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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.

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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…
I want to vary my agricultural product to make a change to the product formulation and no technical assessment is required (Item 12)
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 technical assessment is required (Item 14)
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 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)
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…
I want to vary my veterinary product to make a change to the product formulation and no technical assessment is required (Item 12)
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…
I want to vary my veterinary product to make a change to the product formulation and a technical assessment is required (Item 14)
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…
I want to vary my product to include a new dose rate, frequency, route of administration or application method (vet products only)
Varying the dose, the frequency of administration, or the route of administration of a veterinary medicine product can be done through either:
Item 12: No data of a technical nature is required. This type of application is used…
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)
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…

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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 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) No technical assessment is required (Item 12)

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