European Public Assessment Report
« Back to Glossary IndexA 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.
EPARs are published on the EMA’s website once the European Commission has issued a decision regarding a marketing authorisation.
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