CRED ERP 25

Key Points: • Centralised Procedure is mandatory when requesting MA’s for certain medicinal products. • The European Medicines Agency (EMA) plays a key role in the coordination of the evaluation of applications. • The Committee for Medicinal Products for Human Use (CHMP) is the EMA ’s committee responsible for human medicines and conducts the assessment of CP applications. A rapporteur and co-rapporteur are allocated to perform assessment of the submitted application and the other CHMP members may comment on these assessment reports. A PRAC rapporteur is appointed assessing Risk Management Plan (RMP). The PRAC rapporteur should be from another MS that the CHMP rapporteurs. • Summary: 1 Application, 1 Market Authorisation, 1 set of Product Information (all EU official languages) for all EU markets.

Centralised Procedure flow chart: