Product-information requirements

This section provides information on the linguistic aspects of the product information for human medicines, 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 guidance to provide applicants with practical advice on how to draw up the product information. However, it provides these without prejudice to:

• any final positions from the Agency, the Committee for Medicinal Products for Human Use (CHMP) or European institutions relating to the contents of the documents;
• the binding nature of the relevant legislation;
• any legal interpretations given by the European Commission or the Court of Justice of the European Union.

More information

• Product-information templates
• How to prepare and review a summary of product characteristics
• Exemptions to labelling and package-leaflet obligations
• Linguistic review
• Mock-ups and specimens
• Product information: Reference documents and guidelines