This page lists the current members and alternates of the Co-ordination Group for Mutual Recognition and Decentralised procedures - Human (CMDh). For more information, see European expert declaration of interests and professional qualifications. For contact details, please refer to the affiliated organisations of individual committee members.
The electronic Application Form (eAF) Product Team would greatly appreciate to receive your feedback on your current experience in terms of time spent in filling in the interactive pdf electronic Application Form (eAF) for Variations for Centrally Authorised Products (CAPs) and Nationally Authorised Products (NAPs), and Initial Marketing Authorisation.
Diphtheria, Tetanus, Inactivated Poliomyelitis vaccine End of procedure: 18/08/2023 Date of publication: 31/01/2024
Report from the meeting held on 19-20 March 2024 Report from the meeting held on 20-22 February 2024 Report from the meeting held on 23-24 January 2024
An updated version of the eSubmission Gateway XML delivery file user interface for veterinary VRA submissions is available starting with 17 January 2024, 18:00 CET.
An updated version of the eSubmission Gateway XML delivery file user interface for veterinary VRA submissions is planned for release in the evening of 17th January 2024. This update will introduce a split of the submission type VRA to 4 different submission types according to the Timetable as per defined in the Variation Classification document
From January 2024, EMA is launching a proof-of-concept study to evaluate the added value of using SEND data in the evaluation of new Marketing Authorisation Applications. Applicants are encouraged to submit their SEND data packages, in addition to the eCDT format, as part of their MAA submission. The SEND package must be provided outside the [...]
Member: Petra Gubová Alternate: Kristína Ráczová State Institute for Drug Control Kvetná 11 SK-825 08 BRATISLAVA 26
EMA, together with the eCTD v4.0 EU Subject Matter Experts group, is planning a Vendor Workshop in Q1 2024. To assess the availability, interest and further topics for discussion, the Vendors are invited to complete the eCTD v4.0 Vendor Workshop survey by end of day 15 February 2024.
Yimmugo Date of publication: 20/12/2023