Marketing Authorisation Application under the Mutual Recognition Procedure (MRP)

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 undergone MRP, the corresponding procedure to include additional CMS is called Repeat Use Procedure (RUP) for human medicines and Subsequent Recognition Procedure (SRP) for veterinary medicines.

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.

Norway as RMS in an MRP/RUP/SRP

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.

Upon receipt of a valid request, the DMP can start/begin updating the assessment report.

Applicants are asked to use the standard CMDh/v request forms. 

Request form(s) for MRP/RUP for medicinal products for human use:

• Request for MRP/RUP/Updated assessment report
• Appendix 1 to Request for MRP/RUP for Medicinal Products for Human Use

Request form for Norway as RMS in an MRP/SRP for medicinal products for veterinary use:

Applicant`s template for request to Member States to act as RMS in MRP, SRP or DCP

Submission of the CMDh/v request form:

• and relevant attachments as detailed in the form are sent via email to: mt@noma.no
• Write "<MRP><RUP><SRP> RMS request" in the header of the email.

More information

Applications for Marketing Autorisation- Human Medicines

Application for MA - MRP/RUP - Human Medicines

Applications for Marketing Authorisation - Veterinary Medicines

Best practice guide for veterinary mutual recognition procedure

Best practice guide for subsequent recognition procedure