HMA: CMD(h) Best Practice Guide on the use of eCTD in the MRP/DCP
Further to experience gained both by Industry and National Competent Authorities, the CMD(h) has developed guidance to facilitate the use of eCTD as the submission format in the MRP and DCP. This guidance is available for immediate use by applicants using these two submission procedures. It is highly recommended.
Źródło wiadomośći: http://www.hma.eu/277.html