SPC, Labelling and Package Leaflet

Processing of SPC, Labelling and Packaging

Best Practice Guide for the processing of SPC, Labelling and Package leaflet and the preparation of Multilingual/-country Packaging provided in support of MRP/DCP/SRP and Variations

Submission of high-quality national translations

QRD guidance on the use of approved pictograms on the packaging of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP) and decentralised procedures (DCP)

Additional national requirements on labelling/package leaflet for products authorised via national, mutual recognition, decentralised or centralised procedures - to be developed

 

Packaging

Recommendations on labelling and packaging of veterinary medicinal products

 

CMDv Information Release 20.12.16 - Pilot on Combined Label-Leaflet Template

 

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.

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)