EMA Pre-authorisation guidance (Human Regulatory)

EMA Pre-authorisation guidance

Table of contents

• 1. Types of applications and applicants
• 2. Steps prior to submitting the application
• 3. Preparing the dossier
• 3.1 Product name, product information and prescription status
• 3.2 Orphan and paediatric requirements
• 3.3 Quality
• 3.4 Compliance, environmental risk assessment and pharmacovigilance
• 3.5 Risk management plan (RMP)
• 4. Submission, validation and fees
• 5. Assessment of the application
• 5.1 Procedure
• 5.2 Inspections

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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