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EMA: The linguistic review process of product information in the centralised procedure - Human

07.02.2011
A linguistic review of product information in all EU languages is performed after the adoption of CHMP Opinions to ensure high quality and consistent product information of Centrally Authorised Products (CAPs) in all Member States. Such post-opinion product information linguistic review is part of the Commission Decision-Making Process (DMP) as outlined in Articles 9 and 10, and Articles 34 and 35 of Regulation (EC) No 726/2004, as well as in Articles 20 and 23 of Regulation (EC) No 1234/2008. The timeframes apply to initial Marketing Authorisation applications as well as to relevant post-authorisation procedures. The timeframes refer to calendar days, not working days. This document presents the product information linguistic review process within the DMP timeframes and provides details on its practical implementation.