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July 2010 – Requirements of NeeS and eCTD and paper documentation

The requirements on electronic submissions (NeeS and eCTD) and paper documentation have been updated on the CMDh website. Most NCAs are ready to receive electronic-only documentation and this mode of submission is strongly promoted even when the NCA still accepts paper submissions. No NCA request full paper copy anymore, however some modules might be required in paper beside the full electronic dossier. The dossier requirements are summarised in three tables on the CMDh website: http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/eSubmissions/CMDh-085-2008-Rev6.1.pdf”



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