The pilot phase for technical validation to be performed by the RMS on behalf of all CMSs, starting 1st March 2012, for e-CTD submissions for new Marketing Authorisation applications in DCP (excluding extension applications).
Applicants willing to participate to the pilot are invited to submit their applications according to the instructions given in the document called “Technical validation of e-CTD submissions for new MAAs in DCP – start of pilot phase” that will be published on the CMDh website under “Procedural Guidance, eSubmissions
To find more information please click here
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