Centralized Marketing Authorization

Centralized Marketing Authorization is a process allowing a pharmaceutical company to obtain approval from a single regulatory authority—such as the European Medicines Agency—to market a medicine across multiple countries within a region, like the European Union. This streamlined system means the company submits one comprehensive application, and upon approval, the medicine can be legally sold in all participating countries without needing separate approvals for each. It ensures consistent safety and quality standards across the region, simplifies the approval process for companies, and helps patients access new medications more efficiently.