Marketing Authorisation Application under the Decentralised Procedure

Important information concerning request for Norway to act as RMS in DCP for human medicinal products in 2026. 

​Applicants choose which countries they want to include in their application and requests one of them  to act as the Reference Member State (RMS). An identical application for marketing authorisation is submitted simultaneously to the RMS and other countries included in the procedure as Concerned Member States (CMS).

Reference Member State (RMS)

The main assessment of an application in DCP is carried out by the national competent authority which has accepted the applicant’s Reference Member State (RMS) request. An application in DCP is only submitted after a time slot has been agreed by the RMS and applicant.

Concerned Member State (CMS)

Other countries included in the decentralized procedure (DCP) will be Concerned Member States (CMS). Concerned Member States (CMS) either endorse the Reference Member State (RMS) 's assessment of the application or may raise further questions.

Norway as RMS in a DCP

The Norwegian Medical Products Agency (DMP) are open to receive requests to act as RMS for applications in DCP throughout the year. 

The DMP will assess the requests based on the following factors:

• The extent of the product’s importance for Norwegian patients.
• The available resources within the relevant areas of expertise.

Applicants are asked to use the standard CMDh/v request form when applying for a slot with Norway as RMS.

Request form for Norway as RMS in a DCP for medicinal products for human use:

Request for RMS in a Decentralised Procedure, medicinal products for human use –Common request form

Request form for Norway as RMS in a DCP 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/CMDv request form:

• The form is sent via email to: mt@noma.no
• Write "DCP RMS request " in the header of the email.
• Applicants who want to request slots for more than one product should send one email for each request – do not include multiple slot requests in a single email.
• Applicants who have been notified that DMP will act as RMS for their application must strive to keep the planned submission date, and delays must be notified immediately. Slot cancellations may occur depending on the length of the delay or the cause of the delays.
• Upon receiving confirmed DCP-slot, please note that this is for the specific product and it is not possible to switch the slot for another product.

For more information

Applications for Marketing Authorisation - Human Medicines

Application for MA - DCP - Human Medicines

Applications for Marketing Authorisation - Veterinary Medicines

Best pratice guide for veterinary decentralised procedure