Veterinary data guidelines

Relevant data for module levels—veterinary chemical products

The following sets out the data that may be relevant to particular assessment modules detailed in the Agvet Regulations. This list is not exhaustive and is only intended to provide you with guidance in putting your application together. Please review this information in consultation with the Module Descriptors 6A guideline.

Chemistry

Detailed data guidelines for chemistry and manufacture are available in Part 2 for active constituents and products.

Module 2.1

For applications referred to at 2.1(a)(1), (2), (3), (4), (5), (6), (7) and (8) of the Module Descriptors 6A guideline, a chemistry data package for comprehensive assessment may include submission of the following data or submission of valid scientific argument:

Active constituent

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

Product

  • formulator and formulation plant details
  • formulation type and pharmaceutical dosage form
  • formulation composition
  • reference to quality specifications of the constituents
  • 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

Module 2.2(a)(1)

For applications referred to at 2.2(a)(1) of the Module Descriptors 6A guideline, a chemistry data package for reduced assessment may include submission of the following data or submission of valid scientific argument:

Active constituent

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

Product

  • formulator and formulation plant details
  • formulation type/pharmaceutical dosage form
  • formulation composition
  • reference to quality specifications of the constituents
  • 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

Module 2.2(a)(4)

For applications referred to at 2.2(a)(4) of the Module Descriptors 6A guideline, a chemistry data package for reduced assessment may include submission of the following data or submission of valid scientific argument:

Active constituent

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

Product

  • formulator and formulation plant details
  • formulation type and pharmaceutical dosage form
  • formulation composition
  • reference to quality specifications of the constituents
  • 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

Module 2.2(a)(5) and (6)

For applications referred to at 2.2(a)(5) and (6) of the Module Descriptors 6A guideline, a chemistry data package for reduced assessment may include submission of the following data or submission of valid scientific argument:

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
  • Agriculture Biosecurity Import Permit (where relevant)
  • information on an active constituent consisting of or derived from GMOs (where relevant)

Product

  • formulator and formulation plant details
  • formulation type and pharmaceutical dosage form
  • starting materials (source, specification, function, certificate of analysis, Agriculture Biosecurity 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

Module 2.2(a)(7) and (8)

For applications referred to at 2.2(a)(7) and (8) of the Module Descriptors 6A guideline, a chemistry data package for reduced assessment may include submission of the following data or submission of valid scientific argument:

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

  • formulator and formulation plant details
  • formulation type and pharmaceutical dosage form
  • formulation composition (constituent source, specification, function, certificate of analysis, Agriculture Biosecurity Import Permit where relevant)
  • reference to quality specifications of the constituents
  • manufacturing process
  • quality control
  • product specifications
  • batch analysis
  • stability data
  • analytical procedures
  • validation data
  • packaging

Module 2.2(a)(9)

For applications referred to at 2.2(a)(9) of the Module Descriptors 6A guideline, a chemistry data package for reduced assessment may include submission of the following data or submission of valid scientific argument:

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

  • formulator and formulation plant details
  • formulation type and pharmaceutical dosage form
  • formulation composition
  • reference to quality specifications of the constituents
  • manufacturing process
  • quality control
  • product specifications
  • batch analysis
  • stability data
  • analytical procedures
  • validation data
  • packaging

Module 2.2(a)(10) and 2.2(c)

For applications referred to at 2.2(a)(10) and 2.2(c) of the Module Descriptors 6A guideline, a chemistry data package for reduced assessment may include submission of the following data or submission of valid scientific argument:

Active constituent

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

Product

  • formulator and formulation plant details
  • formulation type and pharmaceutical dosage form
  • formulation composition
  • reference to quality specifications of the constituents
  • manufacturing process
  • quality control
  • product specifications
  • batch analysis
  • stability data
  • in-use stability data (where relevant)
  • analytical procedures
  • validation data
  • packaging

Module 2.3(b)

For applications referred to at 2.3(b) of the Module Descriptors 6A guideline, a chemistry data package for product-only assessment may include submission of the following data or submission of valid scientific argument:

Product

  • formulator and formulation plant details
  • formulation type and pharmaceutical dosage form
  • formulation composition
  • reference to quality specifications of the constituents
  • manufacturing process
  • quality control
  • product specifications
  • batch analysis
  • stability data
  • in-use stability data (where relevant)
  • analytical procedures
  • validation data
  • packaging

Additional data specific to immunobiological products

  • starting materials (source, specification, function, certificate of analysis, Agriculture Biosecurity 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

Additional data specific to direct-fed microbial/enzyme products

  • formulation composition (constituent source, specification, function, certificate of analysis, Agriculture Biosecurity Import Permit where relevant)

Module 2.3(c) and (e)

For applications referred to at 2.3(c) and (e) of the Module Descriptors 6A guideline, a chemistry data package for limited assessment may include submission of the following data or submission of valid scientific argument:

Product

  • formulator and formulation plant details
  • formulation type and pharmaceutical dosage form
  • formulation composition
  • reference to quality specifications of the constituents
  • manufacturing process
  • product specifications
  • batch analysis
  • stability data
  • analytical procedures
  • validation data

For applications for variations to chemistry and manufacture of immunobiological products (excluding changes to the active constituents) referred to at 2.3.3(c) and (e)  of the Module Descriptors 6A guideline, a chemistry data package for limited assessment may include submission of the following data or submission of valid scientific argument:

Product

  • formulator and formulation plant details
  • formulation type and pharmaceutical dosage form
  • starting materials (source, specification, function, certificate of analysis, Agriculture Biosecurity 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)

Details can be found in data guideline for variations to registered veterinary vaccines

Module 2.3(d)

For applications referred to at 2.3(d) of the Module Descriptors 6A guideline, a chemistry data package for limited assessment may include submission of the following data or submission of valid scientific argument:

Product

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

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Toxicology

Detailed data guidelines for toxicology are available in Part 3.

Module 3.1

For applications referred to at 3.1(a) and (b) of the Module Descriptors 6A guideline, a toxicology data package for comprehensive assessment may include submission of the following data or submission of valid scientific argument:

  • chemistry and manufacture (data Part 2 for active constituents and products);
  • Absorption, distribution, metabolism and excretion (toxicokinetics, pharmacokinetics) (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):
  • Chronic toxicity studies
  • Carcinogenicity studies
  • Combined chronic toxicity and carcinogenicity studies
  • reproduction studies;
  • Developmental studies (including developmental neurotoxicity)genotoxicity studies
  • Neurotoxicity studies
  • additional studies
  • toxicity of metabolites and impurities
  • other adverse effects
  • toxicity of mixtures
  • mechanistic studies and mode of action
  • immunotoxicity
  • human toxicological data;
  • no-observed-effect level (NOEL);
  • acceptable daily intake (ADI);
  • acute reference dose (ARfD);
  • first aid instructions and safety directions;
  • Toxicological database/bibliography

Module 3.2

For applications referred to at 3.2(a), (c) and (e) of the Module Descriptors 6A guideline, a toxicology data package for reduced assessment may include submission of the following data or submission of valid scientific argument:

  • chemistry and manufacture (data Part 2 for active constituents and products);
  • Absorption, distribution, metabolism and excretion (toxicokinetics, pharmacokinetics) (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 studies (including developmental neurotoxicity)
  • genotoxicity studies
  • additional studies:
  • toxicity of metabolites and impurities
  • other adverse effects
  • toxicity of mixtures
  • mechanistic studies and mode of action
  • immunotoxicity
  • human toxicological data;
  • no-observed-effect level (NOEL);
  • first aid instructions and safety directions;
  • Toxicological database/bibliography

For applications referred to at 3.2(b) and (d) of the Module Descriptors 6A guideline, in addition to submission of the studies listed above, or submission of valid scientific argument, the following data may be included:

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

Module 3.3

For applications referred to at 3.3(b), (d), (e), (f) and (g) of the Module Descriptors 6A guideline, a toxicology data package for limited assessment may include submission of the following data or submission of valid scientific argument:

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

Notes

Overseas Health Report

Please note for applications for a new product or permit with a new active constituent, a toxicology data package for limited assessment may include submission of an acceptable overseas health report and a data package comprising all of the studies associated with that 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 limited toxicology assessment. Please note that summary reports would not be sufficient to modify the level of assessment required.

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).
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 WH&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.

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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 relevant to scheduling is covered by toxicology modules 3.1, 3.2 or 3.3.

Residues

Detailed data guidelines for residues are in Part 5A

Detailed data guidelines for trade are in Part 5B

Module 5.1

For applications referred to at 5.1(b) of the Module Descriptors 6A guideline, a residues data package for comprehensive assessment may include submission of the following data or submission of valid scientific argument:

  • metabolism and pharmacokinetic data;
  • residue kinetic data
  • residues trial data
  • analytical methodology;
  • residues-in-trade information for the following animals:
    cattle (meat, milk, processed dairy commodities)
    pigs (meat)
    sheep (meat, milk)
    goats (meat, milk)
    poultry (meat, eggs)
    aquatic species
    bees (honey)

Module 5.2

For applications referred to at 5.2(a)(1),(5) and (6) and 5.2(b) of the Module Descriptors 6A guideline, a residues data package for reduced assessment may include submission of the following data or submission of valid scientific argument:

  • metabolism data and pharmacokinetic data (new species or new route of administration)
  • residue kinetic data
  • residues trial data;
  • analytical methodology;
  • residues-in-trade information for the following animals:
    cattle (meat, milk, processed dairy commodities)
    pigs (meat)
    sheep (meat, milk)
    goats (meat, milk)
    poultry (meat, eggs)
    aquatic species
    bees (honey)

Module 5.3

For applications referred to at 5.3(a)(3) of the Module Descriptors 6A guideline, a residues data package for reduced assessment for a permit application may include submission of some or all of the following:

  • metabolism data/valid scientific argument addressing metabolism of active in the new species
  • residue kinetic data
  • preliminary residues trials;
  • overseas residues trials;
  • published residues information: overseas registrations
  • residues in trade information

Module 5.4

For applications referred to at 5.4(b) of the Module Descriptors 6A guideline, a residues data package for limited assessment may include submission of the following data or submission of valid scientific argument:

  • residues trial data;
  • analytical methodology;
  • residues-in-trade information for the following animals:
  • cattle (meat, milk, processed dairy commodities)
    pigs (meat)
    sheep (meat, milk)
    goats (meat, milk)
    poultry (meat, eggs)
    aquatic species
    bees (honey)

Module 5.5

For applications referred to at 5.5(a)(3) and 5.5(c) of the Module Descriptors 6A guideline, a residues data package for limited assessment may include submission of residues trial data, published residues information and / or valid scientific argument as well as residues-in-trade information and risk mitigation strategies to support the permit application

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Occupational health and safety

Detailed data guidelines for occupational health and safety are in Part 6

Module 6.2

For applications referred to at 6.2(a), (b), (f) and (g) of the Module Descriptors 6A guideline, an OH&S data package for reduced assessment may include submission of the following data or submission of valid scientific argument:
Hazard:

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

Exposure:

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

Risk characterisation

  • Margin of exposure (MOE)
  • Further requirements where the MOE is inadequate
  • Risk assessment proposed by the applicant (acute and repeat dose)

Risk management and workplace information

  • Measures to control occupational and public or domestic risks
  • Before and during end-use
  • Re-handling
  • Proposed label wording
  • Safety data sheet (SDS)
  • Training requirements
  • Occupational exposure monitoring
  • Exposure standard
  • Ambient air monitoring
  • Health surveillance
  • Contraindications

Risk assessment:

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

Module 6.3

For applications referred to at 6.3(a) and (d) of the Module Descriptors 6A guideline, an OH&S data package for limited assessment may include submission of the following data or submission of valid scientific argument:
Hazard:

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

Exposure:

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

Risk management and workplace information:

  • Measures to control occupational and public or domestic risks
  • Before and during end-use
  • Re-handling
  • Proposed label wording
  • Safety data sheet (SDS)
  • Training requirements
  • Occupational exposure monitoring
  • Exposure standard
  • Ambient air monitoring
  • Health surveillance
  • Contraindications

For applications referred to at 6.3(b) of the Module Descriptors 6A guideline, an OH&S data package for limited assessment may include submission of the following data or submission of valid scientific argument:
Hazard:

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

Exposure:

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

Risk management and workplace information:

  • Measures to control occupational and public or domestic risks
  • Before and during end-use
  • Re-handling
  • Proposed label wording
  • Safety data sheet (SDS)
  • Training requirements
  • Occupational exposure monitoring
  • Exposure standard
  • Ambient air monitoring
  • Health surveillance
  • Contraindications

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Environment

Detailed data guidelines for environment are in Part 7

Module 7.1, 7.2 and 7.3

For applications referred to at 7.1(c), 7.2 and 7.3(b), (c) and (d) of the Module Descriptors 6A guideline, an environment data package for comprehensive, reduced or limited assessment may include submission of the following studies or submission of valid scientific argument.
Environmental chemistry and fate

  • physical and chemical properties of the active constituent (solubility in water, vapour pressure, low Kow, dissociation constant, UV-visible absorption)
  • rate and route of degradation
  • abiotic degradation (hydrolysis, soil photolysis, aqueous photolysis)
  • biodegradation under aerobic and anaerobic conditions in soil and water/sediment systems
  • mobility (volatility, adsorption/desorption, leaching potential)
  • field accumulation/ dissipation (terrestrial, aquatic)

Environmental toxicology

  • Terrestrial vertebrates
  • Acute, dietary and reproductive toxicity to birds
  • Acute and long-term toxicity to mammals
  • Aquatic life
  • Acute toxicity to fish, microcrustacea and algae
  • Chronic toxicity to aquatic organisms depending on persistence in water
  • Toxicity to sediment-dwelling invertebrates depending on partitioning and persistence in sediment
  • Bioaccumulation in fish depending on bioconcentration potential
  • Bees and other non-target arthropods
  • Acute oral and contact toxicity to bees
  • Bee brood feeding test for insect growth regulators
  • Contact toxicity to predatory and parasitic arthropods
  • Earthworms and other soil macro-invertebrates
  • Acute toxicity to earthworms
  • Chronic toxicity to earthworms and other macro-invertebrates depending on persistence in soil
  • Soil microbial processes (impact on nitrogen transformation and carbon mineralisation)
  • Non-target vegetation (seedling emergence and vegetative vigour)
Note

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 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;
  • where a major change in non-active constituent significantly affects the environmental fate, ecotoxicity 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).

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Efficacy and host animal safety

Detailed data guidelines for efficacy and safety are in Part 8

Module 8.1

For applications referred to at 8.1(a), (c), (e) and (f) of the Module Descriptors 6A guideline, an efficacy and host animal safety data package for comprehensive assessment may include submission of the following data or submission of valid scientific argument:

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)

Module 8.2

For applications referred to at 8.2(b)(1), (2) and (3) and 8.2(e)(2) and (3) [for 8.2(e)(1) see below] of the Module Descriptors 6A guideline, an efficacy and host animal safety data package for reduced assessment may include submission of the following data or submission of valid scientific argument:

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

For applications referred to at 8.2(e)(1), of the Module Descriptors 6A guideline, an efficacy and host animal safety data package for reduced assessment may include submission of the following data or submission of valid scientific argument:

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

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

Module 8.3(b) and (c)

For applications referred to at 8.3(b) and (c) of the Module Descriptors 6A guideline, an efficacy and host animal safety data package for limited assessment may include submission of the following data or submission of valid scientific argument:

Efficacy studies

  • target animal efficacy studies to demonstrate comparable efficacy with the registered reference product where the only study is:
  • blood/plasma level bioequivalence; or
  • measurement of biological effect; or
  • clinical studies; or
  • pharmaceutical equivalence

Target animal safety studies

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

Module 8.3(d) and (h)

For applications referred to at 8.3(d) and (h) of the Module Descriptors 6A guideline, an efficacy and host animal safety data package for limited assessment may include submission of the following data or submission of valid scientific argument:

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

Module 8.2(e), (f) and (j)

For applications referred to at 8.2(e), (f) and (j) of the Module Descriptors 6A guideline, an efficacy and host animal safety data package for limited assessment may include submission of the following data or submission of valid scientific argument:

Efficacy studies

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

Target animal safety studies

  • topical studies, inhalation studies, tissue irritation studies;
  • adverse experiences
Notes
Demonstration of comparable efficacy

For applications where demonstration of comparable efficacy with another product is by in vitro dissolution, an efficacy and host animal safety data package may include submission of in vitro comparative dissolution studies and/or scientific argument relating to efficacy.

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 will be assessed.  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.

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).

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Module 9 Non-food trade

For applications referred to at 9(1) of the Module Descriptors 6A guideline, data specifically relevant to the trade risk may be submitted.

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Module 10 Antibiotic resistance

Detailed data guideline information is in Antibiotic resistance and Antibiotic resistance risk assessments

Module 10.1

For applications referred to at 10.1(1) and (2) of the Module Descriptors 6A guideline, a special data package for comprehensive assessment of antimicrobial resistance may include submission of the following data or submission of valid scientific argument:

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

Module 10.2

For applications referred to at 10.2(a) and (b) of the Module Descriptors 6A guideline, a special data package for reduced assessment of antimicrobial resistance may include submission of information that addresses changes in risk associated with the proposed use or submission of valid scientific argument:

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

Module 10.3 GM organism / other special data

For applications referred to at 10.3(a) of the Module Descriptors 6A guideline, 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.5A, B, C and D of the Agvet Code, may be submitted.

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