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
- Explanatory Note: Pilot on Combined Label-Leaflet Template
- Particulars to appear on the immediate package - combined label and package leaflet
- Comment form | Word
National translations of the combined label and leaflet template can be found on the EMA website.
QRD/CMDv product information template
QRD template v8.2 is revised to specify Northern Ireland in the list of local representatives at the end of the package leaflet.
QRD/CMDv product information template version 9
UPDATE: EMA has published version 9 of the product information template supporting the requirements of Regulation (EU) 2019/6 which applies from 28 January 2022.
The English version is available now while other language versions will be available in October 2021 on the EMA website.