CRED ERP 25

07/07/2025

New Marketing Authorization Application 'S In The Centralised Procedure

SAHANA RAJASHEKAR

Senior Regulatory Affairs Specialist II

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals in Regulatory Affairs

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CENTRALISED PROCEDURE

The Centralised Procedure (CP) for Marketing Authorisation Applications (MAAs) in the EU is designed to streamline the approval of medicines across all EU/EEA countries with a single application, evaluation, and decision by the European Commission . While this procedure has clear regulatory intent and advantages, the "Theory versus Reality" perspective highlights gaps between expectations and real world challenges.[1] AUTHORIZATION OF MEDICINE All medicines must be authorised before they can be marketed and made available to patients. In the European Union (EU), there are two main routes for authorising medicines: a centralised route and a national route.[1] ● Under the centralised authorisation procedure, pharmaceutical companies submit a single marketing authorisation application to EMA.This allows the marketing-authorisation holder to market the medicine and make it available to patients and healthcare professionals throughout the EU on the basis of a single marketing authorisation. However, under EU law EMA has no authority to actually permit marketing in the different EU countries. The European Commission is the authorising body for all centrally authorised product, who takes a legally binding decision based on EMA's recommendation. This decision is issued within 67 days of receipt of EMA’s recommendation. [1] ● CENTRALISED AUTHORISATION PROCEDURE

Once granted by the European Commission, the centralised marketing authorisation is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway.[1]

The Organisation for Professionals in Regulatory Affairs

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