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.

Update: The European Medicines Agency (EMA) has published an action plan to improve the product information for EU medicines:

This follows 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.

One of the key areas of this plan is to explore how electronic or digital means can be used to improve accessibility to medicines' information.

EMA invited stakeholders to send an overview of initiatives on electronic/digital formats for the product information that they were aware of by end of February 2018.

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.

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