EU: CMD(h) releases revision 1 of the BPG on eCTD in MRP/DCP

The CMD(h) released an updated version (revision 1) of the Best Practice Guide (BPG) on the use of the eCTD in the Mutual Recognition and Decentralised Procedures (MRP/DCP).  This BGP has been developed in order to facilitate the use of the eCTD as a submission format in the MRP and DCP and provides clarification for applicants to meet their legal obligations within both procedures in eCTD format. Common principles as well as differences between MRP and DCP eCTD submissions are described.

Changes to revision 0 (April 2008) are numerous and include (but are not limited to) further guidance on the following topics:

• Agreement has been reached between the CMD(h) and the Heads of Agencies to manage national translations of Product Information Files outside the eCTD lifecycle
• Format and usage of the MRP/DCP tracking table
• Applicants can choose to provide documents outside the eCTD or as new eCTD sequence(s) during the validation period
• eCTD sequences from rejected variations
• Change of the Reference Member State (RMS) during procedure
• Switch from paper / NeeS dossier formats
• Usage of "Mixed Format Applications" (CTD / NtA)

The new revision of the BPG is available for download from the
CMD(h) website (see link below).

[Source: CMD(h) website]

Please note: A processed version of the BPG including overall bookmarks and hyperlinks for ease of reading is available free of charge from Exalon

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