3)(a)(vi), an acceptable overseas report or health assessment report means a comprehensive toxicological assessment report on the active constituent which is of OECD-acceptable quality and dated 1 July 2005 or later. Summary reports would not be sufficient to qualify an application for a limited 9
toxicological assessment and a comprehensive or reduced assessment would be required. (c) A limited toxicology assessment is required for any other application for chemical products which require a toxicology assessment that is not in subsection 7(1) or (2) above. For the purposes of subparagraph 7(3)(a)(i), a major formulation change means a change to the formulation of an agricultural or veterinary chemical product, including new combinations of existing active constituents, such that safety to humans, the environment and/or target species may need separate assessment. For example, where: (i) there has been a significant increase in the concentration of the active constituent which could affect the hazard potential, poison scheduling, safety directions or residues; a major change in non-active constituent which significantly affects the performance, stability or other attributes of the product; or the formulation has been changed significantly to accommodate a new application method or use-pattern (for example, changing from a wettable powder to an emulsifiable concentrate or changing from an oral drench to a topical pour-on dosage form).
(d)
(ii)
(ii)
(4)
Several types of applications for chemical products do not require toxicological assessment (Module 3 or 4) as they are not normally associated with any potential risks to human health. Where, however, there is any such risk, an appropriate toxicological assessment is required. The types of application for chemical products which do not normally require toxicological assessment are as follows: (a) applications for veterinary chemical products that are: (i) mineral, vitamin and nutritional supplements for a single animal or a small number of animals and administered directly to the animal or administered daily in food or water; animal bacterial and viral vaccines; direct-fed microbial products where all the microbial active constituents are approved and have been previously considered by the National Drugs and Poisons Schedule Committee (NDPSC); or enzyme products where all the active constituents are approved and have been previously considered by the NDPSC;
(ii) (iii)
(iv) (b) (c)
applications for veterinary chemical products that are applications for an extension of use to non-food-producing animals; or applications for agricultural or veterinary chemical products that are applications for small scale trial permits authorized under APVMA permit 7250 (copy attached at Attachment A). 10
8.
Module 4 Toxicology (requiring poison schedule classification) (Fee of $3,380) This additional module applies to any modular assessment fee application (that is, category 2, 10, 14, 23, 24 or 25) for an agricultural or veterinary chemical product, where the application must be referred to the NDPSC for poisons scheduling, as required under Toxicology Modules 3.1, 3.2 or 3.3 (subsections 7(1), 7(2) and 7 (3) of this Instrument, respectively).
9.
Module 5 Residues (1) Residues assessment includes the establishment of residue definition, maximum residue limits (MRLs), and withholding periods (WHPs) and the assessment of the trade implications of an application including the establishment of any export intervals (EIs).
(2)
(a)
A comprehensive residues assessment comprising residues definition, MRLs, WHPs, and the assessment of trade implications is required for applications of the following type: (i) applications for: (A) (B) new agricultural chemical products containing a new active constituent and which are for use on a food crop; new agricultural chemical products containing an existing active constituent and which involve an extension of use from a non-food crop to a food crop; a variation to the particulars or conditions of registration of agricultural chemical products containing an existing active constituent and which involve an extension of use from a non-food crop to a food crop; or a permit in relation to agricultural chemical products containing a new active constituent and which are for use on a food crop; new veterinary chemical products containing a new active constituent and which are for use in/on foodproducing animals; new veterinary chemical products containing an existing active constituent and which involve an extension of use from companion animals to food-producing animals for the first time for any chemical product containing the active constituent which the veterinary chemical products contain; a variation to the particulars or conditions of registration of veterinary chemical products containing an existing active constituent and which involve an extension of use 11
(C)
(D)
(ii)
applications for: (A)
(B)
(C)
from companion animal to food-producing animals for the first time for any chemical product containing the active constituent which the veterinary chemical products contain; (D) new veterinary chemical products containing an existing active constituent and which have a new route of administration in food-producing animals; or a permit in relation to veterinary chemical products containing a new active constituent and which are for use in/on food-producing animals.
(E)
(3)
Module 5.2 Level 2 Reduced Assessment Product Registration only (Fee of $4,330)
(a)
A reduced residues assessment comprising MRLs, WHPs, and the assessment of trade implications is required for applications of the following type: (i) applications for: (A) (B) new agricultural chemical products; or a variation to the particulars or conditions of registration of agricultural chemical products;
containing an existing active constituent and which involve an extension of use to or use in a major food crop; or (ii) (iii) applications for agricultural chemical products involving a major formulation change; applications for: (A) (B) new veterinary chemical products; or a variation to the particulars or conditions of registration of veterinary chemical products;
containing an existing active constituent and which involve an extension of use to or use in/on new food-producing animals; (iv) applications for: (A) (B) new veterinary chemical products; or a variation to the particulars or conditions of registration of veterinary chemical products;
containing an existing active constituent and which have an increased dose rate or frequency of application to foodproducing animals and where a change to MRLs are required. (b) Applications for variation to the approval of a label of veterinary chemical products which have potential risks of residues and where a change to MRLs are required. 12
(c) (4)
For the purposes of subparagraph 9(3)(a)(ii), a major formulation change has the same meaning as in paragraph 7(3)(d). A reduced residues assessment comprising MRLs and WHPs is required for applications for a permit in relation to agricultural and veterinary chemical products of the following type: (i) applications for a permit in relation to agricultural chemical products containing an existing active constituent for use in a new food crop; or applications for a permit in relation to veterinary chemical products containing an existing active constituent for use in/on new food-producing animals.
Module 5.3 Level 3 Reduced Assessment Permit only (Fee of $2,265)
(a)
(ii)
(5)
Module 5.4 Level 4 Limited Assessment Product Registration only (Fee of $2,025)
(a)
A limited residues assessment comprising WHPs and, where necessary, MRLs and the assessment of trade implications is required for applications for agricultural chemical products of the following type: (i) applications for: (A) (B) new agricultural chemical products; or variations to the particulars or conditions of registration of agricultural chemical products;
containing an existing active constituent and which involve an extension of use to or use in a non-major food crop; or (ii) applications for variation to the approval of a label of agricultural chemical products which have potential risks of residues.
(b)
A limited residues assessment comprising WHPs and, where necessary, assessment of trade implications is required for applications for veterinary chemical products of the following type: (i) applications for new veterinary chemical products containing an existing active constituent and which involve existing use patterns. Such applications are limited to non-aqueous injectables, pour-ons, intramammary dry cow infusions, implants and intraruminal devices only; applications for veterinary chemical products being nonaqueous injectables, pour-ons, intramammary dry cow infusions, implants and intraruminal devices only involving a change in formulation;
(ii)
13
(iii)
applications for variation to the approval of a label of veterinary chemical products which have potential risks of residues and where no change to MRLs are required; or applications for new veterinary chemical products containing an existing active constituent which are similar to a reference product except for a shorter WHP.
(iv)
(c)
A limited residues assessment is required for any other application for chemical products which require a residues assessment that is not in subsections 9(2) or 9(3) or paragraphs 9(5)(a) or 9(5)(b) above. A limited residues assessment comprising WHPs and, where necessary, MRLs is required for applications for agricultural and veterinary chemical products of the following type: (i) applications for a minor use, emergency use or a research permit in relation to agricultural chemical products containing an existing active constituent for use on a food crop; or applications for a minor use, emergency use or a research permit in relation to veterinary chemical products containing an existing active constituent for use in/on food-producing animals.
(6)
Module 5.5 Level 5 Limited Assessment Permit only (Fee of $1,070)
(a)
(ii)
10.
Module 6 Occupational Health and Safety (OH&S) (1)

(a)
A comprehensive OH&S assessment is required for applications for new agricultural chemical products containing new active constituents including biological chemical products. A reduced OH&S assessment is required for applications of the following type: (i) applications for a research permit for use of agricultural chemical products containing a new active constituent and where the permit is for use by all persons; applications for agricultural chemical products containing an existing active constituent and which involve a major formulation change; applications for: (A) (B) new agricultural chemical products; or variations to the particulars or conditions of registration of agricultural chemical products;
(2)
(a)
(ii)
(iii)
14
containing an existing active constituent and which involve a new crop group or new situation and/or a new application method; (iv) applications for: (A) (B) new veterinary chemical products; or a permit in relation to veterinary chemical products
containing a new active constituent and which are for use in/on food-producing animals (including biologicals); (v) applications for: (A) (B) new veterinary chemical products; or a permit in relation to veterinary chemical products
containing a new active constituent and which are for use in/on non-food-producing animals (excluding biologicals). (b) (3) For the purposes of subparagraph 10(2)(a)(ii), a major formulation change has the same meaning as in paragraph 7(3)(d). A limited OH&S assessment is required for applications of the following type: (i) applications for a permit in relation to agricultural chemical products containing an existing active constituent and which involve a new application method or a new use situation and where the permit is for use by all persons; applications for: (A) (B) (C) new veterinary chemical products; a variation to the particulars or conditions of registration of veterinary chemical products; or a permit in relation to veterinary chemical products;
Module 6.3 Level 3 Limited Assessment (Fee of $1,305)
(a)
(ii)
containing an existing active constituent and which involve a major formulation change and/or a change of use pattern; or (iii) applications for a variation to the particulars or conditions of approval of a label for agricultural or veterinary chemical products which involve a change or reassessment of user safety directions and/or re-entry or re-handling statements.
(b)
A limited OH&S assessment is required for any other application for chemical products which require an OH&S assessment that is not in subsections 10(1) or 10(2) or paragraph 10(3)(a) above.
(4)
Several types of applications for chemical products do not require OH&S assessment as they are not normally associated with any potential risks to human health. Where, however, there is any such risk, an appropriate 15
toxicological assessment is required. The types of application for chemical products which do not normally require OH&S assessment are as follows: (a) applications for veterinary chemical products that are: (i) (ii) animal therapeutics and mineral and nutritional supplements in tablet, capsule, slow release bolus or skin implant form; animal therapeutics which have Therapeutic Goods Administration (TGA) approval for direct administration to humans and the use pattern indicates low worker exposure potential (that is, not mob or flock treatments with a drench or a pour-on, or as a feed additive, or other equivalent use pattern, as these have high worker exposure potential); mineral, vitamin and nutritional supplements for single animal or a small number of animals and administered directly to the animal or into daily food or water; vitamins; digestive enzyme supplements; electrolytes; iron and haematopoietic agents; tonics and stimulants; or preservatives; micro-organism and enzyme products for use in companion animals; stock feed additives and nutrition or metabolism products (other than those listed in this paragraph) with established safety directions, which are directly applicable to the concentration of the additive and the form in which it is to be used; animal bacterial and viral vaccines; a research permit in relation to veterinary chemical products. products to be used by the householder in the home and home garden; or a research permit in relation to agricultural chemical products, excluding new application method or new use situation (existing active constituents) for use by all persons.
(iii)
(iv) (v) (vi)
(vii) (ix) (b) (i) (ii)
(viii) extension of use applications to non-food animals; or applications for agricultural chemical products that are:
(c)
applications for agricultural and veterinary chemical products that are microbial products where all the microbial active constituents are approved active constituents.
11.
Module 7 Environment (1)

Phase I Environmental impact assessment for veterinary medicinal products
Phase I environmental impact assessment applies to veterinary chemical products other than biological products. It is assumed that veterinary chemical products with limited use and limited environmental exposure will have 16
limited environmental effects and thus stop in Phase I, meaning that no further environmental assessment is required. If a veterinary chemical product meets any of the following criteria it stops in Phase I: (a) (b) (c) (d) it is exempt from the need for environmental assessment by legislation and/or regulation; it is a natural substance, the use of which will not alter the concentration or distribution of the substance in the environment; it will be used only in non-food-producing animals; it is intended for use in a minor species that is reared and treated similarly to a major species for which an environmental impact assessment already exists; it will be used to treat a small number of animals in a flock or herd (for example: intramammary products, surgical anaesthetics, and hormonal reproductive aids for individual animals); it is extensively metabolised in the treated animal; it is for use in terrestrial species and entry to the terrestrial environment is prevented through disposal of the terrestrial waste matrix; it is for use in terrestrial species, it is neither an ectoparasiticide nor an endoparasiticide, and the predicted environmental concentration of the chemical product in the soil (PECsoil) is less than 100 g/kg; or it is for use in aquatic species reared in a confined facility, it is neither an ectoparasiticide nor an endoparasiticide, and the environmental introduction concentration (EICaquatic) of the chemical product released from aquaculture facilities is less than 1 g/L.
(e)
(f) (g) (h)
(i)
Some veterinary chemical products which might otherwise stop in Phase I may nevertheless require additional environmental information for assessment to address particular concerns associated with their activity and use. For example, exceptional cases will require environmental assessment where the proposed product/use could have a potentially significant impact on a threatened or endangered species, wetland, floodplain, cultural or historical resource, or other environmentally significant resource. Veterinary chemical products which progress to Phase II will require assessment of environmental aspects under Modules 7.1 or 7.2 or 7.3 as described below. (2)
(a)
A comprehensive environment assessment is required for applications of the following type: (i) applications for new agricultural or veterinary chemical products containing a new active constituent (unless included in subsections 11(1), 11(3) or 11(4)); or 17
(ii)
applications for new agricultural chemical products containing a new combination of approved active constituents and where the new product involves an extension of use to a new crop or a new situation.
(3)
(a)
A reduced environment assessment is required for applications of the following type: (i) applications for: (A) (B) new agricultural or veterinary chemical products; or a variation to the particulars or conditions of registration of agricultural or veterinary chemical products;
containing existing active constituents and where the new product or variation involves an extension of use to a new crop, a new situation or a new herd animal; (ii) applications for: (A) (B) new agricultural or veterinary chemical products; or a variation to the particulars or conditions of registration of agricultural or veterinary chemical products;
which involve a major formulation change or an increased dose rate or frequency of application; (iii) applications for a variation to the particulars or conditions of registration of agricultural chemical products involving an extension to aerial use; or applications for a permit in relation to agricultural or veterinary chemical products containing a new active constituent.
(iv) (b) (4)
For the purposes of subparagraph 11(3)(a)(ii), a major formulation change has the same meaning as in paragraph 7(3)(d). A limited environment assessment is required for applications of the following type: (i) applications for: (A) (B) new agricultural chemical products (other than a vertebrate poison); or a variation to the particulars or conditions of registration of agricultural chemical products (other than a vertebrate poison);
(a)
containing new or existing active constituents and where the product is for use: (A) by the householder in the home or home garden; 18
(B) (C) (D) (E) (ii)
by the householder in a swimming pool or spa; in buildings not used in animal production (for example, warehouses, offices, or glasshouses); as a treatment for stored produce or goods; or as a post-harvest application to any crop;
applications for a variation to the approval of a label of agricultural or veterinary chemical products involving environmental instructions or warnings; or applications for a permit in relation to agricultural or veterinary chemical products containing existing active constituents.
(iv) (b)
A limited environment assessment is required for any other application for chemical products which require an environment assessment that is not in subsections 11(2) or 11(3) or paragraph 11(4)(a) above.
(5)
Several types of applications for veterinary chemical products do not require environmental assessment as they are not normally associated with any potential risks to the environment. Where, however, there is any such risk, an appropriate environmental assessment is required. The types of veterinary applications which do not normally require environmental assessment are: (a) animal therapeutics and mineral and nutritional supplements in single, capsule, slow release bolus or skin implant form other than parasiticides; animal immunobiological products (except those containing GMOs); animal therapeutics given by injection for use under prescription in individual animals; applications for extension of use of a registered product in/on non-food animals; or animal therapeutics which are included in the Phase I Environmental Impact Assessment for Veterinary Medicinal Products as described in paragraph 11(1) above.
(b) (c) (d) (e)
12.
Module 8 Efficacy and Safety (1) Assessment of efficacy and safety refers to assessment of efficacy and host crop or animal safety and includes (as relevant to either agricultural or veterinary chemical products as the case may be): (a) (b) (c) (d) (e) assessment of the results of experimental trials for efficacy and safety; effect on following crops or non-target crops; organoleptic tests; effects of residues on subsequent processing of crops; safety to non-target crops; 19
(f) (g) (2) (3)
pharmacologic studies; or compatibility studies.
In this module the term food-producing animal includes fibre-producing species of animals such as sheep, goats, llamas and alpacas.
(a)
A comprehensive efficacy and safety assessment is required for applications of the following type: (i) applications for new agricultural chemical products containing: (A) (B) (C) (ii) a new active constituent; a new combination of existing active constituents; or a significant new formulation not included in module 8.2 below;
applications for new or existing agricultural chemical products containing an existing active constituent and which are for use in a new crop group or new situation and/or for the control of new pests; applications for new veterinary chemical products containing a new active constituent or a new combination of existing active constituents and which involve use in/on a food-producing animal; or applications for new or existing veterinary chemical products containing an existing active constituent and which involve use in/on a new food-producing animal.
(iii)
(iv)
(4)
Module 8.2 Level 2 Reduced Assessment (Fee of $680)
(a)
A reduced efficacy and safety assessment is required for applications of the following type: (i) applications for existing agricultural chemical products which involve an extension of use to a new host or a new pest within the same crop group or situation and with the same general use pattern; applications for new or existing agricultural chemical products containing an existing active constituent and which involve: (A) (B) new household or home garden use; an extension of use involving a new minor use for new pests where the use and the pests are closely similar to an existing use pattern; or a significant new formulation requiring reduced assessment of both efficacy and safety;
(ii)
(C)
20
(iii) (iv)
applications for new veterinary chemical products for use in/on companion animals; applications for new or existing veterinary chemical products involving an extension of use to a new companion animal species; applications for new or existing veterinary chemical products involving an extension of use to a new pest or disease or for a new purpose in/on the same food-producing animal; applications for new or existing veterinary chemical products involving a change to the dosage or administration instructions including treatment number, frequency, duration, dose, and route of administration in/on the same food-producing animal; or applications for new or existing veterinary chemical products for use in/on a food-producing animal with a new formulation which is not the same, nor closely similar, nor similar to a reference product.
(v)
(vi)
(vii)
(b) (5)
For the purposes of subparagraphs 12(4)(a)(iii) or (iv), a companion animal means a dog, cat or horse. A limited efficacy and safety assessment is required for applications of the following type: (i) applications for new agricultural chemical products where efficacy and safety data are required to demonstrate similarity to an existing registered product; applications for variation to: (A) the particulars or conditions of registration of existing agricultural chemical products involving a formulation change; or the approval of a label of existing agricultural chemical products;
(a)
(ii)
(B)
which are expected to have a minor impact on efficacy or crop safety; (iii) applications for variation to the particulars or conditions of registration of agricultural chemical products which involve an extension of use to a minor use within the same crop group or situation and which involve an existing pest and application rate; applications for a permit in relation to agricultural chemical products which involve a minor use on a new crop or situation;
(iv)
21
(v)
applications for new veterinary chemical products where efficacy and safety data are required to demonstrate similarity to an existing registered product; applications for new veterinary chemical products for use in/on a non-food producing animal other than a dog, cat or horse; applications for existing veterinary chemical products which involve an extension of use to a new non-food producing animal other than a dog, cat or horse; (A) (B) the particulars or conditions of registration of existing veterinary products involving a formulation change; or the approval of a label of existing veterinary products;
(vi) (vii)
(viii) applications for variation to:
which are expected to have a minor impact on efficacy or host animal safety; (ix) (x) applications for a permit in relation to veterinary chemical products which involve a minor use in/on a new animal species; applications for veterinary chemical products which involve demonstration of pharmaceutical equivalence with a registered product; or any other application for chemical products which require an efficacy and/or safety assessment of a type that is not included in subsections 12(3), 12(4) or 12(5) above.
(xi)
(6)
For the purposes of section 12, a major formulation change means a change to the formulation of an agricultural or veterinary chemical product, including new combinations of existing active constituents, such that efficacy and/or safety to the host crop/animal requires assessment. For example, where: (a) there has been a significant change in the concentration of active constituent and where the application/dose rate to the crop/animal is changed; a major change in non-active constituent significantly affects the performance, stability or other attributes of the product; there has been a significant change in product specifications; the formulation has been changed significantly to accommodate a new application method or use-pattern (for example, changing from a wettable powder to an emulsifiable concentrate or changing from an oral drench to a topical pour-on dosage form); or the new formulation is not identical, nor closely similar, nor similar to a registered reference product.
(b) (c) (d)
(e)
22
(7)
Applications for major changes in formulation require assessment under Module 8.1. However, applicants may provide valid scientific argument regarding submission of relevant efficacy/safety data to justify a different level of assessment. For example: (a) (b) if the change in formulation is likely to affect only efficacy or safety, then assessment under Module 8.3 would be appropriate; or data to demonstrate comparable efficacy/bioequivalence with the previous formulation would be assessed under Module 8.3.
(8)
For the purposes of subparagraphs 12(3)(a)(iii), 12(3)(a)(iv), 12(4)(a)(v), 12(4)(a)(vi), and 12(4)(a)(vii), a food-producing animal is any animal used to produce food for human consumption, or which is used as food for human beings, and includes any buffalo, cattle, deer, fish (other than ornamental fish), goat, kangaroo, pig, poultry, rabbit, sheep, bee, crustacean or mollusc. For the purposes of efficacy and safety this includes fibre-producing animal species, which is any animal used to produce fibre (including wool and mohair) for human use. New products for use in/on food or fibre-producing animal species other than cattle, sheep, pigs and chickens qualify for a reduced (Level 2) efficacy and safety assessment (for example: goats, llamas, alpacas, and emus).
13.
Module 9 Non-food trade (Fee of $1,070) (1) This module applies to applications for agricultural and veterinary chemical products (as the case may be) involving trade risks not related to food residues, including : (a) (b) (c) (d) residues in wool and fibre; the presence of disease or seropositive testing to exotic or notifiable agents; hormonal growth promotants and other endocrine substances; or genetically-modified produce.
14.
Module 10 Special Data (1) All modular assessment fee applications (that is, for categories 2, 10, 14, 23, 24 or 25) for the registration of chemical products which contain active constituents that are new antibiotic substances or which contain geneticallymodified organisms (GMOs) require the submission of Special data.
Module 10.1 Level 1 Comprehensive Assessment (nil fee)
(2)
(a)
A comprehensive Special Data assessment is required for applications of the following type: (i) applications for new veterinary chemical products containing a new antibiotic active constituent; or
23
(ii)
applications for a permit in relation to veterinary chemical products containing a new antibiotic active constituent (other than for small-scale research).
(3)
Module 10.2 Level 2 Reduced Assessment (nil fee)
(a)
A reduced Special Data assessment is required for applications of the following type: (i) applications for: (A) (B) new veterinary chemical products; or a variation to the particulars or conditions of registration of veterinary chemical products;
containing an existing antibiotic active constituent and which is expected to result in significantly increased volume of use or an increased risk to public health including: (A) (A) an extension of use to a new food-producing species, or a dog or a cat; an extension of use to another major group within the same food-producing species (for example: broiler chickens to layers; beef cattle to dairy cattle); or a change in dosage form or use pattern (for example: from use in individual animals to mass medication).
(B) (ii)
applications for a permit in relation to veterinary chemical products containing an existing antibiotic active constituent and which are for use in/on a new animal species.
(4)
Module 10.3 Level 3 Limited Assessment (nil fee)
(a)
A limited Special Data assessment is required for any application not included in Modules 10.1 or 10.2 which requires an assessment of Special Data including an assessment of agricultural or veterinary chemical products containing GMOs.
15.
Module 11 Finalisation (1) (2) This module encompasses administrative and technical steps in public consultation on and the finalisation of applications.
Module 11.1 Type 1 (Fee of $2,025)
(a)
This module applies to applications for: (i) (ii) (iii) the registration of agricultural or veterinary chemical products; a variation to the particulars or conditions of registration of agricultural or veterinary chemical products; or a permit in relation to agricultural or veterinary chemical products;
24
which require three or more modular assessments from amongst the modules 2.1 through to 10.3, but excluding 2.4. (3)
Module 11.2 Type 2 (Fee of $1,070)
(a)
This module applies to applications for: (i) (ii) the registration of agricultural or veterinary chemical products; or a variation to the particulars or conditions of registration of agricultural or veterinary chemical products;
which require one or two modular assessments only from amongst the modules 2.1 through to 10.3. (4)
Module 11.3 Type 3 (Fee of $565)
(a)
This module applies to applications for a permit in relation to agricultural and veterinary chemical products which require one or two modular assessments only from amongst the modules 2.1 through to 10.3. This module applies to any application involving (i) (ii) no technical assessment; or assessment under module 2.4 only.
(5)
Module 11.4 Type 4 (Fee of $145)
(a)
16.
Module 12 Data Protection (Fee of $155) This module applies to any application which attracts the data protection provisions of Part 7B of the Agricultural and Veterinary Chemicals (Administration) Act 1994; or Division 4A of Part 2; or Part 3 of the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994.
25
Part 3
17.
Fees and Assessment Periods
Modular Assessment Fees If, as a result of this Instrument, a module, level or type of assessment is appropriate for a particular application then the fee payable in respect of that module, level or type is the fee set out in column 4 of Schedule 7.
Note 1 For reference, the fee payable in respect of a module, level or type of assessment is set out (in brackets) in this Instrument beside that module, level or type. Note 2 The method of working out the total modular assessment fee payable in respect of any particular application assessed by modular assessment is set out in regulation 71 of the Agvet Code Regulations.
18.
Modular Assessment Periods If, as a result of this Instrument, a module, level or type of assessment is appropriate for a particular application then the period within which the APVMA must complete that particular modular, level or type is the period set out in column 3 of Schedule 7.
Note 1 The method of working out the total modular assessment period within which the APVMAs assessment of any particular application, which is assessed by modular assessment, must be completed is set out in regulation 77 of the Agvet Code Regulations.
Legal and Governance Program APVMA
June 2004
26
Attachment A
PERMIT TO ALLOW THE CONDUCT OF SMALL-SCALE TRIALS WITH AGVET CHEMICALS

Permit Number PER 7250
This permit, is issued under section 114 of the Agvet Codes, to allow those persons stipulated below to conduct small-scale trials in any jurisdiction, as defined in the conditions of use, with agricultural or veterinary chemical active constituents or products, whether such active constituents or products are approved or registered or not. The permit also allows those persons stipulated below to possess any active constituent or chemical product described below for the purposes described under this permit.
CONDITIONS OF USE 1. Persons who can conduct trials under this permit: All persons who are trained or experienced in the handling and use of agricultural or veterinary chemicals and who handle and use agricultural or veterinary chemicals as part of their normal duties in their employment for an organisation for which they are conducting a trial; Jurisdictions in which this permit applies All jurisdictions. Products/Actives that can be used under this permit Any active constituent or chemical product, except: one which is or contains a genetically modified organism; or veterinary biologicals used outside the confines of a research facility; or any active constituent or chemical product used in a trial where the trial is conducted in a jurisdiction where that active constituent or chemical product is proscribed by legislation or any active constituent or chemical product whose use has been prohibited under the Agricultural and Veterinary Chemicals (Administration) Regulations 2004. 27
2.
3.
4.
Purpose/Situation For the conduct of Small-Scale Trials that, for the purposes of this permit, are defined as: screening tests, laboratory assessment and other research conducted within the confines of a research facility. (A research facility includes research station, research laboratory, research glasshouse, veterinary surgery or hospital, university or similar institution); or trials conducted to generate data relating to efficacy, residues, crop or animal safety or other scientific information outside the confines of a research facility where the size of the trial annually does not exceed the following: a. a total of 5 hectares nationally , with a maximum of 1 hectare in any one jurisdiction in the case of any food and/or fibre field crop or b. a total of 500 plants nationally with a maximum of 100 plants in any one jurisdiction for plants other than those in a food and/or fibre field crop; or c. a total of 100 cattle, pigs, or deer; 1000 sheep or goats; or 2000 poultry; or 100 non-food animal species; or d. patch trials of antifouling paint products where the area treated on each vessel does not exceed 10 square metres and no more than 2 vessels in any one jurisdiction or a total of 10 vessels nationally are treated; or e. raft panel trials using antifouling paints where the total national area of treated panel does not exceed 100 square metres with a maximum of 10 square metres treated at any one site; or f. 5 cubic metres of timber or timber products in any one jurisdiction, or a total of 25 cubic metres nationally; or g. any other situation where the total area treated nationally is not greater than 10 sq metres; or h. fumigation trials conducted under the Australian Standard for General Fumigation Procedures (AS 2476-1981) where the total national area treated does not exceed 400 cubic metres with a maximum of 160 cubic metres to be treated per jurisdiction and no individual treatment site exceeds 40 cubic metres.
(i)
(ii)
ADDITIONAL CONDITIONS 5. Do not dispose of any produce from plants or animals treated during a trial that can result in direct or indirect consumption of this produce by humans for a period of 12 months from application of the agricultural or veterinary chemical. Do not dispose of or allow the use of any treated commodity or item that will result in direct or indirect exposure of humans to the agricultural or veterinary chemical used in the trial. Persons handling/applying the agricultural or veterinary chemical for the purposes of conducting the trial must wear appropriate personal protective equipment to minimise their exposure to the agricultural or veterinary chemical via the eyes, skin, nose or mouth. 28
6.
7.
8.
All trials involving animals must comply with conditions laid down in animal welfare legislation or guidelines, which are applicable in the jurisdiction where trials are conducted. The organisation or individual for which the trial is being conducted must maintain detailed records listing: a. the date the trial is conducted; b. for trials conducted within the confines of a research facility, the name and address of the research facility; for trials conducted outside the confines of a research facility, the jurisdiction and specific location within each jurisdiction that the trials are conducted; c. the trial details, including plants, animals or items treated, the pest controlled or reason for treating, the rates and frequency of application; d. the active constituents or chemical products used plus the total amounts used; e. the method of disposal of produce from treated plants or animals; and f. the names of the persons conducting or controlling the trials.
9.
10.
The organisation or individual for which the trial is being conducted must maintain the records described in 9 a.- f. above for each trial for a period of not less than 2 years from the date of commencing each trial and such records must be made available to the APVMA upon their request.
This permit remains in force until it is cancelled.
DATED: 7 June 2004
. (signature of delegate)
29

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Ag Volume 1

Legislation and applications

VOLUME 1 LEGISLATION AND APPLICATIONS CONTENTS

Current at: 01/04/06

Introduction to MORAG Contents

Current at: 01/04/06

Revision date: 25/01/05

This printing: 21/04/2006

MORAG is published in two versions:

2. HOW IS MORAG USED?

Volume 2 Category requirements and guidelines

Ag and Vet Manuals

1923. Application for permit 2425. Other applications

Ag and Vet Labelling Codes Label approval process

Current at: 01/04/06

1 July 2005 1 October 2005 1 April 2006

Current at: 01/04/06

Figure 1: MORAG map

Application decision trees

Description of category : definition requirements

Outline of data requirements by application type

Detailed data requirements

Current at: 01/04/06

Legal background to the National Registration Scheme

Legal background to the National Registration Scheme Contents

Current at: 01/04/06

Legal background to the National Registration Scheme

Appendix A: Protection periods for application data............................................. 22 Revision history.......................................................................................................... 24

Current at: 01/04/06

Legal background to the National Registration Scheme

Current at: 01/04/06

Legal background to the National Registration Scheme

2. WHY AGRICULTURAL AND VETERINARY CHEMICAL PRODUCTS REQUIRE REGISTRATION

Current at: 01/04/06

Legal background to the National Registration Scheme

3. THE NATIONAL REGISTRATION SCHEME FOR AGRICULTURAL AND VETERINARY CHEMICALS

4. THE ROLE OF THE APVMA

Current at: 01/04/06

Legal background to the National Registration Scheme

5. OTHER GOVERNMENT AGENCIES INVOLVED IN THE REGISTRATION PROCESS

Current at: 01/04/06

Legal background to the National Registration Scheme

Current at: 01/04/06

Legal background to the National Registration Scheme

6. OTHER MATTERS IN THE AGRICULTURAL AND VETERINARY CHEMICALS LEGISLATION

Definition of an agricultural chemical product

Current at: 01/04/06

Legal background to the National Registration Scheme

Current at: 01/04/06

Legal background to the National Registration Scheme

Definition of a veterinary chemical product

A veterinary chemical product does not include: (a)

Current at: 01/04/06

Legal background to the National Registration Scheme

Legislation covering active constituents

Current at: 01/04/06

Legal background to the National Registration Scheme

Veterinary active constituents

Conditions of Approval and Registration

(b) (c) (d) (e)

Current at: 01/04/06

Legal background to the National Registration Scheme

Notification of new Information to the APVMA