CMD(h) plans to revoke the "parallel national" eCTD model for MRP/DCP by mid 2011
In a recent meeting of the Coordination Group for Mutual Recognition and Decentralized Procedures - Human (CMD(h)), it was decided to inform applicants that as of 1st June 2011, the "parallel national eCTD model" will not be accepted any more.
Note: The current version of the "Best Practice Guide on the use of eCTD in MRP/DCP" published on the CMD(h) website strongly recommends applicants to use the "comprehensive model" but allows them to alternatively use the "parallel national model" (click here). The Best Practice Guide will be amended accordingly.
The decision of the CMD(h) is in accordance to the "EU Region Question & Answer and Electronic Submission Specifications & Guidances Change Request" document (click here).
