SPC, Labelling and Package Leaflet

Processing of SPC, Labelling and Packaging

Additional information on labelling/package leaflet that may be required or permitted nationally in accordance with Articles 58 and 64 of Directive 2001/82/EC, as amended, is outlined in the document "Packaging 'blue-box' requirements in MRP/DCP" which can be found under 'General Information on Applications'.


CMDv Information Release 20.12.16 - Pilot on Combined Label-Leaflet Template


New QRD/CMDv product information template 

Update: QRD template v8.2 is revised to specify Northern Ireland in the list of local representatives at the end of the package leaflet.

Implementation plan

Annotated QRD/CMDv PI template and language versions of QRD/CMDv templates for product information