• English
  • Eesti
    NewsNews

    BREXIT and related changes

    16.03.2018
    Printer-friendly version

    Change of the Reference Member State

    When UK leaves the EU, change of Reference Member State for MRP/DCP-approved products with UK as RMS is required. The Estonian State Agency of Medicines welcomes requests 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 contact the State Agency of Medicines as soon as possible to discuss the transfer of the RMS.


    The following criteria must be fulfilled:

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

    Requests for change of RMS should be sent to mrp@ravimiamet.ee. The information should be presented by using the template.

    We will make a product-based assessment on whether the RMS-ship can be accepted, and notify the MAH of this decision as soon as possible.

     

    Change of MAH and batch release site

    EU law requires that marketing authorisation holders are established in the EU (or EEA).

    Also some activities must be performed in the EU (or EEA), related for example to pharmacovigilance, manufacturing, import etc.

    The marketing authorisation holders are asked to consider the necessary arrangements as soon as possible to avoid availability problems. 

    Please also refer to the information published by the CMDh and CMDv on Brexit.