The European Centralized Procedure (CP)

To market a medicinal product, an organization needs marketing authorization from the appropriate regulatory authority. The Centralized Procedure is the pathway for obtaining this authorization, which allows for marketing across all countries in the European Economic Area (EEA). Learn about the functions and requirements of this process.

The Centralized Procedure (CP) is one of three routes available to applicants to gain multinational marketing authorization within the European Economic Area (EEA) on the basis of a single application. In the CP, one successful application leads to a marketing authorization being issued by the European Commission that applies throughout the EEA. The CP is mandatory for certain types of products.

This course describes the various players in the procedure, the sequence and duration of the stages involved, and the requirements on content, format, and timing of submissions. It is primarily aimed at regulatory affairs professionals dealing with marketing authorization applications and related submissions for regulatory approval in Europe. More generally, it will also be of interest to all those involved in the development and registration of medicinal products.

Learn:

• The basics of the Centralized Procedure (CP) process
• Learn what medicinal products qualify for the CP
• The different categories of the Marketing Authorization Application
• About the pre-submission/submission and validation criteria and other important components
• The basics of the fast-track CP process