Skip to main content
  • About
  • Online Services Portal (Opens in a new tab/window)
  • News, forms and publications
  • Contact us
Australian Pesticides and Veterinary Medicines Authority logo Australian Pesticides and Veterinary Medicines Authority logo
  • Registrations and permits
    Registrations and permits
    • Search products and permits
      Search products and permits
      • Search PubCRIS (Opens in a new tab/window)
      • Using PubCRIS
    • Chemical product registration
      Chemical product registration
      • Applying for approvals, registrations and variations
      • Applying for a label approval
      • Which products/chemicals require registration
        Which products/chemicals require registration
        • Does my veterinary product need to be registered?
          Does my veterinary product need to be registered?
          • User guide: what is or isn't a veterinary product?
            User guide: what is or isn't a veterinary product?
            • Animal cosmetic products
              Animal cosmetic products
              • Excluded animal cosmetic products – acceptable cosmetic messages
            • Animal feed products
              Animal feed products
              • Acceptable nutritional messages
              • Feed supplements – acceptable nutritional messages
              • Other requirements for whole unprocessed animal tissue
            • Devices, equipment and physical barrier products
            • Other products that don't require registration
          • Registration self-assessment tool (veterinary)
        • Does my agricultural product need to be registered?
        • Stockfeed and petfood regulation
          Stockfeed and petfood regulation
          • END product FAQs
        • Novel products
        • Arrangements for products of low regulatory concern
          Arrangements for products of low regulatory concern
          • Registration models
            Registration models
            • Oral electrolyte products for the treatment of horses in exercise
          • Reserved chemical products
          • Listed chemical product
        • Substances not permitted for use on food-producing animals in Australia
        • Lures and attractants
      • Before you apply
        Before you apply
        • About the approval and registration process
        • Who can apply
        • Restricted chemical products
        • Conditions of approval or registration and label approval
        • Minor variations
        • The risk analysis process
        • Timeframes and fees
        • Interchangeable Constituent Determination – Item 29
      • What to include in your application
        What to include in your application
        • Data guidelines
        • Guidance for preparing information lists
        • Dossiers
        • Required information
        • Statutory criteria
          Statutory criteria
          • Active constituent
          • Chemical product
          • Satisfying the statutory criteria
        • Providing evidence of GMP
        • Guidance for applicants – submission of international data, standards and assessments
          Guidance for applicants – submission of international data, standards and assessments
          • Accepted international data and standards
          • International and other national assessments
          • How to submit an international assessment
          • What happens once I submit my overseas/international assessment?
      • Guide to completing an online application
        Guide to completing an online application
        • Online Services Portal
        • Decision tree
        • Identification, applicant and nominated agent details
        • Data and information lists
          Data and information lists
          • Using the information list editor
        • Access to information
        • Formulation
        • Manufacturing
        • Packaging and storage
        • Labels
        • Submitting an application
        • Submitting third party information
      • After you apply
        After you apply
        • Preliminary assessment process
          Preliminary assessment process
          • Preliminary assessment guideline
        • Altering applications
        • Requiring additional information
        • Requiring samples to be given for analysis
        • Extended assessment period and maximum response period
        • Requesting information from applicants
      • Primary and secondary applications
      • Renew a registration
      • Technical policy
      • After registration
        After registration
        • Changes to products and actives
          Changes to products and actives
          • Annual returns
            Annual returns
            • Annual returns – FAQs
          • Holders to notify the APVMA of new information
        • Levies charged on chemical products
          Levies charged on chemical products
          • Declaration of leviable values
          • Notice of levy calculation
      • APVMA Permit-to-label project
        APVMA Permit-to-label project
        • Permit-to-label project background
    • Applying for permits
      Applying for permits
      • Before you apply
        Before you apply
        • About the application process
        • Types of permits
          Types of permits
          • Export, research and miscellaneous permits
          • Minor use and emergency permits
            Minor use and emergency permits
            • Guide for determining emergency uses or research purposes
            • Guide for determining minor uses
        • Who can apply
        • Timeframes and fees
        • Ability to comply with conditions
      • What to include in your application
        What to include in your application
        • Required information
        • Statutory criteria
        • Labelling requirements
      • After you apply
        After you apply
        • What happens next
        • Requiring samples or further information
      • Extend the duration of a permit
      • Search for a permit
    • Data guidelines
      Data guidelines
      • Agricultural data guidelines
        Agricultural data guidelines
        • Adopted international technical guidance material
        • Chemistry and manufacture (Part 2)
          Chemistry and manufacture (Part 2)
          • Generation of storage stability data for agricultural chemical products
        • Toxicology (Part 3)
        • Metabolism and kinetics (Part 4)
        • Residues (Part 5A)
          Residues (Part 5A)
          • Specific guidelines
        • Overseas trade (Part 5B)
        • Occupational health and safety (Part 6)
        • Environment (Part 7)
          Environment (Part 7)
          • Roadmap for insect pollinator risk assessments in Australia
        • Pesticides efficacy and crop safety general guideline (Part 8)
          Pesticides efficacy and crop safety general guideline (Part 8)
          • Specific guidelines
        • Special data (Part 10) - Products of gene technology
        • Special data (Part 10) – Products of nanotechnology
        • Guideline for the regulation of biological agricultural products
        • Guidance on assessment and registration of anti-fouling paints
        • Relevant data for module levels – agricultural chemical products
      • Veterinary data guidelines
        Veterinary data guidelines
        • Adopted international technical guidance material
        • Chemistry and manufacture (Part 2)
          Chemistry and manufacture (Part 2)
          • Chemistry and manufacture of active constituents (Part 2)
            Chemistry and manufacture of active constituents (Part 2)
            • Approval of active constituents for which information is not readily available
          • Chemistry and manufacture of products (Part 2)
          • Additional data guidelines for chemistry and manufacture (Part 2)
        • Toxicology (Part 3)
        • Metabolism and kinetics (Part 4)
          Metabolism and kinetics (Part 4)
          • Comparative metabolism studies, selection of marker residues and ratios of marker residues to total residues
        • Residues (Part 5A)
          Residues (Part 5A)
          • Specific guidelines
        • Overseas trade (Part 5B)
          Overseas trade (Part 5B)
          • Veterinary drug residues in food commodities and overseas trade
        • Occupational health and safety (Part 6)
        • Environment (Part 7)
        • Efficacy and target animal safety general guideline (Part 8)
        • Special data (Part 10)
        • Specific guidelines
        • Relevant data for module levels – veterinary chemical products
        • Guidelines for data to support efficacy and safety of teat disinfectants
      • Crop Groups
        Crop Groups
        • What is crop grouping?
        • Crop groupings project – consolidated responses to phase one consultation
          Crop groupings project – consolidated responses to phase one consultation
          • NWPGP grain industry comments
      • Module descriptors
      • Risk assessment manuals
    • Labelling Codes
      Labelling Codes
      • Agricultural Labelling Code
      • Veterinary Labelling Code
        Veterinary Labelling Code
        • Specific labelling requirements
          Specific labelling requirements
          • Anthelmintics for dogs and cats
          • Anthelmintics for horses
          • Anthelmintics for sheep, goats and cattle
          • Anti-inflammatories
          • Antibiotics
          • Complementary animal health products
          • Ectoparasiticides for dogs and cats
          • Ectoparasiticides for sheep and goats
          • Euthanasiates
          • Hormonal growth promotants
          • Immunobiological products (veterinary vaccines, antisera, biologicals)
          • Intramammary preparations
          • Intraruminal products
          • Non-prescription injectable products
          • Products containing minerals
          • Products for application to wounds
          • Professional packs of oral non-prescription products
          • Stomach tubing products
          • Teat dips and sprays
          • Therapeutic pet food products
        • Preparing a label and approval process
        • Label content
          Label content
          • General labelling requirements
          • Anthelmintics for dogs and cats
          • Anthelmintics for horses
          • Anthelmintics for sheep, goats and cattle
          • Anti-inflammatories
          • Antibiotics
          • Complementary animal health products
          • Ectoparasiticides for dogs and cats
          • Ectoparasiticides for sheep and goats
          • Euthanasiates
          • Hormonal growth promotants
          • Immunobiological products (veterinary vaccines, antisera, biologicals)
          • Intramammary preparations
          • Intraruminal products
          • Non-prescription injectable products
          • Products containing minerals
          • Products for application to wounds
          • Professional packs of oral non-prescription products
          • Stomach tubing products
          • Teat dips and sprays
          • Therapeutic pet food products
        • Label presentation and layout
          Label presentation and layout
          • Information required on labels
          • Label layout
          • Printing and legibility requirements
        • Additional guidance
          Additional guidance
          • Globally harmonized system of classification and labelling
          • Promotional and display packs
          • Individual, multi- and variable dose forms
          • QR codes in the labelling and/or package leaflet
          • Removable labels for small single-dose veterinary vaccines
          • Professional packs of oral non-prescription veterinary products
      • Globally harmonized system of classification and labelling
    • Import and export
      Import and export
      • Importing agricultural chemicals or veterinary medicines
      • Export permits
      • Export certificates
        Export certificates
        • Before you apply
          Before you apply
          • About the application process
          • Timeframes and fees
          • Who can apply
          • Common types of certificates
        • What to include in your application
          What to include in your application
          • Information to be provided with a request for a section 70 certificate
      • Consent to import chemical products
    • Holders and nominated agents
      Holders and nominated agents
      • Change a holder or nominated agent
        Change a holder or nominated agent
        • Timeframes and fees for changing a holder or nominated agent
      • Definition of roles and actions for holders, nominated and authorised agents and authorising parties
    • Other government requirements
      Other government requirements
      • Drinking water guidelines – pesticides
    • Limits on use and disclosure of information
      Limits on use and disclosure of information
      • Limitation periods
      • Information lists
      • Authorising party
    • Application guidance
      Application guidance
      • I want to register a new product with an existing active or new combination of approved actives
        I want to register a new product with an existing active or new combination of approved actives
        • I want to register a new agricultural product with an existing active or new combination of approved actives
        • I want to register a new veterinary product with an existing active or new combination of approved actives
      • I want to register a new product that contains a new active constituent
        I want to register a new product that contains a new active constituent
        • I want to register a new agricultural product that contains a new active constituent – full assessment (Item 1)
        • I want to register a new agricultural product that contains a new active constituent – less than a full assessment (Item 2)
        • I want to register a new veterinary product that contains a new active constituent (Item 2)
      • I want to register a product that is based on an existing registered reference product
        I want to register a product that is based on an existing registered reference product
        • I want to register an agricultural product that is similar to a registered reference product and efficacy and safety and chemistry and manufacture data is required (Item 5)
        • I want to register an agricultural product that is closely similar to a registered reference product and chemistry data is required (Item 6)
        • I want to register an agricultural product that is closely similar to a registered reference product – no further data required (Item 7)
        • I want to register a veterinary product that is based on an existing registered reference product and similar efficacy, safety, chemistry and manufacture data is required (Item 5)
        • I want to register a veterinary product that is based on an existing registered reference product and is closely similar and only chemistry data is required (Item 6)
        • I want to register a veterinary product that is based on an existing registered reference product and is closely similar and data is not required (Item 7)
      • I want to register a product that is the same as a reference product
        I want to register a product that is the same as a reference product
        • I want to register an agricultural product that is the same as a reference product (Item 8)
        • I want to register a veterinary product that is the same as a reference product (Item 8)
      • I want to register a product and apply for the concurrent approval of a new source of active
      • I want to register or vary a product and I need information on spray drift assessment and labelling
      • I want an additional marketing name for my existing registered product
        I want an additional marketing name for my existing registered product
        • I want an additional marketing name for my existing registered agricultural product
        • I want an additional marketing name for my existing registered veterinary product
      • I want to vary my product to amend a restraint, contraindication, precaution or side effect statement (vet products only)
        I want to vary my product to amend a restraint, contraindication, precaution or side effect statement (vet products only)
        • I want to vary my product to amend a restraint, contraindication, precaution or side effect statement (vet products only) and no technical assessment is required (Item 12)
        • I want to vary my product to amend a restraint, contraindication, precaution or side effect statement (vet products only) and a technical assessment is required (Item 14)
      • I want to vary my product to alter the shelf life/expiry date, in-use shelf life and/or storage conditions
        I want to vary my product to alter the shelf life/expiry date, in-use shelf life and/or storage conditions
        • I want to vary my agricultural product to alter the shelf life/expiry date, in-use shelf life and/or storage conditions
          I want to vary my agricultural product to alter the shelf life/expiry date, in-use shelf life and/or storage conditions
          • I want to vary my agricultural product to alter the shelf life/expiry date, in-use shelf life and/or storage conditions and no technical assessment is required (Item 12)
          • I want to vary my agricultural product to alter the shelf life/expiry date, in-use shelf life and/or storage conditions and a technical assessment is required (Item 14)
        • I want to vary my veterinary product to alter the shelf life/expiry date, in-use shelf life and/or storage conditions
          I want to vary my veterinary product to alter the shelf life/expiry date, in-use shelf life and/or storage conditions
          • I want to vary my veterinary product to alter the shelf life/expiry date, in-use shelf life and/or storage conditions and no technical assessment is required (Item 12)
          • I want to vary my veterinary product to alter the shelf life/expiry date, in-use shelf life and/or storage conditions and a technical assessment is required (Item 14)
      • I want to vary a re-entry or handling instruction for my product
        I want to vary a re-entry or handling instruction for my product
        • I want to vary a re-entry or handling instruction for my agricultural product and no technical assessment is required (Item 12)
        • I want to vary a re-entry or handling instruction for my agricultural product and a technical assessment is required (Item 14)
        • I want to vary a re-entry or handling instruction for my veterinary product and no technical assessment is required (Item 12)
        • I want to vary a re-entry or handling instruction for my veterinary product and a technical assessment is required (Item 14)
      • I want to vary a withholding period and/or export interval
        I want to vary a withholding period and/or export interval
        • I want to vary a withholding period and/or export interval for an agricultural product and no technical assessment is required (Item 12)
        • I want to vary a withholding period and/or export interval for an agricultural product and a technical assessment is required (Item 14)
        • I want to vary a withholding period and/or export interval for a veterinary product and no technical assessment is required (Item 12)
        • I want to vary a withholding period and/or export interval for a veterinary product and a technical assessment is required (Item 14)
      • I want to vary the use of a product to include a new crop, animal species or situation
        I want to vary the use of a product to include a new crop, animal species or situation
        • I want to vary the use of an agricultural product to include a new crop or situation and no technical assessment is required (Item 12)
        • I want to vary the use of an agricultural product to include a non-food producing crop or situation (Item 14)
        • I want to vary the use of an agricultural product to include a food producing crop or situation (Item 14)
        • I want to vary the use of a veterinary product to include a new animal species or situation and no data of a technical nature is required (Item 12)
        • I want to vary the use of a veterinary product to include a non-food species, including companion animals (Item 14)
        • I want to vary the use of a veterinary product to include a food producing animal species (Item 14)
      • I want to vary the sites of product manufacture
        I want to vary the sites of product manufacture
        • I want to vary the site of manufacture for my veterinary product and the variation involves the addition of an overseas site of manufacture that performs a primary step/s of manufacture
        • Guideline for the transfer of a manufacturing site for immunobiological products
      • I want to vary the pack size of my registered product
      • I want to vary the use of a product to include a new use, new application method, or new use instructions within an existing crop or situation (agricultural chemical products only)
        I want to vary the use of a product to include a new use, new application method, or new use instructions within an existing crop or situation (agricultural chemical products only)
        • I want to vary the use of an agricultural product to include a new use, new application method, or new use instructions within an existing crop or situation and no technical assessment is required (Item 12)
        • I want to vary the use of an agricultural product to include a new use, new application method, or new use instructions within an existing crop or situation and a technical assessment is required (Item 14)
          I want to vary the use of an agricultural product to include a new use, new application method, or new use instructions within an existing crop or situation and a technical assessment is required (Item 14)
          • I want to vary my agricultural product to make a change to the product formulation and a Prescribed Variation is required (Item 13A – only changes to non-active constituents in limited circumstances)
      • I want to vary my product to make a change to the product formulation
        I want to vary my product to make a change to the product formulation
        • I want to vary my agricultural product to make a change to the product formulation and a Prescribed Variation is required (Item 13A – only changes to non-active constituents in limited circumstances)
        • I want to vary my agricultural product to make a change to the product formulation and no technical assessment is required (Item 12)
        • I want to vary my agricultural product to make a change to the product formulation and a technical assessment is required (Item 14)
        • I want to vary my veterinary product to make a change to the product formulation and a Prescribed Variation is required (Item 13A – only changes to non-active constituents in limited circumstances)
        • I want to vary my veterinary product to make a change to the product formulation and no technical assessment is required (Item 12)
        • I want to vary my veterinary product to make a change to the product formulation and a technical assessment is required (Item 14)
      • I want to vary my product to include a new dose rate, frequency, route of administration or application method (vet products only)
        I want to vary my product to include a new dose rate, frequency, route of administration or application method (vet products only)
        • I want to vary my product to include a new dose rate, frequency, route of administration or application method (vet products only) No technical assessment is required (Item 12)
        • I want to vary my veterinary product to include a new dose rate, frequency, route of administration or application method and a technical assessment is required (Item 14)
      • I want to submit a timeshift application
      • Active constituent applications guidance
      • Training resources
        Training resources
        • Permits module
        • Registrations module
    • Get assistance
      Get assistance
      • Pre-application assistance
        Pre-application assistance
        • Applying for pre-application assistance
        • Getting the most out of pre-application assistance
        • Pre-application assistance – timeframes and fees
        • How to withdraw a request for pre-application assistance
      • Technical assessment
    • Seek review of a decision
      Seek review of a decision
      • Reviewing decisions
      • Approval or variation of an active constituent or registration
      • Permits
    • Application summaries
      Application summaries
      • Application summaries FAQs
  • Chemicals and products
    Chemicals and products
    • Active constituents
      Active constituents
      • APVMA standards for active constituents for use in agricultural chemical products
      • Active constituents exempt from the requirements of APVMA approval for use in agricultural or veterinary chemical products
      • General list of impurities and classes of impurities of toxicological concern for agricultural active constituents
      • Approval of active constituents
      • Uniform expression of active constituents
    • FAISD Handbook
    • Health based guidance values
      Health based guidance values
      • Acceptable daily intakes for agricultural and veterinary chemicals
      • Acute reference doses for agricultural and veterinary chemicals
    • Pesticides and veterinary residues
      Pesticides and veterinary residues
      • Export slaughter intervals – cattle
      • Export slaughter intervals – sheep
    • Scheduled drugs and poisons
  • Regulation
    Regulation
    • Adverse Experience Reporting Program
    • Chemical review
      Chemical review
      • Chemical review process
        Chemical review process
        • Legislative basis
        • History of the chemical review program
        • The reconsideration process
        • Timeframes for chemical reviews
      • Listing of chemical reviews
        Listing of chemical reviews
        • Chemicals prioritised for reconsideration
        • Label reviews
          Label reviews
          • Anticoagulant rodenticides
          • 2,4-D
            2,4-D
            • Technical note on standards for the classification of nozzles in Australia
            • Technical note on aquatic regulatory acceptable level calculation
          • Bromoxynil
          • Mercury fungicides
      • Reconsiderations listed in the Ministerial Direction
      • List of voluntary cancellations at the request of the holder
      • Voluntary suspensions at the request of the holder
      • Prioritisation of chemicals nominated for review
      • 2010 spray drift label review nominations
    • Compliance and enforcement
      Compliance and enforcement
      • Enforceable Undertakings
      • Formal warnings
      • Infringement notices
      • Notice to attend, give information or produce documents or items
      • Substantiation notices
      • Responsibilities of holders
      • How we monitor compliance
    • Hormonal growth promotants
      Hormonal growth promotants
      • List of current Hormonal Growth Promotant notification numbers
    • Levy audit program
    • Manufacturing
      Manufacturing
      • COVID-19: advice for veterinary medicine manufacturers and holders
      • Manufacturing licences
        Manufacturing licences
        • Manufacturers’ Licensing Scheme
        • Applying for a manufacturing licence
        • Who can apply
        • Manufacturing licence fees
        • Licence conditions
        • Apply now (Opens in a new tab/window)
        • After you apply
        • Variation of a manufacturing licence
        • Audits to obtain and vary a licence
      • Responsibilities of manufacturers
      • Exporting veterinary chemical products
      • Manufacturing overseas
        Manufacturing overseas
        • GMP in overseas premises
        • Recognition of overseas GMP authorities
        • Overseas GMP documentation
        • Acceptable evidence of GMP compliance
        • APVMA audits of overseas manufacturers
      • Contract manufacture
        Contract manufacture
        • Release for supply
        • Performing release for supply
        • Responsibilities in contract manufacture
      • Good Manufacturing Practice
        Good Manufacturing Practice
        • The legislative basis for the APVMA’s role in manufacturing quality and licensing
        • Manufacturing Principles
      • Veterinary manufacturing permit
      • Audits
        Audits
        • Arranging and undergoing an audit
        • Audit ratings and scores
        • Audits of Australian veterinary chemical product manufacturing sites
        • Audits of overseas manufacturing sites by APVMA-authorised auditors
        • Audit closure
        • The GMP audit cycle
        • Risk-based scheduling of GMP audits
        • Audits – FAQs
      • Licensed manufacturers
    • Recalls
      Recalls
      • List of recalls
    • Report a problem
      Report a problem
      • Report an adverse experience (Opens in a new tab/window)
      • Report suspected non-compliance
      • Holders to notify the APVMA of new information
  • Resources
    Resources
    • Chemicals in the news
      Chemicals in the news
      • 1080
      • Cannabis in veterinary chemical products
      • Chlorpyrifos
      • Glyphosate
        Glyphosate
        • Glyphosate in Australia
        • How does the APVMA determine an agricultural chemical is safe to use in Australia?
        • The APVMA’s previous assessments of glyphosate
        • The IARC assessment explained
        • How is glyphosate regulated around the world?
      • Neonicotinoids
      • Rodenticides
    • Importing chemicals
    • Supplying chemicals
    • Using chemicals
      Using chemicals
      • Information for farmers
      • Information for veterinarians
      • Choosing a chemical
      • Understanding pesticide chemical labels
      • Concerns about chemicals
      • Using chemicals correctly
        Using chemicals correctly
        • Workplace health and safety
        • Protective clothing
        • Spraying chemicals
        • Using veterinary medicines
        • Using pool chemicals
      • Spray drift
        Spray drift
        • Spray drift definitions
        • Spray drift risk operating principles
        • Spray Drift Management Tool permit
      • Emerging technologies
  • About
    About
    • About us
      About us
      • APVMA basics
        APVMA basics
        • What we regulate
        • Our functions and powers
          Our functions and powers
          • Ongoing compliance to ensure safety and efficacy
        • Acronyms and glossary
          Acronyms and glossary
          • Abbreviations and acronyms
          • Definition of terms
      • Integrity
      • Our cost recovery arrangements
        Our cost recovery arrangements
        • 2024 cost recovery review
      • Our history
      • Our legislative framework
      • Our structure
        Our structure
        • APVMA Board
        • Audit and Risk Committee
    • Agvet chemical regulation
      Agvet chemical regulation
      • Access to safe and effective agvet chemicals
      • The Record and Register
      • Domestic collaboration
      • PubCRIS and Permits databases
      • Product regulation according to risk
      • Risk management
    • Use of agvet chemicals in Australia
    • Access to information held by the APVMA
      Access to information held by the APVMA
      • Agricultural and Veterinary Chemicals Code requests
      • Freedom of Information
        Freedom of Information
        • Freedom of information disclosure log
    • Accountability and reporting
      Accountability and reporting
      • Annual product sales data
        Annual product sales data
        • Publication of annual product sales data: 2022–23
      • APS Employee Census
      • Contracts over $100,000
      • Gifts and benefits
      • Indexed list of files
      • Information Publication Scheme
        Information Publication Scheme
        • Information publication scheme agency plan
      • Performance statistics
        Performance statistics
        • September 2024 performance report
          September 2024 performance report
          • Applications in detail
          • Applications by item number
          • Average decision time
        • June 2024 performance report
          June 2024 performance report
          • Applications in detail
          • Applications by item number
          • Average decision time
        • March 2024 performance report
          March 2024 performance report
          • Applications in detail
          • Applications by item number
          • Average decision time
        • December 2023 performance report
          December 2023 performance report
          • Applications in detail
          • Applications by item number
          • Average decision time
        • September 2023 performance report
          September 2023 performance report
          • Applications in detail
          • Applications by item number
          • Average decision time
        • Glossary of terms
      • Portfolio budget statements
      • Public Interest Certificates
      • Statutory appointments
    • Careers
      Careers
      • Benefits and conditions
      • Graduate Development Program
      • Procedures for determining breaches of the APS Code of Conduct
    • Communication and decision making
      Communication and decision making
      • Section 6A Guidelines
        Section 6A Guidelines
        • Overarching principles and processes for the effective and efficient regulation of agricultural and veterinary chemical products
        • Approvals and registrations
        • Permits
        • Licences
        • Recategorising applications
        • Requesting information from applicants
        • Limits on use of information
        • Reconsidering approvals and registrations
        • Varying relevant particulars and conditions
        • Formulation types
        • Previous s 6A Guidelines
      • Communication between applicants and the APVMA
        Communication between applicants and the APVMA
        • Service charter
      • Data handling by the APVMA
        Data handling by the APVMA
        • Guidance on applications involving reference products
        • CCI Practice Statement
      • External advice
      • Transparency
    • Stakeholder engagement
      Stakeholder engagement
      • APVMA Consultative Forum
      • APVMA Agvet Users Forum
      • Stakeholder Survey
    • International collaboration
      International collaboration
      • International activities
        International activities
        • International chemical conventions
        • International participation
        • International standards and guidance
      • International engagement strategy
      • Use of international assessments
        Use of international assessments
        • Collaborative and international assessments
        • Guidance on veterinary drug joint reviews
          Guidance on veterinary drug joint reviews
          • UK–AU guidance on veterinary medicines simultaneous reviews
    • Our website and your privacy
  • Online Services Portal (Opens in a new tab/window)
  • News, forms and publications
    News, forms and publications
    • Chemicals in the news
    • Forms
    • Media releases
    • News
    • Newsletters
    • Publications
      Publications
      • APVMA Gazette
      • Annual Reports
      • Corporate Plan
    • Public consultations
      Public consultations
      • Closed
      • Public Release Summaries
      • Trade Advice Notices
      • How we consult with stakeholders
    • Statements
  • Contact us
    Contact us
    • Accessibility
    • Complaints
    • Copyright
    • Privacy
    • Social media
  • Registrations and permits
    • Search products and permits
    • Chemical product registration
    • Applying for permits
    • Data guidelines
      • Agricultural data guidelines
      • Veterinary data guidelines
      • Crop Groups
      • Module descriptors
      • Risk assessment manuals
    • Labelling Codes
    • Import and export
    • Holders and nominated agents
    • Other government requirements
    • Limits on use and disclosure of information
    • Application guidance
    • Get assistance
    • Seek review of a decision
    • Application summaries
  • Chemicals and products
    • Active constituents
    • FAISD Handbook
    • Health based guidance values
    • Pesticides and veterinary residues
    • Scheduled drugs and poisons
  • Regulation
    • Adverse Experience Reporting Program
    • Chemical review
    • Compliance and enforcement
    • Hormonal growth promotants
    • Levy audit program
    • Manufacturing
    • Recalls
    • Report a problem
  • Resources
    • Chemicals in the news
    • Importing chemicals
    • Supplying chemicals
    • Using chemicals
Search
  • Data guidelines
  • Home
  • Registrations and permits
  • Data guidelines
  • Risk assessment manuals

Risk assessment manuals

Skip to main content
  • Search products and permits
    • Search PubCRIS (Opens in a new tab/window)
    • Using PubCRIS
  • Chemical product registration
    • Applying for approvals, registrations and variations
    • Applying for a label approval
    • Which products/chemicals require registration
      • Does my veterinary product need to be registered?
        • User guide: what is or isn't a veterinary product?
          • Animal cosmetic products
            • Excluded animal cosmetic products – acceptable cosmetic messages
          • Animal feed products
            • Acceptable nutritional messages
            • Feed supplements – acceptable nutritional messages
            • Other requirements for whole unprocessed animal tissue
          • Devices, equipment and physical barrier products
          • Other products that don't require registration
        • Registration self-assessment tool (veterinary)
      • Does my agricultural product need to be registered?
      • Stockfeed and petfood regulation
        • END product FAQs
      • Novel products
      • Arrangements for products of low regulatory concern
        • Registration models
          • Oral electrolyte products for the treatment of horses in exercise
        • Reserved chemical products
        • Listed chemical product
      • Substances not permitted for use on food-producing animals in Australia
      • Lures and attractants
    • Before you apply
      • About the approval and registration process
      • Who can apply
      • Restricted chemical products
      • Conditions of approval or registration and label approval
      • Minor variations
      • The risk analysis process
      • Timeframes and fees
      • Interchangeable Constituent Determination – Item 29
    • What to include in your application
      • Data guidelines
      • Guidance for preparing information lists
      • Dossiers
      • Required information
      • Statutory criteria
        • Active constituent
        • Chemical product
        • Satisfying the statutory criteria
      • Providing evidence of GMP
      • Guidance for applicants – submission of international data, standards and assessments
        • Accepted international data and standards
        • International and other national assessments
        • How to submit an international assessment
        • What happens once I submit my overseas/international assessment?
    • Guide to completing an online application
      • Online Services Portal
      • Decision tree
      • Identification, applicant and nominated agent details
      • Data and information lists
        • Using the information list editor
      • Access to information
      • Formulation
      • Manufacturing
      • Packaging and storage
      • Labels
      • Submitting an application
      • Submitting third party information
    • After you apply
      • Preliminary assessment process
        • Preliminary assessment guideline
      • Altering applications
      • Requiring additional information
      • Requiring samples to be given for analysis
      • Extended assessment period and maximum response period
      • Requesting information from applicants
    • Primary and secondary applications
    • Renew a registration
    • Technical policy
    • After registration
      • Changes to products and actives
        • Annual returns
          • Annual returns – FAQs
        • Holders to notify the APVMA of new information
      • Levies charged on chemical products
        • Declaration of leviable values
        • Notice of levy calculation
    • APVMA Permit-to-label project
      • Permit-to-label project background
  • Applying for permits
    • Before you apply
      • About the application process
      • Types of permits
        • Export, research and miscellaneous permits
        • Minor use and emergency permits
          • Guide for determining emergency uses or research purposes
          • Guide for determining minor uses
      • Who can apply
      • Timeframes and fees
      • Ability to comply with conditions
    • What to include in your application
      • Required information
      • Statutory criteria
      • Labelling requirements
    • After you apply
      • What happens next
      • Requiring samples or further information
    • Extend the duration of a permit
    • Search for a permit
  • Data guidelines
    • Agricultural data guidelines
      • Adopted international technical guidance material
      • Chemistry and manufacture (Part 2)
        • Generation of storage stability data for agricultural chemical products
      • Toxicology (Part 3)
      • Metabolism and kinetics (Part 4)
      • Residues (Part 5A)
        • Specific guidelines
      • Overseas trade (Part 5B)
      • Occupational health and safety (Part 6)
      • Environment (Part 7)
        • Roadmap for insect pollinator risk assessments in Australia
      • Pesticides efficacy and crop safety general guideline (Part 8)
        • Specific guidelines
      • Special data (Part 10) - Products of gene technology
      • Special data (Part 10) – Products of nanotechnology
      • Guideline for the regulation of biological agricultural products
      • Guidance on assessment and registration of anti-fouling paints
      • Relevant data for module levels – agricultural chemical products
    • Veterinary data guidelines
      • Adopted international technical guidance material
      • Chemistry and manufacture (Part 2)
        • Chemistry and manufacture of active constituents (Part 2)
          • Approval of active constituents for which information is not readily available
        • Chemistry and manufacture of products (Part 2)
        • Additional data guidelines for chemistry and manufacture (Part 2)
      • Toxicology (Part 3)
      • Metabolism and kinetics (Part 4)
        • Comparative metabolism studies, selection of marker residues and ratios of marker residues to total residues
      • Residues (Part 5A)
        • Specific guidelines
      • Overseas trade (Part 5B)
        • Veterinary drug residues in food commodities and overseas trade
      • Occupational health and safety (Part 6)
      • Environment (Part 7)
      • Efficacy and target animal safety general guideline (Part 8)
      • Special data (Part 10)
      • Specific guidelines
      • Relevant data for module levels – veterinary chemical products
      • Guidelines for data to support efficacy and safety of teat disinfectants
    • Crop Groups
      • What is crop grouping?
      • Crop groupings project – consolidated responses to phase one consultation
        • NWPGP grain industry comments
    • Module descriptors
    • Risk assessment manuals
  • Labelling Codes
    • Agricultural Labelling Code
    • Veterinary Labelling Code
      • Specific labelling requirements
        • Anthelmintics for dogs and cats
        • Anthelmintics for horses
        • Anthelmintics for sheep, goats and cattle
        • Anti-inflammatories
        • Antibiotics
        • Complementary animal health products
        • Ectoparasiticides for dogs and cats
        • Ectoparasiticides for sheep and goats
        • Euthanasiates
        • Hormonal growth promotants
        • Immunobiological products (veterinary vaccines, antisera, biologicals)
        • Intramammary preparations
        • Intraruminal products
        • Non-prescription injectable products
        • Products containing minerals
        • Products for application to wounds
        • Professional packs of oral non-prescription products
        • Stomach tubing products
        • Teat dips and sprays
        • Therapeutic pet food products
      • Preparing a label and approval process
      • Label content
        • General labelling requirements
        • Anthelmintics for dogs and cats
        • Anthelmintics for horses
        • Anthelmintics for sheep, goats and cattle
        • Anti-inflammatories
        • Antibiotics
        • Complementary animal health products
        • Ectoparasiticides for dogs and cats
        • Ectoparasiticides for sheep and goats
        • Euthanasiates
        • Hormonal growth promotants
        • Immunobiological products (veterinary vaccines, antisera, biologicals)
        • Intramammary preparations
        • Intraruminal products
        • Non-prescription injectable products
        • Products containing minerals
        • Products for application to wounds
        • Professional packs of oral non-prescription products
        • Stomach tubing products
        • Teat dips and sprays
        • Therapeutic pet food products
      • Label presentation and layout
        • Information required on labels
        • Label layout
        • Printing and legibility requirements
      • Additional guidance
        • Globally harmonized system of classification and labelling
        • Promotional and display packs
        • Individual, multi- and variable dose forms
        • QR codes in the labelling and/or package leaflet
        • Removable labels for small single-dose veterinary vaccines
        • Professional packs of oral non-prescription veterinary products
    • Globally harmonized system of classification and labelling
  • Import and export
    • Importing agricultural chemicals or veterinary medicines
    • Export permits
    • Export certificates
      • Before you apply
        • About the application process
        • Timeframes and fees
        • Who can apply
        • Common types of certificates
      • What to include in your application
        • Information to be provided with a request for a section 70 certificate
    • Consent to import chemical products
  • Holders and nominated agents
    • Change a holder or nominated agent
      • Timeframes and fees for changing a holder or nominated agent
    • Definition of roles and actions for holders, nominated and authorised agents and authorising parties
  • Other government requirements
    • Drinking water guidelines – pesticides
  • Limits on use and disclosure of information
    • Limitation periods
    • Information lists
    • Authorising party
  • Application guidance
    • I want to register a new product with an existing active or new combination of approved actives
      • I want to register a new agricultural product with an existing active or new combination of approved actives
      • I want to register a new veterinary product with an existing active or new combination of approved actives
    • I want to register a new product that contains a new active constituent
      • I want to register a new agricultural product that contains a new active constituent – full assessment (Item 1)
      • I want to register a new agricultural product that contains a new active constituent – less than a full assessment (Item 2)
      • I want to register a new veterinary product that contains a new active constituent (Item 2)
    • I want to register a product that is based on an existing registered reference product
      • I want to register an agricultural product that is similar to a registered reference product and efficacy and safety and chemistry and manufacture data is required (Item 5)
      • I want to register an agricultural product that is closely similar to a registered reference product and chemistry data is required (Item 6)
      • I want to register an agricultural product that is closely similar to a registered reference product – no further data required (Item 7)
      • I want to register a veterinary product that is based on an existing registered reference product and similar efficacy, safety, chemistry and manufacture data is required (Item 5)
      • I want to register a veterinary product that is based on an existing registered reference product and is closely similar and only chemistry data is required (Item 6)
      • I want to register a veterinary product that is based on an existing registered reference product and is closely similar and data is not required (Item 7)
    • I want to register a product that is the same as a reference product
      • I want to register an agricultural product that is the same as a reference product (Item 8)
      • I want to register a veterinary product that is the same as a reference product (Item 8)
    • I want to register a product and apply for the concurrent approval of a new source of active
    • I want to register or vary a product and I need information on spray drift assessment and labelling
    • I want an additional marketing name for my existing registered product
      • I want an additional marketing name for my existing registered agricultural product
      • I want an additional marketing name for my existing registered veterinary product
    • I want to vary my product to amend a restraint, contraindication, precaution or side effect statement (vet products only)
      • I want to vary my product to amend a restraint, contraindication, precaution or side effect statement (vet products only) and no technical assessment is required (Item 12)
      • I want to vary my product to amend a restraint, contraindication, precaution or side effect statement (vet products only) and a technical assessment is required (Item 14)
    • I want to vary my product to alter the shelf life/expiry date, in-use shelf life and/or storage conditions
      • I want to vary my agricultural product to alter the shelf life/expiry date, in-use shelf life and/or storage conditions
        • I want to vary my agricultural product to alter the shelf life/expiry date, in-use shelf life and/or storage conditions and no technical assessment is required (Item 12)
        • I want to vary my agricultural product to alter the shelf life/expiry date, in-use shelf life and/or storage conditions and a technical assessment is required (Item 14)
      • I want to vary my veterinary product to alter the shelf life/expiry date, in-use shelf life and/or storage conditions
        • I want to vary my veterinary product to alter the shelf life/expiry date, in-use shelf life and/or storage conditions and no technical assessment is required (Item 12)
        • I want to vary my veterinary product to alter the shelf life/expiry date, in-use shelf life and/or storage conditions and a technical assessment is required (Item 14)
    • I want to vary a re-entry or handling instruction for my product
      • I want to vary a re-entry or handling instruction for my agricultural product and no technical assessment is required (Item 12)
      • I want to vary a re-entry or handling instruction for my agricultural product and a technical assessment is required (Item 14)
      • I want to vary a re-entry or handling instruction for my veterinary product and no technical assessment is required (Item 12)
      • I want to vary a re-entry or handling instruction for my veterinary product and a technical assessment is required (Item 14)
    • I want to vary a withholding period and/or export interval
      • I want to vary a withholding period and/or export interval for an agricultural product and no technical assessment is required (Item 12)
      • I want to vary a withholding period and/or export interval for an agricultural product and a technical assessment is required (Item 14)
      • I want to vary a withholding period and/or export interval for a veterinary product and no technical assessment is required (Item 12)
      • I want to vary a withholding period and/or export interval for a veterinary product and a technical assessment is required (Item 14)
    • I want to vary the use of a product to include a new crop, animal species or situation
      • I want to vary the use of an agricultural product to include a new crop or situation and no technical assessment is required (Item 12)
      • I want to vary the use of an agricultural product to include a non-food producing crop or situation (Item 14)
      • I want to vary the use of an agricultural product to include a food producing crop or situation (Item 14)
      • I want to vary the use of a veterinary product to include a new animal species or situation and no data of a technical nature is required (Item 12)
      • I want to vary the use of a veterinary product to include a non-food species, including companion animals (Item 14)
      • I want to vary the use of a veterinary product to include a food producing animal species (Item 14)
    • I want to vary the sites of product manufacture
      • I want to vary the site of manufacture for my veterinary product and the variation involves the addition of an overseas site of manufacture that performs a primary step/s of manufacture
      • Guideline for the transfer of a manufacturing site for immunobiological products
    • I want to vary the pack size of my registered product
    • I want to vary the use of a product to include a new use, new application method, or new use instructions within an existing crop or situation (agricultural chemical products only)
      • I want to vary the use of an agricultural product to include a new use, new application method, or new use instructions within an existing crop or situation and no technical assessment is required (Item 12)
      • I want to vary the use of an agricultural product to include a new use, new application method, or new use instructions within an existing crop or situation and a technical assessment is required (Item 14)
        • I want to vary my agricultural product to make a change to the product formulation and a Prescribed Variation is required (Item 13A – only changes to non-active constituents in limited circumstances)
    • I want to vary my product to make a change to the product formulation
      • I want to vary my agricultural product to make a change to the product formulation and a Prescribed Variation is required (Item 13A – only changes to non-active constituents in limited circumstances)
      • I want to vary my agricultural product to make a change to the product formulation and no technical assessment is required (Item 12)
      • I want to vary my agricultural product to make a change to the product formulation and a technical assessment is required (Item 14)
      • I want to vary my veterinary product to make a change to the product formulation and a Prescribed Variation is required (Item 13A – only changes to non-active constituents in limited circumstances)
      • I want to vary my veterinary product to make a change to the product formulation and no technical assessment is required (Item 12)
      • I want to vary my veterinary product to make a change to the product formulation and a technical assessment is required (Item 14)
    • I want to vary my product to include a new dose rate, frequency, route of administration or application method (vet products only)
      • I want to vary my product to include a new dose rate, frequency, route of administration or application method (vet products only) No technical assessment is required (Item 12)
      • I want to vary my veterinary product to include a new dose rate, frequency, route of administration or application method and a technical assessment is required (Item 14)
    • I want to submit a timeshift application
    • Active constituent applications guidance
    • Training resources
      • Permits module
      • Registrations module
  • Get assistance
    • Pre-application assistance
      • Applying for pre-application assistance
      • Getting the most out of pre-application assistance
      • Pre-application assistance – timeframes and fees
      • How to withdraw a request for pre-application assistance
    • Technical assessment
  • Seek review of a decision
    • Reviewing decisions
    • Approval or variation of an active constituent or registration
    • Permits
  • Application summaries
    • Application summaries FAQs

APVMA risk assessment manuals:

  • Chemistry and manufacture
  • Environment
  • Human health
  • Residues and trade
  • Spray Drift Risk Assessment Manual
Content last updated: 8 April 2019

Subscribe to receive email updates from the APVMA

Australian Pesticides and Veterinary Medicines Authority logo Australian Pesticides and Veterinary Medicines Authority logo

Contact

General contact details

61 2 6770 2300
enquiries@apvma.gov.au

Postal address

GPO Box 574, Canberra ACT 2601, Australia

Enquiries telephone hours

9.30 am to 4 pm AEDT,
Monday to Friday, excluding public holidays

Media enquiries

+61 2 6770 2402 
media@apvma.gov.au

Help

  • APVMA dictionary

Connect

  • Careers
  • Public consultations

About

  • Service charter
  • Accessibility
  • Copyright
  • Freedom of Information
  • Information Publication Scheme

We acknowledge the traditional owners of the country throughout Australia and their continuing connection to land, sea and community. We pay our respect to them and their cultures and to the elders past and present.

©2024 Commonwealth of Australia