CMDh releases new version of the cover template for new applications submitted through MRP/DCP

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").

Note: the previously included selection between the "comprehensive" and the "parallel national" eCTD model has been removed as it is no longer an option to file eCTDs in MRP/DCP using the "parallel national" model (see our related News article).

The new cover letter template, revision 3 is available as MS Word file from the website of the CMDh (see link below).

[Source: CMDh website]

In Verbindung stehende Artikel:

 CMDh releases updated Best Practice Guide for the use of eCTD in MRP/DCP - 02.12.2011 21:26

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