5. European Public Assessment Report (EPAR)

An EPAR is not a single document but consists of several information components, including a core set of regulatory documents. EPARs are shown on the EMA website and the individual components can be viewed online, downloaded and/or printed.

However, some of the information is regarded as confidential and is not included, like detailed information on the manufacturing of a medicine.

EPARs are updated periodically to reflect the latest regulatory information on medicines. If the original terms and conditions of a marketing authorisation are varied, e.g. through changes in the benefit-risk balance, a new indication of an already authorised medicine, the EPAR and consequently SmPC, Labelling and PL are updated to reflect such changes.

The below figure (Fig. 5) provides an exemplary overview of the structure and content of an EPAR for ‘Brintellix’, displayed on the EMA website using four different sections containing different components of the EPAR.

To note: 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.

Figure 5: An example of the EPAR for the medicine ‘Brintellix’ taken and adapted from the EMA website, with content notes on the four components.
https://www.ema.europa.eu/en/medicines/human/EPAR/brintellix