EN PL

HMA: Requirements on Electronic submissions (NeeS and eCTD) and paper documentation for New Applications within MRP, DCP or National procedures

09.11.2010
Most NCAs are now ready to receive electronic-only applications and applicants are therefore strongly encouraged to submit in electronic format (eCTD or NeeS) to these NCAs, even if many still also accept paper applications. No NCA requires a full paper dossier anymore; however, a few NCAs require some modules in paper beside the full electronic dossier. The requirement for an NCA could also differ depending on the role (RMS or CMS) of that NCA in an MRP/DCP and for national procedures.