EMA Pre-authorisation guidance (Human Regulatory)

July 19, 2022

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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