EU: Updated requirements from CMDh on electronic and paper submissions for MRP/DCP or National procedures

CMDh has released an updated version of the "Requirements on Electronic submissions (NeeS and eCTD) and paper documentation for New Applications within MRP, DCP or National procedures", document CMDh/085/2008/Rev8, version date July 2011.

Compared to the previous revision 7 released in October 2010, only slight modifications were introduced:

• Some footnotes were removed from Table 1 (electronic-only submissions) for the entries of Cyprus and Sweden.
• For Cyprus, entries were added in Table 3 (paper submissions) for the provision of electronic copies of the Product Information and Module 2 documents in MS Word format.

Revision 8 of CMDh/085/2008 is available for download from the CMDh website.

[Source: CMDh website]

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