The templates are developed by EMA's Quality Review of Documents (QRD) group and are available in all EU official languages plus Icelandic and Norwegian. Applicants for centrally authorized medicines use them, and a related set of templates exists for national, mutual recognition and decentralized procedures. The current published version for centrally authorized medicines is 10.4, last revised to remove a reference to Northern Ireland under the Windsor Framework. Version 11, which focuses on making the package leaflet shorter and clearer, went through public consultation in 2025. Check EMA's page for the version currently in force.
Why it matters for labeling
The template drives the structure and wording of the leaflet and parts of the carton, and the product information has to be presented identically in every language. Artwork has to follow its headings and standard statements. When the template version changes, existing leaflets and labels may need to be updated to match, so it helps to know which version a document was built on.
Common mistakes
- Working from an old template version
- Changing standard headings or statements
- Language versions with a different layout or order
- Carton text that has drifted from the approved SmPC and leaflet