08.07.2025.
We kindly remind applicants, when preparing responses to requests related to national marketing authorisation procedures, to observe the following:
- please submit a summary of responses both in PDF format under Module 1 and in Word format (.docx) under the “Working document” folder of the eCTD sequence. The cover page should confirm that both versions are identical,
- when preparing the response document, applicants are encouraged to follow the recommendations provided in the guidance developed by the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), titled:
"Applicant’s response document in Mutual Recognition and Decentralised procedures for Marketing Authorisation Applications" (September 2023, CMDh/091/2003, Rev.11) available here: https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Applicant_Response/CMDh_091_2003_Rev.11_2023_09_clean_-_Applicants_response_document_in_MRP-DCP_for_MAAs.pdf
