The Decentralized Procedure (DCP)

There are many different organizations involved in the authorization procedures for medicinal products. On the basis of a single application, the Decentralized Procedure (DCP) is one of three ways to acquire regulatory approval to market medicinal products in several member states of the European Economic Area. Learn all about the application process and the DCP as a whole.

The Decentralized Procedure is one of three routes available to applicants to gain multinational marketing authorization within the European Economic Area (EEA) on the basis of a single application. It can be used only for a product which has no existing marketing authorization in any member state. It is similar to the Mutual Recognition Procedure (MRP) but with earlier involvement of the Concerned Member States in the assessment by the Reference Member State. The Coordination Group for Mutual Recognition and Decentralized Procedures (CMD) provides guidance and acts to facilitate agreement among the participating states.

This course describes the roles of the various players in the procedure, the sequence and duration of the stages involved, and the requirements on content, format and timing of submissions. It discusses the special issues that apply to generic products in the DCP. It is primarily aimed at regulatory affairs professionals dealing with marketing authorisation applications and related submissions for regulatory approval in Europe. More generally, it will also be of interest to all those involved in the development and registration of medicinal products.

The course will cover:

• Introduction to the Decentralized Procedure – Background information on the Decentralized Procedure. It covers products for which the DCP can be used, the types of Marketing Authorisation Application, and the characteristics of the application procedure.
• DCP Step 1 –The pre-procedural step and the first assessment stage of the DCP, as far as day 120.
• DCP Step 2 –The second assessment stage and the final step of issuing national licenses. Referral of issues to the CMD, and the arbitration process, are also covered.
• Generics and the DCP – An introduction to generics and the special issues facing generics in the DCP.

Learn:

• Basics of the Decentralized Procedure (DCP) process
• The pre-submission and submission criteria and important deadlines
• The three ways to obtain approval to market medicinal products to member states.
• The importance of the applicant, Concerned Member States, the Reference Members State, and the Coordination Group for Mutual Recognition and Decentralized Procedures-Human (CMD(h), and other regulatory authorities
• The difference between the many organizations involved in authorization procedures in Europe