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

 

Annotated QRD/CMDv PI template

 

Language versions of CMDv templates for product information
Download editable version

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