What is the Decentralized Procedure?

What is the Decentralized Procedure (DCP)?

The Decentralized Procedure (DCP) of the European Medicines Agency (EMA) is a regulatory approach within the European Union (EU) designed to grant approval for medicinal products that have not previously received EU authorization. It allows pharmaceutical companies to apply for simultaneous marketing authorization (MA) in many EU Member States via one single application. Through this method, manufacturers can seek simultaneous approval in multiple EU member states. This pathway streamlines the approval process to support timely medicine access across member states.

Overview of the Decentralized Procedure

A pharmaceutical company submits an MA application to a Reference Member State (RMS), who leads the product evaluation. The RMS is typically selected by the MA applicant and is the EU Member State where the pharmaceutical company has its headquarters, or where it plans to launch its product first. The RMS facilitates the application assessment and communicates between other Member States or Concerned Member States (CMS).

The RMS conducts the initial assessment and produces a draft report with product details. The report includes details on the product's Summary of Product Characteristics (SPC), labelling, and the package leaflet. The CMS then reviews the assessment conducted by the RMS and can either agree with it or raise further questions and objections.

If all issues are resolved, the RMS updates the assessment report and submits to EU Member States for national decision making. This report submission also includes agreements related to labelling and product information. Each member state decides whether to grant national marketing authorization for the product or not based on the documentation. This procedure ensures that the application evaluation incorporates the requirements of multiple EU countries.

Timelines for Decentralised Procedure

The first assessment phase after the submission of the MA application to the RMS takes up to 120 days. This includes the collaboration between the RMS and CMS for compiling a draft assessment report.

The Coordination Group then must resolve issues and finalize documentation by day 150.

The finalized report with agreed documentation is submitted to all member states for national decision-making. The goal is the complete the DCP procedure within 210 days. However, the timeline may vary depending on the complexity of the application or requirement for additional information.

DReg’s Capabilities

Authoring, compilation, and review of MAAs for submission to EMA and other EU competent authorities

Preparing responses to agency queries

QPPV support for EEA region

Marketing Authorization Holder (MAH) services for EEA region

Developing robust regulatory strategy for products through centralized procedure

Post approval lifecycle management including variations, change controls, renewals for MAA