Decentralized Procedure (DCP) – Overview
The Decentralized Procedure (DCP) enables applicants to submit a single Marketing Authorization Application (MAA) to multiple European Union (EU) member states simultaneously. This procedure promotes harmonized evaluation and approval of medicinal products across the EU, streamlining the regulatory process and ensuring consistent outcomes.
If an applicant seeks authorization in multiple EU member states and has not previously obtained approval, they can request one EU member state to act as the Reference Member State (RMS), while other selected member states serve as Concerned Member States (CMS). The RMS coordinates the evaluation, and the review cycle typically spans 210 days, including a 30-day national phase to translate product information into the respective regional languages.
LoreX Pharma Plus leverages in-house expertise in generic medicinal product submissions via the DCP to assist manufacturers in:
- Streamlining DCP submissions for timely approval.
- Providing legal/local representative services for applicants without EU establishments.
- Liaising with regional Health Authorities (HAs) to efficiently address queries and facilitate a smooth review process.
Decentralized Procedure (DCP) – Services
“Enables simultaneous marketing authorization in multiple EU member states for medicines not yet approved in the EU.”