10 January 2012

The Danish Medicines Agency: Information on time slots for DCP procedures with Denmark as Reference Member State (RMS)

The Danish Medicines Agency wishes to participate actively as Reference Member State (RMS) for applications going through the decentralised procedure (DCP).

In order to ensure that we can act as RMS in as many procedures as possible, we request that companies wishing to use Denmark as RMS contact us as far in advance as possible. This will enable us to schedule expected application submissions (the so-called time slots) in the best way possible and assist us in utilising our marketing authorisation evaluation resources to maximum effect.

Time slot allocations are currently limited to:
  • new decentralised procedures (DCP), including extensions
  • repeat use procedures (inclusion of additional member states) for approvals having originally taken place through the decentralised procedure (DCP) and/or mutual recognition procedures.
  • duplicates for ongoing or completed DCP procedures.
To find more information please use the below mentioned weblink 

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