• Information on how to submit electronic applications within MRP, DCP and National procedures via the CESP portal is found on the CESP (hma.eu) website.

• For information on use/version numbers eAF for MRP/DCP see https://esubmission.ema.europa.eu/cessp/cessp.htm.

• Following the launch of optional use in February 2025 and the start of the recommended use in May 2025, it is now strongly recommended to use of the PLM Portal web-based eAF for all MRP/DCP and purely national variations, where possible. This is aligned with the timeline and the roadmap towards mandatory use of the PLM Portal web-based eAF for all human variations. Please note that the interactive PDF eAF remains available for use for all variation procedures and while the PLM Portal eAF is now strongly recommended for use for all procedure types, there are some technical limitations, and in these cases you might need to use the interactive pdf forms. Consult the guidance and the release notes.

• CMDh Best Practice Guide on the use of eCTD in the MRP/DCP (April 2020) [Track version]

• Requirements on Submissions for New Marketing Authorisation Applications within MRP, DCP and National Procedures (June 2025) [Track version]

• Requirements on submissions for Variations and Renewals within MRP and National Procedures (June 2025) [Track version]

Questions & Answers on eSubmissions

• Question and answer document covering practical issues for variations in eCTD format

• Q&A on how to handle ongoing procedures in relation to mandatory eCTD format

• Q&A on mandatory eCTD in National Procedures (NP)