Applications to vary a registered product to amend the re-entry or handling instruction may be made via:
- Item 12—No data of a technical nature is required—this type of application is used when risks are equivalent to a registered 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?
For a variation to be processed without a technical assessment (Item 12), all risk areas must be supported by solely referencing another registered product (reference product). Applicants seeking to rely on a reference product should explain the reasons why the reference product supports the variation. This should include how the risks are equivalent between the two products including:
- similarity in instructions for use
- the active constituent and its concentration
- the formulation type.
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.