Finalisation of MRP variations type I without notification

Information for marketing authorisation holder.   

As of October 14, 2009 the applications for MRP variations type I where the variation will not be reflected in the text - SmPC, PIL and package, will be administered without notification. This refers only to variations where the Czech Republic is a concerned member state i.e. CMS. This refer also applications that had been filed within the given date and have not been proceeded by SUKL so far. The date of finalisation of variation to marketing authorisation shall be considered the date of finalisation of the procedure by the reference member state.