Europe – Additional Data requested for New Applications in the Mutual Recognition and Decentralised Procedures

Data requested for New Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines/Recommendation papers

Member States who are not mentioned in the table below do not request additional data.
For number and format requirements on submissions for New Applications within MRP, DCP and National Procedures, including requirements for signed paper copies of eAF and cover letter, please refer to the published document “Requirements on submissions (number and format) for New MA Applications within MRP, DCP or National procedures” at the CMDh website (eSubmissions)…