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/18306
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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 a technical assessment is not required to satisfy the safety, efficacy and trade criteria can be processed under a non-technical fixed fee variation (Item 12). This includes where the proposed new formulation is closely similar to the existing formulation or where a suitable reference product is nominated. Minor changes to non-active constituents may also be considered as non-technical assessments. Select ‘Item 12’ below to see the full list of circumstances where an Item 12 application is likely to be appropriate.
A technical assessment (Item 14) is required for variations to formulations that include changes:
- to immunobiological products and peptide products
- to active constituents or constituents that act as synergists
- to non-active constituents such as addition, substitution or removal of an excipient (some changes can be made as an Item 12 non-technical assessment—select ‘Item 12’ below to see a full list)
- to ligands
- to ingredients that are subject to scheduling in the Poisons Standard
- where there are concerns about stability
- which affect the permeability and bioavailability of the active constituent in a product (eg solvents and surfactants in topical or injectable formulations)
- that result in a change in drug:excipient ratio of greater than five per cent from the original product formulation
Other formulation changes that require a technical assessment will also be considered as Item 14 applications.