Updated guidance of CMDh Procedural Advice on Changing Reference Member State

In exceptional circumstances, a Marketing Authorisation Holder (MAH) may request a change of the Reference Member State (RMS). The change may be needed when a MAH or a subsidiary responsible for the communication on behalf of the MAH has been closed in the RMS, or when amedicinal product has more than one RMS for the different pharmaceutical forms of the medicinal product, or, subject to clear justification, due to the sunset clause in the RMS.
A request for the change of RMS based on scientific disagreement between the MAH and the current RMS (expressed e.g., as a negative recommendation of a variation application by the RMS, where Community interests are involved) is not acceptable. The competent authority of a Member State (MS) may decide upon other reasons of non-acceptance.
A change of RMS cannot take place during a pending procedure. Before accepting a change of RMS, the MAH should in cooperation with the RMS close all the procedures in the current RMS even if they have not yet started and confirm to the new RMS that no procedure is being examined in the current RMS.

Reference: Updated on Dec 2011 

http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/01_General_Info/CMDh-039-2002_Rev4_2011_12_Clean.pdf