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 variations to approved product formulation details require an application to be made. The level of information supporting the variation and the assessment required will vary according to the proposed change and significance it may have with respect to ensuring the continued safety and efficacy of the 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)

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:

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 required
  • Item 14 – technical modular application—all applications not described in any of items 11 to 13A.

Most ‘extension of use’ variations are likely to be made as Item 14 applications.

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 required
  • Item 14 – technical modular application—all applications not described in any of items 11 to 13A.

Most ‘extension of use’ variations are likely to be made as Item 14 applications.

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 required
  • Item 14 – technical modular application—all applications not described in any of items 11 to 13A.

Most ‘extension of use’ variations are likely to be made as Item 14 applications.

I want to vary the use of an agricultural product to include a non-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 required
  • Item 14 – technical modular application—all applications not described in any of items 11 to 13A.

Most ‘extension of use’ variations are likely to be made as Item 14 applications.

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