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

 

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.

Implementation plan

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

 

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.

Applicants should use template v.9 for presenting the product information for all initial marketing authorisation applications validated on or after 28 January 2022. 

QRD veterinary product information annotated template (English) version 9 (pdf) (July 2021)

QRD veterinary product information highlighted template (English) version 9 (word) (July 2021)

QRD veterinary product information template (English) version 9 (word) (July 2021)