The following document 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.

Chemistry

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

Chemistry 1

For applications referred to at Chemistry 1 of the Module Descriptors, a chemistry data package 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
  • functions of constituents in the formulation
  • concentrations of constituents in the formulation
  • overages
  • manufacturing process
  • quality control
  • product specifications
  • batch analysis
  • stability data (including low temperature and photostability data where relevant)
  • in-use stability data (where relevant)
  • analytical procedures
  • validation data
  • packaging

Chemistry 2

Chemistry 2(a)(1) – a new biological active constituent

For applications referred to at Chemistry 2(a)(1) of the Module Descriptors, a chemistry data package for 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
  • functions of constituents in the formulation
  • concentrations of constituents in the formulation
  • overages
  • manufacturing process
  • quality control
  • product specifications
  • batch analysis
  • stability data (including low temperature and photostability data where relevant)
  • in-use stability data (where relevant)
  • analytical procedures
  • validation data
  • packaging

Chemistry 2(a)2 and (a)3 – immunobiologicals

For applications referred to at Chemistry 2(a)2 and (a)3 of the Module Descriptors, a chemistry data package 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

Chemistry 2(a)4 and (a)5

For applications referred to at Chemistry 2(a)4 or (a)5 (new direct fed microbial products or new enzyme products) of the Module Descriptors, a chemistry data package 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

Chemistry 2(a)6 – new herbal product

For applications referred to at Chemistry 2(a)6 (new herbal product) of the Module Descriptors, a chemistry data package 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 (including low temperature and photostability data where relevant)
  • analytical procedures
  • validation data
  • packaging

Chemistry 2(b) – permit for an unregistered product containing a new active constituent

For applications referred to at Chemistry 2(b) of the Module Descriptors, a chemistry data package for 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

Permit (for the end-use 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 (including low temperature and photostability data where relevant)
  • in-use stability data (where relevant)
  • analytical procedures
  • validation data
  • packaging

Chemistry 3(a) and(b)

For applications referred to at Chemistry 3(a) or (b) of the Module Descriptors, a chemistry data package for product-only assessment may include submission of the following data or submission of valid scientific argument:

Product/permit
  • 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 (including low temperature and photostability data where relevant)
  • in-use stability data (where relevant)
  • analytical methods
  • 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)

Chemistry 3(c) – new manufacturing source of an approved active constituent

For applications referred to at Chemistry 3(c) of the Module Descriptors, a chemistry data package may include submission of the following data or submission of valid scientific argument:

Active constituent
  • identification (ISO common name, IUPAC chemical name, molecular and structural formula, confirmation of identity through at least 2 spectral or chromatographic methods)
  • manufacturer(s) name and physical address(es) of the site(s) of manufacture
  • manufacturing process (including quality control, reaction scheme, and details of impurities (description of their formation and structures))
  • manufacturer’s specifications
  • batch analysis data (for at least 3 batches)
  • analytical methods
  • validation data

Chemistry 3(d)

For applications referred to at Chemistry 3(d) of the Module Descriptors, a chemistry data package may include submission of the following data or submission of valid scientific argument:

Variation of an active constituent
  • identification (ISO common name, IUPAC chemical name, molecular and structural formula, confirmation of identity through at least 2 spectral or chromatographic methods)
  • manufacturer(s) name and physical address(es) of the site(s) of manufacture
  • manufacturing process (including quality control, reaction scheme, and details of impurities (description of their formation and structures))
  • manufacturer’s specifications
  • batch analysis data (for at least 3 batches)
  • analytical methods
  • validation data

Chemistry 3(e) – product formulation change or additional formulation

For applications referred to at Chemistry 3(e) of the Module Descriptors, a chemistry data package 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 (including low temperature and photostability data where relevant)
  • analytical procedures
  • validation data

Chemistry 4

Chemistry 4(a) – product variation to change shelf-life, in-use shelf-life, net contents or storage conditions

For applications referred to at Chemistry 4(a) of the Module Descriptors, a chemistry data package may include submission of the following data or submission of valid scientific argument:

  • product specifications
  • stability data
  • in-use stability data
  • analytical methods
  • validation data
  • packaging details
  • draft oversticker/label

For applications for variations to chemistry and manufacture of immunobiological products (excluding changes to the active constituents) referred to Chemistry 4(a) of the Module Descriptors, a chemistry data package may include submission of the following data or submission of valid scientific argument:

Product/permit
  • 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.

Chemistry 4(b) – variation of an active constituent

For applications referred to at Chemistry 4(b) of the Module Descriptors, a chemistry data package may include submission of the following data or submission of valid scientific argument:

  • batch analysis data
  • analytical methods
  • validation data.

Chemistry 5

Chemistry 5(a) – autogenous vaccines

For applications referred to at Chemistry 5(a) of the Module Descriptors, the APVMA guideline for autogenous vaccine permits is available on the APVMA website.

Chemistry 5(b)

For applications referred to at Chemistry 5(a) of the Module Descriptors, a chemistry data package may include submission of the following data or submission of valid scientific argument:

  • 3 certificates of analysis generated within the previous 2 years and confirming compliance with the British, European or United States Pharmacopoeia, as well as other relevant guidelines such as VICH GL18 or ICH Q3D.

Health

Detailed data guidelines for health are available in Part 3.

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

Health 1

For applications referred to at Health 1 of the Module Descriptors, a toxicology data and an OH&S data package may include submission of the following data or submission of valid scientific argument:

Toxicology

  • 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 adverse effect level (NOAEL)
  • acceptable daily intake (ADI)
  • acute reference dose (ARfD)
  • first aid instructions and safety directions
  • toxicological database/bibliography

Hazard characterisation

  • physical and chemical properties
  • toxicity
  • active constituent
  • product
  • individual constituents

Risk characterisation

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

Exposure assessment

  • mixing and loading
  • product application
  • re-handling or re-entry
  • public and/or bystander exposure
  • dermal absorption

Risk management and workplace information

  • measures to control user exposure:
    • before and during end-use
    • re-entry or re-handling
  • measures to control public and bystander exposure:
    • during end-use
    • re-entry or re-handling
  • other restrains and restrictions of use
  • product label
  • Material Safety Data Sheet (MSDS)
  • training requirements
  • occupational exposure monitoring
  • exposure standard
  • ambient air monitoring
  • health surveillance
  • tank mixing
  • contraindications

Health 2

For applications referred to at Health 2 of the Module Descriptors, a toxicology data package assessment may include submission of the following data or submission of valid scientific argument:

Toxicology

  • chemistry and manufacture (data Part 2)
  • 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)
  • sub-chronic toxicity studies (repeat dose)
  • long-term (chronic) toxicity studies (repeat dose):
    • chronic toxicity studies
    • carcinogenicity studies
    • combined chronic toxicity and carcinogenicity studies
  • reproduction studies
  • developmental studies (including developmental neurotoxicity)
  • genotoxicity studies
  • neurotoxicity studies
  • toxicity of metabolites and impurities
  • other adverse effects
  • toxicity of mixtures
  • mechanistic studies and mode of action
  • immunotoxicity
  • human toxicological data
  • NOAEL
  • ADI
  • ARfD
  • first aid instructions and safety directions
  • toxicological database/bibliography

Health 3

Health 3(a) and (b)

For applications referred to at Health 3(a) and (b) of the Module Descriptors, a toxicology data package may include submission of the following data or submission of valid scientific argument:

Toxicology:
  • chemistry and manufacture (data Part 2)
  • 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
  • toxicity of metabolites and impurities
  • other adverse effects
  • toxicity of mixtures
  • mechanistic studies and mode of action
  • immunotoxicity
  • human toxicological data
  • first aid instructions and safety directions
  • toxicological database/bibliography

Health 3(a)

For applications referred to at Health 3(a) of the Module Descriptors, in addition to the above listed studies for toxicology, an OH&S data package may include submission of the following data or submission of valid scientific argument:

Hazard characterisation
  • physical and chemical properties
  • toxicity:
    • active constituent
    • product
    • individual constituents
  • first aid instructions and safety directions
Risk characterisation
  • NOAEL
  • MOE
  • further requirements where the MOE is inadequate
  • risk assessment proposed by the applicant (acute and repeat dose).
Exposure assessment
  • mixing and loading
  • product application
  • re-handling
  • public and/or bystander exposure
  • dermal absorption.
Risk management and workplace information
  • measures to control user exposure:
    • before and during end-use
    • re-handling
  • measures to control public and bystander exposure:
    • during end-use
    • re-handling
  • other restrains and restrictions of use
  • product label
  • MSDS
  • training requirements
  • occupational exposure monitoring
  • exposure standard
  • health surveillance
  • contraindications.

Health 3(c)

For applications referred to at Health 3(c) of the Module Descriptors, in addition to submission of the OH&S data package listed above (Health 3(a)), or submission of valid scientific argument, the following data may be included:

Toxicity
  • long-term (chronic) toxicity studies (12 months or longer):
    • chronic toxicity studies
    • carcinogenicity studies
    • combined chronic toxicity and carcinogenicity studies
  • reproduction studies
  • ADI
  • ARfD.

Health 3(d)

For applications referred to at Health 3(d) of the Module Descriptors, in addition to submission of the OH&S data package listed above (Health 3(a)), or submission of valid scientific argument, the following data may be included:

Toxicology
  • chemistry and manufacture (data Part 2)
  • 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)
  • sub-chronic toxicity studies (repeat dose)
  • long-term (chronic) toxicity studies (repeat dose)
  • chronic toxicity studies:
    • carcinogenicity studies
    • combined chronic toxicity and carcinogenicity studies
  • reproduction studies
  • developmental studies (including developmental neurotoxicity)
  • genotoxicity studies
  • neurotoxicity studies
  • toxicity of metabolites and impurities
  • other adverse effects
  • toxicity of mixtures
  • mechanistic studies and mode of action
  • immunotoxicity
  • human toxicological data
  • NOAEL
  • ADI
  • ARfD.

Health 4

Health 4(a)

For applications referred to at Health 4(a) of the Module Descriptors, a toxicology and an OH&S data package may include submission of the following data or submission of valid scientific argument:

Toxicology
  • chemistry and manufacture (data Part 2)
  • metabolism/kinetic studies
  • acute toxicity studies on a product or data on individual constituents in the formulation
  • genotoxicity
  • short-term studies (route depending on likely source/s of human exposure)
  • sub-chronic toxicity studies by an appropriate route
  • reproduction studies
  • human exposure data
  • additional genotoxicity studies
  • other studies to determine special forms of toxicity
  • and if applicable, for establishing an ADI/ARfD:
    • long-term (chronic) toxicity studies (12 months or longer):
      • chronic toxicity studies
      • carcinogenicity studies
      • combined chronic toxicity and carcinogenicity studies
  • developmental studies (may include developmental neurotoxicity)
  • neurotoxicity studies
  • toxicity of metabolites and impurities
  • toxicological database/bibliography.
Hazard characterisation
  • toxicity
  • active constituent
  • product
  • first aid instructions and safety directions.
Risk characterisation
  • NOAEL
  • MOE
  • further requirements where the MOE is inadequate
  • risk assessment proposed by the applicant (acute and repeat dose).
Exposure assessment
  • mixing and loading
  • product application
  • re-handling or re-entry
  • public and/or bystander exposure
  • dermal absorption
Risk management and workplace information
  • measures to control user exposure:
    • before and during end use
    • re-entry or re-handling
  • measures to control public and bystander exposure:
    • during end-use
    • re-entry or re-handling
  • other restrains and restrictions of use
  • product label
  • MSDS
  • training requirements
  • contraindications.

Health 4(b)

For applications referred to at Health 4(b) of the Module Descriptors, a toxicology and an OH&S data package may include submission of the following data or submission of valid scientific argument:

Toxicity
  • chemistry and manufacture (data Part 2)
  • acute toxicity studies on a product or data on individual constituents in the formulation.
Hazard characterisation
  • physical and chemical properties
  • toxicity:
    • active constituent
    • product
  • first aid instructions and safety directions.
Risk characterisation
  • NOAEL
  • MOE
  • further requirements where the MOE is inadequate
  • risk assessment proposed by the applicant (acute and repeat dose).
Exposure assessment
  • mixing and loading
  • product application
  • re-handling
  • public and/or bystander exposure
  • dermal absorption.
Risk management and workplace information
  • measures to control user exposure:
    • before and during end-use
    • re-handling
  • measures to control public and bystander exposure:
    • during end-use
    • re-handling
  • other restrains and restrictions of use
  • product label
  • MSDS
  • training requirements
  • occupational exposure monitoring
  • exposure standard
  • health surveillance
  • contraindications.

Health 4(b)1

For applications referred to at Health 4(b)1 of the Module Descriptors, in addition to the submission of the toxicity and OH&S data above for Health 4(b), a toxicology data on the active constituent for limited assessment may include submission of the following data or submission of valid scientific argument:

Toxicity
  • long-term (chronic) toxicity studies (12 months or longer):
    • chronic toxicity studies
    • carcinogenicity studies
    • combined chronic toxicity and carcinogenicity studies
  • reproduction studies
  • developmental studies
  • neurotoxicity studies
  • ADI
  • ARfD
  • justification for rescheduling
  • toxicological database/bibliography.

Health 4(c)

For applications referred to at Health 4(c) of the Module Descriptors, toxicity studies and an OH&S data package may include submission of the following data, or submission of valid scientific argument, the following data may be included:

Toxicity
  • metabolism/kinetic studies
  • acute toxicity studies:
    • active constituent
    • product
  • genotoxicity
  • short-term toxicity studies (repeat-dose)
  • sub-chronic toxicity studies by an appropriate route
  • chronic toxicity/oncogenicity studies
  • developmental studies
  • reproduction studies
  • human exposure data
  • other studies to determine special forms of toxicity (ie mode of action).
Hazard characterisation
  • physical and chemical properties
  • toxicity:
    • active constituent
    • product
  • first aid instructions and safety directions.
Risk characterisation
  • NOAEL
  • MOE
  • further requirements where the MOE is inadequate
  • risk assessment proposed by the applicant (acute and repeat dose).
Exposure assessment
  • mixing and loading
  • product application
  • re-handling
  • public and/or bystander exposure
  • dermal absorption.
Risk management and workplace information
  • measures to control user exposure
    • before and during end use
    • re-handling
  • measures to control public and bystander exposure:
    • during end-use
    • re-handling
  • other restrains and restrictions of use
  • product label
  • MSDS
  • training requirements
  • contraindications

More information for Health 4 level applications can be obtained from the APVMA Guideline for the Regulation of Biological Agricultural Products.

Health 5

Health 5(a)

For applications referred to at Health 5(a) of the Module Descriptors, toxicity studies and an OH&S data package may include submission of the following data or submission of valid scientific argument:

Toxicity
  • acute toxicity studies on a product or data on individual constituents in the formulation.
Hazard characterisation
  • physical and chemical properties (data Part 2)
  • toxicity
  • active constituent
  • product
  • first aid instructions and safety directions.
Risk characterisation
  • risk assessment proposed by the applicant (acute and repeat dose).
Risk management and workplace information
  • measures to control user exposure:
    • before and during end use
    • re-handling
  • measures to control public and bystander exposure:
    • during end-use
    • re-handling
  • other restrains and restrictions of use
  • product label
  • MSDS
  • training requirements
  • contraindications.

Health 5(b)

For applications referred to at Health 5(b) of the Module Descriptors, an OH&S data package may include submission of the following data or submission of valid scientific argument:

Hazard characterisation
  • physical and chemical properties (data Part 2)
  • toxicity
  • product.
Risk management and workplace information
  • first aid instructions and safety directions
  • other restrains and restrictions of use
  • product label
  • MSDS
  • training requirements
  • contraindications.

Health 5(c)

For applications referred to at Health 5(c) of the Module Descriptors, an OH&S data package may include submission of the following data or submission of valid scientific argument:

Risk characterisation
  • NOAEL
  • MOE
  • further requirements where the MOE is inadequate
  • risk assessment proposed by the applicant (acute and repeat dose).
Exposure assessment
  • mixing and loading
  • product application
  • re-handling
  • public and/or bystander exposure
  • dermal absorption.
Risk management and workplace information
  • measures to control user exposure:
    • before and during end use
    • re-handling
  • measures to control public and bystander exposure:
    • during end-use
    • re-handling
  • other restrains and restrictions of use
  • product label
  • MSDS
  • training requirements
  • contraindications.

Health 6

For applications referred to at Health 6 of the Module Descriptors, a toxicity data package may include submission of the following data or submission of valid scientific argument:

Toxicity

  • in silico (computational) analysis on genotoxicity, including a rules-based method and a statistically-based method
  • in vivo genotoxicity
  • in vitro genotoxicity

More information for Health 6 level applications are available on the APVMA website:

Poisons 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 National Drugs and Poisons Scheduling Committee for poisons scheduling. Data relevant to scheduling is covered by health modules Health 1, Health 2 or Health 3.

Residues

Detailed data guidelines for residues are in Part 5A.

Detailed data guidelines for trade are in Part 5B.

Residues 1

For applications referred to at Residues 1 of the Module Descriptors, a residues data package may include submission of the following data and/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)

Residues 2

For applications referred to at Residues 2 of the Module Descriptors, a residues data package may include submission of the following data and/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)

Residues 3

For applications referred to at Residues 3 of the Module Descriptors, a residues data package may include submission of the following data and/or submission of valid scientific argument:

  • 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 4

For applications referred to at Residues 4 of the Module Descriptors, a residues data package may include submission of the following data and/or submission of valid scientific argument:

  • residues trial data
  • analytical methodology.

Residues 5

For applications referred to at Residues 5 of the Module Descriptors, a residues data may include reference to previously submitted residues trial data, published residues information and/or valid scientific argument as well as residues-in-trade information and risk mitigation strategies.

Environment

Detailed data guidelines for environment are in Part 7

Environment 1

For applications referred to at Environment 1 of the Module Descriptors, an environment data package 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)
  • Abiotic degradation (hydrolysis, photolysis)
  • Biodegradation under aerobic and anaerobic conditions in soil and water/sediment systems
  • Mobility (adsorption/desorption, leaching potential)

Environmental toxicology

  • Acute toxicity to fish, Daphnia, and algae
  • Chronic toxicity to fish, Daphnia, and sediment-dwellers
  • Bioconcentration in fish
  • Dung fly and beetle tests
  • Chronic toxicity to earthworms
  • Soil microbial processes (impact on nitrogen transformation)
  • Non-target terrestrial plants (seedling emergence)

Environment 2

For applications referred to at Environment 2 of the Module Descriptors, an environment data package may reference data holdings and/or previous assessments, provided there are no limits on use of information.

Environment 3

For applications referred to at Environment 3 of the Module Descriptors, an environment data package may include submission of information as indicated in Environment 1.

Environment 4

For applications referred to at Environment 4 of the Module Descriptors, an environment data package may include submission of the following information, where relevant.

  • Natural occurrence of active constituent (if relevant)
  • Description of production system and rearing conditions (e.g. intensive, pasture, confined)
  • Treated fraction of flock or herd
  • Metabolism in treated animal
  • Treatment of aquaculture effluent (e.g. filtration, settlement, dilution) or terrestrial waste matrix (e.g. incineration, storage, land application).

Efficacy and safety

Detailed data guidelines for efficacy and safety are in Part 8

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

For applications referred to at 8.2(e), (f) and (j) of the Module Descriptors, 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
  • measurement of biological effect
  • clinical studies
  • pharmaceutical equivalence
  • target animal efficacy studies
  • confirmatory clinical/field studies.
Target animal safety studies
  • topical studies, inhalation studies, tissue irritation studies
  • adverse experiences

Module 8.3(b) and (c)

For applications referred to at 8.3(b) and (c) of the Module Descriptors, 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
    • measurement of biological effect
    • clinical studies
    • 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, 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)
  • 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.

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.

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.

Non-food trade

For applications referred to at Non-food trade of the Module Descriptors, data specifically relevant to the trade risk may be submitted.

Special data

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

Special data 1

For applications for registration of a new product or approval of a permit for a product containing a new antibiotic active constituent, 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.

Special data 2

For applications referred to at Special data 2 of the Module Descriptors, a special data package for 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.

Special data 3

For applications referred to at Special data 3 of the Module Descriptors, published data and results of Australian field trials, relevant to the criteria for registration or variation of a product described in s.5A, B, C and D of the Agvet Code, may be submitted.

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