Mutual recognition procedure

For a medicinal product which is already approved through the National Procedure (NP), the Mutual Recognition Procedure (MRP) can be used to expand the registration to one or more other countries (Concerned Member States, CMS). For a product which has been approved through the decentralised procedure (DCP) or which has previously undergone MRP, the corresponding procedure is called RUP (Repeat Use Procedure).

Update the dossier if needed

It is important that applicants, before submitting the request, consider whether any variations need to be submitted to update the dossier for it to comply with current legislation and guidelines.

Please note that any variations must be approved before the request is submitted. If there are ongoing variations, the request will not be further handled until these have been approved. No variations may be ongoing in parallel with the update of the assessment report.

Sweden as RMS in an MRP/RUP

The request must be submitted at least three months before the preferred starting date of the procedure. Applicants do not need to book a time slot in advance. The request is considered valid when there are no ongoing variations and all relevant attachments have been submitted.

This is a formal request to the Swedish MPA to begin updating the assessment report. The invoice for the application fee will be issued when the Swedish MPA has received the request.

• Form and relevant attachments as detailed in the form are sent via email to RIC@lakemedelsverket.se
• Write "MRP RMS request" in the header of the email.

More information

In Swedish: