Application concerning changes in PIL and labelling not resulting in a change in the SmPC.
An Article 61(3)-notification is used for changes in PIL and/or labelling which do not affect the SmPC.
For changes to the common English text for a MRP/DCP product the form “Article 61(3) Changes to patient information Notification form” should be used. For national changes, i.e. changes to a nationally approved product and translational issues etc. for MRP/DCP products, the form “Notification of change of the labelling-package leaflet, national change” should be used. Both can be found to the right.