05.04.2012

EU CMDh updates guidance documents for the submission of variations

Flag of EU

The Co-ordination Group for Mutual Recognition and Decentralized Procedures - Human (CMDh) has released updated guidance documents regarding the submission and processing of variation applications in MRP/DCP.

The update includes:

  1. CMDh BEST PRACTICE GUIDES FOR THE SUBMISSION AND PROCESSING OF VARIATIONS IN THE MUTUAL RECOGNITION PROCEDURE.
    This document is available as "clean" revision CMDh/094/2003/Rev16 and as "tracked" revision CMDh/094/2003/Rev15
  2. Q/A-LIST FOR THE SUBMISSION OF VARIATIONS ACCORDING TO COMMISSION REGULATION (EC) 1234/2008
    This document is available as revision CMDh/132/2009/Rev12 in "clean" and "tracked" version
  3. Table with additional data requirements of Member States for variations and renewals, revision CMDh/197/2010/Rev.2

[Source: CMDh website]







<- Back to: News

© 2007 - 2012 | Exalon GmbH | Fritz-Reichle-Ring 2 | 78315 Radolfzell | Germany | Phone: +49 (0)7732.939.1650 | Fax: -.1655 | e-Mail:info@exalon.com