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  • I want to vary the use of an agricultural product to include a food producing crop or situation (Item 14)

    Varying the use of an agricultural or veterinary chemical product to include a new use is also known as an ‘extension of use’. This variation is made via:

    Item 11 – full assessment fixed fee application Item 12 – no technical assessment is…
  • 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)

    Varying the use of an agricultural or veterinary chemical product to include a new use is also known as an ‘extension of use’. This variation is made via:

    Item 11 – full assessment fixed fee application Item 12 – no technical assessment is…
  • I want to vary the use of a veterinary product to include a non-food species, including companion animals (Item 14)

    Introduction

    The following material provides guidance for varying the use of a veterinary medicine where the change involves an extension of use to a non-food species as a technical modular variation (Item 14). Depending on the nature…

  • I want to vary the use of a veterinary product to include a food producing animal species (Item 14)

    Varying the use of an agricultural or veterinary chemical product to include a new use is also known as an ‘extension of use’. This variation is made via:

    Item 11 – full assessment fixed fee application Item 12 – no technical assessment is…
  • 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)

    Varying the use of an agricultural chemical product to include a new use is known as an extension of use. Within an existing crop or situation, this might include:

    new target pests or diseases new application methods or equipment varying the…
  • 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)

    Legislation Framework

    The Agricultural and Veterinary Chemicals (Administration) Act 1992 establishes the APVMA as an independent statutory authority of the Commonwealth, responsible for the regulation and…

  • 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)

    Legislation Framework

    The Agricultural and Veterinary Chemicals (Administration) Act 1992 establishes the APVMA as an independent statutory authority of the Commonwealth, responsible for the regulation and…

  • I want to vary my product to make a change to the product formulation

    Changes to the formulation of an agricultural or veterinary chemical product may be required for a variety of reasons, including the availability of excipients or changes to the purity of the source of active used in the formulation.

    All…

  • 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)

    Is a technical assessment required for my proposed variation?

    Application for a formulation change as a prescribed variation (Item 13A) is only permitted in very limited circumstances. These circumstances are described below (select Item 13A…

  • 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)

    Is a technical assessment required for my proposed variation?

    Application for a formulation change as a prescribed variation (Item 13A) is only permitted in very limited circumstances. These circumstances are described below (select Item 13A…

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61 2 6770 2300
enquiries@apvma.gov.au

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GPO Box 574, Canberra ACT 2601, Australia

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9.30 am to 4 pm AEDT,
Monday to Friday, excluding public holidays

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+61 2 6770 2402 
media@apvma.gov.au

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