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edited by AIFA’s Office of Osmed and HTA

Glossary


EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
The European Public Assessment Report (EPAR) is a scientific report made available on the EMEA website which reflects the scientific evaluation, discussion and conclusion reached by the Committee for Medicinal Products for Human Use (CHMP) at the time of opinion of a centralised procedure for a marketing authorisation application. The legal basis for the EPAR is contained in Article 13(3) of Regulation (EC) No 726/2004 and it is made available for information to the general public, after deletion of commercially confidential information. The EPAR is updated regularly throughout the marketing lifecycle of a product as changes to the original terms and conditions of the authorisation (i.e. variations, pharmacovigilance issues, specific obligations) are made. The EPAR is accompanied by a summary EPAR, which provides a short description of the main attributes of the product and is written in lay language that is understandable to the general public.
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