HMA: Requirements on electronic submissions for Renewals & Variations within MRP, DCP or National procedures
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. A few NCAs require some modules in paper beside the full electronic dossier. The requirement for an NCA could differ depending on the role (RMS or CMS) of that NCA in an MRP and also for national procedures. It could also differ if the first MA dossier for the product was in paper format.