The Co-ordination Group for Mutual Recognition and Decentralized Procedures - Human (CMDh) has announced in the CMDh meeting report from May 2011 that the deadline for using the optional "parallel national model" in MRP/DCP eCTD submissions will be postponed to the end of the year.
Until then, applicants may still consider the "parallel national model" (see CMDh/084/2008/Rev2; Best Practice Guide on the use of the eCTD in MRP/DCP) as an option for MRP/DCP eCTD submissions. In an earlier communication from February this year, the CMDh has initially declared a deadline of 1st June 2011 for the "parallel national model" (see our previous News article). However, postponing the deadline will allow for the development of further guidance to applicants.
For More Information Please Click: Exalon eCTD submissions in MRP/DCP
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