The Coordination Group for Mutual Recognition and Decentralized Procedures - Human (CMDh) has released revision 3 of the cover letter template that should be used by applicants for initial applications submitted through MRP or DCP.
The template has been restructured significantly and new information has been added including:
- Optional confirmation that format of future submission will be continued in NeeS (NeeS only) or eCTD (NeeS or eCTD)
- Confirmation of technical validity
- Confirmation regarding different formats submitted to different RMS/CMS (not recommended)
- Confirmation for different specific national documents included (e.g. cover letters, application forms, additional data) within the eCTD/NeeS and/or outside the eCTD/NeeS ("workingdocuments").
To find more information please use the below mentioned weblink
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