Brexit, change of Reference Member State from UK to DK

01 February 2018

The Danish Medicines Agency would like to inform marketing authorisation holders that we welcome being the Reference Member State (RMS) for MRP/DCP authorised medicines, should you request Denmark as the future RMS when the UK is leaving the EU.

No fees will be charged for changing the RMS, but the following criteria, agreed in the EU, must be fulfilled to change the RMS:

  • Denmark must already be the CMS in the concerned procedure
  • All ongoing regulatory procedures where the UK is the RMS, e.g. variations, applications for renewal of marketing authorisations, must be closed before a switch can take place.

Please also refer to the information published by the CMDh and CMDv about the factors that marketing authorisation holders must consider in connection with Brexit.

Any requests for change of RMS to Denmark should be sent to licensing@dkma.dk

We kindly advise you that we will be treating requests according to the ‘first come, first served' principle.

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