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.
As there recently has been a decrease in the number of requests the following changes will be introduced as of 1 April 2011:
- requests for time slots with Sweden as RMS in a DCP can be made 4 times a year, see time schedule below, in order for the MPA to accept the majority of requests and to facilitate resource allocation.
- requests should be submitted at least 3 months before planned submission.
- companies can sign up for a mailing list in order to be notified if slots become available due to e.g. cancellations.
In addition, the HMA (Heads of Medicines Agencies) has started an 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)
From 1 November 2011 to 30 November 2011, the Medical Products Agency (MPA) is open for RMS requests for DCP applications to be submitted earliest February 2012.
- 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 reach the MPA between the 1 November 2011 and 30 November 2011.
- The enclosed form must contain all relevant details. The applicant is requested to consider number of Concerned Member States and how many duplicate applications, if any, will be included in the procedure.
- The MPA will reply to the request as soon as possible but no later than 31 December 2011.
- 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.
Time schedule for requests
The applicant is asked to request the MPA to act as RMS at least 3 months before planned submission. The agency will open up for requests 4 times a year, according to the following schedule:
|
Request to be submitted |
Response from MPA at the latest |
Application to be submitted earliest |
|
1-30 November 2012 |
31 December 2011 |
February 2012 |
|
1-31 January 2012 |
29 February 2012 |
April 2012 |
| 1-30 April 2012 |
31 May 2012 |
July 2012 |
| 1-31 August 2012 |
30 September 2012 |
November 2012 |
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 it can occur that we receive more requests than we are able to handle within the stipulated time table for the decentralised procedure.
When reviewing the submitted requests a number of aspects will be considered, among those are:
- Optimisation of resource allocation within the EU, i.e. a generic application is primarily assessed by the Rapporteur/Reference Member state for the reference product.
- Available expertise within the agency.
- To what extent the product meets unmet medical needs.
The website will be updated when new information becomes available.