A new table summarizing the additional Data requested for New Application in the MRP/DCP which are not stated in the current EU legislation and /or volume 2B is available on the CMDh website. To view the table, please click on the link below: http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Application_for_MA/CMDh_043_2007_Rev5_August10.pdf

Following the May 2010 meeting of the CMDh, the HMA has published a list of acceptable and non-acceptable groupings of variations on the same MRP/CDP product. Non acceptable groupings includes: introduction of a new API manufacturer with a new ASMF, variations for several minor changes of type IA and IB (in these cases worksharing procedure should be followed) and changes to module 3 may not be grouped with change in the product name if there is no relation between theses changes and a common assessment is not justified.

Best Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure Link

Best Practice Guide for DCP and MRP Link