Pre-authorisation guidance

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.

This guidance should be read in conjunction with the rules governing medicinal products in the European Union, volume 2, notice to applicants and pre-submission guidance documents.

New or revised Q&As are marked as 'New' or 'Rev.' with the relevant date.

If an issue is not resolved by the Q&As below, please send a question to the European Medicines Agency.

PDF versions of Q&As

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