New features in biocides IT tools
The biocides submission tool (R4BP 3) has been updated to support new features for Union authorisation and authorisation of same biocidal products. The tool for creating summaries of product characteristics (SPC Editor) now supports the creation of a biocidal product family with sub-families.
Helsinki, 27 October 2016 – R4BP 3 has been updated to support new possibilities for the authorisation of identical biocidal products. For example, companies can now get a national authorisation when a Union authorisation application exists for an identical product. These changes were introduced by an update in the regulation on the authorisation of same biocidal products, which will enter into force on 1 November 2016.
R4BP 3 now also has more options to manage Union authorisations, for example to request changes. For simplified authorisation, it is now possible to notify a single product within a product family to another market area.
The Summary of Product Characteristics (SPC) Editor has a new interface that supports the creation of product families with three levels: product family, sub-family (meta-SPC) and product level. The common elements for products now only need to be reported at the highest relevant level (family or sub-family). The existing summaries of product characteristics in R4BP 3 will be migrated to the new three-level format automatically.
To learn more about the new features, have a look at the release note and the updated dossier submission manuals. You can also sign up for our webinar on 9 November.