EMA Templates

The EMA (European Medicines Agency) provides information on the linguistic aspects of the product information for a medicine, which includes the summary of product characteristics, labelling and package leaflet. It explains the content that should be included in these documents, as well as standard headings and the most commonly used standard statements and terms in all official European Union languages plus Icelandic and Norwegian, and defines the format and layout for the product information.

The European Medicines Agency has developed these templates and glossaries to provide applicants with practical advice on how to draw up the product information.

The glossaries were created by manually processing these documents.

Names of EU-EEA countries (Version 27/01/2011)

Copyright of the source texts: © European Medicines Agency

Copyright of the glossaries: Siegfried Armbruster (siegfried.armbruster[at]gxp-language-services.com)

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