MRP with Medical Products Agency as RMS

When an applicant intends to use a national approval in Sweden in order to obtain a marketing authorisation in one or more countries via the mutual recognition procedure (MRP) a request for Sweden to act as reference member state (RMS) must be submitted to the Medical Products Agency.

The form for requesting that Sweden should act as reference member state (RMS) in the MRP or Repeat Use is available on the right under Related Information.

Send the form, including relevant attachments, by e-mail to RIC@mpa.se (enter ”MRP RMS Request” in the subject line of the e-mail).

Receipt of the request for Sweden to act as RMS constitutes a formal request that the Medical Products Agency should start updating the assessment report. Please note that the invoice for the application fee will therefore be issued in connection with the receipt of this request by the Medical Products Agency.

Before submitting the request for MRP/Repeat Use it is important for the company to consider whether any variations are required in order to update the dossier, such as in order for it to be in accordance with legislation in force, for example. See also CMDh Procedural Advice on Repeat Use (link to the right).

It is important that any variation applications are submitted before the request for Sweden to act as RMS. However, the variation procedure does not need to be completed before the request is submitted.  

 
 
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information