Procedural advice on the accelerated assessment of marketing authorisation applications pursuant to Article 44 (3) of Regulation (EU) No 2019/6

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Table of Contents

• 1. Introduction 2
• 2. General considerations 2
• 3. Scope 2
• 4. Legal basis 3
• 5. Steps and timing of submission of a request for accelerated review 3
• 5.1. Notification of intent to submit a request for accelerated assessment 3
• 5.2. Pre-submission dialogue with the European Medicines Agency (EMA) 3
• 5.3. Request for an accelerated assessment procedure 4
• 5.3.1. Justification for a request for accelerated assessment 4
• 5.4. CVMP assessment of the request for accelerated assessment 5
• 6. Accelerated assessment of the marketing authorisation application 5
• 6.1. General considerations 5
• 6.2. Possible switch to normal timetable 6
• 7. Timelines (examples) 6
• 7.1. Pre-submission phase 6
• 7.2. Accelerated assessment procedure 7
• References 8