Veterinary Manual of Requirements and Guidelines - Vet MORAG

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Modular Levels for Modular Categories

1.   DATA PARTS AND MODULES

1.1.   Introduction

Schedule 6 of the Agvet Code Regulations provides a definition of the categories under which applications may be made for:

  • approval of a new active constituent
  • registration of an agricultural or veterinary chemical product
  • approval of an agricultural or veterinary chemical product label
  • variation of the particulars or conditions of approval of an approved active constituent
  • variation of the particulars or conditions of product registration
  • variation of the particulars or conditions of label approval
  • issue of a permit
  • any other assessment of a technical nature.

There are 25 application categories. Of these, 18 have a fixed fee and assessment period which is provided in Schedule 6 of the Agvet Code Regulations. Seven of the application categories are modular (Categories 2, 10, 14, 21, 23, 24 and 25). The fee and assessment period for modular categories depends on which modules are required to enable assessment of the application. The modules, their fees and assessment periods are provided in Schedule 7 of the Agvet Code Regulations.

Applicants must submit technical or scientific data with each application, except for applications made under the following six application categories, which by their nature do not require assessment of technical or scientific data:

Category 7 Registration of a product closely similar to a registered product
Category 8 ‘Repack’ of a registered product
Category 12 Minor variation to label or product details
Category 13 Minor non-technical variation to label or product details, required by the APVMA
Category 19 Application for a permit to possess or supply for export an unapproved active constituent or unregistered chemical product
Category 20 Application to ‘renew’ or ‘reissue’ a previously-issued permit

For all other application categories, the APVMA must assess the technical or scientific data the applicant has submitted, so that the APVMA can meet its obligation provided by the Agvet Code, that before granting an application, the APVMA must be satisfied of the product’s safety and efficacy.

1.2.  Data Parts

The technical or scientific data which may be required to assess a product application are divided into 10 data Parts. Each data Part is an area of a product’s characteristics, or potential hazards, which the APVMA must assess order to be satisfied of the product’s safety and efficacy. The data Parts are:

1  Application Overview

2  Chemistry and Manufacture

3 Toxicology

4 Metabolism and Kinetics

5a Residues

5b Overseas Trade

6 Occupational Health and Safety (OH&S)

7 Environment

8 Efficacy and target animal safety

9 Non-food trade assessment

10 Special data

An application may be subject to assessment of any or all of the 10 data Parts, depending on the nature of the application. For example, an application for registration of a new product containing a new active constituent for use in food-producing animal species will require submission of data for data Parts 1, 2, 3, 4, 5a, 5b, 6, 7, 8, and possibly 9 and/or 10, however an application for approval of a minor formulation change may require submission of data only for data Parts 1 and 2.

Details of requirements and guidelines for each of the data Parts are set out in separate chapters of this volume.

1.3.   Modules for modular application categories

Modular application categories reflect the different levels of hazard and risk for different types of products which may be assessed within the broad application categories. These different levels of hazard and risk require different levels of assessment.

As stated previously, seven of the application categories are modular (Categories 2, 10, 14, 21, 23, 24 and 25). The fee and assessment period for these categories depends on which modules are required to enable assessment of the application. The modules, their fees and assessment periods are provided in Schedule 7 of the Agvet Code Regulations.

Each data Part is made up of a number of data elements. A sub-group of these data elements makes up a module.

Schedule 7 of the Agvet Code Regulations provides that modules may be one of five levels:

  • level 1 (comprehensive assessment)
  • level 2 (reduced assessment )
  • level 3 (reduced or limited assessment)
  • level 4 (limited assessment)
  • level 5 (limited assessment).

For an application whose hazard and risk characteristics require a comprehensive assessment of one or more of the data Parts, the applicant must submit the data elements described in level 1 for those data Parts. The same application may require a reduced assessment of other data Parts, and so the applicant must submit the data elements described in level 2 or level 3 for those data Parts. In this way, the total data requirements for an application are built up module-by-module for each relevant data Part.

Section 3 of this chapter, ‘Modules which apply to different types of applications’ sets out for each type of product, the module which will apply for each of the data Parts.

By referring to the relevant sections of this chapter, an applicant can determine which data elements are required for each module required for assessment of an application which fits into a modular application category.

Four of the data Parts have a single module level:

  • data Part 1 (Application Overview) is combined with the application form, and is also a summary of all the other data Parts. There is a single module level for data Part 1
  • there are no modules for data Part 4 (Metabolism and Kinetics). However there is a module 4 (Scheduling) which is a module applied to applications in modular categories which must be forwarded to the National Drugs and Poisons Scheduling Committee (NDPSC) for poisons scheduling
  • there is a single module level for data Part 9 (Non-food trade)
  • there is a single level for module 12 (Data protection)

In addition to the modules derived from the data Parts (modules 1-10), there are two additional modules, module 11 (Finalisation) and module 12 (Data protection). There are four levels for module 11 and a single level for module 12.

1.4.   Relevance of modules to fixed application categories

Modules are also relevant for some fixed application categories, because the data elements for the different data Parts also are linked to modules. By referring to the relevant application category chapter in Volume 2: Category requirements and guidelines, an applicant can determine what data are required for a fixed application category.

1.5.   Relationship of this document to the Legislative Instrument in Volume 1

This document interfaces with the Legislative Instrument in Volume 1, titled Agricultural and Veterinary Chemicals Code (Fees and Timeframes) Instrument 2007, which describes application types that require assessment under the various levels and types of modules in Schedule 7 of the Agvet Code Regulations. This document ‘Module levels for modular categories’ provides applicants with information not contained in the Legislative Instrument, on the data packages that are required for the different application types.

The Legislative Instrument also provides for a reduced or limited assessment (under Modules 2.2, 2.4, 3.3, 5.4, 6.3, 7.3 or 8.3) of application types that are not otherwise described.

Where there is any dispute as to the module assessment level required for a type of application, the Legislative Instrument is the authoritative document.

1.6.   Fee and timeframe

Schedule 7 of the Agvet Code Regulations provides the fee and timeframe for modular assessments by the APVMA. The fees are set out in section 5 of this document).

The total fee for assessing an application can be determined by totalling the fees payable for all the modules necessary to evaluate the application.

Note that although the timeframe for an application for a minor use permit under Category 21 is a modular assessment period, the fee for this application is fixed at $350.

The timeframe can be determined by taking whichever module timeframe is the longest, and adding it to the relevant finalisation module.

Note that the screening module does not have a timeframe, so that the measurement of the modules’ timeframe (’clock time’) does not commence until the application has passed screening. However, section 11A of the Agvet Code provides that the APVMA must make a decision whether or not an application has passed screening, within 30 days of the application having been lodged.

1.7.   APVMA assessment of applications

The APVMA conducts the assessment of applications for approval of active constituents, registration of products and approval of their labels, the issue of a permit, or variations of existing approval and registrations, within a legislative framework.

Section 14 of the Agvet Code provides that the APVMA must grant an application for approval of an active constituent, or registration of a chemical product, or approval of a label for containers for a chemical product if (amongst other things) the AVPMA is satisfied that the use of the active constituent or product in accordance with its instructions for use:

  • would not be an undue hazard to the safety of people exposed to it during its handling, or people using anything containing its residues; and
  • would not be likely to have an effect that is harmful to human beings; and
  • would not be likely to have an unintended effect that is harmful to animals, plants or things or to the environment; and
  • would not unduly prejudice trade or commerce between Australia and places outside Australia; and
  • that if the application is for a chemical product, use of the product would be effective when used in accordance with label instructions.

Section 29 of the Agvet Code provides for applications for variation of relevant particulars, or of conditions of approval, or registration, which may have been granted under section 14.

During assessment of applications the APVMA often seeks the advice of other government agencies or expert individual reviewers, in order to assist in determining whether the APVMA is satisfied that an application meets the criteria prescribed by the Agvet Code. The APVMA does a final technical evaluation and risk assessment before an authorised delegate makes a decision to grant or refuse an application.

2.   Modular assessments

When an application falls into one of the modular categories (2, 10, 14, 21, 23, 24 or 25) it is subject to assessment under several or all of the technical module items: chemistry and manufacture; toxicology; residues; OH&S; environment; efficacy and target animal safety; non-food trade; and special data.

All applications are subject to screening (Module 1) and finalisation (Module 11.1-11.4) and, where studies have been provided which require technical assessment, data protection (Module 12).

The tables commencing in section 4 of this document outline the types of applications in relation to which an assessment of chemistry and manufacture; toxicology; residues; OH&S; environment; efficacy and target animal safety; non-food trade; and special data, will be required to allow the APVMA to finalise an application. If an application is of a type described in the first column, an assessment of data packages specified in the second column will be required.

When searching for a description of the type of application it is important to read the entire table section for the particular module in order to characterise the application. For example, when searching for the appropriate Chemistry module for a new veterinary product with a new active constituent, the product at first may seem to be assessed under Chemistry module 2.1. However, if the active constituent is an immunobiological agent, it would qualify for assessment under Chemistry module 2.2.

2.1.   Screening (Module 1)

Applications normally undergo up to three levels of screening before they are accepted for evaluation by the APVMA:

  • admin istrative screening:

assesses that the application has been made in the correct form and that the required fees have been paid;
  • technical screening:

assesses that all the data which are required for an application have been submitted;
  • agency screening:

assesses whether all of the required data have been submitted to allow the Australian Government agencies which provide advice relevant to toxicology, OH&S and environment, to evaluate the application.

The screening module does not have levels.

2.2.  Chemistry (Modules 2.1, 2.2, 2.3, 2.4)

The APVMA’s Chemistry and Residues Program normally conducts assessments of chemistry data in order to determine the quality of the product and its active constituent.

Chemistry refers to assessment of applications for registration or variation with respect to the chemistry aspects of s.14(4) and s.14(5) of the Agvet Code. These are the chemistry aspects of:

  • the active constituent
  • the formulated product
  • manufacturing process
  • quality contro
  • specifications
  • batch analysis
  • storage stability
  • analytical methods
  • packaging and labelling.

Schedule 7 to the Agvet Code Regulations provides four levels for module 2 (Chemistry). The module level required for Chemistry assessment of an application will be determined by the nature of the application as described in section 3 of this document.

2.3.  Toxicology (Modules 3.1, 3.2, 3.3)

The Office of Chemical Safety (OCS) within the Department of Health and Ageing (DoHA) normally provides advice to the APVMA on toxicology aspects of applications.

Toxicology refers to assessment of:

  • applications for approval of active constituents or registration of products with respect to the toxicological aspects of s.14(3), s.14(4) and s.14(5) of the Agvet Code
  • applications for variation of approval or registration with respect to the toxicological aspects of s.29(1) of the Agvet Code
  • applications for issue of a permit under s.112(2) of the Agvet Code.

The toxicology evaluation considers whether an acceptable daily intake (ADI) and acute reference dose (ARfD) have been established for the active constituent. If they have not been set and the use-pattern of the product requires that they be set, OCS sets an ADI and ARfD. The OCS publishes the ADI and ARfD in: ADI List: Acceptable daily intakes for agricultural and veterinary chemicals.

If an ADI and ARfD have already been set, the application is considered against these values and a decision is made whether they should be retained or amended.

The toxicology evaluation includes:

  • kinetics and metabolism studies
  • short-term studies
  • sub-chronic studies
  • chronic studies
  • reproduction studies
  • developmental studies
  • genotoxicity studies
  • additional relevant studies
  • hazard characterisation
  • ADI and ARfD considerations
  • Poisons Schedule considerations.

Schedule 7 to the Agvet Code Regulations provides three levels for module 3 (Toxicology). The module level required for Toxicology assessment of an application will be determined by the nature of the application as described in section 3 of this document.

2.3.1.   Application types which do not routinely require toxicological assessment

The following veterinary applications will not routinely be submitted to OCS for toxicological evaluation:

  • mineral, vitamin and nutritional supplements for single / small number of animals and administered directly to the animal or administered daily in food or water;
  • animal bacterial and viral vaccines;
  • extension of use applications to non-food-producing animals;
  • 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);
  • enzyme products where all the active constituents are approved and have been previously considered by the NDPSC.
  • small scale trial permits under permit 7250.

2.4.   Scheduling (Module 4)

This is an additional module which applies to any application for either an agricultural or veterinary chemical, where the application must be referred to the NDPSC for Poisons Scheduling, as required under Toxicology modules 3.1, 3.2 or 3.3.

The Toxicology modules cover data requirements.

2.5.  Residues (Modules 5.1, 5.2, 5.3, 5.4, 5.5)

The APVMA’s Chemistry and Residues Program normally conducts assessments of residues data.

Residues refers to assessment of applications for registration or variation with respect to the residues aspects of s.14(3)(e)(i), s.14(3)(e)(iv) and s.14(5) of the Agvet Code, or of s.112(2) for permit applications.

The residues assessment includes:

  • establishment of residue definition, maximum residue limits (MRLs), and withholding periods (WHPs);
  • trade implications of the application, including an export interval (EI).

Schedule 7 to the Agvet Code Regulations provides five levels for module 5 (Residues). The module level required for residues assessment of an application will be determined by the nature of the application as described in sections 3 and 4 of this document.

2.6.   Occupational health and safety [OH&S] (Modules 6.1, 6.2, 6.3)

The OCS normally provides advice to the APVMA on OH&S aspects of applications.

OH&S refers to assessment of applications for registration with respect to the occupational health and safety aspects of s.14(3) and s.14(5) of the Agvet Code, or of s.29(1) for variations, or of s.112(2) for permit applications.

Schedule 7 to the Agvet Code Regulations provides three levels for module 6 (OH&S). The module level required for the OH&S assessment of an application will be determined by the nature of the application as described in section 3 of this document.

2.6.1.   Application types which do not routinely require OH&S assessment

The following veterinary applications will not routinely be submitted to OCS for OH&S assessment:

  • animal therapeutics and mineral and nutritional supplements in tablet, capsule, slow release bolus or skin implant form
  • animal therapeutics which have TGA approval for direct administration to humans and the use pattern indicates low worker exposure potential (i.e. not mob/flock treatment with a drench, or pour-on, or as feed additive, or other equivalent use pattern, as these have high worker exposure potential and will be assessed)
  • mineral, vitamin and nutritional supplements for single / small number of animals and direct to animal or into daily food or water
  • vitamins; digestive enzyme supplements; electrolytes; iron and haematopoietic agents; tonics and stimulants; preservatives
  • micro-organism and enzyme products for use in companion animals
  • stock feed additives and nutrition / metabolism products (other than those listed above) 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
  • extension of use applications to non-food animals
  • veterinary applications for research permits.
  • microbial products where all the microbial active constituents are approved.

2.7.   Environment (Modules 7.1, 7.2, 7.3)

The Department of the Environment and Water Resources (DEW) normally provides advice to the APVMA on environmental aspects of applications.

Environment refers to assessment of applications for registration with respect to the environmental aspects of s.14(3) and s.14(5) of the Agvet Code, or of s.29(1) for variations, or of s.112(2) for permit applications.

Schedule 7 to the Agvet Code Regulations provides three levels for module 7 (Environment). The module level required for environmental assessment of an application will be determined by the nature of the application as described in sections 3 and 4 of this document.

2.7.1.   Application types which do not require environmental assessment

Several types of veterinary applications do not normally require environmental assessment. These types of veterinary applications are:

  • 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 use to non-food animals
  • animal therapeutics which are included in the VICH Phase I Environmental Impact Assessment for Veterinary Medicinal Products as described below.

VICH Phase I Environmental impact assessment for veterinary products

The APVMA has adopted two VICH guidelines for environmental assessment. The two guidelines are numbers 6 and 38 and are titled:

Evaluation by DEW is not normally required for animal therapeutics which stop at VICH Phase I and do not progress to VICH Phase II.

VICH Phase I 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 limited environmental effects and thus stop in VICH Phase I, meaning that no further environmental assessment is required.

If at least one of the VICH Phase I criteria has been met, the applicant must briefly address this in subpart 1.7 of the Application Overview (Part 1). In the case of the last two criteria listed below (soil or aquatic concentrations), applicants must provide a short VICH Phase I environmental impact assessment report discussing the basis for the decision. Applications involving products with new active constituents will be subject to preliminary assessment at screening to ensure compliance with VICH Phase I if the applicant claims this. If determined that VICH Phase I criteria have not been met, then the application will require a VICH Phase II assessment under Module 7.1, 7.2 or 7.3.

VICH Phase I criteria

If a veterinary product meets any of the following criteria it stops in VICH Phase I:

  • 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 (e.g. 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 not an ecto- and/or endoparasiticide, and the predicted environmental concentration of the chemical product in the soil (PECsoil) is < 100 μg/kg, or
  • it is for use in aquatic species reared in a confined facility, it is not an ecto- and/or endoparasiticide, and the environmental introduction concentration (EICaquatic) of the chemical product released from aquaculture facilities is < 1 μg/L.

Some veterinary chemical products that might otherwise stop in VICH 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 VICH Phase II will require assessment of environmental aspects under Module 7.1 or 7.2 or 7.3 as described in sections 3 and 4 of this document.

Definitions:

Biological products may be either agricultural or veterinary chemical products.

A biological product is a product where the active constituent comprises or is derived from a living organism (plant, animal, micro-organism etc), with or without modification.

An immunobiological product is a product which, when administered to the target, provides, induces or changes an immune response to a target chemical or biological entity. Immunobiological products include vaccines, antisera, antibodies and cytokines.

A biotechnology product is a product which is developed by means of one of the following biotechnological processes:

  • 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.

Genetically-modified organisms (GMOs) are biotechnology products.

2.8.     Efficacy and target animal safety (Modules 8.1, 8.2, 8.3)

Expert reviewers external to the APVMA, or APVMA reviewers conduct evaluations of efficacy and target animal safety.

Efficacy and target animal safety refers to assessment of applications for registration with respect to the efficacy and safety aspects of s.14(3), s.14(5) and s.14(6) of the Agvet Code, or of s.29(1) for variations, or of s.112(2) for permit applications.

The efficacy and target animal safety assessment includes:

  • assessment of the results of experimental trials for efficacy and safety
  • organoleptic tests
  • pharmacologic studies
  • compatibility studies.

Schedule 7 to the Agvet Code Regulations provides three levels for module 8 (Efficacy and Safety). The module level required for efficacy and target animal safety assessment of an application will be determined by the nature of the application as described in sections 3 and 4 of this document.

For the purposes of efficacy and safety assessment the term ‘food-producing animals’ includes fibre-producing species of animals such as sheep, llamas and alpacas.

2.9.   Non-food trade (Module 9)

This module covers an application that requires assessment of trade risk relating to non-food residue situations e.g. residues in wool and fibre, presence of disease or seropositive testing to exotic or notifiable agents, hormonal growth promotants and other endocrine substances, or genetically-modified produce.

The non-food trade module does not have levels.

2.10.   Special data (Modules 10.1, 10.2, 10.3)

There are two principal types of applications for approval of active constituents or registration of products which require the submission of special data:

  1. New antibiotic products

    The APVMA seeks advice from the Expert Advisory Group on Antimicrobial Resistance (EAGAR) on these types of applications.

    EAGAR is an expert committee of the National Health and Medical Research Council and was established as a consequence of government’s acceptance of the recommendations of the 1999 report of the Joint Expert Technical Advisory Committee on Antibiotic Resistance (JETACAR). The role of EAGAR is to review antibiotic risk assessments conducted by the applicant or APVMA.

    EAGAR’s review of the risk assessment includes:
    • use patterns of the antibiotic in human medicine
    • risk of the emergence of bacterial antibiotic resistance
    • risk of transfer of bacterial antibiotic resistance into human pathogens due to agricultural or veterinary use.
  2. Genetically-modified organisms (GMOs)

The Gene Technology Act 2000, which came into force on 21 June 2001, introduces a national scheme for the regulation of GMOs in Australia. This is in order to protect the health and safety of Australians and the Australian environment by identifying risks posed by, or as a result of gene technology, and to manage those risks by regulating certain dealings with GMOs.

The Office of the Gene Technology Regulator (OGTR) has been established within DoHA to provide scientific and administrative support to implementation of the Gene Technology Act 2000.

The APVMA seeks advice from the OGTR on these applications which involve GMOs in accordance with paragraph 14(3)(ca) of the Agvet Code and paragraph 8A(2)(a) of the Agricultural and Veterinary Chemicals (Administration) Act 1992.

OGTR’s assessment identifies any risks to people or the environment posed by, or as a result of gene technology.

Schedule 7 to the Agvet Code Regulations provides three levels for module 10 (special data). The module level required for Special Data assessment of an application will be determined by the nature of the application as described in section 3 of this document.

Modules 10.1 and 10.2 relate specifically to antibiotic resistance.

Module 10.3 relates to GMOs and any other application which requires assessment of special data.

2.11.   Finalisation (Modules 11.1, 11.2, 11.3, 11.4)

This module encompasses administrative and technical steps in public consultation and finalisation of applications. There are no data requirements associated with the finalisation module.

Schedule 7 to the Agvet Code Regulations provides four levels for module 11. The module level for an application will be determined by the number of other modules which are required for an application as summarised below:

Module

Type of application

Module 11.1
  • a product registration or variation or permit application which requires three or more modular assessments (modules 2.1 to 10.3, excluding 2.4)

Module 11.2
  • a product registration or variation application which requires one or two modular assessments (modules 2.1 to 10.3)

Module 11.3
  • a permit application which requires one or two modular assessments (modules 2.1 to 10.3)

Module 11.4
  • any minor application requiring no technical assessment or technical assessment with only module 2.4

2.12.   Data protection (Module 12)

This module covers administrative and technical steps in assigning protection to relevant data.

The data protection module has only a single level.

3.   MODULES WHICH APPLY TO DIFFERENT TYPES OF APPLICATIONS

Module 2.1      Chemistry

Type of application:

  1. New product with new active constituent, or new active constituent only (unless included in Module 2.2)

Module 2.2      Chemistry

Type of application:

  1. New biological product with new active constituent (except those described in Module 2.1 )
  2. New ectoparasiticide product with new source of existing active constituent (for which there is no acceptable compendial standard), or new source of ectoparasiticide active constituent only
  3. New immunobiological product with new active constituent
  4. Major change to seed strains of immunobiological product
  5. New direct-fed microbial product with new active constituent
  6. New enzyme product with new active constituent
  7. New herbal product with new active constituent
  8. Permit, new active constituent
  9. New product where the active constituent has previously been assessed under permit

Module 2.3      Chemistry

Type of application:

  1. New product with existing active constituent

Module 2.4      Chemistry

Type of application:

  1. Variations to chemistry and manufacture details of chemical products
  2. Extension of shelf life
  3. Extension of in-use shelf life
  4. Change to storage temperature / conditions
  5. Change to packaging material (immediate container and/or closure system)
  6. Other applications where assessment of only stability data ± product specifications may be required
  7. Variations to chemistry and manufacture of immunobiological products
  8. Permit application – where minor chemistry assessment is required (e.g. extension of shelf life of a batch of product)

Module 3.1      Toxicology

Type of application:

  1. New product with new active constituent, or new active constituent only (unless included in Module 3.2 or 3.3)
  2. Permit application for a new active constituent (unless included in Module 3.2 or 3.3)

Module 3.2      Toxicology

Type of application:

  1. New product / permit, new active constituent, for non-food-producing use
  2. Research permit, new active constituent, for food-producing use, with restrictions (single season / single use / specified research personnel)
  3. New product / product variation / permit, existing active constituent – extension of use from non-food-producing to food-producing use for the first time for the active constituent (ADI ± ARfD required)

Module 3.3      Toxicology

Type of application:

  1. New product / permit, existing active constituent – new formulation or major change in formulation
  2. New biological chemical product containing new active constituent, adjuvant or excipient
  3. Label variation – change to safety directions (hazard statements) and / or change to label first aid statements and / or poison scheduling
  4. Research permit, new active constituent, for non-food-producing use, with restrictions (single season / single use / specified research personnel)
  5. New product / permit, new active constituent, where an acceptable overseas report or health assessment report has been supplied1

Module 4         Scheduling

This is an additional module which applies to any application for either an agricultural or veterinary chemical, where the application must be referred to the NDPSC for poisons scheduling.

Data requirements are covered by Toxicology modules 3.1, 3.2 or 3.3.

Module 5.1      Residues

Type of application:

  1. New product, new active constituent – use in food-producing animal species
  2. New product / product variation, existing active constituent – extension of use from companion animal to food-producing animal species for the first time for the active constituent
  3. New product, existing active constituent – new route of administration in food-producing animal species
  4. Permit, new active constituent – use in food-producing animal species

Module 5.2      Residues

Type of application:

  1. New product / product variation, existing active constituent – extension to or use in new food-producing animal species
  2. New product / product variation, existing active constituent – increased dose rate or frequency of application to food-producing animal species (change to MRL required)
  3. Label variation with potential residue risks (change to MRL required)

Module 5.3      Residues

Type of application:

  1. Permit, existing active constituent – use in new food-producing animal species

Module 5.4      Residues

Type of application:

  1. New product, existing active constituent, existing use pattern (non-aqueous injectables, pour-ons, intramammary dry cow infusions, implants, intraruminal devices only)
  2. Existing product, change in formulation (non-aqueous injectables, pour-ons, intramammary dry cow infusions, implants, intraruminal devices only)
  3. Label variation with potential residue risks (no change to MRL required)
  4. New product, existing active constituent – similar to reference product, except for a shorter WHP

Module 5.5      Residues

Type of application:

  1. Permit application, existing active constituent – minor use, emergency use or research permits for a food-producing animal species
  2. Application for assessment of a trial protocol for use of a product in food-producing animals, where WHPs and (if necessary) MRLs must be set

Module 6.2      Occupational health & safety

Type of application:

  1. New product / permit, new active constituent, for use on food-producing animal species (including biologicals)
  2. New product / permit, new active constituent, for use on non-food-producing animal species (excluding biologicals)

Module 6.3      Occupational health and safety

Type of application:

  1. New product / product variation / permit, existing active constituent – major formulation change and / or change of use pattern
  2. Label variation – change / reassessment of user Safety Directions and / or re-handling statements

Module 7.1      Environment

Type of application:

  1. New product, new active constituent (unless included in VICH Phase I)
  2. New product / product variation, existing active constituent – where the proposed use does not meet VICH Phase I criteria for the first time for the active constituent

Module 7.2      Environment

Type of application:

  1. New product / product variation, existing active constituent – extension of use to a new herd animal species
  2. New product / product variation – major formulation change or increased dose rate / frequency of application
  3. Product containing new active constituent for use under permit

Module 7.3      Environment

Type of application:

  1. Label variation – change to environmental instructions and warnings
  2. Product containing existing active constituent for use under permit

Module 8.1      Efficacy and target animal safety

Type of application:

  1. New product for use in/on a food-producing animal species containing new active constituent or new combination of existing active constituents
  2. New or existing product, existing active constituent, for use in/on a new food-producing animal species

Module 8.2      Efficacy and target animal safety

Type of application:

  1. New product for use in/on companion animal species (dog, cat, or horse)
  2. Extension of use to a new companion animal species (dog, cat, or horse)
  3. Extension of use to a new pest / disease / purpose in/on the same food-producing animal species
  4. Change to dosage and administration instructions (treatment number, frequency, duration, dose, route of administration) in/on the same food-producing animal species
  5. Product for use in/on a food-producing animal species with a new formulation which is not identical, not closely similar, and not similar to a reference product

Module 8.3      Efficacy and target animal safety

Type of application:

  1. New product where efficacy and safety data are required to demonstrate similarity to an existing registered product
  2. New product for use in/on a non-food-producing animal species other than dog, cat or horse
  3. Extension of use to a new non-food-producing animal species other than dog, cat or horse
  4. Label and formulation changes that are expected to have a minor impact on efficacy or safety
  5. Permit application – minor use in a new animal species
  6. Demonstration of comparable efficacy with another product by in vitro dissolution

Module 9         Non-food trade

Type of application:

  1. Veterinary chemicals involving trade risks not related to food residues, including: residues in wool and fibre; presence of disease or seropositive testing to exotic or notifiable agents; hormonal growth promotants and other endocrine substances; genetically-modified produce

Module 10.1    Antibiotic resistance

Type of application:

  1. New product with a new antibiotic active constituent
  2. Permit for use of a new antibiotic active constituent (other than for small scale research)

Module 10.2    Antibiotic resistance

Type of application:

  1. New product / product variation, existing antibiotic active constituent, expected to result in significantly increased volume of use / risk to public health, including: extension of use to a new food-producing animal species / dog / cat; extension of use to another major group within the same food-producing animal species (e.g. broiler chickens to layers; beef cattle to dairy cattle); change in dosage form or use pattern (e.g. from use in individual animals to mass medication)
  2. Permit for use of an existing antibiotic active constituent in a new animal species

Module 10.3    GM Organism / Other special data

Type of application:

  1. Any application requiring an assessment of special data such as assessment of a product containing a genetically-modified organism (GMO)

4.    MODULE DATA REQUIREMENTS

Module 2.1      Chemistry

MODULE 2.1    CHEMISTRY
Type of application Data required
  1. New product with new active constituent1, or new active constituent only (unless included in Module 2.2)

Footnote 1:  Active constituents where a full chemistry assessment is required:

A full chemistry assessment is expected to be required for products that contain a new active constituent which meets any of the following criteria:

  • active constituent manufactured by chemical synthesis;
  • highly purified and well-characterised active constituent derived from plants or animals;
  • semi-synthetic active constituent manufactured by the chemical modification of a highly purified and well-characterised intermediate derived from plants or animals;
  • semi-synthetic active constituent manufactured by the chemical modification of an intermediate produced by conventional fermentation;
  • active constituent produced by conventional fermentation or using recombinant DNA technology (excluding those veterinary biologicals in Module 2.2);
  • active constituent produced by transgenic technology (excluding those veterinary biologicals in Module 2.2);
  • growth regulators, antibiotics and polypeptides;
  • some animal tissue extracts and some plant extracts/oils.

A Chemistry data package for comprehensive assessment requires submission of all of the following data, or submission of valid scientific argument not to submit certain data:

Active constituent

  • identification of the active constituent
  • physical and chemical properties
  • stability data
  • method of manufacture
  • active constituent standard/specification
  • batch analysis data
  • analytical methods
  • validation data
  • analytical reference standards
  • packaging
  • data list

Product

  • distinguishing product name
  • formulator and formulation plant details
    • evidence of GMP compliance
  • formulation type/pharmaceutical dosage form
  • formulation composition
  • reference to quality standards
  • colouring additives, flavourings and perfumes
  • materials of animal origin
  • function of constituents in the formulation
  • amount of constituents in the formulation
  • overages
  • manufacturing process
  • quality control
  • product specifications
  • batch analysis
  • stability data
    • in-use stability data (where relevant)
  • analytical procedures
  • validation data
  • packaging
  • data list
Detailed data requirements are in Part 2

Module 2.2      Chemistry

MODULE 2.2    CHEMISTRY
Type of application Data required
  1. New biological product with new active constituent (except those described in Module 2.11)

A Chemistry data package for reduced assessment requires submission of all of the following data, or submission of valid scientific argument not to submit certain data:

Active constituent

  • identification of the active constituent
  • physical and chemical properties
  • stability data
  • method of manufacture
  • active constituent standard/specification
  • batch analysis data
  • analytical methods
  • validation data
  • analytical reference standards
  • packaging
  • data list

Product

  • distinguishing product name
  • formulator and formulation plant details
    • evidence of GMP compliance
  • formulation type/pharmaceutical dosage form
  • formulation composition
  • reference to quality standards
  • colouring additives, flavourings and perfumes
  • materials of animal origin
  • function of constituents in the formulation
  • amount of constituents in the formulation
  • overages
  • manufacturing process
  • quality control
  • product specifications
  • batch analysis
  • stability data
    • in-use stability data (where relevant)
  • analytical procedures
  • validation data
  • packaging
  • data list

Detailed data requirements are in Part 2
MODULE 2.2    CHEMISTRY
Type of application Data required
  1. New ectoparasiticide product with new source of existing active constituent (for which there is no acceptable compendial standard), or new source of ectoparasiticide active constituent only

A Chemistry data package for comprehensive assessment requires submission of all of the following data, or submission of valid scientific argument not to submit certain data:

Active constituent

  • identification of the active constituent
  • physical and chemical properties
  • stability data
  • method of manufacture
  • active constituent standard/specification
  • batch analysis data
  • analytical methods
  • validation data
  • analytical reference standards
  • packaging
  • data list

Product

  • distinguishing product name
  • formulator and formulation plant details
    • evidence of GMP compliance
  • formulation type/pharmaceutical dosage form
  • formulation composition
  • reference to quality standards
  • colouring additives, flavourings and perfumes
  • materials of animal origin
  • function of constituents in the formulation
  • amount of constituents in the formulation
  • overages
  • manufacturing process
  • quality control
  • product specifications
  • batch analysis
  • stability data
    • in-use stability data (where relevant)
  • analytical procedures
  • validation data
  • packaging
  • data list

Detailed data requirements are in Part 2
MODULE 2.2    CHEMISTRY
Type of application Data required
  1. New immunobiological product with new active constituent
  2. Major change to seed strains of immunobiological product (substitution of source / addition of antigen)

Active constituent

  • master seed lot:
    • source, preparation and description
    • quality assurance and testing
    • identification and characteristics
    • storage conditions
  • working seed lot:
    • preparation and description
    • quality assurance and testing
    • storage conditions
  • AQIS import permit (where relevant)
  • information on an active constituent consisting of or derived from GMOs (where relevant)

Product

  • distinguishing product name
  • formulator and formulation plant details
    • evidence of GMP compliance
  • formulation type/pharmaceutical dosage form
  • starting materials (source, specification, function, certificate of analysis, AQIS import permit where relevant)
  • media preparation
  • manufacturing process (including validation data, Standard Operating Procedures)
  • quality assurance and testing:
    • in-process control tests
    • finished product tests (batch release specifications)
  • batch analysis
  • stability data:
    • stability of finished product
    • reconstitution/in-use stability data (where relevant)
  • packaging
  • data list

Detailed data requirements are in Part 2
MODULE 2.2    CHEMISTRY
Type of application Data required
  1. New direct-fed microbial product with new active constituent
  2. New enzyme product with new active constituent

Active constituent

  • identification of micro-organisms / enzymes (name, taxonomic description, EC number)
  • occupational health and safety data (Material Safety Data Sheet or equivalent)
  • information on an active constituent consisting of or derived from GMOs (where relevant)
  • potency, purity and activity of each organism
  • manufacturer and site of manufacture (site of culture collection, strain registration and deposition)
  • manufacturing process (including quality control, impurities)
  • batch analysis data
  • validation data
  • packaging and storage conditions

Product

  • distinguishing product name
  • formulator and formulation plant details
    • evidence of GMP compliance
  • formulation type/pharmaceutical dosage form
  • formulation composition (constituent source, specification, function, certificate of analysis, AQIS import permit where relevant)
  • reference to quality standards
  • manufacturing process
  • quality control
  • product specifications
  • batch analysis
  • stability data
  • analytical procedures
  • validation data
  • packaging
  • data list

Detailed data requirements are in Part 2
MODULE 2.2    CHEMISTRY
Type of application Data required
  1. New herbal product with new active constituent

Active constituent

  • description of the plant and parts of the plant from which the active constituent is derived
  • manufacturer and site of manufacture
  • flow chart of the extraction process (including quality control, impurities - pesticides, fumigants, heavy metals)
  • characterisation of constituents
  • identification tests for constituents
  • assay of active constituents or relevant marker substances
  • physical and chemical properties
  • analytical procedures

Product

  • distinguishing product name
  • formulator and formulation plant details
    • evidence of GMP compliance
  • formulation type/pharmaceutical dosage form
  • formulation composition
  • reference to quality standards
  • colouring additives, flavourings and perfumes
  • manufacturing process
  • quality control
  • product specifications
  • batch analysis
  • stability data
  • analytical procedures
  • validation data
  • packaging
  • data list

Detailed data requirements are in Part 2
MODULE 2.2    CHEMISTRY
Type of application Data required
  1. Permit, new active constituent
  2. New product where the active constituent has been previously assessed under permit

Active constituent

  • identification of the active constituent
  • physical and chemical properties
  • stability data
  • method of manufacture
  • active constituent standard/specification
  • batch analysis data
  • analytical methods
  • validation data
  • analytical reference standards
  • packaging
  • data list

Product

  • distinguishing product name
  • formulator and formulation plant details
    • evidence of GMP compliance
  • formulation type/pharmaceutical dosage form
  • formulation composition
  • reference to quality standards
  • colouring additives, flavourings and perfumes
  • reference to quality standards
  • manufacturing process
  • quality control
  • product specifications
  • batch analysis
  • stability data
    • in-use stability data (where relevant)
  • analytical procedures
  • validation data
  • packaging
  • data list

Detailed data requirements are in Part 2

Module 2.3      Chemistry

MODULE 2.3    CHEMISTRY
Type of application Data required
  1. New product with existing active constituent

A Chemistry data package for product-only assessment requires submission of all of the following data, or submission of valid scientific argument not to submit certain data:

Product

  • distinguishing product name
  • formulator and formulation plant details
    • evidence of GMP compliance
  • formulation type/pharmaceutical dosage form
  • formulation composition
  • reference to quality standards
  • manufacturing process
  • quality control
  • product specifications
  • batch analysis
  • stability data
  • in-use stability data (where relevant)
  • analytical procedures
  • validation data
  • packaging
  • data list

Additional data specific to immunobiological products

  • starting materials (source, specification, function, certificate of analysis, AQIS import permits where relevant)
  • media preparation
  • manufacturing process (including validation data, Standard Operating Procedures)
  • quality assurance and testing:
    • in-process control tests
    • finished product tests (batch release specifications

Additional data specific to direct-fed microbial/enzyme products

  • formulation composition (constituent source, specification, function, certificate of analysis, AQIS import permit where relevant)

Detailed data requirements are in Part 2

Module 2.4      Chemistry

MODULE 2.4    CHEMISTRY
Type of application Data required
  1. Variations to chemistry and manufacture details of registered veterinary chemical products including:
  • minor formulation change requiring technical assessment;
  • change to product specifications with or without a change in manufacturing process;
  • change to non-active constituent specifications requiring technical assessment

A Chemistry data package for limited assessment requires submission of all of the following data, or submission of valid scientific argument not to submit certain data:

Product

  • distinguishing product name
  • formulator and formulation plant details
    • evidence of GMP compliance
  • formulation type/pharmaceutical dosage form
  • formulation composition
  • reference to quality standards
  • manufacturing process
  • product specifications
  • batch analysis
  • stability data
  • analytical procedures
  • validation data
  • data list

Detailed data requirements are in Part 2
MODULE 2.4    CHEMISTRY
Type of application Data required
  1. Extension of shelf life
  2. Extension of in-use shelf life
  3. Change to storage temperature / conditions
  4. Change to packaging material (immediate container and/or closure system)
  5. Other applications where assessment of only stability data ± product specifications may be required

Product

  • distinguishing product name
  • reference to quality standards
  • product specifications
  • stability data
  • in-use stability data (where relevant)
  • analytical procedures
  • validation data
  • data list

Detailed data requirements are in Part 2
MODULE 2.4    CHEMISTRY
Type of application Data required
  1. Variations to chemistry and manufacture of immunobiological products (excluding changes to the active constituents)

Product

  • distinguishing product name
  • formulator and formulation plant details
    • evidence of GMP compliance
  • formulation type/pharmaceutical dosage form
  • starting materials (source, specification, function, certificate of analysis, AQIS import permit where relevant)
  • media preparation
  • manufacturing process (including validation data, Standard Operating Procedures)
  • quality assurance and testing:
    • in-process control tests
    • finished product tests (batch release specifications)
  • batch analysis data
  • stability data:
    • stability of finished product
    • reconstitution/in-use stability data (where relevant)
  • data list
MODULE 2.4    CHEMISTRY
Type of application Data required
  1. Permit application – where minor chemistry assessment is required (e.g. extension of shelf life of a batch of product)

Product

  • product specifications
  • batch analysis data
  • stability data
  • analytical methods
  • validation data
  • draft oversticker / label

Detailed data requirements are in Part 2

Module 3.1      Toxicology

MODULE 3.1    TOXICOLOGY
Type of application Data required
  1. New product with new active constituent, or new active constituent only (unless included in Module 3.2 or 3.3)
  2. Permit application for a new active constituent (unless included in Module 3.2 or 3.3)

A Toxicology data package for comprehensive assessment requires submission of all of the following studies, or submission of valid scientific argument not to submit certain studies:

  • chemistry and manufacture (data Part 2);
  • toxicokinetics and metabolism (data Part 4);
  • acute toxicity studies:
    • studies on the active constituent;
    • studies on the product;
  • short-term toxicity studies (repeat-dose studies of less than 90 days duration);
  • sub-chronic toxicity studies (90 days to less than 12 months);
  • long-term (chronic) toxicity studies (12 months or longer):
    • carcinogenicity studies;
    • chronic toxicity and/or carcinogenicity studies;
  • reproduction studies;
  • developmental (teratology) studies;
  • genotoxicity studies
  • additional studies
    • toxicity of metabolites and impurities;
    • other adverse effects;
    • toxicity of mixtures;
  • human toxicological data;
  • no-observed-effect level (NOEL);
  • acceptable daily intake (ADI);
  • acute reference dose (ARfD);
  • first aid instructions and safety directions;
  • toxicological database

    •  

    Detailed data requirements are in Part 3

Module 3.2      Toxicology

MODULE 3.2    TOXICOLOGY
Type of application Data required
  1. New product / permit, new active constituent, for non-food-producing use
  2. Research permit, new active constituent, for food-producing use, with restrictions (single season / single use / specified research personnel)

A Toxicology data package for reduced assessment requires submission of all of the following studies, or submission of valid scientific argument not to submit certain studies:

  • chemistry and manufacture (data Part 2);
  • toxicokinetics and metabolism (data Part 4);
  • acute toxicity studies:
    • studies on the active constituent;
    • studies on the product;
  • short-term toxicity studies (repeat-dose studies of less than 90 days duration);
  • sub-chronic toxicity studies (90 days to less than 12 months);
  • developmental (teratology) studies;
  • genotoxicity studies
  • additional studies:
    • toxicity of metabolites and impurities;
    • other adverse effects;
    • toxicity of mixtures;
  • human toxicological data;
  • no-observed-effect level (NOEL);
  • first aid instructions and safety directions;
  • toxicological database

Detailed data requirements are in Part 3
MODULE 3.2    TOXICOLOGY
Type of application Data required
  1. New product / product variation / permit, existing active constituent – extension of use from non-food-producing to food-producing use for the first time for the active constituent (ADI ± ARfD required)

In addition to submission of all of the studies above, or submission of valid scientific argument not to submit some of the studies above, the following data are required:

  • long-term (chronic) toxicity studies (12 months or longer):
    • carcinogenicity studies;
    • chronic toxicity and/or carcinogenicity studies;
  • reproduction studies;
  • acceptable daily intake (ADI);
  • acute reference dose (ARfD)

Detailed data requirements are in Part 3

Module 3.3      Toxicology

MODULE 3.3    TOXICOLOGY
Type of application Data required
  1. New product / permit, existing active constituent – new formulation or major change in formulation1
  2. New biological chemical product2 containing new active constituent, adjuvant or excipient
  3. Label variation – change to safety directions (hazard statements) and / or change to label first aid statements and / or poison scheduling
  4. Research permit, new active constituent, for non-food-producing use, with restrictions (single season / single use / specified research personnel)

A Toxicology data package for limited assessment requires submission of all of the following studies, or submission of valid scientific argument not to submit certain studies:

  • chemistry and manufacture (data Part 2);
  • acute toxicity studies:
    • studies on the active constituent;
    • studies on the product  

Detailed data requirements are in Part 3
MODULE 3.3    TOXICOLOGY
Type of application Data required
  1. New product / permit, new active constituent, where an overseas report or health assessment report has been supplied3

A Toxicology data package for limited assessment requires submission of an acceptable overseas health report and a data package comprising all of the studies associated with that report.  

Detailed data requirements are in Part 3

Footnote 1:  Definition of a major formulation change

For the purposes of Module 3.3 and Module 6.3 a major formulation change is 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.  Some examples include:

  • where there has been a significant increase in the concentration of active constituent which could affect the hazard potential, poison scheduling, safety directions or residues;
  • where a major change in non-active constituent significantly affects the performance, stability or other attributes of the product; or
  • where the formulation has been changed significantly to accommodate a new application method/use-pattern (e.g. changing from a wettable powder to an emulsifiable concentrate; changing from an oral drench to a topical pour-on dosage form).
Footnote 2:  Definition of a biological chemical product:

Biological chemical products may be either agricultural or veterinary chemical products.  A biological chemical product is a chemical product where the active constituent comprises or is derived from a living organism (plant, animal, micro-organism, etc), with or without modification.

Definition of an immunobiological chemical product:

Immunobiological chemical products are products which, when administered to the host, provide, induce or change an immune response to a target chemical or biological entity.  Immunobiological products include vaccines, antisera and other immunobiologicals (eg antibodies and cytokines).

New immunobiological veterinary products are generally exempt from requirements for toxicological and OH&S assessments except in the case of new adjuvants or other excipients of OH&S concern.  Aerosolised vaccines may require toxicological and occupational health & safety assessment.  Vaccines containing genetically-modified organisms require evaluation by the Office of the Gene Technology Regulator (OGTR) and environmental assessment.

Definition of a biotechnology chemical product:

A biotechnology chemical product is one that is developed by means of one of the following biotechnological processes:
  • recombinant DNA technology.
  • controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including transformed mammalian cells.
  • hybridoma and monoclonal antibody methods.

Footnote 3:  Definition of an applicant-supplied overseas report or health assessment report:

The provision of a comprehensive toxicological assessment report on the active constituent, which is of -acceptable quality and dated from 1 July 2005, would enable classification of the application as a Level 3 toxicology assessment. Note that summary reports would not be sufficient to modify the level of assessment required.

Module 4         Scheduling

MODULE 4    SCHEDULING

This is an additional module that applies to any application for either an agricultural or veterinary chemical, where the application must be referred to the NDPSC for poisons scheduling.

Data requirements are covered by Toxicology modules 3.1, 3.2 or 3.3.

Module 5.1      Residues

MODULE 5.1    RESIDUES
Type of application Data required

MRL, WHP, residues definition and trade assessment required:

  1. New product, new active constituent – use in food-producing animal species
  2. New product / product variation, existing active constituent – extension of use from companion animal to food-producing animal species for the first time for the active constituent
  3. New product, existing active constituent – new route of administration in food-producing animal species
  4. Permit, new active constituent – use in food-producing animal species

A Residues data package for comprehensive assessment requires submission of all of the following data, or submission of valid scientific argument not to submit certain studies:

  • residues trial data;
  • metabolism data;
  • analytical methodology;
  • residues-in-trade information for commodities listed in Part 5B of Volume 3 as follows:

    cattle
    cattle dairy products
    pigs
    sheep
    goats
    poultry and eggs
    abalone
    tuna
    prawns

Detailed residue data requirements are in Part 5A

Detailed trade data requirements are in Part 5B

Module 5.2      Residues

MODULE 5.2    RESIDUES
Type of application Data required

MRL, WHP and trade assessment required:

  1. New product / product variation, existing active constituent – extension to or use in new food-producing animal species
  2. New product / product variation, existing active constituent – increased dose rate or frequency of application to food-producing animal species (change to MRL required)
  3. Label variation with potential residue risks (change to MRL required)

A Residues data package for reduced assessment requires submission of all of the following data, or submission of valid scientific argument not to submit certain studies:

  • residues trial data;
  • analytical methodology;
  • residues-in-trade information for commodities listed in Part 5B of Volume 3 as follows:

    cattle
    cattle dairy products
    pigs
    sheep
    goats
    poultry and eggs
    abalone
    tuna
    prawns

Detailed residue data requirements are in Part 5A

Detailed trade data requirements are in Part 5B

Module 5.3      Residues

MODULE 5.3    RESIDUES
Type of application Data required

MRL and WHP required:

  1. Permit, existing active constituent – use in new food-producing animal species

A Residues data package for reduced assessment for a permit application requires submission of residues data and analytical methodology for some or all of the following:

  • preliminary residues trials;
  • overseas residues trials;
  • published residues information

Detailed residue data requirements are in Part 5A

Module 5.4      Residues

MODULE 5.4    RESIDUES
Type of application Data required

WHP ± trade assessment required:

  1. New product, existing active constituent, existing use pattern (non-aqueous injectables, pour-ons, intramammary dry cow infusions, implants, intraruminal devices only)
  2. Existing product, change in formulation (non-aqueous injectables, pour-ons, intramammary dry cow infusions, implants, intraruminal devices only)
  3. Label variation with potential residue risks (no change to MRL required)
  4. New product, existing active constituent – similar to reference product, except for a shorter WHP

A Residues data package for limited assessment requires submission of all of the following data, or submission of valid scientific argument not to submit certain studies:

  • residues trial data;
  • analytical methodology;
  • residues-in-trade information (if appropriate) to consider an export slaughter interval for:

    cattle
    cattle dairy products
    pigs
    sheep
    goats
    poultry and eggs

Detailed residue data requirements are in Part 5A

Detailed trade data requirements are in Part 5B

Module 5.5      Residues

MODULE 5.5    RESIDUES
Type of application Data required

WHP ± MRL required:

  1. Permit application, existing active constituent – minor use, emergency use or research permits for a food-producing animal species

A Residues data package for limited assessment requires submission of published residues information and / or valid scientific argument to support the permit application.

Detailed residue data requirements are in Part 5A

Module 6.2      Occupational Health & Safety

MODULE 6.2    OCCUPATIONAL HEALTH & SAFETY
Type of application Data required
  1. New product / permit, new active constituent, for use on food-producing animal species (including biologicals)
  2. New product / permit, new active constituent, for use on non-food-producing animal species (excluding biologicals)

An OH&S data package for reduced assessment requires submission of all of the following data, or submission of valid scientific argument not to submit certain information:

Hazard:

  • physical and chemical properties:
    • active constituent;
    • product;
    • individual constituents;
  • toxicology;

Occupational exposure:

  • mixing and loading;
  • product application;
  • re-handling;
  • dermal absorption;

Risk management and workplace information:  

  • measures to control occupational exposure:
    • before and during end-use;
    • re-handling;
  • product label;
  • Material Safety Data Sheet (MSDS);
  • training requirements;
  • occupational exposure monitoring:
    • atmospheric monitoring;
    • health & safety;
  • contraindications

Risk assessment:

  • margin of exposure (MOE);
  • further requirements where the MOE is inadequate;
  • risk assessment proposed by the applicant (acute and repeat dose)

Detailed data requirements are in Part 6

Module 6.3      Occupational health & safety

MODULE 6.3    OCCUPATIONAL HEALTH & SAFETY
Type of application Data required
  1. New product / product variation / permit, existing active constituent – major formulation change1 and / or change of use pattern

An OH&S data package for limited assessment requires submission of all of the following data, or submission of valid scientific argument not to submit certain information:

Hazard:

  • physical and chemical properties:
    • active constituent;
    • product;
    • individual constituents;

Occupational exposure:

  • mixing and loading;
  • product application;
  • re-handling;
  • dermal absorption;

Risk management and workplace information:  

  • measures to control occupational exposure:
    • before and during end-use;
    • re-handling;
  • product label;
  • Material Safety Data Sheet (MSDS);
  • training requirements;
  • occupational exposure monitoring:
    • atmospheric monitoring;
    • health surveillance;
  • contraindications

Detailed data requirements are in Part 6
MODULE 6.3    OCCUPATIONAL HEALTH & SAFETY
Type of application Data required
  1. Label variation – change / reassessment of user Safety Directions and / or re-handling statements

Hazard:

  • physical and chemical properties:
    • active constituent;
    • product;
    • individual constituents;

Occupational exposure:

  • mixing and loading;
  • product application;
  • re-handling;

Risk management and workplace information:  

  • measures to control occupational exposure:
    • before and during end-use;
    • re-handling;
  • product label;
  • Material Safety Data Sheet (MSDS);
  • training requirements;
  • tank mixing;
  • contraindications

Detailed data requirements are in Part 6

Modules 7.1, 7.2, 7.3    Environment

MODULES 7.1, 7.2, 7.3    ENVIRONMENT
MODULE 7.1 Data required
Type of application
  1. New product, new active constituent (unless included in VICH Phase I)
  2. New product / product variation, existing active constituent – where the proposed use does not meet VICH Phase I criteria for the first time for the active constituent

An Environment data package for comprehensive, reduced or limited assessment requires submission of all of the following studies, or submission of valid scientific argument not to submit certain studies:

Environmental chemistry and fate

  • assessment of the extent of, and potential for, environmental exposure:
    • amount of chemical to be used;
    • manufacturing plant of the active constituent;
    • formulating plant of the product;
    • use and application;
    • product disposal;
    • accidental release;
  • physicochemical degradation:
    • hydrolysis;
    • photodegradation (aqueous, soil, degradation in air);
  • biodegradation:
    • soils (aerobic, anaerobic);
    • water;
  • mobility:
    • volatility;
    • adsorption/desorption;
    • leaching potential;
  • field dissipation:
    • soils;
    • water;
    • air;
    • plants;
  • accumulation/metabolism:
    • bioaccumulation in fish and aquatic organisms;
    • accumulation potential in soils;
    • metabolism in target animals;
    • other species e.g. birds, earthworms;
    • modelling studies

Environmental toxicology

  • wild birds, mammals and other vertebrates:
    • acute;
    • short-term;
    • special studies – chronic, reproduction, simulated or actual field testing;
  • aquatic organisms (freshwater and marine):
    • acute (fish, microcrustacea, algae);
    • short-term (sub-chronic);
    • special studies — chronic, sediment, simulated or actual field testing;
  • non-target terrestrial invertebrates:
    • predators;
    • parasites;
    • bees;
    • earthworms and soil invertebrates;
    • soil micro-organisms;
    • other;
  • non-target vegetation:
    • results from laboratory tests;
    • observations from field trials or efficacy tests;
  • assessment of environmental hazard

Detailed data requirements are in Part 7
MODULE   7.2
Type of application
  1. New product / product variation, existing active constituent – extension of use to a new herd animal species
  2. New product / product variation – major formulation change1 or increased dose rate / frequency of application
  3. Product containing new active constituent for use under permit
MODULE 7.3
Type of application
  1. Label variation – change to environmental instructions and warnings
  2. Product containing existing active constituent for use under permit

Footnote 1:  Definition of a major formulation change

For the purposes of Module 7.2 a major formulation change is 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. Some examples include:

  • where there has been a significant increase in the concentration of active constituent which could affect the hazard potential, poison scheduling, safety directions or residues;
  • where a major change in non-active constituent significantly affects the performance, stability or other attributes of the product; or
  • where the formulation has been changed significantly to accommodate a new application method/use-pattern (eg changing from an oral drench to a topical pour-on dosage form).

Module 8.1      Efficacy and host animal safety

MODULE 8.1    EFFICACY & HOST ANIMAL SAFETY
Type of application Data required
  1. New product for use in/on a food-producing animal species2 containing:
  • new active constituent; or
  • new combination of existing active constituents1
  1. New or existing product:
  • existing active constituent for use in/on a new food-producing animal species2

An Efficacy and Host Animal Safety data package for comprehensive assessment requires submission of all of the following studies, or submission of valid scientific argument not to submit certain studies:

Efficacy studies

  • laboratory model efficacy studies;
  • target animal efficacy studies:
    • dose determination studies;
    • dose confirmation studies;
    • confirmatory clinical / field studies including Australian confirmatory studies

Target animal safety studies

  • ‘margin of safety’ studies;
    • dose rate;
    • duration of treatment;
  • topical studies, inhalation studies, tissue irritation studies;
  • bacterial endotoxin testing / pyrogen testing studies;
  • reproductive function studies;
  • adverse experiences

Pharmacological data/studies

  • pharmacokinetics;
  • pharmacodynamics

Related studies

  • compatibility studies;
  • effects on hides and fleeces;
  • accidental administration or exposure to non-target animals;
  • effects on taste of produce (organoleptic effects)

Detailed data requirements are in Part 8

Module 8.2      Efficacy and host animal safety

MODULE 8.2    EFFICACY & HOST ANIMAL SAFETY
Type of application Data required
  1. New product for use in/on companion animal species (dog, cat, or horse)
  2. Extension of use to a new companion animal species (dog, cat, or horse)

An Efficacy and Host Animal Safety data package for reduced assessment requires submission of all of the following studies, or submission of valid scientific argument not to submit certain studies:

Efficacy studies

  • target animal efficacy studies:
    • dose determination studies;
    • dose confirmation studies;
    • confirmatory clinical / field studies including Australian confirmatory studies

Target animal safety studies

  • ‘margin of safety’ studies;
    • dose rate;
    • duration of treatment;
  • topical studies, inhalation studies, tissue irritation studies;
  • bacterial endotoxin testing / pyrogen testing studies;
  • reproductive function studies;
  • adverse experiences

Pharmacological data/studies

  • pharmacokinetics;
  • pharmacodynamics

Related studies

  • compatibility studies;
  • accidental administration or exposure to non-target animals

Detailed data requirements are in Part 8
MODULE 8.2    EFFICACY & HOST ANIMAL SAFETY
Type of application Data required
  1. Extension of use to a new pest / disease / purpose in/on the same food-producing animal species2
  2. Change to dosage and administration instructions (treatment number, frequency, duration, dose, route of administration) in/on the same food-producing animal species2
  3. Product for use in/on a food-producing animal species2 with a new formulation which is not identical, not closely similar, and not similar to a reference product1

Efficacy studies

  • target animal efficacy studies:
    • dose determination studies;
    • dose confirmation studies;
    • confirmatory clinical / field studies including Australian confirmatory studies

Target animal safety studies

  • topical studies, inhalation studies, tissue irritation studies;
  • adverse experiences

Related studies

  • effects on hides and fleeces;
  • effects on taste of produce (organoleptic effects)

Detailed data requirements are in Part 8

Module 8.3      Efficacy and host animal safety

MODULE 8.3    EFFICACY & HOST ANIMAL SAFETY
Type of application Data required
  1. New product where efficacy and safety data are required to demonstrate similarity to an existing registered product

An Efficacy and Host Animal Safety data package for limited assessment requires submission of all of the following studies, or submission of valid scientific argument not to submit certain studies:

Efficacy studies

  • target animal efficacy studies to demonstrate comparable efficacy with the registered reference product:
    • blood level bioequivalence; or
    • measurement of biological effect; or
    • clinical studies

Target animal safety studies

  • ‘margin of safety’ studies;
    • dose rate;
    • duration of treatment;
  • topical studies, inhalation studies, tissue irritation studies;
  • adverse experiences

Detailed data requirements are in Part 8
MODULE 8.3    EFFICACY & HOST ANIMAL SAFETY
Type of application Data required
  1. New product for use in/on a non-food-producing animal species other than dog, cat or horse
  2. Extension of use to a new non-food-producing animal species other than dog, cat or horse

Efficacy and Safety studies for the proposed or related formulations (same active constituent)

  • target animal efficacy studies;
  • scientific literature:
    • published target species efficacy and safety data (supporting label claims); or
    • recommended use information from textbooks or other reputable sources

Target animal safety studies for the proposed or related formulations (same active constituent)

  • ‘margin of safety’ studies;
    • dose rate;
    • duration of treatment;
  • topical studies, inhalation studies, tissue irritation studies;

  • adverse experiences;
  • scientific literature:
    • published target species safety data

Detailed data requirements are in Part 8
MODULE 8.3    EFFICACY & HOST ANIMAL SAFETY
Type of application Data required
  1. Label and formulation changes that are expected to have a minor impact on efficacy or safety1
  2. Permit application – minor use in a new animal species

Efficacy studies

  • target animal efficacy studies to demonstrate comparable efficacy with the previously approved formulation:
    • blood level bioequivalence; or
    • measurement of biological effect; or
    • clinical studies; or
  • target animal efficacy studies:
    • confirmatory clinical / field studies

Target animal safety studies

  • topical studies, inhalation studies, tissue irritation studies;
  • adverse experiences

Detailed data requirements are in Part 8
MODULE 8.3    EFFICACY & HOST ANIMAL SAFETY
Type of application Data required
  1. Demonstration of comparable efficacy with another product by in vitro dissolution
  • in vitro comparative dissolution studies;
  • scientific argument relating to efficacy

Detailed information is in bioequivalence guideline

Footnote 1:  Major formulation change

For the purposes of efficacy and safety a major formulation change is 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 animal requires assessment.  Some examples include:

  • where there has been a significant change in the concentration of active constituent and where the application/dose rate to the animal is changed; or
  • where a major change in non-active constituent significantly affects the performance, stability or other attributes of the product; or
  • where there has been a significant change in product specifications; or
  • where the formulation has been changed significantly to accommodate a new application method/use-pattern (e.g. changing from an oral drench to a topical pour-on dosage form); or
  • where the new formulation is not identical, not closely similar, and not similar to a registered reference product.

Major changes in formulation are expected to 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:

  • If the change in formulation is likely to affect only efficacy or safety, assessment under Module 8.3 could be appropriate;
  • Data to demonstrate comparable efficacy/bioequivalence with the previous formulation could be assessed under Module 8.3.

Footnote 2:  Food-producing animal species:

A food-producing animal species 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 food/fibre-producing animal species other than cattle, sheep, pigs and chickens qualify for a reduced (Level 2) efficacy and safety assessment (eg goat, llama, alpaca, emu).

Module 9         Non-food trade

MODULE 9    NON-FOOD TRADE
Type of application Data required
  1. Veterinary chemicals involving trade risks not related to food residues, including:
  • residues in wool and fibre
  • presence of disease or seropositive testing to exotic or notifiable agents
  • hormonal growth promotants and other endocrine substances
  • genetically-modified produce

Data specifically relevant to the trade risk

 

 

 

 

 

 

Detailed information is in Part 9

Module 10.1    Antibiotic resistance

MODULE 10.1    ANTIBIOTIC RESISTANCE
Type of application Data required
  1. New product with a new antibiotic active constituent
  2. Permit for use of a new antibiotic active constituent (other than for small scale research)

A Special Data data package for comprehensive assessment of antibiotic resistance requires submission of all of the following studies, or submission of valid scientific argument not to submit certain studies:

Description of the antibiotic constituent

  • name and identification of antibiotic;
  • class of antibiotic;
  • mechanism and type of antimicrobial action;
  • antimicrobial activity of the antibiotic;
  • antibiotic resistance mechanisms and genetics;
  • occurrence and rate of transfer of antimicrobial resistance genes;
  • occurrence of cross-resistance;
  • occurrence of co-resistance / co-selection;
  • in vitro mutation frequency studies;
  • other animal studies

Description of the product

  • general (name; pharmaceutical dosage form; pack sizes; claim; poisons scheduling; label);
  • pharmacokinetic / pharmacodynamic profile of the active constituent after administration of the product;
  • antimicrobial agent activity in the intestinal tract;
  • registration status in Australia and overseas

Proposed MRLs

  • proposed MRLs for food-producing species

Risk Assessment

  • summary of the risk profile;
  • hazard characterisation;
  • exposure characterisation;
  • impact characterisation;
  • assessment of the uncertainty of the data used in the risk assessment;
  • benefits of use of the antibiotic in Australian animal health;
  • risk characterisation;
  • summary of the risk assessment;
  • recommendation in support of the proposed use pattern and risk management suggestions

Detailed data requirements are in Part 10

Module 10.2    Antibiotic resistance

MODULE 10.2    ANTIBIOTIC RESIS CE
Type of application Data required
  1. New product / product variation, existing antibiotic active constituent, expected to result in significantly increased volume of use / risk to public health, including:
  • extension of use to a new food-producing animal species / dog / cat;
  • extension of use to another major group within the same food-producing animal species (e.g. broiler chickens to layers; beef cattle to dairy cattle);
  • change in dosage form or use pattern (e.g. from use in individual animals to mass medication)
  1. Permit for use of an existing antibiotic active constituent in a new animal species

A Special Data data package for reduced assessment of antibiotic resistance requires submission of information that addresses changes in risk associated with the proposed use, or submission of valid scientific argument not to submit certain studies:

Description of the antibiotic constituent

  • name and identification of antibiotic;
  • class of antibiotic;
  • mechanism and type of antimicrobial action;
  • antimicrobial activity of the antibiotic;
  • antibiotic resistance mechanisms and genetics;
  • occurrence and rate of transfer of antimicrobial resistance genes;
  • occurrence of cross-resistance;
  • occurrence of co-resistance / co-selection;
  • in vitro mutation frequency studies;
  • other animal studies

Description of the product

  • general (name; pharmaceutical dosage form; pack sizes; claim; poisons scheduling; label);
  • pharmacokinetic / pharmacodynamic profile of the active constituent after administration of the product;
  • antimicrobial agent activity in the intestinal tract;
  • registration status in Australia and overseas

Proposed MRLs

  • proposed MRLs for food-producing species

Risk Assessment

  • summary of the risk profile;
  • hazard characterisation;
  • exposure characterisation;
  • impact characterisation;
  • assessment of the uncertainty of the data used in the risk assessment;
  • benefits of use of the antibiotic in Australian animal health;
  • risk characterisation;
  • summary of the risk assessment;
  • recommendation in support of the proposed use pattern and risk management suggestions

Detailed data requirements are in Part 10

Module 10.3    GM Organism / Other Special Data

MODULE 10.3    GM ORGANISM / OTHER SPECIAL DATA
Type of application Data required
  1. Any application requiring an assessment of special data such as assessment of a product containing a genetically modified organism (GMO)

Published data and results of Australian field trials relevant to the criteria for approval of an active constituent or registration of a product, described in s.14 of the Agvet Code

5.    MODULE FEES AND TIMEFRAMES

  – amended from Schedule 7 to the Regulations to the Agvet Code
Module
Fee*
Timeframe†
1        Screening
$505
  
2.1     Chemistry
$3,255
12 months
2.2     Chemistry
$2,230
8 months
2.3     Chemistry
$1,030
5 months
2.4     Chemistry
$200
3 months
3.1     Toxicology
$19,490
12 months
3.2     Toxicology
$14,620
8 months
3.3     Toxicology
$2,900
4 months
4        Scheduling
$3,720
12 months
5.1     Residues
$5,595
12 months
5.2     Residues
$4,765
6 months
5.3     Residues
$2,490
6 months
5.4     Residues
$2,230
3 months
5.5     Residues
$1,175
3 months
6.1     OH&S
$4,310
12 months
6.2     OH&S
$2,900
6 months
6.3     OH&S
$1,435
4 months
7.1     Environment
$12,605
12 months
7.2     Environment
$3,255
6 months
7.3     Environment
$620
4 months
8.1     Efficacy & host animal safety
$1,865
5 months
8.2     Efficacy & host animal safety
$750
4 months
8.3     Efficacy & host animal safety
$500
3 months
9        Non-food trade
$1,175
5 months
10.1   Antibiotic resistance
Nil fee
12 months
10.2   Antibiotic resistance
Nil fee
6 months
10.3   GM Organism / other special data
Nil fee
6 months
11.1   Finalisation
$2,230
3 months
11.2   Finalisation
$1,175
2 months
11.3   Finalisation
$620
2 months
11.4   Finalisation
$160
2 months
12      Data protection
$170
  

* To calculate the fee for the application, total the modular fees for all items.

† To calculate the assessment period for the application, add the longest assessment period for modules 2–10 to the relevant module 11 assessment period.

Appendix A:   Further detail on the modules

Module for screening of applications

1.      This module covers administrative work, handling and advice at screening for all applications before they are accepted for evaluation.

Modules for assessment of product quality, batch-to-batch consistency and stability

2.1    This module covers an application that requires a comprehensive assessment of chemistry and manufacture data for both the active/s and the product.

2.2    This module covers an application that requires a reduced assessment of chemistry and manufacture data for the active/s and the product that is not as extensive as the assessment required in 2.1 above.

2.3    This module covers an application that requires an assessment of chemistry and manufacture data for the product only.

2.4    This module covers an application for a variation to chemistry and manufacture details for the product, or any other application requiring a limited chemistry and manufacture assessment.

Modules for assessment of toxicological hazards and advice of public health standards

3.1    This module covers an application that requires a comprehensive assessment of toxicological data for the active/s and the product.

3.2    This module covers an application that requires a reduced assessment of toxicological data that is not as extensive as the assessment required in 3.1 above.

3.3    This module covers any other application requiring a limited toxicological assessment.

4.      This module covers drugs and poisons scheduling.

Modules for assessment of food residue levels and human dietary residue exposure and advice on maximum residue limit standards

5.1    This module covers an application that requires a comprehensive assessment of residue data.

5.2    This module covers a registration application that requires a reduced assessment of residue data that is not as extensive as the assessment required in 5.1 above.

5.3    This module covers a permit application that requires a reduced assessment of residue data that is not as extensive as the assessment required in 5.1 above.

5.4    This module covers any other registration application requiring a limited residue assessment.

5.5    This module covers any other permit application requiring a limited residue assessment.

Modules for assessment of personal user safety

6.1    This module covers an application that requires a comprehensive assessment of occupational health and safety data.

6.2    This module covers an application that requires a reduced assessment of occupational health and safety data that is not as extensive as the assessment required in 6.1 above.

6.3    This module covers any other application requiring a limited occupational health and safety assessment.

Modules for assessment of environmental safety

7.1    This module covers an application that requires a comprehensive assessment of environmental data.

7.2    This module covers an application that requires a reduced assessment of environmental data that is not as extensive as the assessment required in 7.1 above.

7.3    This module covers any other application requiring a limited environmental safety assessment.

Modules for assessment of label claims and adequacy of label instructions and precautions relating to target species efficacy and safety

8.1    This module covers an application that requires an efficacy and safety review carried out on either:

  1. an agricultural chemical product containing:
    1. a new active constituent; or
    2. a new combination of active constituents; or
    3. an existing active constituent/s for use in a new crop or situation; or
    4. a significant new formulation not included in module 8.2;  OR
  2. a veterinary chemical product for use in/on a food-producing species containing:
    1. a new active constituent; or
    2. a new combination of active constituents; or
    3. an existing active constituent/s for use in/on a new food animal

8.2    This module covers an application that requires an efficacy and safety review carried out on either:

  1. an agricultural chemical product when module 8.1 is not justified (for example, an extension of use within the same food group);  OR
  2. a veterinary chemical product:
    1. used on companion animals (dog, cat or horse); or
    2. where extension of use is in/on the same food-producing species; or
    3. where a new formulation for a product for use in/on a food-producing species is not identical, closely similar or similar to a reference product.

8.3    This module covers any other application requiring a target species efficacy and/or safety review.

Module for assessment of non-food trade risk

9.      This module covers an application requiring assessment of trade risk relating to non-food residue situations eg – fibre residues, presence of disease or seropositive testing to exotic or notifiable disease agents, genetically modified produce.

Modules for assessment of other data

10.1  This module covers an application that requires a comprehensive assessment of part 10 special data.

10.2  This module covers an application that requires a reduced assessment of part 10 special data that is not as extensive as the assessment required in 10.1 above.

10.3  This module covers any other application requiring an assessment of special data such as assessment of product containing a GMO.

Module for administrative and technical steps in public consultation and finalisation of applications

11.1  This module covers finalisation of a registration or permit application that requires three or more modular assessments covered in items 2.1 to 10.3 above, except for item 2.4.

11.2  This module covers a registration application that requires less than three of the modular assessments covered in items 2.1 to 10.3 above.

11.3  This module covers a permit application that requires less than three of the modular assessments covered in items 2.1 to 10.3 above.

11.4  This module covers any minor application requiring technical assessment including modular items 2.4.

Module for assigning data protection

12.    This module covers administrative and technical steps in assigning protection to relevant data.

FOOTNOTES

  1. Note: the Office of Chemical Safety (OCS) determines what type of overseas report is an ‘acceptable overseas report’, on a case-by-case basis. Applicants should consult the APVMA before submitting an application where the toxicology data are based on an overseas report.

REVISION HISTORY

Revision Date Description of Revision
1 July 2005 First edition
1 October 2005

Second edition

  • application for approval of new active constituent only added to chemistry Module 2.1 and toxicology Module 3.1
  • application for approval of new source of ectoparasiticide active constituent added to chemistry Module 2.2
  • application for new product or variation, where proposed use no longer meets VICH Phase I criteria, added to environment Module 7.1
  • preliminary assessment for environment VICH Phase I criteria added to explanation of VICH Phase I in paragraph 1.5.8.

1 April 2006

Third edition

  • minor typographical errors corrected in paragraphs 1.1, 1.5.1 and 1.5.9
  • Module tables: added reference to Data Parts for detailed requirements
  • Module 2.4: changed wording of application type involving only stability ± product specifications
  • Module 3 Toxicology tables: data elements modified to reflect revised Part 3
  • Module 6 OH&S tables: data elements rearranged to reflect revised Part 6
  • Module 8 Efficacy & host animal safety tables: data elements modified to reflect revised Part 8
  • Module 8.3: changed wording of in vitro dissolution application type
  • Modules 10.1 and 10.2: Antibiotic resistance tables: data elements modified to reflect revised Part 10.
1 July 2007

Fourth edition

  • paragraph 1: expand to improve the explanation of data Parts and modules; split into 2 sections
  • paragraph 1.5: change the name of the legislative instrument in Volume 1
  • Module 3.3: insert ‘acceptable’ before ‘overseas report’ to make the definition consistent with the definition in Legislative Instrument No. 2
  • Module 5.5: edit to allow use of this module for trial protocols, consistent with Legislative Instrument No. 3
  • make note to module 3.3 to say that OCS defines ‘overseas technical report’ on a case-by-case basis
  • edit data elements for all of chemistry and manufacturing modules, to make them consistent with edits to Part 2 Chemistry and Manufacturing