The European Medicines Agency (EMA) has created a menu on its website dedicated to the topic "Variations". In the submenu "Improving quality of submissions" you can find a checklist which is supposed to help marketing authorisation holders to compile the complete documentation needed for submissions of type IA and IAIN variations. The text on the website gives the explanation why the publication of this so called "pre-notification checklist" has been considered necessary. In the past, the EMA has been receiving several type IA and IAIN variation notifications which were incorrect or incomplete. The Agency strongly recommends that applicants use the checklist before they send their variation notification in order to save time and avoid unnecessary questions and to facilitate an efficient processing of the variation procedure.
The checklist has been created on the basis of the incorrect variation notifications that have been submitted so far. The new Variations Regulation (EC) No 1234/2008 entered into force on the 1st January 2010. It hasn't been so long now and variation notifications still need to be improved. The checklist certainly offers precious help for applicants who have to compile documents for a variation notification under time pressure.
Please go to the checklist for the details.Note: variations in marketing authorisation dossiers will be a main topic in the ECA Education Course "Handling Changes and Variations" in Prague, Czech Republic, from 10-11 May 2011.
Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)