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  • Registrations and permits
    Registrations and permits
    • Search products and permits
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      • 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
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              Animal feed products
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              • Feed supplements – acceptable nutritional messages
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            • Other products that don't require registration
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        • Does my agricultural product need to be registered?
        • Stockfeed and petfood regulation
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          Arrangements for products of low regulatory concern
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            • Oral electrolyte products for the treatment of horses in exercise
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        • 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
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        • Statutory criteria
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          • Active constituent
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        • 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
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          Data and information lists
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        • 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
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        After registration
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          Annual returns
          • Annual returns – FAQs
        • Changes to products and actives
          Changes to products and actives
          • 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
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        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
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        • 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)
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          • Specific guidelines
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        • 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)
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  • Pre-audit notification and information (Overseas)

Pre-audit notification and information (Overseas)

Document
Pre-audit notification and information (Overseas) - October 2025.docx (57.57 KB)
Type
Form
Publication date
01/10/2025

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