New Best Practice Guides for the Submission and Processing of Variations published

As a part of the Heads of Medicines Agencies, the CMD(h) (Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human) is publishing a number of interesting documents. Besides the questions-and-answers sections, so called Best Practice Guides give valuable information regarding the point of view of the European registration and supervisory authorities. Now, the Best Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure has been updated.

Besides editorial changes, some further explanations have been added for example on pre-submission activities for a worksharing procedure.

For further details please see the document with tracked changes.

The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human, CMD(h), has been set up in the revised Pharmaceutical Legislation (Directive 2004/27/EC amending Directive 2001/83/EC) for the examination of any question relating to marketing authorisation of a medicinal product in two or more Member States in accordance with the mutual recognition procedure or the decentralised procedure. The CMD(h) has started its activities in November 2005 and replaced the informal Mutual Recognition Facilitation Group, which was in operation over 10 years, to coordinate and facilitate the operation of the mutual recognition procedure.

A Conference on Handling Changes and Variations on 10 - 11 May 2011 in Prague is intended to provide guidance on the provisions laid down in the new EU variation regulation and the supporting guidelines.

Wolfgang Schmitt
Concept Heidelberg (a service provider entrusted by the ECA Foundation)