EMA common repository

Explanation

a solution that is hosted at the data centre of the EMA implemented within the context of the introduction of electronic submissions as part of the centralised human procedure for the marketing authorisation of medicinal products in the European market. It contains the entirety of electronic common technical document (eCTD) submissions submitted to the EMA in eCTD format in the context of the Centralised Procedure. The entire system is called European Review System (EURS). The Common Repository became available for NCAs in February 2014 and the use of the Common Repository became mandatory on 1 July 2015.

  • Abbreviation(s): EMA CR