Φαρμακευτικές Υπηρεσίες


The Decentralised Procedure (DCP) can be used to obtain a marketing authorisation for medicinal products which meet the following criteria:

(1) A medicinal product with exactly the same pharmaceutical, toxicological and clinical documentation is NOT already registered in the EEA with a National or MRP/DCP authorisation, and,

(2) the applicant for the marketing authorisation wishes to obtain a marketing authorisation for the same product in at least one other Member State.

The applicant selects one of the Member States participating in the procedure to evaluate the medicinal product΄s dossier and submits identical files to all Member States involved. The Member State that undertakes the evaluation of the medicinal product for both MRP and DCP procedures is known as the Reference Member State (RMS). The RMS evaluates the product and sends the assessment report to the other Member States involved in the process, known as Concerned Member States (CMSs).

Further detailed information on the MRP / DCP procedures, guidelines, timeframes and all necessary documentation and standards are available at the following CMDh (Coordination Group for Mutual Recognition and Decentralized Procedures) links.

· Decentralised Procedure Members States' Standard Operating Procedure

· Best Practise Guide for Decentralised and Mutual Recognition Procedures

and on the European Commission's website "EudraLex - Volume 2 - Pharmaceutical legislation on notice to applicants and regulatory guidelines for medicinal products for human use" https://ec.europa.eu/health/documents/eudralex/vol-2_en









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