Changes in procedure for requesting Sweden as RMS in DCP
Tuesday, April 05, 2011
The Swedish Medical Products Agency participates actively in the decentralised procedure (DCP) 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 some changes will be introduced as of 1 April 2011.
In summary the changes made to the procedure for requesting time slots with Sweden acting as RMS in the decentralised procedure are:
- requests for time slots with Sweden as RMS in a DCP can be made 4 times a year 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.
For more detailed information, see link under the heading Related information.