EU: Updated CMD(h) BPG for the submission and processing of variations in the MRP released

The Co-ordination Group for Mutual Recognition and De-centralized Procedures - Human (CMD(h)) has released yet another updated version of the "Best Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure". This new revision 11 from November 2010 contains only few modifications that concerns chapter 7 (Worksharing), section 4 "Pre-submission activities". Clarification has been provided on how to inform about forthcoming worksharing procedures in case of single RMS or multiple RMS:

• Multiple RMS:
  "In case the intended worksharing procedure includes MR/DC procedures with more than one RMS, the pre-submission information should be submitted to the CMD via H-CMDhSecretariat@ema.europa.eu."

• Single RMS:
  "In case the intended worksharing procedure only includes MR/DC procedures with the same RMS and the MAH proposes the RMS to be the preferred reference authority, the pre-submission information should be directly submitted to the RMS. The RMS will forward the information to the CMDh Secretariat for inclusion in the agenda of the next CMDh meeting and will inform the CMDh Secretariat if they agree with the proposal or not."

The new revision of the BPG is available for download from the CMD(h) website in "clean" and "track change" version.

[Source: CMD(h) website]

Related News:

 CMDh releases updated Best Practice Guide for the use of eCTD in MRP/DCP - 02.12.2011 21:26

 EU: CMD(h) updates guidance documents for the submission of variations - 09.11.2010 14:28

<- Back to: News Archiv