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 a MRP or Repeat Use is available to the right under Forms. Please note that there are different forms for human and veterinary medicinal products. Send the form, including relevant attachments, by e-mail to RIC@lakemedelsverket.se (enter "MRP RMS Request" in the subject 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 Swedish Medical Products Agency.

Before submitting the request for MRP/Repeat Use it is important for the applicant to consider whether any variations are required in order to update the dossier, e.g. in order for the dossier to be in accordance with the legislation in force. See also CMDh Procedural Advice on Repeat Use (link to the right under Related information). Please note that all such variations must have been submitted and approved before submission of the request for Sweden to act as RMS. No pending variations are allowed during the update phase of the assessment report.

 
 
 

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