Marketing authorisation

The European Medicines Agency (EMA) is responsible for the scientific evaluation of centralised marketing authorisation applications (MAA). Once granted by the European Commission, the centralised marketing authorisation is valid in all European Union (EU) Member States, Iceland, Norway and Liechtenstein.

In this section: general requirements for all applications

• Assessment templates and guidance
• Clinical data publication
• Compliance: marketing authorisation
• Data on medicines (ISO IDMP standards): marketing authorisation
• Fees payable to the European Medicines Agency
• Marketing authorisation guidance documents
• Obtaining an EU marketing authorisation, step-by-step
• Pharmacovigilance: marketing authorisation
• Pre-authorisation guidance
• Product-information requirements
• Submission dates
• The evaluation of medicines, step-by-step

In this section: particular application types

• Accelerated assessment
• Advanced therapies: marketing authorisation
• Biosimilar medicines: marketing authorisation
• Conditional marketing authorisation
• Generic and hybrid applications
• Medicines for use outside the European Union
• Orphan designation: marketing authorisation
• Paediatric medicines: Marketing authorisation