European Public Assessment Report« Back to Glossary Index
A European Public Assessment Report (EPAR) is an assessment produced for all medicines where marketing authorisation is sought through the centralised procedure at the European Medicines Agency (EMA). It is a series of documents, and includes:
- a lay summary,
- details about the marketing authorisation holder,
- product information (such as the package leaflet and summary of product characteristics),
- details about the assessment carried out at EMA.