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European Medicine Agency

 This list of Questions and Answers (Q&As) has been drafted by the CMDh taking into account the European Commission's and EMA's Questions and Answers on the same issues within the framework of the centralised procedure. This version is a first update of the initial list of Q&As published on 31 May2017 and it replaces that initial list of Q&As. The new text introduced in this version of Q&As is indicated by the word "NEW". The Q&As may be further updated and complemented in the future.

Link to the document