Decentralised Procedure (DCP) Infographic Regulatory Affairs Asphalion

Process Timetable of a Decentralised Procedure (DCP) in EMA

The decentralised procedure (DCP) is the European Union-wide procedure for authorising medicines in more than one European Union Member State in parallel.

The decentralised procedure (DCP) is the European Union-wide procedure for authorising medicines in more than one European Union Member State in parallel.
July 19, 2021

What is a Decentralised Procedure?​

The decentralised procedure (DCP) is the European Union-wide procedure for authorising medicines in more than one European Union Member State in parallel. It can be used for medicines that do not need to be authorised via the centralised procedure and have not already been authorised in any Member State.

The decentralised procedure falls under the Directive 2004/27/EC of the European Commission.

 

The Process Flow of a Decentralised Procedure (DCP)

In the decentralised procedure, the applicant chooses one country as the reference Member State when making its application for marketing authorisation.

The process of a DCP is quite challenging and there are a lot of timelines to be met. As the chart shows, the process starts with the Pre-submission step that encompasses all application and pre-procedural formalities. Once the analysis is done, RMS starts the procedure, and the days’ count down starts. ​

​It is important to bear in mind that the Decentralised Procedure flow comprises up to 270 days in total, plus a closing time of 30 days.

In the final steps, the marketing authorisation in all chosen Member States is received simultaneously, enabling simultaneous marketing of the medicine and reducing the administrative and regulatory burden.

 

Experts in Decentralised Procedures (DCP) in Europe

At ASPHALION we are experts in Decentralised Procedures (DCP) in Europe, and have successfully submitted over 80 DCP. We have over 20 years of experience advising on Global Regulatory Submissions, liaising with agencies, and resolving all potential hurdles.​

We have summarized all Decentralised Procedures (DCP) steps in this flow chart for you to download and keep always at hand.

DOWNLOAD HERE

For further information you can contact us at: info@asphalion.com

Search News & Events

  • Filter by category

Share

Related news and events

EVENT | 20th Biosimilar Medicines Conference by MFE

During these two interactive days, actors of the healthcare community alongside world experts in biosimilar medicines will gather and debate the evolving biosimilar medicines landscape and emerging trends. Discussion will focus on sharing good practices and setting collective aims to achieve the depth, breadth and speed of the use of biosimilar medicines as a lever to untap their transformative value.

New opening! | Pamplona office

At Asphalion, we are thrilled to announce the opening of our new office in Pamplona! This strategic decision reflects our commitment to being closer to

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting