EU CMDh introduces pilot phase for Type IA "supergrouping"

The EU Co-ordination Group for Mutual Recognition and Decentralized Procedures - Human (CDMh) has announced a 6-months pilot phase starting on 1^st August 2011 allowing marketing authorisation holders to submit grouped type IA variations including more than one Reference Member State (RMS) and to give instructions to marketing authorisation holders for the submission of such variations (see CMDh meeting report from July 2011). (Note: Up to now, grouping of type IA or IA_IN variations of different Marketing Authorisations (MA) in acc. to article 8 of Commission Regulation (EC) No 1234/2008 was to be performed per RMS - in case different RMS were assigned in the application procedures of the individual MAs).

The corresponding CMDh "Best Practice Guide for the submission and processing of variations in the Mutual Recognition Procedure" has already been updated to revision 14 correspondingly. The updates concern exclusively chapter 6 of the Best Practice Guide dealing with the submission of grouped variation applications. 

According to this, an applicant that intends to submit a grouped application with variations of type IA or IA_IN or a grouped variation of type IA/IA_IN for a group of products with different RMS has to choose a "Lead"-RMS for this grouped application and to request his acceptance to act as this. The "Lead"-RMS coordinates the following so-called "supergrouping" procedure. The exact procedure, including documentation requirements and flowchart is detailed in the updated chapter 6 of the revised Best Practice Guide, which is available for download in "clean" and "track-change" format from the CMDh website.

[Source: CMDh website]

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