This content is current only at the time of printing. This document was printed on 19 June 2021. A current copy is located at http://www.plural-consulting.com/taxonomy/term/18251
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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)
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 rate (eg concentration, frequency, or number of applications)
- varying the use instructions or critical comments (eg varying timing of application, crop safety statements, or tank mixes).
Depending on the nature of the variation, different technical assessment modules will apply. In general, an extension of use requires the submission of new information or data to support the safety and efficacy of the varied use. The amount of new information or data required will vary depending upon how significant the change is, and what new assessments are necessary.
These variations are made via:
- Item 12—no technical assessment is required—this application type is used when risks are equivalent to a registered reference product not subject to data protection
- Item 14—technical modular application—all applications not meeting the requirements of Item 12.
Is a technical assessment required for my proposed variation?
Most extension of use variations are likely to be made as Item 14 applications, as they will require technical assessment.
For a variation to proceed without a technical assessment (Item 12), the application is usually supported by referencing another registered product (reference product).
The suitability of a reference product includes the reference product as having:
- the same active constituent/s at the same concentration/s
- the same other ingredients, or if different these perform a similar function
- the same formulation type
- the label refers to the same crops, situations and pests
- the same label claims
- no limits on use of information apply (or consent to use is provided).
Limits on use of information
When using a reference product where there are limits on use of information on the product which is being referenced, written consent from the authorising party is required.