European public assessment report

EMA provides public information on a medicine, including how it was assessed by EMA. This information is referred to as European public assessment report (EPAR) in Article 13(3) of Regulation (EC) No 726/2004, which requires EMA to publish a public assessment report for each centrally authorised medicine together with a public-friendly overview.

The detailed format and content of the public-friendly overview have been adapted and enhanced over time, but the main principles are set out in a reflection paper:

Reflection paper on European public assessment report summary for the public