NeeS is out from MRP (eCTD only for all submissions in EU procedures) from 1 January 2018


We in Billev Pharma East are ready for many years. Pharmaceutical companies will no longer be able to submit MRP (mutual recognition procedure ) applications in the NeeS submission format, as outlined in the eSubmission Roadmap. The change will be effective from 1 January 2018. From this date, the NeeS format is only accepted for purely national applications (NP). This change forms part of the common European phasing-out plan for the NeeS format. (Note: baseline submissions are not required)