Change of reference member state

Exceptional circumstances may include, for example:

• when the marketing authorisation is withdrawn in the current Reference Member State (RMS)
• when the marketing authorisation holders (the MAH’s) local representative, has ceased its activity in the current RMS; or
• other reasons as justified by the marketing authorisation holder.

In addition, a change of the RMS will be permitted if the current RMS has initiated a withdrawal process from the EU.

Current procedures must be concluded

In order for a change of the RMS to take place, all current procedures, such as variation applications and renewal applications, must be concluded. In order to switch to Sweden as the new RMS, Sweden must be a CMS (concerned member state) in the relevant procedure. However, the national approval need not be issued if the European phase of the procedure has been completed.

Request to change RMS to Sweden

Requests to change the RMS must contain details of the product concerned.

Use the CMDh’s template ‘Template for RMS change’.

Send the request to the Swedish Medical Products Agency (Swedish MPA) by email: RIC@lakemedelsverket.se

The Swedish MPA will carry out a product-based assessment of whether the RMS is acceptable and will notify the MAH as soon as possible, normally within 2 weeks.

The assessment is based on several circumstances that the Swedish MPA use to follow in order to assess and make the decision whether to take over the RMS ship or not.

Change of RMS in connection with withdrawal in Sweden

If a product with Sweden as the RMS is to be withdrawn in Sweden but remain in other CMS, the MAH must turn to one of the remaining countries to ask them to take over the role of RMS.

This should be done before the application for withdrawal in Sweden is submitted to the Swedish MPA. State in the application which country will be the new RMS and the new procedure number. The Swedish MPA then handles the change of RMS to the new country in connection with withdrawal in Sweden.