Decentralised Procedure (DCP), Mutual Recognition and Repeat Use Procedures (MRP/RUP)

Both DCP and MRP/RUP are open for all applications for marketing authorization that do not fall within that mandatory scope of the Centralised Procedure. The Applicant initiates the MRP in the Member State where the medicinal product has already received a MA at the time of application. The DCP is initiated by the Applicant in a Member State (MS) where the medicinal product has not received a MA at the time of application.

MRP and DCP approve a medicinal product within the European Union (EU), the Member States, and the three EFTA Member States (Norway, Iceland, and Liechtenstein). Both mentioned procedures lead to independent national MAs.

The Applicant initiates the DCP in a MS where the medicinal product has not received a MA at the time of application. Please note the guidelines from the Application for Marketing Authorisation (MA). The Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh) develops and publishes corresponding guidelines on the DCP on its website, where further information on the procedure can be found, e.g., Decentralised Procedure Members States’ Standard Operating Procedure, Best Practise Guide for Decentralised and Mutual Recognition Procedures.

Information on submission dates for Applicants of the DCP is indicated at Recommendations on submission dates in 2021 for Applicants of the DCP.

A MAH can use the MRP for the same authorization more than once after completion of a first MRP or a Decentralised Procedure (DCP) for the recognition of a marketing authorization by other MS. This procedure is known as “Repeat Use” (RUP). Please note the guidelines from the Application for Marketing Authorisation (MA). The Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh) develops and publishes corresponding guidelines on the MRP/RUP on its website, where further information on the procedure can be found, e.g., MRP/RUP.

Information on submission dates for Applicants of the MRP/RUP is indicated at Recommendations on submission dates in 2021 for Applications of the MRP.

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