This section of the website provides information on submitting applications for marketing authorisation to the European Medicines Agency. It is intended for companies and individuals involved in developing and marketing medicines for human use in the European Union (EU).
- Presubmission guidance: questions and answers
- Generic / hybrid applications: questions and answers
- Similar-biological-medicine applications: questions and answers
- Assessment templates and guidance
- Templates for industry
- Submission dates
- Pre-authorisation regulatory and procedural guidance
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