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