Processing of SPC, Labelling and Packaging
Additional national requirements on labelling/package leaflet for products authorised via national, mutual recognition, decentralised or centralised procedures - to be developed
CMDv Information Release 20.12.16 - Pilot on Combined Label-Leaflet Template
QRD/CMDv product information template
QRD/CMDv product information template version 9
EMA has published version 9 of the product information template supporting the requirements of Regulation (EU) 2019/6 which applies from 28 January 2022.
Applicants should use template v.9 for presenting the product information for all initial marketing authorisation applications validated on or after 28 January 2022.
Please find other language versions of the template on the following EMA website:
QRD combined label-leaflet template version 9
National translations of the combined label and leaflet template can be found on the EMA website.
QRD template v8.2 is revised to specify Northern Ireland in the list of local representatives at the end of the package leaflet.