EMA Pre-authorisation guidance
Table of contents
These questions and answers (Q&As) provide an overview of the European Medicines Agency's (EMA) advice on issues that are typically addressed in discussions or meetings with marketing authorisation holders in the application phase.
PDF versions of Q&As
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: Document with tracked changes
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