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1.10.8 European Public Assessment Report

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EMA publishes detailed information on the medicines assessed by the Committee for Medicinal Products for Human Use (CHMP) and Committee for Medicinal Products for Veterinary Use (CVMP) which are granted (or refused) central marketing authorization by the European Commission. The main vehicle for this information is known as a European Public Assessment Report (EPAR), which is a full scientific assessment report of medicines authorized in the EU.

An essential 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 expert opinion on whether to approve an application.

EPARs are updated periodically to reflect the latest regulatory information on medicines. If the original terms and conditions of a marketing authorization are varied, the EPAR is updated to reflect such changes with an appropriate level of detail.

EPARs are a valuable source of information about innovator biologics and biosimilars.85

Biologics, Biosimilars, and Biobetters

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