This best practice guidance has been developed in order to facilitate the use of the eCTD as a submission format in the Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP). The guidance shows the way for an applicant to meet their legal obligations within MRP and DCP in eCTD format. Some general principles apply to both procedures but there are some differences between the details for the MRP and DCP.
For More Information Please click: CMDh eCTD Best Practice Guidance for MRP and DCP
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