Centralized Procedure (CP) – Overview
The Centralized Procedure (CP) is a regulatory pathway used to obtain marketing authorization valid across all European Union (EU) member states.
Introduced in 1995, the CP has been mandatory for:
- Medicinal products manufactured using biotechnological processes.
- Orphan medicinal products.
- Human products containing a new active substance not authorized in the EU before May 20, 2004 (per Regulation (EC) No. 726/2004).
- Products intended for the treatment of AIDS, cancer, neurodegenerative disorders, or diabetes.
The CP is optional for:
- Products containing new active substances not authorized in the EU before May 20, 2004.
- Products representing a significant therapeutic, scientific, or technical innovation.
- Products requiring community authorization in the interest of patient or animal health.
Centralized Procedure (CP) – Services
“Enables a single EU-wide marketing authorization through the European Medicines Agency (EMA), ensuring harmonized approval for innovative and biotechnological products across all Member States.”