A real-world walkthrough for biopharma companies pursuing EU market authorization.

Getting a product authorized in the EU is rarely straightforward. This case study shows how a company successfully navigated France's complex homeopathic MA requirements.

What you'll learn:

• How to confirm eligibility under Article 16(2) and French national provisions
• What a compliant CTD dossier looks like for homeopathic medicinal products
• How to leverage bibliographic evidence in place of conventional clinical trials
• Why Mutual Recognition and Decentralized Procedures don't apply here, and what to do instead
• How to anticipate ANSM requirements and avoid procedural pitfalls

Each section reflects real regulatory decisions, French-specific requirements, and practical strategies that led to a successful national MA.