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      • 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
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        I want to register a new product that contains a new active constituent
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        • 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)
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        I want to register a product that is based on an existing registered reference product
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        • 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
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        • I want to register a veterinary product that is the same as a reference product (Item 8)
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        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
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        • Guideline for the transfer of a manufacturing site for immunobiological products
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      • 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)
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        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)
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        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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  • Veterinary Medicines Working Group – terms of reference
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  • Veterinary Medicines Working Group – terms of reference
  • Veterinary Medicines Working Group – terms of reference

Veterinary Medicines Working Group – terms of reference

Document
APVMA Veterinary Medicines Working Group - Terms of Reference.pdf (138.62 KB)
Document
APVMA Veterinary Medicines Working Group - Terms of Reference.docx (710.13 KB)
Type
Draft document
Publication date
07/07/2025

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