The "Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human" (CMDh) as part of the "Heads of Medicines Agencies" coordinates both the implementation of the mutual recognition procedures and of decentralised procedures in the case of marketing authorisations of drugs. It also cares for the questions regarding the "Variations Regulation" (EC) 1234/2008, which came into force on 1 January 2011. This regulation has been completed by two "Supporting Guidelines". In these documents, you can find the reformed rules affecting the submission of variations applications and their treatment by the regulatory authorities. However, real complex questions may still arise and the answers are not necessarily to be found directly in the texts of the regulation and the guidelines. The CMDh has therefore published an updated Q&A document on its website which provides answers to different complex matters concerning the submission of variations and their classification.
In the following, two questions and their respective answers are given as example:
Is an update of the overall summary necessary for any kind of type II variations?
Yes, the updated overall summary has to be submitted together with the other amended data as necessary documents with every type II variation application.
When do I have to submit national translations for a variation procedure?
For Type IA and Type IB variations the national translation(s) have to be submitted together with the application. For Type II variations national translation(s) have to be submitted within five days after the end of the procedure.
To find further helpful information please see the Q&A List.
During the ECA Conference "Change Control - New aspects and best practices" in Vienna, Austria, on 10/11 March 2011 you will get to know the aspects of the new European changes procedures and of the classification of changes.
On the ECA Course "Handling Changes and Variations" in Prague, 10/11 May 2011 you will get first-hand information from industry and authority representatives on how to efficiently submit and process variations within the new Variations Regulation.
Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)