Decentralised procedure

Published: November 29, 2019
Last updated: February 27, 2025

In the decentralised procedure (DCP), the medicinal product is not previously approved for the applicant in the EU nor Iceland, Liechtenstein and Norway. Applicants choose to which countries they want to submit their application and which one of these should take responsibility as the Reference Member State.

Reference Member State

The main assessment of an application in DCP is carried out by the national authority which has accepted the applicant’s Reference Member State (RMS) request. Other countries included in the procedure will be Concerned Member States (CMS). An application in DCP is only submitted after a time slot has been agreed by the prospective RMS and applicant.

The total assessment time shall not exceed 210 calendar days. Applicants are given the opportunity to supplement their application based on the questions raised by RMS and CMS. The applicant prepares the response during a so-called clock-stop, which is not included in the assessment time. If the applicant answers all questions satisfactorily and the benefit-risk balance is judged to be positive, all countries involved agree upon approval before end of procedure. In cases where the assessment is negative and the procedure will end in rejection, the applicant may choose to withdraw the application.

Sweden as RMS in a DCP

The Swedish Medical Products Agency (Swedish MPA) continuously receives requests to act as RMS for applications in DCP.

From 1 March 2025, the Swedish MPA will be accepting slot requests with Sweden acting as Reference Member State in the Decentralised procedure (RMS DCP) for October 2025 – December 2025.

Information about booking slots for January 2026 or later will be published on our website and via our regulatory newsletter at a later stage.

Please note that this does not apply to veterinary DCP applications.

The form is sent via email to registrator@lakemedelsverket.se.
Write "DCP RMS request" in the header of the email.
Applicants who want to request slots for more than one product should send one email for each request – do not include multiple slot requests in a single email.
All requests will be answered as soon as possible but no later than three weeks after the request was received.
Applicants who have been notified that the MPA will act as RMS for their application must be able to keep the planned submission date and inform the agency immediately if there are delays.
Please note that a confirmed DCP-slot is for a specific product and it’s not possible for the applicant to change the slot for another product.

Form - Sweden as RMS in a DCP

Assessment of requests

The Agency's resources are limited, and there may be more RMS requests than we can handle for a certain time slot. In these cases, a number of factors may need to be taken into account when assessing requests received.

The focus is on:

The availability of assessors in the relevant areas of expertise.
Working for optimal resource utilisation in the EU, e.g. that a Member State with an existing registration for a reference product will assess future generic applications.
The extent to which the product is important for Swedish patients.

Sometimes slot cancellations come at short notice. Applicants may therefore in their request state a wish to submit their application earlier than three months after the request was made. As we normally accept requests three months before the submission date, this will mean submissions in slots that become available will have to be made at short notice.