DCP with Sweden as RMS

The Swedish Medical Products Agency participates actively in the decentralised procedure as reference member state (RMS) and has since the start received a high number of requests for time slots. As from 1 February 2009 a new procedure for requesting time slots was introduced, in order to better schedule expected applications and optimising the use of our resources. This procedure is continuously reviewed and revised in accordance with the number of requests received.

As of 1 March 2012 we are once again making some changes to the procedure of requesting time slots. These changes mean that a request for the MPA to act as RMS in a DCP can be submitted at any time and is no longer limited to certain time periods. 

The HMA (Heads of Medicines Agencies) has already taken initiative to reach a common approach towards addressing the issues of resources for assessment of applications and differences in policies of allocating time slots. A result of this initiative is the common RMS request form.

Request for time slot for applications via the Decentralised Procedure (DCP) with Sweden as Reference Member State (RMS)

A request for the MPA to act as RMS in a DCP can be submitted at any time and is no longer limited to certain time periods. In order to optimize the use of our resources and to be able to accept as many applications as possible, the request should be submitted at least 3 months before planned submission.

  • The request should be made by filling in the request form, which can be found on the right hand side, under the heading Related information.
  • The request should be sent by email only to registrator@mpa.se. Please include the following text in the heading of the email: DCP RMS request.
  • The request should be submitted to the MPA at least 3 months before planned submission.  
  • The enclosed form must contain all relevant details. The applicant is requested to consider the number of Concerned Member States and how many duplicate applications, if any, that will be included in the procedure.
  • The MPA will reply to the request as soon as possible but no later than 3 weeks upon receipt.
  • Applicants who receive a confirmation for a time slot must be prepared to keep the submission deadline and notify the MPA as soon as possible in case of a delay.

Mailing list for information on available slots

In order to optimise the use of our resources companies can sign up to receive information through email when the MPA has available slots due to e.g. cancellations. Since we accept requests 3 months before planned submission this would only apply to slots being available with short notice. In order to sign up for this mailing list please send an email to DCP-RMS-booking@mpa.se and include “DCP RMS mailing list” in the heading of the email.
 

Other considerations

As the resources of the MPA are limited we may receive more requests than we are able to handle within the stipulated time table for the decentralised procedure. If that occurs a number of aspects will be considered when reviewing the submitted requests, among those are:

  • Available expertise within the agency.
  • Optimisation of resource allocation within the EU, e.g. a generic application should primarily be assessed by a Member state in which the reference product is authorised.
  • To what extent the product meets unmet medical needs.

The website will be updated when new information becomes available.


 

 

 
 
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information