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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
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  • Chemistry and manufacture (Part 2) - Veterinary

Chemistry and manufacture (Part 2) - Veterinary

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      • Chemistry and manufacture (Part 2)
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      • 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)
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        • Anthelmintics for dogs and cats
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        • 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
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  • 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
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  • Get assistance
    • Pre-application assistance
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  • Chemistry and manufacture of active constituents (Part 2)
  • Chemistry and manufacture of products (Part 2)
  • Additional data guidelines for chemistry and manufacture (Part 2)
  • Overview on approval of active constituents
Content last updated: 8 October 2018
Content last reviewed: 14 June 2023

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