BREXIT requires changes of Reference Member State for MRP/DCP-approved medicinal products

When UK leaves the EU, change of Reference Member State for MRP/DCP-approved products with UK as RMS is required. The Swedish Medical Products Agency welcome requests for Sweden to act as Reference Member State (RMS) for medicines authorised in MRP/DCP with UK as RMS today. No fees will be charged for changing the RMS.

We encourage marketing authorisation holders to liaise with the MPA as early as possible in order to plan the transfer of the RMS-ship.

The following criteria, agreed in the EU, must be fulfilled:

  • Sweden 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.

How to proceed

Requests for change of RMS to Sweden should be sent to RIC@mpa.se with information about the product in accordance with the CMDh “Template for RMS change”, published at http://www.hma.eu/90.html. The MPA will then make a product-based assessment on whether the RMS-ship can be accepted, and notify the MAH of this decision as soon as possible.

Dictionary

MRP – Mutual Recognition Procedure

DCP – Decentralised procedure

RMS – Reference Member State

MAH – Marketing Authorisation Holder

CMS – Concerned Member State

 
 
 
 

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