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 (EU) languages plus Icelandic and Norwegian, and defines the format and layout for the product information.

New: On 31 January 2019 the European Medicines Agency (EMA) published draft key principles for the development and use of electronic product information (ePI) for medicines for human use in the EU. Stakeholders and members of the public can submit comments using an online form until 31 July 2019

Exploring how electronic or digital means can be used to improve accessibility to medicines' information is one of the key areas in EMA's action plan to improve the product information for EU medicines, published in November 2017:

This followed a report from the European Commission in March 2017 concluding that, despite ongoing efforts to make product information easy to read and useful, there is a need to improve how information on medicines is conveyed to patients and healthcare professionals.

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

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