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”

An updated list of contact email addresses for submision of electronic response documents for applications for marketing authorisations, variations and renewals in mutual recognition procedures and DCP is available on the CMDh website.

The CMDh has issued a revised version of the best practice guide on the uses of eCTD in Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP). The guide supports applicants in meeting the legal obligations within the MRP and DCP in eCTD format.

National translations in MRP and DCP should be handled outside the eCTD; only the final English version should be submitted within the eCTD. National translations should be submitted in a separate folder beside the eCTD or in a totally different system, via Eudralink or email as recommended per national guidance.