Further guidance on eSubmissions can be found on the EMA website under eSubmission
- CMDh Best Practice Guide on the use of eCTD in the MRP/DCP (November 2011) [Track version]
Any change requests for the document should be handled in accordance with the change request instructions given on the EMA eSubmissions website.
The CMDh agreed to handle specific purely national regulatory activities outside the eCTD. The list of these activities can be found in Q&A 1.6 on eSubmissions.
- Technical validation of eCTD submissions for new MAAs in DCP - start of pilot phase (voluntary) [Track version] (March 2013)
The pilot phase will end on 31 December 2013.
A more efficient process for the technical validation is currently being discussed. The objectives as set up in the EMRN eSubmission Roadmap will be taken into account. The draft Roadmap is published on the HMA CESP website (http://cesp.hma.eu/Home).