CMDh releases updated Best Practice Guide for the use of eCTD in MRP/DCP
The Co-ordination Group for Mutual Recognition and Decentralized Procedures - Human (CMDh) has released an updated revision 3 of the "Best Practice Guide on the Use of the Electronic Common Technical Document (eCTD) in the Mutual Recognition and Decentralised Procedures" (CMDh/084/2008/Rev3).
The Best Practice Guide (BPG) has been greatly revised and contains some major revisions along with many editorial changes. Some major important changes are summarized below. Please note that this is not an exhaustive list. For more details, please be referred to the original BPG (see links at the bottom of this article).
- The BPG focuses now more on the mutual phase of MRP/DCP as it has been agreed already previously by the Heads of Medicines Agency (HMA) and the CMDh to handle national translations of the Product Information completely outside the eCTD.
- The requirements of the Tracking Table has been more detailed, including the usage of the its operation attribute "new"
- Revocation of the "Parallel National" model: As announced (and delayed) earlier, the usage of the "Parallel National" eCTD model (RMS and each CMS receive individual eCTD lifecycle dossiers) will no longer be an option starting 2012. Applicants should transfer existing "Parallel National" eCTDs to the "Comprehensive" model (all country information included in same eCTD dossier, RMS and CMS share sequence numbers).
- Details have been included for the validation phase of the dossier. It has now been clearly separated between technical validation and content validation of the dossier. Only in case of technical invalid eCTDs, a corrected sequence with the same eCTD sequence number should be provided immediately to the RMS and all CMS. Findings of the content validation need to be addressed by e-mail first, following a single, consolidated eCTD lifecycle sequence at the end of the validation procedure.
- Additional clarification on the handling of response documents is provided
- Additional clarification on the usage of "workingdocuments" for national translations of the Product Information is provided
- The section dealing with Repeat-use procedures has undergone some major revisions
- Tracking table examples in the annex have been updated accordingly.
The BPG is available from the CMDh website as clean and tracked version.
[Source: CMDh website]
- Related News:
- CMDh releases new version of the cover template for new applications submitted through MRP/DCP - 01.02.2012 16:42
- CMD(h) plans to revoke the "parallel national" eCTD model for MRP/DCP by mid 2011 - 23.02.2011 10:23
- EU: Updated CMD(h) BPG for the submission and processing of variations in the MRP released - 25.11.2010 10:15
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