Product-information requirements

The European Medicines Agency (EMA) provides guidance and templates to provide marketing authorisation applicants with practical advice on how to draw up the product information for human medicines, which includes the summary of product characteristics, labelling and package leaflet. EMA's guidance 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.

EMA's guidance is 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.

Update: Guidance is available on flexibilities to help developers of COVID-19 vaccines prepare and roll out packaging and labelling for their vaccines quickly. It includes practical advice on exemptions to some requirements that are possible, while keeping in line with regulatory requirements:

The guidance aims to facilitate the large-scale and rapid deployment of COVID-19 vaccines within the EU.

It provides details further to the European Commission's memorandum of Understanding (MoU) with Member States on regulatory flexibility for COVID-19 vaccines.

Electronic product information initiative

In January 2020, EMA, the Heads of Medicines Agencies (HMA) and the European Commission published key principles to guide the development and use of electronic product information (ePI) for human medicines in the EU:

The development of electronic tools to improve access of patients and healthcare professionals to information on medicines is one of the key recommendations in a 2017 report from the European Commission and EMA's subsequent action plan to improve the product information for EU medicines:

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