Art 61(3)-notification (MRP and national procedure)

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.  

 
 
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information