SPC, Labelling and Package Leaflet

Processing of SPC, Labelling and Packaging

Submission of high-quality national translations
updated November 2017, clean

Submission of high-quality national translations
updated November 2017, track changes

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


Packaging

 

Language versions of CMDv templates for product information
Download editable version

bălgarski (bg)
čeština (cs)
dansk (da)
deutsch (de)
eesti keel (et)
elliniká (el)
english (en)
español (es)
français (fr)
Íslenska (is)
italiano (it)
latviešu valoda (lv)
lietuviu kalba (lt)
magyar (hu)
malti (mt)
nederlands (nl)
norsk (no)
polski (pl)
português (pt)
româna (ro)
slovencina (sk)
slovenšcina (sl)
suomi (fi)
svenska (sv)