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Australian Pesticides and Veterinary Medicines Authority logo Australian Pesticides and Veterinary Medicines Authority logo
  • Registrations and permits
    Registrations and permits
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    • 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
              • Acceptable nutritional messages
              • 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?
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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
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      • 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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        • Required information
        • 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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        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 – 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
      • 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
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        • 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
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        • 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
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      • 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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  • Public Release Summary on cephalonium in the product Coopers Cepravin Dry Cow Intramammary Antibiotic
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  • Public Release Summary on cephalonium in the product Coopers Cepravin Dry Cow Intramammary Antibiotic
  • Public Release Summary on cephalonium in the product Coopers Cepravin Dry Cow Intramammary Antibiotic

Public Release Summary on cephalonium in the product Coopers Cepravin Dry Cow Intramammary Antibiotic

Document
Public Release Summary on cephalonium in the product Coopers Cepravin Dry Cow Intramammary Antibiotic.pdf (1.54 MB)
Type
Public Release Summary (PRS)
Publication date
02/10/2025

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