New template for RMS switch due to Brexit

Brexit has led to a larger number of files relating to changes in Reference Member State (RMS). A new template has accordingly been developed to streamline this process.

The template was designed by the CMDh (Coordination Group for Mutual Recognition and Decentralised Procedures, Human), and should be used for all RMS change requests from now on. The template covers all the required information so it will not be necessary to request additional information later in the procedure.

In parallel to this, CMDh have also made changes to the document CMDh procedural advice on changing the RMS . This document explains the use of the template and provides additional information about the procedure. For instance, it contains information about situations where there is no Concerned Member State (CMS) that has approved all the strengths of a particular medicine, or where all Concerned Member States refuse to become the new Reference Member State.

Contact

prelicensing@fagg-afmps.be

Last updated on
27/04/2018