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Public Assessment Reports for medicines

The Public Assessment Reports provided are compiled and edited in accordance with EC Directive 2004/27/EC.

In accordance with this Directive, the MHRA makes the assessment reports available for all new licences granted after 30 October 2005, albeit with commercially or personally confidential information removed.

The compilation and editing of the original assessment reports into the Public Assessment Reports are performed by experienced medical writers. The draft copies of the Public Assessment Reports are then checked by medical, pharmaceutical, and, if necessary, preclinical and statistical assessors. The assessment reports are amended to incorporate any assessors’ comments. Before being made available to the public, all Public Assessment Reports are sent to the Marketing Authorisation holder (or a designated person of their choice) for comment.

Latest Public Assessment Reports


Page last modified: 20 December 2005