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

• Explanatory Note: Pilot on Combined Label-Leaflet Template
• Particulars to appear on the immediate package - combined label and package leaflet
• Comment form | Word

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. 

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)

Please find other language versions of the template on the following EMA website:

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

QRD combined label-leaflet template version 9

QRD combined label-leaflet annotated template (English) version 9 (pdf) (April 2022)

QRD combined label-leaflet annotated template (English) version 9 (word) (April 2022)

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.

Implementation plan

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