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.
For further information you can contact us at: [email protected]
