According to a specific reference, EC approval refers to a particular process for bringing a product to market within the European Union.
Understanding the Definition
Based on the provided reference, EC APPROVAL is defined as:
Approval of a Product for marketing in the European Union by the European Commission ("EC"). This approval is granted under specific conditions:
- Centralized Route: Upon recommendation by the EMEA.
- Mutual Recognition Route (Specifically for Lilly): If Lilly seeks approval through mutual recognition, the approval can be granted by the Ministry of Health of certain Major European Countries, including:
- United Kingdom
- France
- Germany
- Italy
- Spain
This definition outlines two potential paths for obtaining this specific EC approval for a product intended for the EU market.
