Under certain circumstances a Marketing Authorisation Holder (MAH) may request a change of the Reference Member State (RMS).
In this case the MAH should approach the current RMS and the chosen future RMS to discuss the situation before any further steps are taken. It is the MAH’s obligation to ensure that both the current RMS and the future RMS accept the change of RMS.
In order to request the change of RMS from any Member State to Austria, a completed CMD(h) request form (Template for RMS change) should be sent to rmsbasg.gvat.The CMD(h) request form can be found in the Download section or on the CMD(h) website.
This form should contain, among others, the following information:
- The reason(s) for changing the RMS.
- Confirmation that the current RMS has agreed to the RMS change.
- Information if all procedures have been finalised.
- A list of the Concerned Member States (CMS).
In case of acceptance a new procedure number will be allocated by the new RMS. Please be informed that from 02.01.2014 a fee according to the Regulation issued by the Federal Office for Safety in Health Care regarding the Schedule of Fees pursuant to the GESG Act will be charged for taking over a product as RMS (laid out in section V.6).
It is the MAH's responsibility to supply all necessary dossier/assessment reports to the new RMS if requested. It is the obligation of the previous RMS to assist in providing the relevant information from previous procedure(s).