This content is current only at the time of printing. This document was printed on 25 June 2021. A current copy is located at http://www.plural-consulting.com/taxonomy/term/18286
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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.
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.
Depending on the change the following registration pathways may be utilised:
- Item 12: No data of a technical nature is required—this application type is used when the change is minor and does not affect the physico-chemical properties of the product.
- Item 13A: Prescribed variation—changes to non-active constituents (excipients) in certain limited circumstances.
- Item 14: Technical modular application—all applications that are not Items 12 or 13A.
Most formulation variations are likely to be made as Item 14 applications. Applicants should familiarise themselves with the scope of each of these pathways and select the pathway which is most appropriate for the formulation change being sought.
This guidance does not cover changes to use patterns, or to the frequency or rate of application. This information is provided in other tailored guidance pathways.
Which application form do you need?
Specific information on completing this application form is provided below. Once you are familiar with the content you can proceed to ‘Start an application’ at the button below.
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 Prescribed Variation).?
Applications for formulation changes where the supporting information does not require a technical assessment to satisfy the safety, efficacy and trade criteria can be processed under a non-technical fixed fee variation (Item 12). Formulation variations of an agricultural product that may be eligible for submission under Item 12 include formulation changes where:
- excipients in the formulation are the same and at similar concentrations to those in the approved formulation
- one or more excipients in the formulation have been substituted with similar chemicals that perform the same function and are not expected to impact on the physico chemical properties of the formulation or on efficacy or crop safety
- the variation is to add, remove or substitute dyes or fragrances
- the existing formulation is closely similar (see below) to the proposed new formulation
- the formulation has previously been assessed for a reference product which has the same label instructions as the current product.
For an agricultural product formulation to be considered closely similar to another formulation:
- its active constituent/s and concentration of active constituent/s must be the same as the reference formulation
- other ingredients in the formulation of the product may be different from those in the reference formulation, but must perform similar functions (eg emulsifier, surfactant, dye, solvent)
- its formulation type must be the same as that of the reference formulation.
Other formulation changes are likely to require technical assessment and should be made as Item 14 applications.
Limits on use (data protection)
Where there are limits on use of information on the reference product written consent from the authorising party is required when access to the information is necessary to determine the application.
Where the reference product does not fully support all risk areas or the product is subject to limits on use and additional data is being provided to satisfy the safety, efficacy or trade criteria these applications should be lodged as Item 14 applications.