The EU Co-ordination Group for Mutual Recognition and Decentralized Procedures - Human (CDMh) has announced a 6-months pilot phase starting on 1st 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 IAIN 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.
For More information please click here: Exalon: EU CMDh introduces pilot phase for Type IA "supergrouping"
No comments:
Post a Comment