30 July 2012

Exalon: CMDh releases updated guidance documents regarding submission of variations

The Co-ordination Group for Mutual Recognition and Decentralized Procedures - Human (CMDh) has released some updated guidance regarding the submission of variations in accordance to Commission Regulation (EC) 1234/2008. 

The update concerns the corresponding Q/A list (document CMDh/132/2009) which has been released as revision 13, dated June 2012 (available as "clean version" and "track-change version"). Compared with revision 12, the update contains the following changes:

  • New Question 1.7 dealing with how changes in the SmPC/Labelling/PL should be identified when submitted with an applicant`s response: If such comments are made during the variation procedure a new version of the SmPC/Labelling/PL including all revised wording clearly identified, preferably using track-changes function should be provided. Note: It is not acceptable if the highlighted texts only identify the changes made in part of the variation procedure, e.g. since clock stop. Furthermore, it should be clear "what changes originate from the initial submission and what changes are proposed as a response to the received comments. The highlighted final texts circulated by RMS to CMS at the end of procedure should clearly identify all changes approved during the procedure" 
  • The response to Question 4.13 asking whether it is allowed to submit different class labellings agreed by PhVWP/CMDh as a grouped application has been transfered to the document "Examples for acceptable and not acceptable groupings for MRP/DCP products" which has been updated in parallel (see below)

To find more information please use the below mentioned weblink    


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