The Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh) has updated its guidance on permissible reasons for changing RMS to include the reference member state (RMS) triggering Article 50 of the Treaty of the European Union.
In exceptional circumstances, a Marketing Authorisation Holder (MAH) may request a change of the RMS. To date, appropriate circumstances for such a request included when an MAH or a subsidiary responsible for the communication on behalf of the MAH had closed in the RMS, or when a medicinal product had more than one RMS for the different pharmaceutical forms of the medicinal product. It is also possible to put forward other reasons with a justification.
Member states have agreed that “the RMS has triggered Article 50 of the Treaty on European Union” is an acceptable reason to request a change in RMS. In this regard, it was also agreed that it would be possible to switch back to the MS who triggered Article 50 if there is an exemption agreed as a result of negotiations between that RMS and the EU.
A change of RMS cannot take place during a pending procedure so before accepting a change of RMS, the MAH should work with the current RMS to close all the procedures, even those that have not yet started, and confirm to the new RMS that no procedure is ongoing in the current RMS.
To read the revised guidance, please click here.