Possibility of Slovenia's acceptance of RMS role in MRP and DCP procedures following Brexit

    |     Obvestila za imetnike dovoljenj za promet

Following decision on the withdrawal of the United Kingdom (UK) from the European Union (EU), made at a Brexit referendum that took place in 2016, after the Article 50 of the Treaty on European Union was activated, UK should leave the EU on March 29, 2019. Consequently, when UK leaves the EU, change of Reference Member State for MRP/DCP - approved products with UK as RMS is required.

 

With this announcement we would like to inform all MAHs that the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia still has capacities and therefore welcomes and invites requests for Slovenia to act as Reference Member State (RMS) for medicines authorised in MRP/DCP with UK as current RMS. No fees will be charged for changing the RMS.

 

RMS change consideration requests should be sent to the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia at: srz-h@jazmp.si.

 

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

•          Slovenia 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.

 

“Template for RMS change,” is published at www.hma.eu/90.html. The Agency for Medicinal Products and Medical Devices of the Republic of Slovenia will then make a product - based assessment on whether the RMS-ship can be accepted and notify the MAH, within 10 days at the latest.  

 

In relation to available information on Brexit, please also refer to the documents published by the CMDh about the factors that Marketing Authorisation Holders must consider in connection with Brexit: http://www.hma.eu/535.html.