24 February 2012

CMDh: Technical validation of eCTD submissions for new MAAs in DCP - Start of pilot phase (voluntary)

The CMDh has agreed on a pilot phase for technical validation to be performed by the RMS on behalf of all CMSs, starting 1 March 2012, for eCTD submissions for new Marketing Authorisation applications in DCP (excluding extension applications). The pilot phase will be run for one year and followed up continuously (see contact details below) by the end of the pilot an evaluation will be made to decide on future handling. Applicants are therefore encouraged to submit applications within this pilot workflow so that it can be truly tested and evaluated. Following a positive evaluation of the pilot phase it is envisaged to extend the pilot to include also other submission types like variations and renewals as well as submissions in NeeS-format. 

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