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        Which products/chemicals require registration
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          Does my veterinary product need to be registered?
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            User guide: what is or isn't a veterinary product?
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          Arrangements for products of low regulatory concern
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        Before you apply
        • About the approval and registration process
        • Who can apply
        • Restricted chemical products
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        • Minor variations
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        • Interchangeable Constituent Determination – Item 29
      • What to include in your application
        What to include in your application
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        • 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
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          • What happens once I submit my overseas/international assessment?
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        After you apply
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        APVMA Permit-to-label project
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        Before you apply
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          Types of permits
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            Minor use and emergency permits
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        What to include in your application
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          Chemistry and manufacture (Part 2)
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          Pesticides efficacy and crop safety general guideline (Part 8)
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          Chemistry and manufacture (Part 2)
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            Chemistry and manufacture of active constituents (Part 2)
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          • 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
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        • Crop groupings project – consolidated responses to phase one consultation
          Crop groupings project – consolidated responses to phase one consultation
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        Veterinary Labelling Code
        • Specific labelling requirements
          Specific labelling requirements
          • Anthelmintics for dogs and cats
          • Anthelmintics for horses
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          • Anti-inflammatories
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          • Ectoparasiticides for sheep and goats
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          • Intramammary preparations
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        • Preparing a label and approval process
        • Label content
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          • 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
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        • Additional guidance
          Additional guidance
          • Globally harmonized system of classification and labelling
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          • 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
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        Export certificates
        • Before you apply
          Before you apply
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        • 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
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      • Change a holder or nominated agent
        Change a holder or nominated agent
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    • Other government requirements
      Other government requirements
      • Drinking water guidelines – pesticides
    • Limits on use and disclosure of information
      Limits on use and disclosure of information
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      • 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
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  • APVMA Advisory Group – Terms of reference
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  • APVMA Advisory Group – Terms of reference

APVMA Advisory Group – Terms of reference

Document
APVMA Advisory Group - Terms of Reference.pdf (132.85 KB)
Document
APVMA Advisory Group - Terms of Reference.docx (709.56 KB)
Type
Draft document
Publication date
07/07/2025

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