Centralised Community Procedure

(EU) Process used to submit new biologics intended for human use to the EMEA for marketing approval. Medicinal products developed by biotechnological means (Part A products), have been required to use the Centralised Procedure since its inception. Other medicinal products (Part B products) have had the option to use it. But the regulations have changed, and now all products that contain new active ingredients, derived from biotechnology or not, must follow the Centralised Procedure. (See "Submitting New Drugs and Biologics in the European Union.").