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Changes in the submission of marketing authorisation documentation

08.07.2015.
 

Changes in the submission of marketing authorisation documentation

European Medicines Agency (EMA) informs that from 1 July 2015 marketing authorisation holders should send their centralised procedure applications for human medicines to the EMA via eSubmission Gateway/Web Client only. These applications companies should not sent to national agencies of European Union, including the State Agency of Medicines (SAM), on CDs/DVDs or via the Common European Submission Platform (CESP). Read more