Overview
Accessing the European market requires navigating the European Medicines Agency (EMA) and its centralized procedure. We guide you through the specific requirements of the MAA, including PIPS, eligibility requests, and the Rapporteur/Co-Rapporteur appointment process.
Key Features
Centralized Procedure management
SmPC and PIL development
Rapporteur interaction strategy
Response to Day 80/120 questions
Our Process
1
Eligibility
Confirming access to the Centralized Procedure.
2
Pre-Submission
Meeting with EMA and handling administrative steps.
3
Review Management
Coordinating responses to the CHMP's assessment.
Project Complete & Deliverables Provided
Frequently Asked Questions
The standard assessment timeline is 210 days, but this excludes clock stops. At Day 120 and Day 180, the clock stops while you respond to CHMP questions—typically 3-6 months per clock stop. After a positive CHMP opinion (around Day 210), the European Commission has 67 days to issue the marketing authorization. Total time from submission to approval is typically 12-15 months.
Why Choose Us
- Single license for all EU member states
- Streamlined assessment process
- Access to 450 million patients
- Harmonized labeling
Get More Details
Request a personalized consultation and detailed information about this service.
Personalized consultation
Detailed service information
Custom timeline & proposal
We'll respond within 24 hours
Ready to get started?
Contact our team to discuss your specific needs for EMA Marketing Authorization (MAA).
Schedule ConsultationWhat Our Clients Say
"The Day 120 questions were extensive—over 200 items. Adelphi helped us prioritize, draft clear responses, and negotiate which studies were truly necessary. We received a positive CHMP opinion on the first cycle."
Dr. Hans Mueller
Head of EU Regulatory
Global Pharmaceutical
Related Services
Explore other ways we can support your regulatory needs