European Public Assessment Reports

A European public assessment report (EPAR) is published for every human or veterinary medicine application that has been granted or refused a marketing authorization. This follows an assessment by the EMA of an application submitted by a pharmaceutical company in the framework of the Central authorization of medicines.
An EPAR provides public information on a medicine, including how it was assessed by the EMA.
The EPAR is referred to in Article 13(3) of Regulation (EC) No 726/2004, which requires the EMA to publish a public assessment report for each centrally authorized medicine together with a public-friendly summary.
The EMA has developed the EPAR concept over time to ensure that it delivers a usable, transparent and appropriately detailed body of information. The EPAR content and structure have therefore evolved over time and may be further developed in future.
An important role of the EPAR is to reflect the scientific conclusions of the relevant EMA committee at the end of the assessment process, providing the grounds for the committee opinion on whether or not to approve an application.
Under the centralized authorization procedure, pharmaceutical companies submit a single marketing-authorization application to EMA. This allows the marketing-authorization holder to market the medicine and make it available to patients and healthcare professionals throughout the EU on the basis of a single marketing authorization.
EMA’s Committee for Medicinal products for Human Use (CHMP) or Committee for Medicinal products for Veterinary Use (CVMP) carry out a scientific assessment of the application and give a recommendation on whether the medicine should be marketed or no.
An orphan designation allows a pharmaceutical company to benefit from incentives from the European Union to develop a medicine for a rare disease, such as reduced fees and protection from competition once the medicine is placed on the market. Applications for orphan designation are examined by the COMP, which adopts an opinion that is forwarded to the European Commission. The European Commission then decides whether to grant an orphan designation for the medicine in question.